Textbook of

Pharmaceutical
Inorganic Chemistry
for Bachelor of Pharmacy (BPharm) Course
As per PCI Syllabus
BPharm (Semester I)
Subject Code: BP l 04T
 Textbook of
Pharmaceutica I
Inorganic Chemistry
for Bachelor of Pharmacy (BPharm) Course
As per PCI Syllabus
BPharm (Semester I)
Subject Code: BP l 04T

Arun Kumar Gupta

MPharm PhD
Principal and Professor
Chameli Devi Institute of Pharmacy
Indore (MP)
Revathi A Gupta
MPharm PhD
Principal and Professor
Institute of Pharmacy
Dr. AP J. Abdul Kalam University
Indore (MP)

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W e feel great honor and an immense pleasure in bringing out this book entitled
Textbook of Pharmaceutical Inorganic Chemistry is written according to the syllabus
for Bachelor of Pharmacy (B Pharmacy) approved and implemented by the Pharmacy
Council of India. The major thrust to make the book is, students need a textbook in a
comprehensive descriptive manner with updated details of the topic covered in their
syllabus. They also expect good quality readable books include basic principles with
relevant examples rather than standalone concepts, allowing students to see the
relevance of the subject in future professions. The main purpose of writing this book
is to provide a qualitative book to pharmacy students and allied health professionals
those who are dealing with this subject.
This book covers all the theoretical aspects of the subject BP 104T for B Pharmacy
first year students. It is a classic common textbook for an undergraduate course in
inorganic chemistry. This book is divided into five units. Each unit in the book is self-
contained and serves as dual teaching function to highlight the basic concepts. This
book not only good introduction of the subject but also tried to describe various
inorganic compounds, minimum chemical facts and concepts that are necessary to
understand modern inorganic chemistry. Unique very advanced and comprehensive
descriptive coverage of all the official compounds included, with a strong focus on
preparation, properties, assay and pharmaceutical applications. The book will lay the
foundation for students in B Pharm first semester regarding the subject knowledge.
This book presented in a very systematic way. All the topics in each chapter have
been provided with reasonable account, covering the information in easy to understand
manner.
In this book we cover basic concepts with respective topic have been discussed
which will help to understand the students in a better manner. We also includes revision
exercises at the end of the every chapter in the form of multiple choice questions, fill
in blanks, short questions and long questions which will help them to prepare better
for their exams and self-assess himself/herself. In this book, we also highlights the
medical and pharmaceutical terms along with explanation for easy understanding of
students. This book will give valuable source of information and appropriate subject
knowledge to students, teachers as well as other allied persons.
We are indeed delighted to present the work which will be very fruitful for pharmacy
professionals working in different areas of pharmaceutical sector and as well as
students at undergraduate and postgraduate levels. We heartily welcome comments
along with valuable suggestions from all corners of the profession which will help us
in improving the content of the book in ensuing editions of this book and also in other
books that are on the anvil. We are gratified to CBS Publishers and his editorial team
for their kind assistance in bringing out this book.
Arun Kumar Gupta
Revathi A Gupta
 Course: B Pharm (As per PCI Syllabus)
Semester I Subject code: BP 104T

• Impurities in pharmaceutical substances: History of pharmacopoeia, sources

and types of impurities, principle involved in the limit test for chloride, sulphate,
iron, arsenic, lead and heavy metals, modified limit test for chloride and sulphate.
• General methods of preparation, assay for the compounds superscripted with
asterisk (*), properties and medicinal uses of inorganic compounds belonging to
the following classes

• Acids, bases and buffers: Buffer equations and buffer capacity in general, buffers
in pharmaceutical systems, preparation, stability, buffered isotonic, solutions,
measurements of tonicity, calculations and methods of adjusting, isotonicity.
• Major extra and intracellular electrolytes: Functions of major, physiological ions,
electrolytes used in the replacement therapy: sodium, chloride*, potassium
chloride, calcium gluconate* and oral rehydration salt (ORS), physiological acid
base balance.
• Dental products: Dentifrices, role of fluoride in the treatment of dental, caries,
desensitizing agents, calcium carbonate, sodium fluoride, and zinc, eugenol
cement.

• Gastrointestinal agents:
Acidifiers: Ammonium chloride* and Dil. HCl
Antacid: Ideal properties of antacids, combinations of antacids, sodium
bicarbonate*, aluminum hydroxide gel, magnesium hydroxide mixture
Cathartics: Magnesium sulphate, sodium orthophosphate, kaolin and bentonite
Antimicrobials: Mechanism, classification, potassium permanganate, boric acid,
hydrogen peroxide*, chlorinated lime*, iodine and its preparations

• Miscellaneous compounds:
Expectorants: Potassium iodide, ammonium chloride*.
Emetics: Copper sulphate*, sodium potassium tartarate
Haematinics: Ferrous sulphate*, ferrous gluconate
Poison and Antidote: Sodium thiosulphate*, activated charcoal, sodium nitrite
Astringents: Zinc sulphate, potash alum

Radiopharmaceuticals: Radio activity, measurement of radioactivity, properties of ,

,  radiations, half-life, radioisotopes and study of radioisotopes: Sodium iodide 131I,
storage conditions, precautions and pharmaceutical application of radioactive
substances.
Preface v
Unit 1 Impurities in Pharmaceutical Substances 1

Unit 2 Acids, Bases and Buffers 29

Unit 2.1 Major Extracellular and Intracellular Electrolytes 46

Unit 2.2 Dental Products 63

Unit 3 Gastrointestinal Agents 74

Unit 3.1 Acidifiers 76

Unit 3.2 Antacid 80

Unit 3.3 Cathartics 87

Unit 3.4 Antimicrobials 98

Unit 4.1 Expectorants 111

Unit 4.2 Emetics 118

Unit 4.3 Hematinics 123

Unit 4.4 Poison and Antidote 134

Unit 4.5 Astringents 145

Unit 5 Radiopharmaceuticals 150

 • Introduction • Limit Test
• Pharmacopeia • Limit Test for Chloride
• History of Pharmacopeia • Limit Test for Sulfate
Indian Pharmacopoeia • Modified Limit Test for Chloride
British Pharmacopoeia • Modified Limit Test for Sulfate
European Pharmacopoeia • Limit Test for Iron
• Pharmacopeia Internationals • Limit Test for Heavy Metals
United States Pharmacopeia (USP) • Limit Test for Arsenic
• Impurity • Limit Test for Lead
• Sources and Types of Impurities • Important Questions/Answers

Pharmaceutical chemistry is a branch of chemistry that deals with the chemical,

biochemical and pharmacological aspects of drugs. It includes synthesis/isolation,
identification, structural elucidation, structural modification, Structural Activity
Relationship (SAR) studies, study of the chemical characteristics, biochemical changes
after drug administration and their pharmacological effects. It is specialized science
which depends on other chemical disciplines, such as inorganic, organic, analytical,
physical chemistry and also on medicobiological disciplines, such as pharmacology,
physiology and biological chemistry, etc.
Inorganic chemistry is the study of all the elements and their compounds except
carbon and its compounds (which is studied under organic chemistry). Inorganic
chemistry describes the characteristics of substances such as nonliving matter and
minerals which are found in the earth except the class of organic compounds. The
distinction between the organic and inorganic are not absolute, and there is much
overlap, especially in the organometallic chemistry, which has applications in every
aspect of the pharmacy, chemical industry including catalysis in drug synthesis,
pigments, surfactants and agriculture.
Inorganic pharmaceutical chemistry is a science which makes use of the laws of
chemistry to study inorganic substances as drugs. It deals with the study of both non-
essential and essential elements about their preparation, chemical nature, structure,
standards of purity, test for identification, limit tests, storage, assay methods and uses
of inorganic agents used as pharmaceutical aids and as therapeutic and diagnostic
agents.
Compounds being synthesized by the geological systems and lack of hydrocarbon
(carbon-hydrogen) are known as inorganic compounds while organic compounds are
those found in biological systems. In 19th century, inorganic compounds are inanimate
described by Berzelius chemist. The first important synthetic inorganic compound
was ammonium nitrate for soil fertilization. Medicinally useful substances are derived
from either organic or inorganic sources in which inorganic chemicals contributing
significantly in some of the ailments, even after the development of many drugs from
synthetic and plant sources. Many of the inorganic salts (antimony, arsenic and
mercury) are known to be poison but still they are used in medicine cautiously.
The word ‘Pharmaceutical’ is used for any chemical substance which is useful in
preventive or therapeutic or finds used in the preparation of medicament. Quality of
all these pharmaceuticals must be carefully controlled. Hence, specifications of quality
are mentioned for each pharmaceutical and their descriptions are reported in the
pharmacopeia.

The word pharmacopeia is derived from Greek words ‘pharmakon’ means a drug (both
remedy and poison) and ‘poiein’ means to make or create. Pharmacopeia is a book
containing directions for the identification of samples and the preparation of compound
medicines and published by the authority of a government or a medical or
pharmaceutical society. Pharmacopeia is a legislation of a nation which sets standards
and mandatory quality indices for drugs, raw materials used to prepare them and
various pharmaceutical preparations. Knowledge of the history of pharmacy would
help us better to understand the development of pharmacopeias.

Monographs are complete descriptions of pharmaceutical preparations which include

chemical formulae, atomic and molecular weight, definition, statement of content,
category, dose, description, solubility, identification tests, assay, other test, limits for
impurities, quantities and conditions for storage. The appendices also include standards
for apparatus, reagents and solutions, indicators, reference substances, test animals,
calculation of results, other chemicals techniques, processes, etc. of the concerned
pharmaceuticals. In another way it is a reference work for pharmaceutical drug
specifications. By the direction of the council of the pharmaceutical society of the certain
nations, the world’s most comprehensive source of drug information in a single volume
is published periodically in the society’s department of pharmaceutical sciences. It is
the traditional activity, to help the practicing pharmacists and physicians aiming to
provide unbiased concise reports on the actions and uses of most of the world’s drugs
and medicines.
By reflecting clinical practice, every publication of pharmacopeia monographs is
accurately organized based on the updated needs of today’s pharmacist. Details are
provided about new compounds in the form of new monographs accompanied by
some of the previous monographs are deleted which are not in continued use. The
overall effect is to provide an increase in the average of drugs with typographical
improvements to assist the reader in locating sections of a monograph.
With the search for an effective treatment of diseases a few of the developing
therapeutics are revised continuously in pharmacopeia such as anti-HIV agents. In
pharmacopeia, the drug’s distinguished features are updated, renewed and discussed
for the treatment of infections and development of antiviral, antiprotozoal and
antibacterial therapy. Along with novel approaches in the treatment advances in the
cardiovascular group of drugs are included. The other areas like antimalarial drugs,
anti-neoplastic agents, anti-parkinsonism drugs, etc. are also included in pharmacopeia.
Pharmacopeia is divided into three different major parts based on the published
information. Each part is comprised of several chapters.
Part I: Generally, the drugs that have similar use or actions are bringing together
by part I of pharmacopeia. The cross references is used to guide reader to find out the
drug that may be of interest. Many of the chapters are providing background
information with an introduction on that group of drugs having many common actions.
Part II: It includes monographs of new drugs, drugs under investigation, drugs
which are not easily classified and obsolescent drugs still of interest are presented in
this part. It also provides details regarding effects of required drug therapy.
Part III: Composition of the proprietary medicines that are advertised to the public
in different countries and herbal medicines which have been omitted are included in
part III of pharmacopeia.
Only the pharmaceuticals which are commonly and currently in use are included
in the pharmacopeia; whereas the substances which are found to be undesirable and
are not currently in use are excluded. Moreover part of pharmacopeia may also
comprise the pharmaceuticals which are used for application or internal consumption
by human beings.
In the pharmacopeia only minimum standards are prescribed for pharmaceuticals,
but with more stringent standards the manufacturer may supply these substances.
Hence a drug has to obey strictly the standards prescribed by anyone of the
pharmacopeias. The medication may be considered as substandard if it does not obey
these standards and usually it is not prescribed by medical practitioners.

Every country has legislation on pharmaceutical preparations which sets a standards

and required quality indices for medicament, raw materials and preparations employed
in the manufacture of drugs. These regulations are presented in separate articles.
General and specific matters relating to individual drugs are published in the form of
a book called a Pharmacopeia. On 15th December 1820, the first United State
Pharmacopeia (USP) was released. The first British Pharmacopoeia (BP) was published
in 1864 with inclusion of monographs on camphor, lactose, sucrose, benzoic acid, gallic
acid, tartaric acid, tannic acid and seven alkaloids along with their salts.

British Pharmacopoeia was utilised as the official book of standards in India before
independence. The government passed Drugs and Cosmetics Act in 1940. The Drugs
and Cosmetics Act 1940 stated that the Indian Pharmacopoeia is the book of standards
for drugs included therein would be official. If considered necessary, these standards
can be amended and the secretary of the Indian Pharmacopoeia Committee is
authorized to issue such amendments. The general notices and appendices included
in the Indian Pharmacopoeia and as amended in addendum apply both to the matter
contained in the Indian Pharmacopoeia and to the matter contained in this Addendum.
• The actual process of publishing the first Indian Pharmacopoeia started in the
year 1944 under the chairmanship of Col. R. N. Chopra.
• The list of drugs was published in the year 1946 and was put forth for approval.
• The government of India constituted a permanent Indian Pharmacopoeia
Committee in 1948 for the preparation of the Indian Pharmacopoeia and
established a central Indian Pharmacopoeia Laboratory at Ghaziabad, Uttar
Pradesh to keep it up to date.
• The first edition of the Indian Pharmacopoeia (IP) was published in the year 1955
under the chairmanship of Dr BN Ghosh. Ministry of Health and Family Welfare,
Government of India publishes Indian Pharmacopoeia based on the
recommendation of Indian Pharmacopoeia Committee (in accordance with Drugs
and Cosmetics Act, 1940, Dangerous Drugs Act, 1930, and Poisons Act, 1919 and
the rules framed thereunder).
• Supplement for first edition of Indian Pharmacopoeia was published in the year
1960. It contained both western and traditional system drugs commonly used in
India.
• After eleven years, under the chairmanship of Dr. B. Mukherji the second edition
of Indian Pharmacopoeia was released in 1966 with some modification.
• The supplement to the second edition of Indian Pharmacopoeia was published in
1975.
• There had been a phenomenal growth and development of Indian pharma
industry especially from early 1970 both in the range of active pharmaceutical
ingredients (APIs) and the dosage forms produced. In view of these rapid
advances, it was decided to publish a new edition of the Pharmacopoeia and its
addenda at regular and shorter intervals for which the Indian Pharmacopoeia
Committee was reconstituted in 1978.
• Third edition of Indian Pharmacopoeia were in two volumes published in 1985
under the chairmanship of Dr. Nityanand. In this Pharmacopoeia inclusion of
traditional system of drugs was limited. However, most of the new drugs
manufactured and/or marketed were included while only those herbal drugs
which had definite quality control standards had got place in it.
• Addendum/supplement I and II to third edition has been published in 1989 and
1991 respectively.
• Fourth edition of the Indian Pharmacopoeia was published in two volumes under
the chairmanship Dr. Nityanand in 1996 which omitted many lesser used and
obsolete product monographs and added monographs based on the therapeutic
merit, medicinal need and extent of use of such articles in the country.
• Addendum to fourth edition has been published initially in 2000 followed by in
2002. In addition, supplement for veterinary products are also released.
• Third addendum was published in 2005 which included a large number of
antiretroviral drugs, and raw plants commonly used in making medicinal
products not covered by any other.
• The Indian Pharmacopoeia Commission (IPC) has been established in the year
2005.
• It is the 5th edition of IP in 2007. The IPC provided systematic approach and
practices for publication of Indian Pharmacopoeia 2007 with focus on those drugs
and formulations that cover the National Health Care Programmes and the
national essential medicines. It contained monographs on antiretroviral,
anticancer, antitubercular and herbal drugs. It also emphasized on biological
monographs, such as vaccines, immunosera for human use, blood products,
biotechnological and veterinary (biological and non-biological) preparations.
• Addendum 2008 to the IP 2007 was published which had taken care of the
amendments to Indian Pharmacopoeia 2007 and also incorporated 72 new
monographs.
• Government of India declared Indian Commission, an autonomous institution
under the Ministry of Health and Family Welfare by its resolution of 6th May 2008
and declared Central Indian Pharmacopoeia Laboratory, Ghaziabad as
subordinate office since 1st Jan 2009.
• The 6th edition of IP published in 2010. The sixth edition of IP published in
accordance with the principles and designed plan decided by the scientific body
of the IPC. To establish transparency in setting standards for this edition, the
contents of new monographs, revised appendices and other information have
been published on the website of IPC.
• The IPC secretariat and Indian Pharmacopoeia laboratory staff, with the support
of different advisory expert committee, and expert members of the scientific body
have examined the suitability of the standards. In order to make Indian
Pharmacopoeia 2010 user friendly, the existing formatting pattern has been
suitably revised.
• The Indian Pharmacopoeia 2010 has been considerably revised and improved in
respect of the requirements of monographs, appendices and testing protocols by
introducing advanced technology. The contents of appendices are by and large
revised in consonance with those adopted internationally. The monographs of
special relevance disease of this region have been given special attention.
• National Formulary of India 4th edition was published in the same year and it
meant for the guidance of the members of the medical profession such as medical
students, nurses and pharmacists working in hospitals and other areas.
• The seventh edition of the IP 2014 has been published in Nov 2013 by the Indian
Pharmacopoeia Commission (IPC). It is presented in four volumes. The scope of
the Pharmacopoeia has been extended to include products of biotechnology,
indigenous herbs and herbal products, veterinary vaccines and additional
antiretroviral drugs and formulations, inclusive of commonly used fixed-dose
combinations. Standards for new drugs and drugs used under National Health
Programmes are added and the drugs as well as their formulations not in use
nowadays are omitted from this edition.
• The IP 2014 incorporates 2548 monographs of drugs out of which 577 are new
monographs consisting of APIs, excipients, dosage forms, antibiotic monographs,
insulin products and herbal products, etc. 19 New radiopharmaceutical
monographs and 1 general chapter is first time being included in this edition.
• First Addendum 2015 of IP 2014 has been released on 2014. It incorporates 82 new
monographs consisting of 57 chemical monographs, 13 herbal monographs, 02
human vaccines monographs and 10 radiopharmaceutical monographs, etc.
 • Second Addendum 2016 of IP 2014 has been released on 2015. It incorporates 89
new monographs consisting of 64 chemical monographs, 14 herbal monographs,
3 vaccines and immunosera for human use, 3 radiopharmaceuticals monographs,
1 blood related products, 4 biotechnology products monographs and 2 general
chapters being included in this addendum.
• The latest edition of the IP 2018 has been published in 29th Sep 2017. IP 2018 has
been brought out in 4 volumes incorporating 220 new monographs (chemical
monographs (170), herbal monographs (15), blood and blood related products
(10), vaccines and immunosera for human use monographs (2), radio-
pharmaceutical monographs (3), biotechnology derived therapeutic products (6),
veterinary monographs (14)), 366 revised monographs and 7 omissions.

Keeping in view the essential requirement for harmonization of analytical methods

with those accepted internationally, steps have been taken for monitoring drug
standards.
• It is effective from 1st January, 2018
• Presented in 4 hard bound volumes with DVD
• Total monographs 2761, 220 new monographs included.
• Veterinary product monographs are the integral part of this edition
• Use of chromatographic methods has been greatly extended
• Obsolete monographs have been omitted
• Herbal drug monographs have been added
• General chemical tests and thin layer chromatography (TLC) for identification of
an article have been almost eliminated and more specific infrared, ultraviolet
spectrophotometer and HPLC tests have been given emphasis. The concept of
relying on published infrared spectra as a basis for identification has been
continued.
• Most of the existing assays and related substances test methods are upgraded by
liquid chromatographic in view to harmonize with other International
Pharmacopoeia.
• Pyrogen test has been replaced by bacterial endotoxin test (BET) in parenteral
preparations and other monographs.
• For ease of access to make pharmacopoeia more user-friendly, index has been
incorporated in volume I along with that already existing in volume IV of IP.
• 53 new fixed dose combination (FDC) monographs have been included, out of
which 25 FDC monographs are not available in any pharmacopoeia.
• 10 new general chapters on pharmaceutical, microbiological and biological have
been incorporated.
• General chapters on volumetric glassware, conductivity, dissolution test,
disintegration test, dimensions of hard gelatin capsule shells, etc. have been
revised.
• For controlling the microbial quality of the entire medicinal product, general
chapter on maintenance, identification, preservation and disposal of
microorganism have been revised.
• IP 2018 has been incorporated with a security feature to avoid counterfeiting.
Pharmacopoeia possesses wealth of information with no explanation. The person must
familiarize himself with the general notices and the various appendices of
pharmacopoeia to consult the pharmacopoeia. One can obtain most complete
information from Extra Pharmacopoeia (Martindale) on every type of pharmaceutical
or drug. A practicing pharmacist William Martindale in the year 1883 published the
Extra Pharmacopoeia. This book was rich especially with therapeutic and clinical
information of the drugs.
For inorganic pharmaceuticals there are several other useful literature references
are included. With an aim to provide practical and up-to-date information concerning
drugs and gelenicals included in the British Pharmacopoeia. In the span of three years
four editions of Martindale were published. Due to the accumulation of information
up to the year 1910 the subject matter to be divided into two volumes in the initial
editions of Martindale. The first double volume edition was published in 1912.
In December 1933, the Pharmaceutical Society of Great Britain acquired the copy
right of the Extra Pharmacopoeia upon the death of Dr W.H Martindale son of William
Martindale. Thereafter the society is continuing to issue it under the editorship of the
Director of its Department Pharmaceutical Sciences. 23rd edition of Volume II was
published in 1955 and the 24th edition of Volume I was published in 1958. Supplement
for 24th edition was published in 1961. In February 1967 the 25th edition was published
by the Pharmaceutical Society of Great Britain while 26th edition was released in July
1972. In 30th edition of Martindale contains up-to-date authoritative information on
drugs and medicine which are used throughout the world was published in 1993. It is
written for all those involve in use of drugs and medicines including practicing
pharmacists and physicians.
In order to meet the requirements of today’s reader the latest edition of Martindale
has been markedly changed. It includes a significant shift to a more clinical emphasis
an increase in the number of referenced reviews and massive increase information on
proprietary medicines. In addition usual period between editions was shortening to
meet the need for up-to-date information.

Medical Act, 1858 under Section 54 was stressed the need of publication of a book
having a list of medicines and compounds about their manner of preparing them
together with true weights and measures by which they are to be prepared and mixed.
Hence, the British Pharmacopoeia was decided to publish.
• In the year 1864 the first British Pharmacopoeia was published by combining the
three old and reputed Pharmacopoeias, namely Pharmacopoeia Londinensis
(1618), Edinburgh Pharmacopoeia (1699) and Dublin Pharmacopoeia (1807). New
editions and addendum were released quickly.
• The 2nd edition was released in 1867.
• The 3rd and 4th editions were published in the year 1885 and 1898 respectively.
• Addendum to 2nd and 3rd editions was released in the year 1874 and 1890
respectively.
• Separate parts such as preparation of compounds are included in the year 1864
British Pharmacopoeia. In this edition contents had been arranged alphabetically.
A gap in revision belated the next edition of British Pharmacopoeia until 1914.
 • Further edition was published in 1928 and 1932.
• A range of diagnostic materials was included in 1932 revision. An important
addition was inclusion of standards and tests for antitoxins and insulin.
• Thereafter the commission was recommended to revise the BP every 10 years
once.
• Seven addenda covered the interim between 1932 and next edition of 1948.
• In this 1948 edition (7th), for substances newly introduced into medicine, generic
names were provided. Methods of analysis such as disintegration tests for tablets
and sterilization methods were expanded. Many new monographs related to sex
hormones and penicillin’s were included.
• Due to the rapid development of pharmaceutical and pharmacological progress
at this time it was decided that the normal interval between new editions should
be 5 instead of 10 years.
• The next edition was released in the year 1953. It incorporates the titles of drugs
and preparations were given in English instead of Latin.
• The 9th edition (1958) contains 160 new monographs. Spectrophotometric
analysis and inclusion of tranquillizing drugs are the other features of this edition.
• The next, i.e. tenth edition was published in 1963. The duties of the British
Pharmacopoeia Commission were defined clearly in medicines order 1970.
The first edition of British Pharmacopoeia that was prepared strictly under the
provisions of Medicines Act was the thirteenth edition which was published in the
year 1980. Due to an expansion of drug information latter the British Pharmacopoeia
was decided to publish in two volumes.
Authoritative standard for the quality of many substances preparation and articles
used in medicine and pharmacy for some 130 years was provided in 1993 edition of
British Pharmacopoeia. For the convenience of user this edition consolidates and
extends the 1988 edition with its 1989, 1991, and 1992 addenda. Moreover monographs
of the European Pharmacopoeia were also included in this particular edition.
The last year edition of the British Pharmacopoeia (BP), i.e. British Pharmacopoeia
2013 comprises six volumes which contain nearly 3,000 monographs for drug
substances, excipients and formulated preparation, together with supporting general
notices, appendices (test methods, reagents, etc.) and reference spectra used in the
practice of medicine. All are comprehensively indexed and cross-referenced for easy
reference. Items used exclusively in veterinary medicine in the UK are included in the
BP (veterinary).
The volume I and II deals with medicinal substances, whereas volume III describes
about formulated preparations, blood related preparations, immunological products,
radiopharmaceutical preparations, surgical materials and homeopathic preparations.
The volume IV contains appendices, infrared reference spectra and index. The volume
V is for veterinary purpose, i.e. British Pharmacopoeia (veterinary). The volume VI is
the CD-ROM version of British Pharmacopoeia, British Pharmacopoeia (veterinary)
and British approved names. The 2013 edition of British Pharmacopoeia is available
as a printed volume and electronically in both on line and CD-ROM versions, the
electronic products use sophisticated search techniques to locate information quickly.
For example, pharmacists referring to a monograph can immediately link to other
related substances and appendices referenced in the content by using 1,30,000 plus
hypertext links within the text.
 The British Pharmacopoeia 2013 package comprises five volumes and a single
volume of the British Pharmacopoeia (veterinary) 2013, along with a fully searchable
CD-ROM and online access which provided flexible resources. The British
Pharmacopoeia 2013 was legally effective from 1 January 2013 and contains 41 new
British Pharmacopoeia monographs, 40 new European Pharmacopoeia monographs,
619 amended monographs, 6 new and 1 amended infrared reference spectra and
European Pharmacopoeia 7th edition material up to and including Supplement 7.5. In
addition updates in January, April and July to harmonize with the European
Pharmacopoeia was also provided. The current edition of the British Pharmacopoeia,
i.e. British Pharmacopoeia 2014 comprises five volumes and a single volume of the
British Pharmacopoeia (veterinary) 2014, along with a fully searchable CD-ROM and
online access to provide with flexible resources. The latest edition was published in
2018 which includes around 4000 monographs spread out in six printed volumes.

An official book of standards adopted by Germany, France, Italy, Netherlands,

Switzerland and Belgium is European Pharmacopoeia. The council of Europe issued
an order to frame out European Pharmacopoeia in July 1964. In 1969 onwards in the
respective member countries it was appeared as official standard book for medicinal
substances and other drugs. Later on it was revised continuously to keep the
information up-to-date.

In various countries there are no uniformity in terminology and strengths of

pharmaceutical preparations used. In the year 1874, a view had been expressed that
uniformity in the standards for potent drugs must necessary to overcome various
problems. In 1936, the Health Organization of the League of Nations established a
Technical Commission of Pharmacopeial Experts. The work was undertaken by the
WHO after the World War II which was ended in 1946. Finally volume I of the long
awaited International Pharmacopeia was published in 1951 by Latin with translation
into English and French. This International Pharmacopeia contains monographs for
over 200 drugs and chemicals, with appendices on reagents tests and biological assays.
Second volume was published in 1955. In 1967 the second edition followed by a
supplement in 1971. Third edition was published in 1979 spread out in several volumes.
The pharmacopeial authorities of all countries are expected to give due considerations
to its standards so as for achieving uniformity of standards as far as practicable even
though the International Pharmacopeia cannot be imposed legally on any country.

United States Pharmacopeia and the National Formulary (USP-NF) are recognized as
official compendia for determining standard of pharmaceutical products. The first
USP was published in 1820 with 217 drugs. National formulary was published in 1888
under the authority of American Pharmacists Association. After 1975, USP and NF
are published in combined volume as USP-NF by United State Pharmaceutical
Convention. It was published at an interval of five years. After 2000, USP-NF has been
published annually. The current version of USP-NF standards deemed official by USP
are enforceable by the US Food and Drug Administration for medicines manufactured
and marketed in the United States. The USP 42-NF 37 becomes official on 1st May
2019.

Most of the pharmacopeias including Indian Pharmacopoeia consist of the three major
sections, namely (a) introduction including general notices, (b) monographs of the
official drugs, (c) appendices.

It is useful information to pharmaceutical progress since last edition. It summarizes

the different changes including additions/deletions in the current edition compared
to last edition. To avoid misinterpretation, misunderstanding of later parts of the text,
attention should be paid to general notices at the outset.

The general monographs for dosage forms of active pharmaceutical ingredients (APIs)
are grouped together at the beginning of volume II of IP 2010. The written study of a
subject was implied by the word ‘monograph’ (mono—single, graph—to write). These
are considered as very important because medicinal substances are used for the cure
and/or prevention of diseases. Therefore their written studies appear as monographs.
Monographs are arranged in the alphabetical order of their names and are somewhat
stereotyped in style.

An official monograph for a drug and pharmaceutical substance generally includes

the following.
1. Title: The official name of the compound in English is stated in the title.
Sometimes common names or synonyms are also mentioned, e.g. calcium
carbonate can also be called precipitated chalk, milk of magnesia can also be
called magnesium hydroxide mixture.
2. Chemical formulae: When the chemical structure of an official compound is
known, the graphic, molecular formulae and molecular weight are given at the
beginning of the monograph.
3. Chemical names: Sometimes the International Union of Pure and Applied
Chemists (IUPAC). IUPAC name of the substance is also given in the monograph.
4. Atomic and molecular weight: The atomic and molecular weight is shown, as and
when appropriate at the top right hand corner of the monograph.
5. Category: This part of monograph expresses the pharmacological or therapeutic
or pharmaceutical application of the compound. Although the compound may
have other applications usually this part describes the main application.
Analgesics, antibiotic, antacid, laxative, etc. are some of the main categories for
inorganic pharmaceuticals in the pharmacopeia.
6. Dose: Dose mentioned in the IP is intended merely for general guidance and
represent the average range of quantities regarded as suitable for adults when
administered by mouth.
 7. Description: It illustrates physical and organoleptic properties of the substance
such as amorphous nature or crystalline, odor, color and taste, etc. It helps in the
preliminary evaluation of the integrity of an article and should not be considered
as analytical requirements.
8. Solubility: The solubility of the substance given in the monograph is primarily
for the information and should not be regarded as standards or test for purity.
The term “partly soluble” is used to describe a mixture where only some of the
components dissolve. If the exact solubility of the substance is not known,
the approximate solubility of the substance is indicated by the descriptive terms.
The solubility mentioned in Indian Pharmacopoeia is the approximate solubility
at a temperature between 15°C and 30°C.
Descriptive term Part of solvent required for
part of solute to dissolve
Very soluble Less than 1 part
Freely soluble From 1 to 10 parts
Soluble From 10 to 30 parts
Sparingly soluble From 30 to 40 parts
Slightly soluble From 100 to 1000 parts
Very slightly soluble From 1000 to 10000 parts
Insoluble or practically insoluble More than 10000 parts

9. Standards: IP prescribes the standard of purity and strength of all official

substances. A substance is not deemed to be of standard quality unless it complies
with the requirements stated under this of its monograph.
10. Identification test: It is to ensure the correct labelling of substances. Identification
tests are specific, but they are not necessarily sufficient in establishing the absolute
proof of identity of the substance. This usually involves specific chemical test or
tests for identifying the substance. It provides a means of verifying that the
identity of the material under examination is in accordance with the label on the
container. There is substantial overlap between identification and limit tests.
Limit tests are designed to ensure that the undesirable impurities are within the
prescribed limits. Identification tests, whether physical or chemical, provided
they are sufficiently specific, can be used as the basis of a quantitative estimation.
Physical constants, such as boiling point, melting point, solubility, refractive
index, viscosity, optical rotation, etc. have characteristic values for a given
substance. It can be used in identification, checking quality and maintaining
standard of purity.
11. Tests for purity: Tests for purity are tests for the presence of impurities in the
substance and fix the limits of tolerance for undesirable impurities.
12. Assay: Assay is used for the quantitative determination of active ingredients of
the official substance and their preparations.
13. Storage: It contains information regarding the storage conditions of official
substance so they can be protected against possible contamination and
deterioration. The precautions need to be taken with the effect of atmosphere,
moisture, heat and light are also indicated in the monograph. In case of some
drugs or pharmaceutical substances, lower or higher temperatures produce
undesirable effects.
 The storage conditions are defined by the following terms:
a. Store in a dry, well-ventilated place at a temperature not exceeding 30°C
b. Store in a refrigerator (2°C to 8°C) and do not freeze
c. Store in a freezer (–2°C to –18°C)
d. Store in a deep freezer (below –18°C).
The storage conditions not related to temperature are indicated in the following
terms:
a. Store protected from light
b. Store protected from light and moisture
where no specific storage directions or limitations mentioned, it is to be
understood that the storage conditions include protection from moisture, freezing
and excessive heat (any temperature above 40°C).
14. Storage containers: The storage containers in the pharmacopeia are indicated in
the following terms:
a. Well-closed containers: This implies the substance is stable and gets protected
from dust, dirt, insects, etc.
b. Tightly closed container: The substances in such cases get affected by
atmospheric oxygen or moisture or carbon dioxide. For example, reducing
agents, hygroscopic substances, strong bases, etc. must be stored in tightly
closed containers. It may also include such compounds are volatile or contain
dissolved gases, etc.
c. Light resistant container: Substances which are affected by light are stored in
amber or dark colored containers.
d. Single dose containers: This is generally prescribed for some injectables which
once opened should not be used again.
15. Labeling: The labeling statements may appear on the container, the package, a
leaflet accompanying the package or certificate of analysis associated with the
article, as decided by the competent authority.

A comprehensive section of appendices are presented followed by the general notices

and monographs.
Appendix 1: It describes the apparatus that are needed for various pharmacopeial
tests and assays
Appendix 2: It describes biological tests and assays
Appendix 3: It describes the details of various chemical tests and assays
Appendix 4: It describes the details of microbiological tests and assays
Appendix 5: It describes some physical tests and determinations like loss on drying,
determination of pH, melting range, etc.
Appendix 6: It describes includes the useful directions on cleaning glassware.
Appendix 7: It describes the reagents and solutions needed for the various tests
and assays, their method of preparation, standards, etc.
Appendix 8: Describes reference substances
Appendix 9: It describes the names, symbols used in the pharmacopeia and their
atomic weights.
In pharmaceuticals, impurity is defined as any other material besides the drug
substance such as intermediates or starting material or by products, interaction
products or degradation products due to any side reactions.
Substances which are used in pharmaceutical field must be pure so that they can be
used safely. But it is very difficult to obtain an almost pure substance. Impurities defined
as a foreign particle that affects the purity of a substance.
An impurity in a drug substance as defined by the International Conference on
Harmonisation (ICH) Guidelines is any component of the drug substance that is not
the chemical entity defined as the drug substance and affects the purity of active
ingredient or drug substances.

As we know that almost pure substances are difficult to get and some amount of
impurity is always present in the material. So, the impurities which are present in the
substances may have the following effects:
• Impurities may bring about incompatibility with other substances
• Impurities may lower the shelf life of the substances
• Impurities may cause difficulties during formulations and use of the substances
• Sometimes impurities changes the physical and chemical properties of the
substances
• Therapeutic effect can be decreased
• Shows toxic effect after a certain period
• Injurious when present above certain limits
• It may change odor, color, taste of the substance.

To prevent these impurities many test such as limit test are carried out to lower the
impurities to make the pharmaceuticals safer.
A substance having foreign materials is termed to be impure. The cause of impurities
in drugs is from various sources and phases of the synthetic process. Many of the
impurities may arise from starting materials, by products, synthetic intermediates,
synthetic route of manufacturing process and degradation products. The
pharmaceutical preparation should be free from toxic and other impurities.
The impurities commonly found in pharmaceutical substances are:
• Raw materials employed in manufacture
• Method or the process used in manufacture
• Chemical processes and the plant materials employed in the processes
• Due to color and flavoring substances
• Incompatibility of active ingredient with other substance
• Storage conditions
• Decomposition
• Impurities due to humidity and temperature.
The various sources of impurities in pharmaceutical substances are as follows:
1. Raw materials employed in the pharmaceutical process: Pharmaceutical
substances are either isolated from natural sources or synthesized from chemical
starting materials which have impurities. Impurities associated with the raw
materials may be carried through the manufacturing process to contaminate the
final product, e.g. rock salt used for the preparation of sodium chloride is
contaminated with small amounts of calcium and magnesium chlorides, many
sulfide ores containing lead and heavy metals as impurities.
2. Method or manufacture process: The process of manufacture may introduce new
impurities. Due to impure reagents, catalysts and solvents, reaction vessels and
reaction intermediates employed at various stages.
a. Reagents employed in the manufacturing process: If reagents are employed in the
process are not completely removed and these reagents may be present in the
final products, e.g. calcium carbonate contains ‘soluble alkali’ as impurity.
Anions like Cl– and SO 2– 4 are common impurities in many substances because
of the use of hydrochloric acid and sulfuric acid respectively. Barium ion may
be an impurity in hydrogen peroxide.
b. Reagents used to eliminate other impurities: Barium is used to remove sulfate from
potassium bromide, which can be found, itself (barium) as impurity at the end
of process.
3. Solvents: In pharmaceutical substances, solvents employed in preparation and
purification of the product and it may also contaminate the product. Water is the
most commonly used solvent in the pharmaceuticals which can be the major
source of impurities. Different types of water are as follows.
a. Distilled water: It is free from all inorganic and organic impurities and best
solvent for pharmaceutical preparation.
b. Demineralized water: It is free from magnesium, calcium, sodium, sulfates,
chlorides, carbonates impurities and prepared by ion exchange method. It
contains bacteria, pyrogens and organic impurities.
c. Tap water: It contains magnesium, calcium, sodium, sulfates, chlorides,
carbonates as impurities.
d. Softened water: It is prepared from tap water and it contains sodium and
chloride ions as impurities.
4. Intermediates: An intermediate substance produced during the manufacturing
process may contaminate the final product, e.g. sodium bromide is prepared by
reaction of sodium hydroxide and bromine in slight excess.
6NaOH + 3Br2  NaBrO3 + 5NaBr + 3H2O
The sodium bromate an intermediate product is reduced to sodium bromide by
heating the residue with charcoal.
NaBrO3 + 3C  NaBr + 3CO
If sodium bromate is not completely converted to the sodium bromide then it is
likely to be present as an impurity.
 5. Atmospheric contamination during the manufacturing process: Atmosphere
may contain dust (aluminium oxide, sulfur, silica, soot, etc.) and some gases like
carbon dioxide, sulfur dioxide, arsine and hydrogen sulfide. These may
contaminate the final product during the manufacturing process, e.g. sodium
hydroxide readily absorbs atmospheric carbon dioxide when exposed to
atmosphere.
2NaOH + CO2  Na2CO3 + H2O
6. Chemical process: Various chemical reactions such as oxidation, reduction,
halogenation and hydrolysis are involved in the synthesis of pharmaceuticals. In
these reactions chemical and solvents are used which may found in the product
as a impurities.
7. Manufacturing hazards: Sometimes certain manufacturing hazards which can
lead to product contamination.
a. Contamination from the particulate matter: The unwanted particulate matter can
arise by accidental introduction of dirt or glass, porcelain, plastic or metallic
fragments from sieves, granulating, filling machines and the product
container.
b. Cross-contamination of the product: It can occur by airborne dust arising out of
handling of powders, granules and tablets in bulk. If two or more products are
manufactured in same time this type of contamination is possible.
c. Contamination by microbes: Microbes like bacteria, fungi, algae, etc. can
contaminate the final product. Many liquid preparations and creams intended
for topical applications are liable to contamination by microbes from the
atmosphere during manufacturing.
d. Errors in the packaging: Similar looking products such as tablets of the same
size, shape and color are packed in similar containers can result in mislabeling
of either or both of the products.
8. Instability of the product:
a. Chemical instability:
• Many pharmaceutically important substances undergo chemical
decomposition when storage conditions are inadequate.
• Chemical decomposition is often catalyzed by light, traces of acid or
alkali, traces of metallic impurities, air oxidation, carbon dioxide and
water vapors.
• Impurities can also arise during storage because of chemical instability.
b. Reaction with container material: The reaction between the container material
and the contents can affect the stability. Preparations susceptible to reaction
with metal surfaces, e.g. salicylic acid ointment must not be packed in metal
tubes.
c. Temperature: The rate of chemical decomposition and physical changes of
stored products depends upon the temperature.
To minimize and prevent impurities many test such as limit test carried out to
diminish the impurities and make the pharmaceuticals safer.
Limit test is defined as quantitative or semiquantitative
test designed to identify and control small quantities of
impurity which is likely to be present in the substance.
Limit test for chlorides, sulfates, iron, lead and heavy
metal are carried out in Nessler cylinders (Fig. 1.1). It is
made up of borosilicate glass having fixed diameter and
length as per IP. Two similar kinds of cylinders are
required for test and standard to make the comparison
in identical manner. No numerical values for the limits
in these tests are prescribed in pharmacopeia as it is not
practicable. The sample quantity may vary according to
the limits while standard remains constant.
In these tests, the test opalescence/turbidity/color/
stain produced by the reaction of specified amount of
impurity in the test sample with the reagent is compared
with the standard opalescence/turbidity/color/stain
produced by the reaction of known amount of impurity
[standard] with the reagent. It is generally carried out Fig. 1.1: Nessler cylinders
to determine the inorganic impurities present in
compound.
Importance of limit tests:
• To find out the harmful amount of impurities
• To find out the avoidable/unavoidable amount of impurities.

Limit test of chloride is based on the simple reaction between silver nitrate and soluble
chlorides in presence of dilute nitric acid to give opalescence of silver chloride.
Cl– + AgNO3  AgCl + NO 3–
A comparison Limit Test is made of the opalescent solution so obtained with the
standard opalescence containing a known amount of chloride ions.

Chloride standard solution (25 ppm CI): Dilute 5 ml of 0.0824% w/v solution of
sodium chloride in 100 ml of water.
Silver nitrate solution (0.1 M): 0.1 M silver nitrate was prepared by dissolving
17 g of silver nitrate in sufficient water to produce 1000 ml.
Nitric acid, dilute: Contains approximately 10% w/w of HNO3. Dilute 106 ml of
nitric acid to 1000 ml with water.

Take two (50 ml) Nessler cylinders and label it one as ‘Standard’ and other as
‘Test’.
 Test solution Standard solution
Dissolve the specified quantity of the substance Take 1 ml of chloride standard solution
under examination in water and transfer to a (25 ppm Cl–) in a Nessler cylinder
Nessler cylinder
Add 10 ml of dilute nitric acid Add 10 ml of dilute nitric acid
Dilute to 50 ml with distilled water Dilute to 50 ml with distilled water
Add 1 ml of 0.1 M silver nitrate Add 1 ml of 0.1 M silver nitrate
Stir immediately with a glass rod and keep aside Stir immediately with a glass rod and keep
for 5 minutes protected from light aside for 5 minutes protected from light
Observe the opalescence/turbidity Observe the opalescence/turbidity

Both the Nessler cylinder viewed transversely

against a black background for comparison of
opalescence (Fig. 1.2).
Observation: The opalescence produced in test
solution should not be greater than standard
solution. If opalescence produces in test solution is
less than the standard solution, the sample will pass
the limit test of chloride and vice versa.
Reason for adding nitric acid:
• It extracts a common ion effect by furnishing
nitrate ions and thereby suppression of disso-
ciation of silver chloride.
• Dilute nitric acid is used to dissolve other
impurities if present and helps silver chloride Fig. 1.2: Comparison of limit test
precipitate to make solution turbid at the end for chloride
of process.
Precautions:
• Distilled water must be used because chloride present in the tap water will
interfere the result
• Same glass rod should not be used because it will affect your observation.
• Silver nitrate is photosensitive store it in amber color bottle.

Limit test of sulfate is based on the reaction of soluble sulfate with barium chloride in
presence of dilute hydrochloric acid to form barium sulfate which appears as solid
particles (turbidity) in the solution.
SO –4 + BaCl2  BaSO4 + 2Cl–
A comparison is made of the turbid solution so obtained with the standard turbidity
containing a known amount of sulfate ions.

Barium chloride solution (25% w/v): It is prepared by dissolving 25 gm of barium

chloride in sufficient quantity of water and volume was adjusted to 100 ml.
 Acetic acid solution (5M): 5M acetic acid solution prepared by diluting 185 ml of
glacial acetic acid with sufficient water to produce 1000 ml.
Ethanolic sulfate standard solution (10 ppm): Dilute 1 volume of 0.181% w/v
solution of potassium sulfate in ethanol (30%) to 100 volume with ethanol (30%).
Sulfate standard solution (10 ppm SO4): Dilute 1 volume of a 0.181% w/v solution
of potassium sulfate in distilled water to 100 volumes with the same solvent.

Test solution Standard solution

To 1 ml of a 25% w/v solution of barium chloride To 1 ml of a 25% w/v solution of barium
chloride in a Nessler cylinder add 1.5 ml of etha- chloride in a Nessler cylinder, add 1.5 ml
nolic sulfate standard solution (10 ppm SO4), of ethanolic sulfate standard solution
mix and allow to stand for 1 minute (10 ppm SO4), mix and allow to stand for
1 minute
Dissolve the given sample in 15 ml of water and Add 15 ml of sulfate standard solution
0.15 ml of 5M acetic acid (10 ppm SO4) and 0.15 ml of 5M acetic acid
Add sufficient water to produce 50 ml Add sufficient water to produce 50 ml
Stir immediately with a glass rod and keep aside Stir immediately with a glass rod and keep
for 5 minutes aside for 5 minutes.
Observe the opalescence/turbidity Observe the opalescence/turbidity

Observation: The opalescence/turbidity produced in test solution should not be

greater than standard solution. If opalescence/turbidity produces in test solution is
less than the standard solution, the sample will pass the limit test of chloride and vice
versa.
Reason for adding:
• Hydrochloric acid helps to make solution acidic
• Potassium sulfate is used to increase the sensitivity of the test by giving ionic
concentration in the reagent.

In modified limit test for chloride, as KMnO4 gives purple color in aqueous solution
that interferes in the comparison of opalescence and turbidity, so the aqueous solution
first be decolorized. KMnO4 is an oxidizing agent and ethanol is reducing agent. When
KMnO4 is treated with ethanol in presence of heat, redox reaction will takes place
which reduces KMnO4 to manganese dioxide (precipitate) and the filtrate is colorless
to proceed the limit chloride.
Method: Weighed amount of test substance after treated with suitable reducing
agent dissolve it in water. Transfer the solution to Nessler cylinder and add 10 ml
dilute of nitric acid, except when nitric acid is used in the preparation of solution and
make up the volume to 50 ml with water. Then add 0.1 ml of silver nitrate, mix well
and allow it stand for 5 minutes protected from light. On viewing transversely against
a black background, any opalescence produced in the test solution should not be greater
than that formed by treating a mixture of 10 ml of standard chloride solution (25 ppm
Cl) and 5 ml of water in the similar manner.
 Method: Take 1 ml of 25% w/v barium chloride solution in a Nessler cylinder; add
1.5 ml of standard ethanolic sulfate solution (10 ppm), mix well and allowed to stand
for 1 minute. Then add 15 ml of the test solution prepared as specified in monograph
and 0.15 ml of 5 M acetic acid after treatment with suitable reducing agent. Dilute the
solution up to the mark (50 ml) with water, stir well immediately with a glass rod and
allowed to stand for 5 minutes. On viewing transversely against a black background,
any opalescence produced in the test solution should not be greater than that formed
by treating a mixture of 15 ml of standard sulfate solution (10 ppm SO4) in the similar
manner.

Limit test of iron is based on the reaction of iron impurities with thioglycolic acid to
form ferrous thioglycolate which produce purple color in the solution.

A comparison is made of the color solution so obtained with the standard color
containing a known amount of iron.

Iron-free citric acid solution (20% w/v): It is prepared by dissolving 20 gm of iron

free citric acid in sufficient quantity of water and volume was adjusted to 100 ml.
Iron-free ammonia solution: Contains approximately 10% w/w of NH3. Dilute
425 ml of strong ammonia solution to 1000 ml.
0.05 M sulfuric acid: It is prepared by careful adding 2.7 ml sulfuric acid to equal
volume of water and further diluting 1000 ml with water.
Iron standard solution (20 ppm Fe): Dilute 1 volume of a 0.1726% w/v solution of
ferric ammonium sulfate in 0.05 M sulfuric acid to 10 volumes with water. Contains
iron in ferric state.

Test solution Standard solution

Dissolve the specified quantity of the substance Take 2 ml of iron standard solution
in water and then volume is made up to 40 ml (20 ppm Fe) diluted with water up to 40 ml
Add 2 ml of a 20% w/v solution of citric acid Add 2 ml of a 20 % w/v solution of citric
(iron-free) acid (iron-free)
(Contd.)
 Test solution Standard solution
Add 0.1 ml of thioglycolic acid Add 0.1 ml of thioglycolic acid
Add ammonia to make the solution alkaline Add ammonia to make the solution alkaline
Adjust the volume to 50 ml Adjust the volume to 50 ml
Keep aside for 5 minutes Keep aside for 5 minutes
Color developed is viewed vertically and com- Color developed is viewed vertically and
pared with standard solution compared with standard solution

Observation: The purple color produce in sample solution should not be greater
than standard solution. If purple color produces in sample solution is less than the
standard solution, the sample will pass the limit test of iron and vice versa.
Reason for adding:
• Citric acid (iron free) is used to complex metal cations other than iron if present
• Thioglycolic acid helps to oxidize iron (II) to iron (III)
• Ammonia to make solution alkaline.

• Distilled water must be used during preparation of all the solution if required.
• Same glass rod should not be used because it will affect your observation.
• Iron free ammonia and citric acid are used during preparation of reagents.

Limit test of heavy metals is based on the reaction of heavy metals impurities with
saturated solution of hydrogen sulfide to forms sulfides, which produce color
(brownish) in the solution. A comparison is made of the color solution so obtained
with the standard color (reaction of known amount of lead with saturated solution of
hydrogen sulfide).
Heavy metal + H2S/Na2S  Heavy metals sulfides + 2H+
(Brownish color)
Metals that response to this test are lead, mercury, bismuth, arsenic, antimony, tin,
cadmium, silver, copper, and molybdenum. The metallic impurities in substances are
expressed as parts of lead per million parts of the substance. The usual limit as per
Indian Pharmacopoeia is 20 ppm.

Dilute acetic acid solution (approx. 6% w/w): It is prepared by diluting 57 ml of

glacial acetic acid to 1000 ml with water.
Dilute ammonia solution (approx. 10% w/w): It is prepared by diluting 425 ml of
strong ammonia solution to 1000 ml with water.
Lead standard solution (0.1% Pb): Dissolve 0.400 gm of lead nitrate in water
containing 2 ml nitric acid and add sufficient quantity of water to produce 250 ml.
Lead standard solution (100 ppm): Dilute 1 volume lead standard solution (0.1 %
Pb) to 10 volumes with water.
Lead standard solution (20 ppm): Dilute 1 volume lead standard solution
(100 ppm Pb) to 5 volumes with water.
Indian Pharmacopoeia provided four methods depending on resulting solution
substance (i.e. based on solubility, color, etc.)
Method A: It is used for the substance which gives clear colorless solution under
the specific condition.
Test solution Standard solution
Solution is prepared as per the monograph and Take 2 ml of standard lead solution (20 ppm
25 ml is transferred in Nessler’s cylinder Pb) and dilute to 25 ml with water
Adjust the pH between 3 to 4 by adding dilute Adjust the pH between 3 to 4 by adding
acetic acid or dilute ammonia solution dilute acetic acid or dilute ammonia
solution
Dilute with water to 35 ml Dilute with water to 35 ml
Add freshly prepared 10 ml of hydrogen sulfide Add freshly prepared 10 ml of hydrogen
solution sulfide solution
Dilute with water to 50 ml Dilute with water to 50 ml
Allow to stand for 5 minutes Allow to stand for 5 minutes
View downwards over a white surface View downwards over a white surface

Observation: The color produce in sample solution should not be greater than
standard solution. If color produces in sample solution is less than the standard solution,
the sample will pass the limit test of heavy metals and vice versa.
Method B: It is used for the substance which does not give clear colorless solution
under the specific condition. In this method hydrogen sulfide is used after igniting
the substance.
Test solution Standard solution
Weigh in a suitable crucible the quantity of the substance speci- Take 2 ml of standard lead
fied in the individual monograph, add sufficient sulfuric solution (20 ppm Pb) and
acid to wet the sample, ignite carefully at a low temperature dilute to 25 ml with water
until thoroughly charred. Add to the charred mass 2 ml of nitric
acid and 5 drops of sulfuric acid and heat cautiously until
white fumes are no longer evolved. Ignite, preferably in a muffle
furnace at 500 to 600°C, until the carbon is completely burnt off.
Cool and add 4 ml of hydrochloric acid cover, digest on a water
bath for 15 minutes, uncover and slowly evaporate to dryness
on a water bath. Moisten the residue with 1 drop of hydrochloric
acid, add 10 ml of hot water and digest for 2 minutes
Add ammonia solution dropwise until the solution is just alka- Adjust the pH between 3 to 4
line to litmus paper, dilute to 25 ml with water and adjust with by adding dilute acetic acid
dilute acetic acid to a pH between 3.0 and 4.0. Filter, if necessary or dilute ammonia solution
dilute with water to 35 ml Dilute with water to 35 ml
Add freshly prepared 10 ml of hydrogen sulfide solution Add freshly prepared 10 ml of
hydrogen sulfide solution
Dilute with water to 50 ml Dilute with water to 50 ml
Allow to stand for 5 minutes Allow to stand for 5 minutes
View downwards over a white surface View downwards over a
white surface

Observation: The color produce in sample solution should not be greater than
standard solution. If color produces in sample solution is less than the standard solution,
the sample will pass the limit test of heavy metals and vice versa.
 Method C: Use for the substance which gives clear colorless solution and used
sodium sulfide solution after treating the substance with sodium hydroxide solution.
Test solution Standard solution
Dissolve the specified quantity of the substance under Take 2 ml of standard lead solution
examination in a mixture of 20 ml of water and add (20 ppm Pb)
5 ml of dilute sodium hydroxide solution
Make up the volume to 50 ml with water Add 5 ml of dilute sodium hydroxide
solution and make up the volume to
50 ml and mix
Add 5 drops of sodium sulfide solution Add 5 drops of sodium sulfide solution
Mix and allow to stand for 5 minutes Mix and allow to stand for 5 minutes
View downwards over a white surface View downwards over a white surface

Observation: The color produce in sample solution should not be greater than
standard solution. If color produces in sample solution is less than the standard solution,
the sample will pass the limit test of heavy metals and vice versa.
Method D:
Test solution Standard solution
Prepare as directed in the individual Pipette 10.0 ml of either lead standard solution
monograph and pipette 12 ml into a (1 ppm Pb) or lead standard solution (2 ppm Pb) and
small Nessler cylinder add 2.0 ml of the test solution
Add 2 ml of acetate buffer pH 3.5 Add 2 ml of acetate buffer pH 3.5
Add 1.2 ml of thioacetamide reagent Add 1.2 ml of thioacetamide reagent
Allow to stand for 2 minutes Allow to stand for 2 minutes
View downwards over a white surface View downwards over a white surface

Observation: The color produce in test solution is not more intense than standard
solution. If color produces in test solution is less than the standard solution, the sample
will pass the limit test of heavy metals and vice versa.
Reasons for adding: Dilute acetic acid and ammonia solution is added to maintain
the pH between 3.0 to 4.0 so that precipitate formed is colloidal and uniform.

• Distilled water must be used during preparation of all the solution if required.
• Same glass rod should not be used because it will affect your observation.

The principle is based on converting any arsenic impurity present in the sample to
arsine gas by a series of reaction. The arsine gas is made to come in contact with
mercuric chloride test paper when by it produces a yellow or brown stain due to the
formation of mercuric arsenide. It is also called Gutzeit test and requires special
apparatus.
The arsenic impurity is converted in acidic medium into arsenious acid or arsenic
acid depending upon the valency state of arsenic.
As 5  
 O  As(OH)3 or H 3 AsO 4
Pentavalent Arsenic acid
 As 3  
 As(OH)3 or H 3 AsO 3
Trivalent Arsenious acid
Any arsenic acid formed is converted into arsenious acid by reduction with stannous
chloride and hydrochloric acid
SnCl 2 /HCl
H 3 AsO 4   As(OH)3 or H 3 AsO 3
Arsenic acid Arsenious acid
The arsenic acid is further reduced to arsine gas with the help of nacent hydrogen
obtained in the reaction between zinc and hydrochloride acid
Zn/HCl
H 3 AsO 3   AsH 3  3H 2 O
Arsenious acid Arsine
Arsenic gas reacts with mercuric choride test paper to produce yellow to brown
stain due to formation of mercuric arsenide
AsH 3  HgCl 2 
 Hg(AsH 2 )2  2HCl
Arsine Mercuric arsenide
The stain (yellow or brown) produce by the sample is compare to a standard stain
produced by standard.

Potassium iodide, 1 M: Dissolve 166 g of potassium iodide in sufficient water to

produce 1000 ml.
Sodium hydroxide, 2 M: Dissolve 80 g of sodium hydroxide in sufficient water to
produce 1000 ml.
Arsenic standard solution (10 ppm As): Dissolve 0.330 g of arsenic trioxide in 5 ml
of 2M sodium hydroxide and dilute to 250.0 ml with water. Dilute 1 volume of this
solution to 100 volumes with water.
Lead acetate solution: A 10% w/v solution of lead acetate in carbon dioxide-free
water.
Stannous chloride solution: May be prepared by either of the following two
methods.
1. Dissolve 330 g of stannous chloride in 100 ml of hydrochloric acid and add
sufficient water to produce 1000 ml.
2. Dilute 60 ml of hydrochloric acid with 20 ml of water, add 20 g of tin, heat gently
until no more gas is evolved and add sufficient water to produce 100 ml. Store
over a little of the undissolved tin remaining in the solution and protected from
air.

Test solution: The test solution is prepared by dissolving specific amount in water
and stannated HCl (arsenic-free) and kept in a wide mouthed bottle.
To this solution 1 gm of KI, 5 ml of stannous chloride acid solution and 10 gm of
zinc is added (all this reagents must be arsenic-free). Keep the solution aside for
40 min and stain obtained on mercuric chloride paper is compared with standard
solution.
Standard solution: Transfer 1 ml of arsenic standard solution (10 ppm As) diluted
to 50 ml with water. Add 10 ml of stanneted hydrochloric acid, 5 ml of 1 M potassium
iodide and 10 g of zinc AsT. Immediately assemble the apparatus and immerse the
flask in a water bath at a temperature such that a uniform evolution of gas is maintained.
Keep aside for 40 minutes observe the stain produced on the mercuric chloride paper.
Observation: Stain produced by test sample is not more intense than that obtained
by standard sample or equals to the standard one, passes the limit test. If stain produced
by test sample is more intense than that obtained by standard sample which fails the
limit test for arsenic as per IP.
Arsenic apparatus: This apparatus details are as follows:
• It consists of a 100 ml bottle or conical flask closed with a rubber or ground glass
stopper through which passes a
glass tube (about 20 cm × 5 mm).
• The lower part of the tube is
drawn to an internal diameter of
1.0 mm, and 15 mm from its tip is
a lateral orifice 2 to 3 mm in
diameter.
• When the tube is in position in
the stopper the lateral orifice
should be at least 3 mm below
the lower surface of the stopper.
• A second glass tube of the same
internal diameter and 30 mm
long is placed in contact with the
first and held in position by two
spiral springs or clips.
• Into the lower tube insert 50 to
60 mg of lead acetate cotton, loosely
packed.
• Between the flat surfaces of the
tubes place a disc or a small
square of mercuric chloride paper
large enough to cover the orifice of
the tube.
The arsenic apparatus is shown in
Fig. 1.3.
Fig. 1.3: Arsenic apparatus
Reason for adding:
• Lead acetate papers are used to trap any hydrogen sulphide which may be
evolved together with arsine
• Stannous chloride is used for complete evolution of arsine
• HCl is used to make the solution acidic
• Zinc, potassium iodide and stannous chloride is used as a reducing agent.

• The most suitable temperature for carry out this test is 40°C.
• Care must be taken that the filter paper remains quite dry during the reaction.
 • During the succeeding tests the tube must be washed with HCl AsT rinsed with
water and dried.
• All the reagents used for this test should be free from arsenic and mentioned as
AsT.

It is based on the violet color produced in chloroform due to the reaction between lead
impurity and dithizone (diphenyl thiocarbazone) which results in the formation of
lead dithizonate. The intensity of final violet color produced in the chloroform medium
is compared with standard.

Lead dithizonate complex

Preparation of standard lead solution (1 ppm Pb): Dissolve 0.4 g of lead nitrate in
water containing 2 ml of dilute nitric acid and add sufficient water to produce
250 ml. This gives standard lead solution (1% Pb). Standard lead solution (1 ppm Pb)
is prepared by diluting 1 volume of standard lead solution (1% Pb) to 1000 volumes
with water.
Preparation of dithizone extraction solution: Dissolve 30 mg of dithizone in
1000 ml of chloroform and add 5 ml of ethanol (95%). The solution is stored in
refrigerator. Before use, the solution is shaken with about half of its volume of
1% v/v nitric acid solution and acid is discarded.
Preparation of dithizone standard solution: Dissolve 10 mg of dithizone in 1000
ml of chloroform.

Test solution Standard solution

A known quantity of sample solution is trans- A standard lead solution is prepared equivalent
ferred in a separating funnel to the amount of lead permitted in the sample
under examination
Add 6 ml of ammonium citrate Add 6 ml of ammonium citrate
Add 2 ml of potassium cyanide and 2 ml of Add 2 ml of potassium cyanide and 2 ml of
hydroxylamine hydrochloride hydroxylamine hydrochloride
Add 2 drops of phenol red Add 2 drops of phenol red
Make solution alkaline by adding ammonia Make solution alkaline by adding ammonia
solution solution
Extract with 5 ml of dithizone until it becomes Extract with 5 ml of dithizone until it becomes
green green
(Contd.)
 Test solution Standard solution
Combine dithizone extracts are shaken for Combine dithizone extracts are shaken for
30 mins with 30 ml of nitric acid and the 30 mins with 30 ml of nitric acid and the chloro-
chloroform layer is discarded form layer is discarded
To the acid solution add 5 ml of standard To the acid solution add 5 ml of standard dithi-
dithizone solution zone solution
Add 4 ml of ammonium cyanide Add 4 ml of ammonium cyanide
Shake for 30 mins Shake for 30 mins
Observe the color Observe the color

Comparison of stain: Compare the voilet color of the chloroform layer.

Observation: The intensity of the color of complex is depends on the amount of
lead in the solution. The color produce in sample solution should not be greater than
standard solution. If color produces in sample solution is less than the standard solution,
the sample will pass the limit test of lead and vice versa.
Reason for adding:
• The interference by other metal ions is eliminated by adjusting the optimum pH
for the extraction by using reagents like ammonium citrate, potassium cyanide
and hydroxylamine hydrochloride.
• Lead present as an impurities in the substance, gets separated by extracting an
alkaline solution with a dithizone extraction solution.
• Phenol red is used as indicator to develop the color at the end of process.

• All reagents used for the test should have as low a content of lead as practicable.
• All reagent solutions should be stored in containers of borosilicate glass.
• Glassware should be rinsed thoroughly with warm dilute nitric acid followed by
water.

1. Indian Pharmacopoeia is published by:

a. Indian Pharma Commission c. Indian Patent Commission
b. Indian Pharmacopoeia Commission d. None of the above
2. Impurities may be present in pharmaceutical substances because of:
a. Raw material c. Manufacturing process
b. Chemical instability d. All of the above
3. Why HCl is used in the limit test of sulfate?
a. Forms precipitate c. Remove the impurities of sulfate
b. Clear the solution d. All of the above
4. Limit test is performed in:
a. Round bottom flask c. Volumetric flask
b. Nessler cylinder d. Conical flask
5. ...... is also called Gutzeit test.
a. Limit test of sulfate c. Limit test of lead
b. Limit test of chloride d. Limit test of arsenic
 6. In pharmacopeia, directions and specifications of drugs mentioned which are
intended for medicinal use is known as:
a. Test for impurity c. Limit test
b. Monograph d. Quality parameters
7. Indian Pharmacopoeia update frequency of addendum is once in every ...... years.
a. Two c. Three
b. Four d. Five
8. Which reagent is added to prevent supersaturation of barium sulfate in the limit
test of sulfate?
a. Ethanol c. Methanol
b. HCl d. Butanol
9. In limit test of heavy metals, the metal sulfides formed are in ...... color.
a. Orange c. Brownish
b. Yellow d. Green
10. Limit test for iron, formation of ...... produce purple color.
a. Citric acid c. Arsine
b. Thioglycolic acid d. Nitric acid
11. Limit test for lead is based on the reaction between lead and ...... in an alkaline
medium.
a. Diphenylamine c. Methanol
b. Aluminum chloride d. Diphenylthiocarbazone
12. The limit test for lead is based upon reaction of lead with ...... in an alkaline media.
a. Ethanol c. Methanol
b. HCl d. Butanol

1. b 2. d 3. c 4. b 5. d 6. b 7. b 8. a 9. c 10. b 11. d
12. a

1. The standard and test solution used for limit test are prepared in .......
2. The limit test for arsenic is based upon ...... test.
3. In limit test for arsenic ...... is converted into arsenous acid/arsine gas.
4. Arsine gas is carried and comes into contact with ...... in produces a yellow or
brown stain.
5. The function of granulated Zn in limit test for arsenic is .......
6. Limit test for sulfate has been based upon the precipitate of sulfate with ..... in the
presence of .......
7. In limit test for sulfate to prevent the supersaturation of BaSO4 a small amount of
...... has been added in the reagent.
8. Limit test for iron is based upon reaction of Fe with ...... in presence of a ......
solution buffered with ammonium citrate.
9. Limit test for iron purple color is due to formation of .......
10. In limit test for iron ...... prevent the precipitate of iron as Fe(OH) solution.
11. In limit test for iron ferrous thioglycolate has stable pink to reddish purple colour
in ...... medium.
12. Limit test is ...... test designed to identify and control small quantities of
impurities.
13. Limit test for chloride has been based open reaction between ...... and ...... to obtain
silver chloride.
14. Limit test for Pb has been based upon reaction between ...... and ...... to form
complex.
15. Ppm is ...... and one ppm is .......

1. Distilled water
2. Gutzeit test
3. Arsenious acid
4. Mercuric chloride
5. Slow and prolonged evolution of nascent H2 gas
6. Barium chloride, dilute hydrochloric acid
7. Alcohol
8. Thioglycolic acid, citric acid
9. Iron thioglycolate
10. Citric acid
11. Alkaline
12. Quantitative
13. Silver nitrate and soluble chloride
14. Lead and diphenyl thiocarbazone
15. Parts per million, 1 mg in 1 kg

1. Define pharmaceutical inorganic chemistry.

2. Write a note on sources of impurities in pharmaceutical preparation.
3. Explain the importance of inorganic chemistry in pharmacy.
4. Write the salient features of recent edition of Indian Pharmacopoeia.
5. What is the role of citric acid, thioglycolic acid and ammonia in the limit test of
iron?
6. What is the use of stannous chloride in limit test of arsenic?

1. Briefly explain the history of Indian Pharmacopoeia.

2. Discuss about various pharmacopeias.
3. Define the term monograph and explain with any one official drug.
4. Explain the development of pharmacopeias.
5. Discuss limit test of iron.
6. Explain the principle and procedure for the limit test of sulfate.
7. Discuss in detail about the apparatus used in limit test of arsenic.
8. Discuss the principle of limit test of sulfate, arsenic and chloride.
9. Give complete principle and method as per IP of limit test of lead.
10. Explain the limit test of heavy metals.
 • Introduction Buffer Capacity
• Acids and Bases Buffers in Pharmaceutical System
Henderson-Hasselbalch Equation Buffer Solutions
Theories of Acids and Bases Buffered Isotonic Solution
• Buffers • Tonicity
Mechanism of Buffer Action Methods used for the Measurement of Tonicity
Types of Buffers Methods of Adjustment of Tonicity
Buffer Action • Important Questions/Answers

Electrolytes are dissolved in water which is split up into two or more electrically
charged particles. The most of living creatures comprises about 70% of water. Water
is a polar solvent which dissolves most charged or polar molecules and most salts by
hydrating them (forming hydrogen bond) and after stabilizing the cations and anions
by weakening their electrostatic interactions between them.

An acid may be defined as a substance which is able to donate protons which has sour
taste and its aqueous solution turns blue to red. It reacts with bases to form ionic
compounds called salts and water.
A base may be defined as a substance which accepts protons. It has bitter taste and
its aqueous solution turns red to blue.
BH  B– + H+
In the above example, BH is an acid because it donates proton and B is an anion
liberated by the deprotonation of the acid. B– behaves like a base, so it is called conjugate
base.
Acids can be classified into strong acids and weak acids.
1. Strong acids get dissociated almost completely, e.g. hydrochloric acid, sulfuric
acid. This is because the conjugate bases of these acids are very weak (have less
affinity for the proton).
2. Weak acids get dissociated partially, e.g. acetic acid, carbonic acid. This happens
because the conjugate bases of these acids are strong (have greater affinity for
proton).
 Henderson-Hasselbalch equation: Since the dissociation of the weak acids is partial,
the equilibrium constant for the dissociation reaction of the weak acid (BH) can be
written as follows:
BH  B– + H+
By applying the law of mass action at equilibrium:

[B – ] [H  ]
Ka 
[BH]
Ka is dissociation constant.
The equilibrium constants for ionization reactions are commonly called ionization
or dissociation constant (Ka). The above equation can be rearranged as:
Ka  [BH]
[H+] 
[B – ]
By multiplying the above equation by –1 and taking logarithm of both sides, the
following expression can be derived
 Ka  [BH] 
–[H+]  –  – 
 [B ] 
–log10 [H+] = – log10 Ka – log10 [BH]/[B–] – log10 [H+] is pH
As the hydrogen ion concentration increases, the pH of the solution decreases. As
the hydrogen ion concentration decreases, pH will increase. Hydrogen ion
concentration and pH are reciprocally related.
pH = pKa + log10 [B–]/[BH]
[Conjugate base]
 pKa  log 10
[Acid]
This expression is called Henderson-Hasselbalch equation. If the conjugate base
and acid concentration is the same, then pH = pKa. The value of pKa is lower for
strong acids and higher for weak acids.

Like many other chemical theories, the three main theories of acids and bases have
been widely used today. They are:
1. Arrhenius theory
2. Bronsted-Lowry theory or proton transfer theory
3. Lewis theory or electronic theory
Arrhenius theory: In 1887, Arrhenius explained this property of electrolytes and
hence it is known as Arrhenius theory of electrolyte dissociation. Water molecules
are produces H+ and OH– ions through ionization.
The charged particles, which are formed when the electrolyte is dissolved in water,
are called ions, and this process is called ionization. The process of ionization is
reversible. These ions may have positive or negative charge. Since they are charged,
they are responsible for carrying the electric current through the solution.
 According to the Arrhenius model, “Acids are substances that dissociate in water
to produce H+ ions and bases are substances that dissociate in water to produce OH–
ions”
NaOH (aq)  Na+ (aq) + OH– (aq) Base
HCl (aq)  H+ (aq) + Cl– (aq) Acid
The extent of ionization is given by the ratio of the total number of dissociated
molecules to the number of molecules dissolved. The degree of ionization can be
increased by diluting the solution in case of weak electrolytes.
According to neutralization reaction, these two ions combine to form salt and water.
NaOH + HCl  NaCl + H2O

1. It is simple, limited only to aqueous solution and not to substance.

2. It could not explain the acidic character of the substances.
3. The neutralization of acid and base in absence of solvent could not be explained.
4. It could not explain the basic character of the substances such as NH3 which do
not contain OH– ions.
Bronsted-Lowry theory or proton transfer theory: In 1923, Bronsted-Lowry theory
was proposed by Danish chemist J. N. Bronsted and British chemist J.M. Lowry. It is
also called proton transfer theory of acids and bases.
According to him, “An acid is any substance (molecular or ionic) which is able to
donate protons (proton donor) to any other substance, whereas base is any substance
which accepts protons (proton acceptor)”.
Examples of acids are as follows:
HCl  H+ + Cl–
CH3COOH  CH3COO– + H+
For base OH– + H+  H2O
NH3 + H+  NH4
Conjugate acid–base pair: Acid–base pair is a substance which can be formed from
each other mutually by the gain or loss of a proton is called conjugate acid–base pair.
Thus, conjugate of an acid is a substance formed by the loss of proton while conjugate
of an base is a substance formed by the gain of proton.
Some examples, a reaction of acetic acid in water:
CH3COOH + H2O  H3O+ + CH3COO–
Acid Base Acid Base
HCl + H2O  H3O+ + Cl–
In the above reaction, acetic acid donates proton to water therefore an acid. Water
accepts proton and therefore acts as base. In the reverse reaction hydronium ions
donate proton to acetate ions and acetate ions accept protons.

1. This concept lays emphasis on the proton transfer. Although it is true that most
common acids are protonic in nature, yet there are many which are not.
 2. A large number of acid–base reactions are known in which no proton transfer
takes place, e.g.
SO2 + SO2  SO2+ + SO32–
Acid1 Base2 Acid2 Base1

Thus, the protonic definition cannot be used to explain the reactions occurring in
non-protonic solvents such as COCl2, SO2, N2O4, etc.
Lewis theory or electronic theory: In 1923, An American chemist Lewis introduced
another concept of acid and base along with the formation of coordinate bond.
According to Lewis, “An acid may be defined as any species (molecule, ion or
radical) that can accept an electron pair to form coordinate bond while base may be
defined as any species that can donate an electron pair to form coordinate bond. In
Lewis system, an acid is electron pair acceptor and base is an electron pair donor”.
The reaction between Lewis acid and base results in a product which is described
as adduct, e.g.
H+ + :NH3  H  NH3
Here (H+) accepts one electron pair from NH3 molecule and is therefore a Lewis
acid, whereas NH3 molecule donates one electron pair is a base. The adduct is NH 4
ion.
Lewis acid: NH4+, H+, Na+, K+, Cu2+, Al3+, etc.
Lewis base: OH–, H2O, NH3, Cl–, CN–, S2–, etc.

1. The relative strength of an acid and bases depend on the type of reaction and
cannot be explained on the basis of Lewis theory.
2. A Lewis acid–base reactions involve electrons therefore it is expected to be very
fast reaction, however many Lewis acid–base reactions which are slow.

Buffers are solutions that resist changes in the pH when an acid or alkali is added.
The buffer system has an acid component and salt component. Buffers are prepared
by mixing a weak acid and its salt with a strong base or by mixing weak base and its
salt with a strong acid.

When a strong acid is added, protons are scavenged by the salt component of the
buffer system. Similarly, when an alkali is added, acid component will get deprotonated
and the alkali combines with the proton to form water.
Acetate buffer is made up of acetic acid (CH 3COOH) and sodium acetate
(CH3COONa).
i. When acid like HCl is added to the acetate buffer system, CH3COONa (sodium
acetate) gets converted to CH3COO– (acetate). Acetate combines with the protons
  to give acetic acid, which
released by the strong acids  is a weak acid, and the
change in pH is very small.

ii.When a strong alkali like NaOH is added, OH– combines with H+ released by the
CH3COOH to form water. Na+  combines with acetate to
form sodium acetate.

According to Henderson-Hasselbalch equation, when the concentration of the salt

component and the acid component of the buffer system is equal, pH of the solution
equals pKa. At this pH, buffer can respond equally to both added acid as well as the
alkali.

Generally, buffers are classified into three categories.

1. Acidic buffers
2. Basic buffers
3. Phosphate buffers (double salt buffers).
Acidic buffers: An acidic buffer is a combination of weak acid and its salt with a
strong base, i.e. Weak acid and salt with strong base (conjugate base).
Examples: Mixture of acetic acid and sodium acetate (CH3COOH/CH3COONa),
H2CO3/NaHCO3, H3PO4/NaH2PO4, HCOOH/HCOONa.
The pH of acid buffer can be calculated from the dissociation constant, Ka of the
weak acid and the concentrations of the acid and salt used.
HA  H+ + A-
pOH = pKb – log [base]/[salt]
or pOH = pKb + log [salt]/[base] (2.3)
Equation (2.3) is called Henderson-Hasselbalch equation for base. It helps in
calculating the pOH value of buffer solution, if the concentrations of base as well as
that of the salt are known.
Basic buffers: A basic buffer is a combination of weak base and its salt with a strong
acid, i.e. weak base and salt with strong acid (conjugate acid).
Examples: Mixture of ammonium hydroxide and ammonium chloride (NH4OH/
NH4Cl), NH3/NH4Cl, NH3/(NH4)2CO3.
The pH of basic buffer can be calculated from the dissociation constant, Kb of the
weak base and the concentrations of the base and salt used.
BOH  B+ + OH–
pOH = pKb – log [base]/[salt]
or pOH = pKb + log [salt]/[base] (2.4)
 Equation (2.4) is called Henderson-Hasselbalch equation for base. It helps in
calculating the pOH value of buffer solution, if the concentrations of base as well as
that of the salt are known.
pKw = pH + pOH
pOH = 14 – pH
Equation (2.4) can be rewrite as
14 – pH = pKb – log [base]/[salt]
–pH = pKb – 14 – log [base]/[salt]
pH = 14 – pKb + log [salt]/[base] (2.5)
Phosphate buffers (double salt buffers): Besides the two general types of buffers
(i.e. acidic and basic), a third appears to exist.
This is buffer system composed of two salts: Monobasic potassium phosphate
(KH2PO4), dibasic potassium phosphate (K2HPO4).
Neutral buffer solution: It is having mixture of weak acid and weak base.
Example: Mixture of acetic acid and ammonium hydroxide.

The resistance of a buffer solution to a change in pH is known as buffer action even

when small amount of acid or base is are added to its solution.
Pure water is considered to ionize into a small degree and represented by following
equation.
Hydrogen ion concentration
H2O  H+ + OH–
[H  ] [OH – ]
K 
[H 2 O]
K[H2O] = [H+] [OH–]
Kw = [H+] [OH–]
where Kw is an ion product constant. It is expressed by only the concentration of ionic
substances on the right hand side of the reaction. It has a constant value at 25°C of
1 × 10–14. So
[H+] [OH–] = 1 × 10–14
In pure water both the concentrations of ions are equal such as value of 1 × 10–7 M
[H+] = [OH–] = 1 × 10–7
If acid or base is added to the water, hydrogen ion concentration is greater than
hydroxide ion concentration. So, the value of hydrogen ion concentration (pH) is
10–7 gm ion per liter.
pH of the buffer: Sorenson introduced the practical concept of expressing acidity
that is pH scale. Negative logarithm (to the base 10) of hydrogen ion concentration is
called pH. It is expressed as gram equivalent per liter or mole per liter.
pOH term is defined as negative logarithm of hydroxyl ion concentration.
pH = –log [H+]
= –log 1/[H+]
 In pure water H+] = [OH–] = 1 × 10-7
pH = –log [1 × 10–7] = –Log 1 + Log 107
=7
Hence, the pH scale range from 0–14.
In Neutral solution [H+] = [OH–] ions are equal.
[H+] ions are high then the solution is acidic
[H+] > [OH–] (pH is < 7)
[H+] ions are low then the solution is basic
[H+] < [OH–] (pH is > 7)
Relationship between pH and pOH.
Ionic product of water is given by
Kw = [H3O+] [OH–]
Take a log on both sides
Log Kw = Log [H3O+] [OH–]
Log Kw = Log [H3O+] + Log [OH–]
By multiplying by –1 by both sides
–Log Kw = –Log [H3O+] – Log [OH–]
Considered pH = –Log [H3O+]
and pOH = –Log [OH–]
pKw = pH + pOH
= –Log Kw [Kw = 10–14]
so –Log Kw = –log (10–14)
pKw = (–14) Log 10 [Log 10 =1]
= 14 Log 10
= 14
By this equation, the pH of a buffer solution can be calculated from the initial
concentrations of the weak acid and the salt provided when Ka is given. However, the
Henderson equation for a basic buffer will give pOH, and so pH can be calculated as;
pkw = pH + pOH
or pH = pkw – pOH
= 14 – pOH or pOH = 14 – pH
Also, the dissociation constant of a weak acid (pKa) or a weak base (pKb) can be
calculated by measuring the pH of a buffer solution containing equimolar
concentrations of the acid (or base) and the salt.

1. Calculate the pH of a buffer solution containing 0.03 moles/liter of acetic acid and
0.1 moles/liter of sodium acetate. pKa for CH3COOH is 4.57.
Solution:
Conc. of acid = 0.03 M
Conc. of salt = 0.1 M
so, pH = pKa + log [salt]/[acid]
= 4.57 + log 0.1/0.03
= 4.57 + 0.52
= 5.09
Result: The pH of the buffer solution containing 0.03 M of acetic acid and 0.1 M of
sodium acetate is 5.09.
2. Calculate the pH of a buffer solution containing 0.25 moles/liter of formic acid
(HCOOH) and 0.10 moles/liter of sodium formate (HCOONa). Ka for formic acid
is 1.8 × 10–4.
Solution:
Conc. of acid = 0.25 M
Conc. of salt = 0.10 M
Ka = 1.8 × 10–4
and pKa = –log Ka = –log 1.8 × 10–4
= –(log 1.8 × 10–4) = – (log 1.8 + log 10–4)
= –[0.25 + (–4)] = –(–3.75) = 3.75
so, pH = pKa + log [salt]/[acid]
= 3.75 + log 0.10/0.25
= 3.75 – 0.397
= 3.34
Result: The pH of a buffer solution containing 0.25 M of formic acid and 0.10 M of
sodium formate is 3.34.

The buffer capacity of a buffer solution is “a measure of its magnitude of its resistance
to change in the pH on an addition of an acid or a base.” Buffer capacity is also referred
as buffer index, buffer value, buffer efficiency or buffer coefficient or capacity of the buffer to
resist the change in the pH of a solution when an acid or alkali is added is called
buffering capacity. It is estimated by calculating the amount of acid or alkali required
to change the pH of 1 L of buffer by 1 unit.
Buffering capacity depends upon the following factors:
1. The concentration of the acid and base component of the buffer: As the
concentration of acid and base component of the buffer increases, buffering
capacity of the buffer also increases.
2. The pH of the buffer: Buffer can act best at pH = pKa, and its buffering range is
about one pH unit above or below the pKa value.
The buffer capacity represented by  may also be defined as the ratio of the increment
(amount added) of strong acid or base to the small change in pH (pH) brought about
by this addition.
 = A or B/pH
where, A or B represents the small increment (in gram equivalents/liter of strong
acid or base added) to the buffer to bring about a pH change of pH.
According to the above equation, a solution has a buffer capacity of 1 when 1 L of it
requires 1 gm equivalent of a strong acid or base to change the pH by 1 unit. So,
smaller the pH change in a solution upon the addition of an acid or base, greater is the
buffer capacity and vice versa.

Prepare a buffer solution of pH 5 from acetic acid (CH3COOH) and CH3COONa.

Required:
• pH = 5
• pKa = 4.7
• Molar concentration of acid = 1 M
• Molar concentration of base = x M = ?
So, by putting above information in equation, we get:
pH = pka + log [salt]/[acid]
5 = 4.7 + log [x]/[1]
5 – 4.7 = log x – log 1
as log 1 = 0,
0.3 = log x
x = log – 0.3 (‘log –’ means antilog)
=2
Result: In order to prepare buffer solution of pH 5, acetic acid CH3COOH and
sodium acetate CH3COONa must be mixed in a ratio of 1 M : 2 M.

In biological systems: The pH of blood is maintained at about 7.4 by two buffer

systems. That are:
a. Primary buffers: These are present in plasma. The plasma contains carbonic acid/
carbonate and acid/alkali sodium salt of phosphoric acid.
b. Secondary buffers: These are present in erythrocytes which are oxyhemoglobin/
hemoglobin and acid/alkali potassium salts of phosphoric acid.
In pharmaceutical systems: Buffers are widely used in the field of pharmacy as
ingredients in most of the pharmaceutical formulations in order to adjust the pH of
the product to that required for maximum stability. It also plays vital role in ensure
the solubility of the system:
a. Solubility: Buffers control the solubility of the medicinal compound by providing
a suitable and stable pH media. Many inorganic salts like phosphates, borates are
soluble in acid media but precipitate out in basic media. Organic compounds with
acidic functional groups are soluble in basic media.
b. Stability: Certain compounds when exposed to redox conditions undergo
decomposition due to auto-oxidation, e.g. ascorbic acid and penicillin is unstable
in basic pH, nitrite becomes brown in acidic media due to formation of nitrogen
oxides.
c. Solid dosage form: Buffers have been widely for controlling the pH of the
environment around the solid particles. This has practical application for the
drugs that have dissolution rate limited absorption from unbuffered solutions.
Gastric irritation caused by acidic drugs is reduced with application of buffers,
e.g. antacids are used for the purpose of reducing toxicity.
 d. Semi-solid dosage form: Buffers are used to maintain their stability in semi-solid
preparations. Due to long storage time, they undergo pH changes, resulting in its
reduced stability. Citric acid, sodium citrate or phosphoric acid/sodium
phosphate is used.
e. In parenteral preparations (i.e. injections): In case of parenteral preparations, pH
should be considered carefully as large deviations of pH may lead to serious
consequences. The ideal pH of a parenteral product is 7.4, which is pH of blood.
The most commonly used buffers in parenteral products (injections) are acetate,
phosphate, citrate and glutamate.
f. In ophthalmic preparations: Buffers are generally used in ophthalmic prepara-
tions to maintain the pH within the physiological pH range of lacrimal fluid (i.e.
eye fluid). The lacrimal fluid has a pH in range 7–8, but it has good buffering
capacity and can tolerate preparations having pH values between 3.5 and 10.5
with little discomfort. Outside this range (i.e. 3.5–10.5), increase lacrimation may
occur with other complications. The buffering agents most commonly used in
ophthalmic preparations include borate, carbonate and phosphates.
g. In ointments and creams: Topical products (which are used on skin) such as
ointments and creams are also buffered to ensure stability of the formulation. The
most commonly used buffers in ointments and creams are citric acid/its salts and
phosphoric acid/its salts.

Buffer solutions are mentioned in the pharmacopoeia under appendix for solutions
and reagents. There are two kinds of buffer solutions.
1. Standard buffer solutions
2. Other buffer solutions
Standard buffer solutions: These are solutions which have standard pH which is
used to fulfil many pharmacopeial tests that require adjustments or maintenance of a
specific pH and for reference purposes in pH measurements. Appropriate combinations
of 0.2 M HCl or 0.2 M NaOH is required for preparation of standard buffer solutions
for various ranges of pH values between 1.2 and 10.
Composition of standard buffer solutions:
Name of buffer pH Method of preparation
Hydrochloric acid buffer 1.2–2.2 Measure and transfer 50 ml of the 0.2 M KCl and add
specified quantity of 0.2 M HCl and then dilute the solution
with water up to 200 ml
Acid phthalate buffer 2.2–4.0 Measure and transfer 50 ml of the 0.2 M potassium
hydrogen phthalate and add specified quantity of 0.2 M
HCl and then dilute the solution with water up to 200 ml
Neutralized phosphate 4.2–5.8 Measure and transfer 50 ml of the 0.2 M potassium hydro-
buffer gen phthalate and add specified quantity of 0.2 M NaOH
and then dilute the solution with water up to 200 ml
Phosphate buffer 5.8–8.0 Measure and transfer 50 ml of the 0.2 M potassium
dihydrogen phosphate and add specified quantity of 0.2 M
NaOH and then dilute the solution with water up to 200 ml
Alkaline borate buffer 8.0–10.0 Measure and transfer 50 ml of the 0.2 M boric acid and KCl
and add specified quantity of 0.2 M NaOH and then dilute
the solution with water up to 200 ml
 Other buffer solutions: A large number of various buffer solutions are mentioned
in the Appendix of Indian Pharmacopoeia along with the method of preparation, e.g.
acetate buffer solutions in various pH, ammonia buffer solution and phosphate buffer
solution.

Isoelectric point: The isoelectric point of the protein is the pH at which any given
protein has no charge or zero charge due to an equal number of positive and negative
charges. In protein purification and electrophoresis, this property has important
biochemical implications.
Pharmaceutical preparations which are meant for application to delicate membranes
of the body should adjust to some osmotic pressure as that of body fluids.
Osmosis: It is the process in which solvent molecules cross the semipermeable
membrane from lower to higher concentration to establish concentration equilibrium.
Osmotic pressure: The pressure driving osmosis is called osmotic pressure and it is
colligative property governed by the number of “particles” of solute in solution.

It is a measure of the osmotic pressure of two solutions separated by a semipermeable

membrane. Tonicity of the solution mainly depends on the number of particles present
in the solution.
Isosmotic solutions: Solutions that have the same osmotic pressure. An isosmotic
solution containing specific amount of drug is isotonic to blood only when blood cells
are impermeable to the solute (drug) molecules and permeable to solvent molecules.
Osmolality and osmolarity are the two colligative properties which measure the
concentration of solutes independently of their ability to cross the membrane.
Osmolality means amount of osmotically active particles present in the solution. It is
denoted by milliosmole or osmole.
Isotonic solution: Two solutions having the same osmotic pressure as a specific
body fluid.
Isotonic solutions should not cause no swelling or no contraction when in contact
with tissues and produce no discomfort when used with nasal tract, blood, eye and
other body tissues.

Based on solute concentration, there are three types of solutions in our body.
1. Isotonic solution: In this type of solution concentration of solute is same in both
inside and outside of the cell, e.g. a small quantity of blood is mixed with a
solution containing 0.9% NaCl, the cell retain their normal size.
2. Hypotonic solution: The concentration of solute is greater in inside of the cell
than outside, e.g. the blood is mixed with a 0.2% NaCl solution causing them to
swell and finally burst.
3. Hypertonic solution: The concentration of solute is greater in outside of the cell
than inside of it, e.g. red blood cells are suspended in a 2% NaCl solution causes
shrinkage.
 Hypertonic Isotonic Hypotonic
NaCl 2% NaCl 0.9% NaCl 0.2%
Solute < solute Solute = solute Solute > solute
Inside outside Inside outside Inside outside
Shrinkage Equilibrium Swelling

Reasons for maintenance of isotonicity:

1. The formulations of the parenteral product should be isotonic with in vivo body
fluids.
2. If any isotonicity and pH differences may cause irritation, hemolysis, necrosis and
tissue toxicity.
3. Ophthalmic solutions should be isotonic with lacrimal fluid (tears) to prevent
irritation and pain.
4. Similarly, injectable solutions should be isotonic with blood plasma.
On injecting the hypotonic solution into bloodstream.
• It may enter the red blood cells in an attempt to produce equilibrium
• The cells swell rapidly until they burst leading to hemolysis
• As this damage is irreversible may lead to serious danger to red blood cells.
When hypertonic solution is injected into the bloodstream:
• The water comes out of the membrane of red blood cells in order to reach the
equilibrium
• The cells shrink leading to crenulations which is only a temporary damage
• When the osmotic pressure of two solutions becomes equal, the shrinking cells
will come to its original position.

In various pharmaceutical preparations, many drugs and chemicals are used and these
substances contribute to maintain the tonicity of the solution. Therefore, various
methods are used to measure and adjust the tonicity. There are two methods are used
to measure the tonicity of the solution.
1. Hemolytic method: In this method, to examine the effect of various solutions of
the drug is observed on the appearance of red blood cells in the solution. The
appearance of red blood cells is observed for swelling, shrinking, wrinkling and
bursting of the blood cells. A quantitative method developed by hunter, based on
the concept of that hypotonic solution liberates oxyhemoglobin released is
proportional to the number of cells hemolyzed. In hypertonic solutions, the cells
shrink and become wrinkled, whereas in case of isotonic solutions the cells do not
undergo any change. Van’t Hoff ‘i’ factor of drug solution can be determined.
2. Determination of slight temperature difference: Isotonicity values are
determined by slight temperature difference is measured from difference in the
vapor pressure of thermally insulated samples present in the humidity chamber,
e.g. freezing point of blood and tears and it was necessary to make solutions
isotonic with these fluids. Freezing point of both was found to be –0.52°C. This
temperature is analogous to the freezing point of a 0.9% NaCl solution, therefore
which is considered to be isotonic with blood and lacrimal fluid.
 3. Using Liso values: Isotonicity is also measured from colligative properties of the
solutions. Freezing point depression (Tf) property is most widely used.
Tf = Lc
L value can be find out from the freezing point depression of solutions of a given
ionic type at a concentration of c. L is denoted as Liso.

There are several methods used to adjust the isotonicity of the pharmaceutical
substances by which amount of NaCl, dextrose and other substances can be calculated
to include them to solutions of drugs to make them isotonic. The amount of adjusting
agents to be added is easy to determine by using the appropriate calculations based
on colligative properties of the solutions. It helps to overcome the side effects due to
drug administration which containing adjusting agents.
The methods are divided into two classes.
Class I methods: Add a material to a hypotonic solution to adjust the freezing point
depression (FPD) to –0.52°C.
a. Cryoscopic method: Calculate how much sodium chloride required to further
drop FPD by X°C.
Freezing point depression (FPD)
0.52 – a
w% 
b
where w% is conc. gm/100 ml of adjusting substance
a is FPD of 1% of unadjusted substance (table) X percentage strength
b is FPD of 1% of adjusting substance, i.e NaCl

How much NaCl is required to render 100 ml of a 1% soln. of apomorphin HCl isotonic?
FPD of 1% NaCl = 0.58°
FPD of 1% drug = 0.08°
0.52 – a
w% 
b
0.52 – 0.08

0.58
= 0.76%
1% drug  0.08° (0.52° – 0.08° = 0.44°C)
1% NaCl  0.58°
w% NaCl  0.44° W% = 0.76%
Thus, 0.76% NaCl will lower the freezing point by 0.44°C and will render the solution
isotonic.

Adjust isotonicity of procaine HCl 3% using NaCl?

FPD of 1% NaCl = 0.57°
FPD of 1% drug = 0.112°
 0.52 – a
w% 
b
0.52 – (0.112 * 3)

0.576
= 0.32 gm/100 ml  NaCl
b. Sodium chloride equivalence: Calculate contribution of drug in terms of sodium
chloride equivalent and make up to 0.9% with addition of NaCl. NaCl equivalent
is denoted by “E”.
Amount of NaCl that is equivalent to [i.e. has the same osmotic effect (same FPD)
as] 1 gm of drug. First calculate ENaCl and second add NaCl to reach 0.9%
To calculate amount of NaCl by
w% = 0.9 – (drug% × ENaCl)
w% = weight of NaCl in gm per 100 ml (to make solution isotonic)
drug% = weight of drug in gm per 100 ml
ENaCl = NaCl equivalent weight to 1 gm of drug
0.9 = Isotonic solution of NaCl

Calculate ENaCl of drug (M·wt = 187, Liso= 3.4)?

17 Liso (drug)
ENaCl 
M  wt drug

= 0.31 gm
(0.31 g (NaCl) = 1 gm (drug)
(0.62 g (NaCl) = 2 gm (drug)
0.9 – 0.62 = 0.28 gm (NaCl)
=  2 gm drug, 0.28 gm NaCl complete with water to 100 ml

Calculate amount of NaCl needed to adjust 1.5% atropine SO4.

ENaCl = 0.12 g
= 0.9 – (W × E)
= 0.9 – (1.5 × 0.12)
= 0.72 gm of NaCl should be added
Thus, it require 1.5 gm of drug and 0.72 gm of NaCl.
Class II methods: Start with drug powder, make an isotonic drug solution, then
make up to final volume with isotonic salt solution or isotonic buffer: a. White-Vincent
method, b. Sprowls method.
a. White-Vincent method: The class II methods of calculating tonicity involve the
addition of water to the drugs to make an isotonic solution than add isotonic
vehicle to bring solution to final volume.
 White-Vincent introduces simplified equation for calculating the volume of
isotonic solution prepared by mixing drug with water.
v = w × ENaCl × 111.1
where v = Volume of H2O
w = Weight of drug
111.1 = 100/0.9

Suppose preparing 30 ml of 1% drug isotonic with body fluid (ENaCl = 0.16 gm)
1 gm  100 ml
?  30 ml = 0.3 gm
Amount of NaCl eq. to 0.3 drug
= 0.3 × 0.16 = 0.048 gm
• 0.9 gm  100 ml
• 0.048 gm ? ml = 5.3 ml
V = 0.3 × 0.16 × 111.1 = 5.3 ml

Add volume of H2O and then complete with isotonic solution

• Phenacaine HCl 0.06 gm (ENaCl = 0.16)
• Boric acid 0.3 gm (ENaCl = 0.5)
• Sterile distilled H2O up to 100 ml
V = 111.1 × (weight × ENaCl)
V =111.1 × [(0.06 × 0.16) + (0.3 – 0.5)]
= 17.7 ml H2O
b. Sprowls method: The equation V = 0.3 × 0.21 × 111.1, could be used to construct a
value of V, when the weight of drug W is fixed. Sprowls choose the weight of drug
is 0.3 gm, the quantity for 1 fluid ounce of 1% solution. Compute the volume V of
isotonic solution of 0.3 gm drug with sufficient water, for drugs commonly used
in parenteral and ophthalmic preparations.

The addition of any compound to a solution will affect the isotonicity since isotonicity
is a property of the number of particles in solution. So, the osmotic pressure of a
solution will be affected not only by the drug but also by any buffer compounds that
are included in the formulation. But after these compounds have been added, it is still
possible that the solution will not be isotonic. It may be necessary to add additional
sodium chloride to bring the solution to isotonicity.

1. Acid is a:
a. Proton donor b. Ligand donor
c. Proton acceptor d. All of the above
 2. When acid and base is mixed:
a. New acid formed b. No reaction occurs
c. Salt and water formed d. New base formed
3. ...... is also known as slaked lime.
a. Calcium chloride b. Calcium hydroxide
c. Calcium carbonate d. Calcium fluoride
4. Which one of the following buffer is used to maintain acid–base balance in blood?
a. Acidic buffer b. Phosphate buffer
c. Carbonic acid and bicarbonate d. Acetic acid and sodium carbonate
5. ...... methods are used to adjust the tonicity.
a. White-Vincent b. Sprowls
c. Both a and b d. None of the above
6. Commonly used biological buffer for pharmaceutical formulation is ......
a. Acidic buffer b. Phosphate buffer
c. Basic buffer d. None of the above
7. Which one is the conjugate acid–base pair?
a. HCl and OH– b. CH3COOH and OH–
c. HCN and CN– d. None of the above
8. Sodium hydroxide is known as ......
a. Baking soda b. Slaked lime
c. Quick lime d. Spirit of salt
9. ...... is prepared by Haber’s process.
a. Caustic soda b. Strong ammonium chloride
c. Strong ammonium hydroxide d. None of the above
10. The value of hydrogen ion concentration is ......
a. 1 × 10–7 b. 1 × 107
8
c. 1 × 10 d. 1 × 10-8

1. a 2. c 3. b 4. c 5. c 6. b 7. c 8. d 9. c 10. a

1. Base has ...... taste.

2. Acid turns ...... litmus .......
3. pH can be measured by .......
4. pH = pKa + .......
5. pH of blood in human body is .......
6. Buffers are solutions that resist changes in the .......
7. ....... is a measure of the osmotic pressure of two solutions separated by a semi-
permeable membrane.
8. The concentration of solute is greater in outside of the cell than inside of it is
known as .......
9. ....... means amount of osmotically active particles present in the solution.
10. The ...... of the protein is the pH at which any given protein has no charge or zero
charge due to an equal number of positive and negative charges.
 1. Bitter
2. Blue, red
3. pH meter
4. [Conjugate base]/[Weak acid]
5. 7.3–7.4
6. pH
7. Tonicity
8. Hypertonic solutions
9. Osmolality
10. Isoelectric point.

1. Define buffers with examples.

2. Explain the type of buffer solution.
3. Write any three pharmaceutical applications of buffers.
4. Describe the mechanism of action of buffer.
5. What is isoelectric point?
6. What do you understand the term buffer capacity? Give a note on factors affecting
buffer capacity.
7. Discuss the method of preparation of some standard buffer solutions.
8. Enumerate the buffered isotonic solutions.
9. Define isotonic solutions.
10. Differentiate buffer system and buffer capacity. Explain how buffer system resists
small changes in pH.
11. Discuss the various acid–base theories in detail.
12. What do you understand the term conjugate acid–base pairs?
13. Discuss the different methods for adjustment of tonicity.
14. Explain methods used for the measurement of tonicity.
 • Introduction • Calcium Gluconate
• Major Physiological Ions • Oral Rehydration Salt (ORS)
• Electrolyte Replacement Therapy • Physiological Acid–Base Balance
• Sodium Chloride • Important Questions/Answers
• Potassium Chloride

Body fluids are mainly consist of inorganic and organic substances. In cell and tissues,
these components should be in balance to maintain the constant environment. Despite
of various changes in life, stress introduced by diseases, the volume and composition
of the body fluids are continued to be remarkably constant by considerably varying
from one compartment to another. The electrolyte concentration in various body fluids
is maintained constant in healthy person.
Electrolytes are minerals that carry an electric charge when they are dissolved in a
fluid (suitable ionizing solvents). It is a substance when dissolved in solution separates
into ions and is able to carry an electrical current. This includes most soluble acids,
bases and gases. It dissociates into cations (positively charged electrolyte) and anions
(negatively charged electrolyte). The internal homeostasis is preserved by various
regulatory mechanisms operating in the body which are capable to control pH, ionic
balances, osmotic balance, etc. which in turn maintain the concentration of solutes in
various fluids.
Electrolytes are used in replacement therapy and for correction of ionic balance in
various body fluids. The electrolyte concentration will vary with a particular fluid
compartment. The total body fluids are divided into three compartments. The various
body fluids are:
1. Intracellular fluid: It is present inside the cell, e.g. cytoplasm, fluid within the cell
constitutes 45–50% of body weight and its volume in 30 liters.
2. Extracellular fluid (ECF): The fluid present in the interstitial and vascular
compartments are referred to collectively known as extracellular fluid.
3. Interstitial fluid: This is the fluid which is present between the cells. This
constitutes 12–15% of body weight and its volume in 10 liters.
4. Plasma or vascular fluid: This is the fluid which is present within the blood
vascular system. This constitutes 4–5% of body weight and its volume in 3–5 liters.
(of body weight).
 5. Transcellular fluid: Fluids inside the GIT, humor of eye, excretory system,
glands, cerebrospinal, pericardial and synovial fluid.
All the body fluids are composed of electrolytes (solutions of inorganic and organic
solutes). All these fluids have different concentration of electrolytes and all the fluid
compartments are separated from each other by membranes that are permeable to
water and many organic and inorganic solutes. They are nearly impermeable to
macromolecules such as proteins and are selectively permeable to certain ions such as
Na+, K+, Mg2+. Each fluid compartment has a distinct solute pattern [sodium and
chloride are found in the plasma and interstitial fluids while potassium and phosphate
(HPO 2–4 ) are found in intracellular fluid]. The solution in each compartment is ionically
balanced.
The major electrolytes found in the body are sodium, potassium, calcium,
magnesium, chloride, bicarbonate, phosphate and sulfate.

Ions Plasma Interstitial Intracellular

(mEq/L) fluid (mEq/L) fluid (mEq/L)
Cations
Na+ 142 145 10
K+ 4 4 160
Mg2+ 5 3 –
Ca2+ 3 2 35
Totals 154 154 205
Anions
HCO –3 27 30 8
Cl– 103 115 2
HPO 24 – 2 2 140
SO 24 – 1 1 –
Organic
Acids 5 5 –
Protein 16 1 55
Totals 154 154 205

The amount intake and output of water maintain the electrolyte balance in the body.
The average daily intake is 2500 ml [intake by fluids, food and metabolic water] and
average daily output is 2500 ml [excreted by urine, feces, perspiration, insensible
perspiration].
The concentrations of individual ions are expressed by mEq/L (milliequivalents/
liter) rather than weight/volume (w/v). Dosages of individual ions are expressed in
mEq/L. Equivalent weight is obtained by dividing the atomic or molecular weight by
the valence.
mEq/L = mg of substance/L ÷ Eq. wt
= mg of substance/L ÷ (Mol. wt/valence)
Mineral salts (inorganic compounds) are necessary within the body for carrying out
all body processes. Important functions served by electrolytes in general, are as muscle
contraction, nerve impulses, cellular signaling, cellular transport, waste excretion,
maintaining pH balance, physiological function and osmotic balance.

It is the principal cation in the extracellular fluid. More than adequate amounts of
sodium are contained in the daily diet with nearly complete absorption from the
intestinal tract. Excess sodium is excreted by the kidneys which make them the ultimate
regulator of the sodium content of the body. 80–85% of the sodium in the glomerular
filtrate is reabsorbed and this reabsorption is under hormonal control. The main source
of sodium required for our body is table salt which is used for cooking. Normal
concentration of sodium is 135–145 mEq/L.

It plays an important role in:

1. Transmission and conduction of nerve impulses
2. Many processes in the body, especially in the brain, nervous system, and muscles
3. Responsible for osmolarity of vascular fluids
4. Responsible for charge balance in body fluid
5. Regulation of body fluid levels
6. Assists with regulation of acid–base balance by combining with Cl– or HCO 3– to
regulate the balance.
Hyponatremia: Deficiency of sodium (<135 mEq/L) due to:
a. Extreme urine loss in diabetes insipidus (a disease of pituitary gland that secretes
less antidiuretic hormone ADH that causes decreased water permeability of the
collecting duct of nephrons and thus causes large amounts of urine to be
produced).
b. Metabolic acidosis in which the sodium is excreted.
c. Addison’s disease with decreased excretion of ADH hormone, aldosterone.
d. Diarrhea and vomiting.
e. Kidney damage.
Symptoms of hyponatremia are muscle weakness, respiratory depression, headache
and faintness.
Hypernatremia: Increase of sodium (145 mEq/L) is caused by:
a. Hyperadrenalism (Cushing’s syndrome) with increased aldosterone production.
b. Severe dehydration.
c. Certain types of brain injury.
d. Excess treatment with sodium salts.
Symptoms of hypernatremia are thirst, flushed skin, dry mucus membranes, low
urinary output, tachycardia, seizures and hyperactive deep tendon reflexes.
It is the major intracellular cation, present in a concentration approximately 23 times
higher than the concentration of potassium in the extracellular fluid compartments.
This concentration differential is maintained by an active transport mechanism. This
active transport mechanism has been called the sodium-potassium pump. Normal
concentration of potassium is 3.5–5.0 mEq/L (in ECF). The main source of potassium
in food includes milk, meat, some vegetables and whole grains. Human body has
about 2 to 6 per kg weight of potassium.

• It maintains the electrolyte balance in body’s cells

• Manages blood pressure and keeps heart functioning properly
• It involves transmission of nerve impulses
• It helps the muscles contract
• Enhances muscle control, the growth and health of cells
• Promotes efficient cognitive functioning by helping to deliver oxygen to the brain.
Hypokalemia: Decrease of potassium (<3.5 mEq/L) is caused by:
• Inadequate intake (malnutrition)
• Excessive use of diuretics—thiazides, loop diuretics, amphotericin, cisplatin and
mineral/glucocorticoids
• Illness in which postoperative treatment includes IV administration of solutions
(deficient of potassium) for long-time
• While treatment of dehydration or alkalosis with sodium and water, there occurs
depletion of potassium
• GI losses.
Signs and symptoms of hypokalemia are anorexia, nausea, vomiting, drowsiness,
lethargy, confusion, leg cramps, muscle weakness, hyper-reflexia (overactive or over-
responsive reflexes), hypotension, cardiac dysrhythmias and polyuria.
Hyperkalemia: Increase of potassium (>5 mEq/L) is caused by:
• Excessive intake
• Excessive release from cells due to burns, rhabdomyolysis, tumor lysis syndrome
and acidosis
• Decreased excretion due to acute or chronic kidney disease.
Signs and symptoms of hyperkalemia are apathy, confusion, numbness/paresthesia
of extremities, abdominal cramps, nausea, flaccid muscles, diarrhea, oliguria,
bradycardia and cardiac arrest.

In our body 99% of calcium is found in bones. The remaining Ca is found largely in
extracellular fluid. Ca is absorbed from the upper part of the small intestine where the
intestinal contents are still acidic. As the intestinal contents remain neutral to basic,
Ca is precipitate as the CaHPO4, carbonate, oxalate and sulfate salts. Actual absorption
is controlled by parathyroid hormone and metabolite of vitamin D. it is an important
constituent for teeth and bones. The main sources of calcium include milk, cheese,
green vegetables, fish and egg. Normal concentration of calcium in extracellular fluid
is 4–5 mEq/L. Daily requirement of phosphate is 400 mg/day and greater amount is
needed in children and during pregnancy and lactation.

1. Usually combined with phosphorus to form the mineral salts of bones and teeth.
Functionally, 99% of all body Ca is supportive, being found in bone as
hydroxyapatite.
2. Ionic Ca involved in blood clotting, muscle contraction, nerve signaling
(important in the transmission of nerve impulses across synapses).
3. In CVS Ca is essential for contraction in cardiac muscles and for the conduction of
electric impulse in certain regions of heart.
4. It plays role in maintaining the integrity of mucosal membrane, cell adhesion and
function of the individual cell membrane.
Calcium regulated by the parathyroid gland. In parathyroid hormone it helps with
calcium retention and phosphate excretion through the kidneys, promotes calcium
absorption in the intestines and helps mobilize calcium from the bone.
Hypocalcemia: Decrease of calcium (<4 mEq/L) is caused by:
a. Hypoparathyroidism
b. Vitamin D deficiency
c. Osteoblastic metastasis
d. Acute pancreatitis
e. Hyperphosphatemia
f. Bone is the dynamic tissue involving constant exchange of calcium and phosphate
ions with the body fluids. Much of this exchange is under hormonal control.
Signs and symptoms of hypocalcemia are muscle cramps, hyperactive deep tendon,
reflexes, paresthesia of fingers, toes and face, tetany, laryngeal spasms, confusion,
memory loss and cardiac dysrhythmias.
Hypercalcemia: Increase of calcium (>5 mEq/L) is caused by:
a. Excessive intake
b. Excessive use of antacids with phosphate-binding
c. Prolonged immobility
d. Excessive vitamin D intake
e. Thiazide diuretics
f. Cancer
g. Thyrotoxicosis.
Signs and symptoms of hypercalcemia include muscle weakness, personality
changes, nausea and vomiting, extreme thirst, anorexia, constipation, polyuria,
pathological fractures, calcifications in the skin and cornea and cardiac arrest.

It is the second most plentiful cation in the intracellular fluid compartment. Most of
the absorption takes place in the acid medium of the duodenum. Approximately 54%
in bone while approximately 45% in intracellular fluid. Normal concentration of
magnesium is 1.5–2.4 mEq/L. Daily requirement of magnesium is 350 mg. Dietary
source of magnesium is nuts, soybeans, whole grains and sea foods.

• Magnesium cation has a definite pharmacological action

• Role in protein synthesis and carbohydrate metabolism
• Helps in cardiovascular system function (vasodilation)
• Regulates muscle contractions
• Helps in Na+/K+ ATPase pump
• Controls blood sugar level and helps support the body’s defense (immune)
system.
Hypomagnesemia: Serum Mg2+ level <1.5 mEq/L is caused by:
• Poor dietary intake
• Poor GI absorption
• Excessive dietary intake of Ca2+ or vitamin D
• Excessive GI/urinary losses
• Chronic alcoholism
• Excessive diuretic therapy.
Signs and symptoms of hypomagnesemia include muscle weakness, cardiac
arrhythmias, nausea, confusion and anorexia.
Hypermagnesemia: Serum Mg2+ level >3.0 mEq/L is caused by:
• Usually results from renal failure
• Excessive intake
• Untreated diabetic ketoacidosis
• Hypoadrenalism.
Signs and symptoms of hypermagnesemia include lethargy and drowsiness, depress
neuromuscular activity, hypotension, bradycardia and cardiac arrest.

It is the major extracellular anion. Chloride ions principally responsible for maintaining
proper hydration, osmotic pressure and normal cation-anion balance in the extracellular
fluid. Food is the main source of chloride with the anion being almost completely
absorbed from the intestinal tract. Chloride is removed from the blood by glomerular
filtration and possibly is reabsorbed by the kidney tubules. The extracellular fluid
contains 100 to 106 mEq/L chloride. The total chloride ion present in the body is about
50 mEq per body weight and body daily requirement is 5–10 gm as sodium chloride.
The main source of chloride is table salt which is used for cooking.

1. Chloride travels primarily with sodium and water and helps generate the osmotic
pressure of body fluids.
2. It is an important constituent of stomach hydrochloric acid (HCl), the key
digestive acid.
3. Chloride is also needed to maintain the body’s acid–base balance. Chloride may
also be helpful in allowing the liver to clear waste products.
 Hypochloremia: Deficiency of chloride ion concentration is caused by:
a. Salt-losing nephritis (inflammation of the kidney) associated with chronic
pyelonephritis (inflammation of the kidney and its pelvis) leading to a lack of
tubular reabsorption of chloride.
b. Metabolic acidosis such as found in diabetes mellitus and renal failure, causing
either excessive production or diminished excretion of acids leading to the
replacement of chloride by acetoacetate and phosphate.
c. Prolonged vomiting with loss of chloride as gastric hydrochloric acid.
Symptoms of hypochloremia are alkalosis, respiratory depression and muscle spasm.
Hyperchloremia: Increase of chloride ion concentration is caused by:
• Dehydration
• Decreased renal blood flow found in congestive heart failure
• Severe renal damage
• Excessive chloride intake
• Excess loss of bicarbonate ions.

It is the second most prevalent anion in ECF. Bicarbonate levels are measured to monitor
the acidity of the blood and body fluids. The acidity is affected by foods or medications
that we ingest and the function of the kidneys and lungs. Disruptions in the normal
bicarbonate level may be due to diseases that interfere with respiratory function, kidney
diseases and metabolic conditions. Normal arterial bicarbonate is 22–26 mEq/L while
normal venous bicarbonate is 26–30 mEq/L (in venous blood, bicarbonate is measured
as carbon dioxide content).
Each day kidney filters about 4320 milliequivalents of bicarbonate and under normal
conditions all of this is reabsorbed from the tubules, thereby conserving the primary
buffer system of the extracellular fluid. When there is reduction in the ECF hydrogen
ion concentration (alkalosis) the kidneys fail to reabsorb all the filtered bicarbonate
thereby increasing the excretion of bicarbonate.
Because bicarbonate ions normally buffer hydrogen in the extracellular fluid, this
loss of bicarbonate is as good as adding a hydrogen ion to the extracellular fluid.
Therefore, in alkalosis, the removal of bicarbonate ions raises the ECF hydrogen ion
concentration back towards normal. In acidosis, the kidneys reabsorb all the filtered
bicarbonate and produces new bicarbonate which is added back to the ECF. This
reduces the ECF H+ concentration back towards normal, i.e. reverse of acidosis since
(HPO 3– ) is alkaline.

1. The bicarbonate ion acts as a buffer to maintain the normal levels of acidity (pH)
in blood and other fluids in the body.
2. It is the major form in which CO2 is transported.
3. It acts as a base (alkaline substance).

It is principal anion of ICF compartment. Inorganic phosphate in the plasma is mainly

in two forms hydrogen phosphate (HPO –4 ) and dihydrogen phosphate (H 2 PO 4– ). Only
the dihydrogen phosphate anion will be absorbed from the intestines. When pH of
the ECF becomes more acidic there is relative increase in H 2 PO 4– and decrease in HPO –4
and vice versa. Normal concentration of phosphate is 2.5–4.5 mEq/L (in ECF). Daily
requirement of phosphate is 400 mg/day and greater amount is needed in children
and during pregnancy and lactation. Dietary source of phosphate is milk, milk
products, legumes, whole grains and nuts, etc.

1. HPO –4 and H 2 PO 4– make an important buffer system of body.

2. Phosphorus is essential for proper metabolism of calcium, normal bone and tooth
development.
3. The phosphoric acid anhydride linkage is the body’s means of storing potential
chemical energy as adenosine triphosphate (ATP).
4. Hexoses are metabolized as phosphate esters.
Hyperphosphatemia: Increase of phosphate is caused by:
a. Renal failure due to the inability to excrete phosphate into the urine
b. Hypoparathyroidism (lack of parathyroid hormone) permits renal tubular
reabsorption of phosphate which results in decreased urinary phosphate and a
rise in serum phosphate
c. Hypervitaminosis D which increases intestinal phosphate absorption along with
calcium.
Hypophosphatemia: Decrease of phosphate is caused by:
a. Vitamin D deficiency (rickets)
b. Decreased intestinal calcium absorption
c. Hyperparathyroidism
d. Long-term aluminum hydroxide gel antacid therapy.

It is an important component of hemoglobin which carries oxygen in blood. Dietary

sources of iron include green leafy vegetables, millets like bajra and ragi. It is necessary
for growing children and pregnant women. The deficiency of iron causes anemia and
goiter.

Under normal physiological condition, the body is able to adjust the electrolyte balance
while in some conditions such as prolonged fever, severe diarrhea and vomiting, there
occurs heavy loss of water and electrolyte. So, there is a need to administration of lost
electrolyte in appropriate concentration of tonicity is essential. These products include
electrolytes, acids and bases, blood products, carbohydrates, amino acids and proteins.
There are some electrolytes which are used in replacement therapy are sodium chloride
and its salts, such as sodium chloride injection, hypertonic solution, sodium lactate,
potassium chloride and its salts.
There are two types of supply of electrolytes
1. Rapid initial replacement: Solution contains electrolytes with concentration
resemble with the electrolytes concentration found in extracellular fluids.
2. Subsequent replacement: Solution containing lower concentration of electro-
lytes.
Molecular formula: NaCl Molecular weight: 58.44
Category: Pharmaceutical aid (tonicity agent)—fluid and electrolyte replenisher.
IP limit: Sodium chloride contains not <99.0% and not >100.5% of NaCl, calculated
with reference to the dried substance.

1. From sea water: It is prepared by evaporation of sea water.

2. From common salt: Common salt was dissolved in water and subsequently HCl
gas passing through the solution. Crystal of sodium chloride precipitated out.
NaCl (solution) + HCl  NaCl
Properties: It occurs as colorless cubic crystals or as white crystalline powder having
saline taste.
Solubility: It is freely soluble in water, and slightly more soluble in boiling water,
soluble in glycerine and slightly soluble in alcohol.
Storage: Stored in tightly-closed containers.
Acidity or alkalinity: To 20 ml of 20% w/v solution and add 0.1 ml of bromothymol
blue solution; not >0.5 ml of 0.01 M hydrochloric acid or of 0.01 M sodium hydroxide is
required to change the colour of the solution.
Clarity and color of solution: 20% w/v solution is clear and colorless.

Arsenic: Dissolve 10 gm in 50 ml of water and 12 ml of stannated hydrochloric acid

AsT. The resulting solution complies with the limit test for arsenic (1 ppm).
Heavy metals: Not >5 ppm, determined by Method A on a solution of 4 gm in 2 ml
of dilute acetic acid and sufficient water to produce 25 ml.
Iron: 2 gm dissolved in 20 ml of water complies with the limit test for iron (20 ppm).
Loss on drying: Not >1%, determined on 1 gm by drying in an oven at 105°C for 3
hours.

Weigh accurately about 0.1 gm and dissolve in 50 ml of water in a glass-stoppered

flask. Add 50 ml of 0.1 M silver nitrate, 5 ml of 2 M nitric acid and 2 ml of dibutyl
phthalate, shake well and titrate with 0.1 M ammonium thiocyanate using 2 ml of
ferric ammonium sulfate solution as indicator, until the color becomes reddish yellow.
Each ml of 0.1 M silver nitrate is equivalent to 0.005844 gm of NaCl.
Uses: Used as fluid and electrolyte replenisher, manufacture of isotonic solution,
flavor enhancer.

1. Sodium chloride injection: It is a sterile isotonic solution of sodium chloride in

water for injection. It contains not <0.85% and not >0.95% w/v of sodium
chloride. It contains no antimicrobial agents. It is a clear, colorless solution with
pH between 4.5 and 7.
 2. Sodium chloride hypertonic injection (hypertonic saline): It is a sterile solution
of sodium chloride in water for injection. It contains not <1.52% and not >1.68%
w/v of sodium chloride. It contains no antimicrobial agents. It is a clear, colorless
solution with pH between 5.0–7.5.
3. Compound sodium chloride injection (Ringer injection): It contains not <0.82%
and not >0.9% w/v of sodium chloride, not <0.0285%, not >0.0315% w/v of
potassium chloride and not <0.03% and not >0.036% w/v of calcium chloride in
water for injection. It contains no antimicrobial agents. It is a clear, colorless
solution with pH between 5 and 7.5.
4. Sodium chloride and dextrose injection: It is a sterile solution of sodium chloride
and dextrose in water for injection. It is clear colorless or faintly straw colored
solution with pH between 3.5 and 6.5. It contains not <95% and not >105% w/v
of the stated amount of sodium chloride and dextrose.

Molecular formula: KCl Molecular weight: 74.56

Category: Electrolyte replenisher.
IP limit: Potassium chloride contains not <99% and not >100.5% of KCl, calculated
with reference to the dried substance.

It is prepared by the reaction of hydrochloric acid with potassium carbonate or

bicarbonate
K2CO3 + HCl  2KCl + CO2 + H2O
KHCO3 + HCl  KCl + CO2 + H2O
Properties: It occurs as colorless crystals or white, crystalline powder and odorless.
It is having saline taste.
Solubility: Freely soluble in water—practically insoluble in ethanol and in ether.
Storage: Stored in tightly-closed containers.
Acidity or alkalinity: 5 gm dissolved in 50 ml of carbon dioxide-free water requires
not >0.5 ml of 0.01 M sodium hydroxide or 0.01 M hydrochloric acid for neutralization
to bromothymol blue solution.
Clarity and color of solution: 10% w/v solution is clear and colorless.

Arsenic: Dissolve 10 gm in 50 ml of water and add 10 ml of stannated hydrochloric

acid AsT. The resulting solution complies with the limit test for arsenic (1 ppm).
Heavy metals: Not >10 ppm, determined by Method A on 2 g dissolved in 10 ml of
water to which are added 2 ml of dilute acetic acid and 13 ml of water.
Iron: 20 ml of solution A complies with the limit test for iron (20 ppm).
Loss on drying: Not >1%, determined on 1 gm by drying in an oven at 105°C.
Weigh accurately about 0.15 gm, dissolve in 50 ml of water and titrate with 0.1 M
silver nitrate using potassium chromate solution as indicator. Each ml of 0.1 M silver
nitrate is equivalent to 0.007455 gm of KCl.
Uses: Electrolyte replenisher in potassium deficiency, familial periodic paralysis,
myasthenia gravis.

Molecular formula: C12H22CaO14·H2O Molecular weight: 448.40

Category: Calcium replenisher.
IP limit: Calcium gluconate contains not <98.55 and not >102% of C12H22CaO14·H2O.

It is prepared by boiling the solution of gluconic acid with calcium carbonate.

Properties: It occurs as white, crystalline powder or granules, odorless and tasteless.

Solubility: Sparingly soluble in water but freely soluble in boiling water; insoluble
in ethanol (95%).
Storage: Store in well-closed containers.
Acidity or alkalinity: Dissolve 0.5 gm in 20 ml of water, add 0.1 ml of 0.01 M
hydrochloric acid and 0.1 ml of phenolphthalein solution; no color is produced. Add
0.3 ml of 0.01 M sodium hydroxide; a pink color is produced.
Clarity and color of solution: A 2% w/v solution at 60o is not more intensely colored
than reference solution YS6, on cooling to room temperature the solution is not more
opalescent than opalescence standard OS2.
Arsenic: Dissolve 5 gm in 50 ml of water and 12 ml of stannated hydrochloric acid. The
resulting solution complies with the limit test for arsenic (2 ppm).
Heavy metals: Not >20 ppm, determined by Method A on 1 gm dissolved in 4 ml of
dilute hydrochloric acid and sufficient water to produce 25 ml.
Chloride: 1 gm complies with the limit test for 250 ppm of chloride.
Sulfate: 1 gm complies with the limit test for sulfates (150 ppm).
Weigh accurately about 0.5 gm and dissolve in 50 ml of warm water; cool, add 5 ml of
0.05 M magnesium sulfate and 10 ml of strong ammonia solution and titrate with 0.05 M
disodium edetate using mordant black II mixture as indicator. From the volume of 0.05 M
disodium edetate required subtract the volume of the magnesium sulfate solution added.
Each ml of the remainder of 0.05 M disodium edetate is equivalent to 0.02242 gm of
C12H22CaO14·H2O.
Uses: An excellent source of calcium in oral treatment of calcium deficiency.

1. Calcium gluconate injection: Calcium gluconate injection is a sterile solution of

calcium gluconate in water for injection. Not >5% of the calcium gluconate may
be replaced with a suitable calcium salt as a stabilizing agent.
Usual strengths: The equivalent of 500 mg and 1 gm of calcium gluconate in 5 ml;
the equivalent of 1 gm of calcium gluconate in 10 ml. (A 10% w/v solution of
calcium gluconate contains approximately 0.45 mmol of Ca++ per ml).
2. Calcium gluconate tablets:
Standards: Calcium gluconate tablets contain not <95% and not >105% of the
stated amount of calcium gluconate, C12H22O14Ca·H2O.
Usual strengths: 325 mg, 500 mg, 650 mg, 1 gm.
Storage: Stored in well-closed containers.

Oral rehydration salts are dry, homogeneously mixed powders containing dextrose,
sodium chloride, potassium chloride and either sodium bicarbonate or sodium citrate
for use in oral rehydration therapy after being dissolved in the requisite amount of
water. Composition of the formulation in terms of the amount (in gm) is to be dissolved
in sufficient water to produce 1000 ml in ancient times home-made ORS is used which
contains 1 tablespoonful of salt and 2 tablespoonful of sugar in 1000 ml of water.

S. Salt name Gram Electrolytes mmol/L

no.
1 Sodium chloride 2.6 Sodium 75
2 Dextrose (anhydrous) 13.5 Potassium 20
3 Dextrose monohydrate 14.85 Chloride 65
4 Potassium chloride 1.5 Citrate 10
5 Sodium citrate 2.9 Dextrose 75

Role of each ingredient:

1. Water: Water is the essential ingredient to a rehydration solution, as a solvent.
2. Sodium chloride: Sodium and chloride is a replenisher.
3. Glucose (dextrose): It provides energy to the cells.
 4. Potassium chloride: Potassium also acts as a replenisher.
5. Trisodium citrate dihydrate: Buffering agent.
Properties: A white to creamy-white, amorphous or crystalline powder, odorless.
The total osmolar concentration of the solution in terms of mOsm per liter is 245.
Storage: Store protected from moisture in sachets, preferably made of aluminum
foil, containing sufficient powder for a single dose or for a day’s treatment or for use
in hospitals, in bulk containers containing sufficient quantity to produce a volume of
solution appropriate to the daily requirements of the hospital concerned.
Uses: It is used as an excellent source of electrolytes like sodium potassium and
chloride. It is used for the treatment of dehydration in heavy water loss and electrolyte
replacement therapy. It is also used as energy source. It is used in cases of severe
vomiting, diarrhea and prolonged fever.

Body fluids are having balanced quantity of acids and bases and this is maintained by
intricate mechanism. Balance depends on regulation of free hydrogen ions and
concentration of hydrogen ions is measured in pH. The maintenance of this balance
quantity is essential for biochemical reactions taking place in the body and are very
sensitive even a small changes in acidity or alkalinity. Arterial blood gases are the
major diagnostic tool for evaluating acid–base balance. The pH values of certain body
fluids are given as follows:
Body fluid pH value
Gastric juice 1.5–3.5
Saliva 5.4–7.5
Bile 6.0–8.5
Blood 7.4–7.5
Semen 7.2–7.6
Urine 4.5–8
Acidosis and alkalosis conditions are generated due to change in body pH. Acidosis
(pH <7.35) caused by accumulation of acids or by a loss of bases and alkalosis
(pH >7.45) occurs when bases accumulate or acids are lost.
Acids are continuously being produced during metabolism. Since most metabolic
reaction occurs only within a very narrow pH range, the body utilizes several buffer
systems. Three of the major buffer systems in the body are:
1. Bicarbonate/carbonic acid found in plasma and kidneys.
2. Phosphate/dihydrogen phosphate found in the cells and kidney.
3. Hemoglobin buffer system which is the most effective single system for buffering
carbonic acid produced during metabolic processes.
Carbon dioxide is continuously produced in the cells. It diffuses from the cells into
the plasma where a small portion is dissolved and another small portion reacts with
the water to form carbonic acid. The increased carbonic acid is buffered by plasma
protein. Most CO2 enters the erythrocytes where it either rapidly forms carbonic acid
by the action of carbonic anhydrase or combines with hemoglobin.
 The tendency to lower the pH of the electrolyte due to increased concentration of
carbonic acid is compensated by hemoglobin.
Carbonic
 H 2 CO 3 
anhydrase
CO2 + H2O   H   HCO 3–
Bicarbonate anion then diffuses out of the erythrocyte and chloride anion diffuses
in this has been named chloride shift. The bicarbonate in plasma along with the plasma
carbonic acid, now acts as an efficient buffer system.
H2CO3 + K+ + HbO 2–  K   HCO 3–  HHb  O 2
Most metabolic reactions take place only within a very narrow pH range; homeo-
stasis of H+ concentration becomes essential for survival and is done by involving the
following three major mechanisms:
1. Respiratory system
2. Chemical buffer system
3. Kidneys.

The above process is reversible in lungs due to large amounts of oxygen present where
oxygen combines with the deoxyhemoglobin, releasing protons. These further combine
with the bicarbonate, forming carbonic acid, which then dissociates to carbon dioxide
and water. The carbon dioxide is exhaled by the lungs.
O2 + HCO 3– + K+ + HHb  K   HbO 2–  H 2 CO 3  H 2 O  CO 2 

It acts immediately. It is combining with offending acid or base to neutralize harmful

effects until another system takes over.
• Bicarbonate buffer: Mainly responsible for buffering blood and interstitial fluid
• Phosphate buffer: Effective in renal tubules
• Protein buffers: Most plentiful like hemoglobin in body cells and plasma.

The third mechanism is via reabsorb or excretes excess acids or bases into urine.
Absorption of certain ions and elimination of others are able to maintain the acid–
base balance in body fluids.
Acid excretion in the kidneys occurs as follows:
1. Sodium salts of mineral and organic acids are removed from the plasma by
glomerular filtration.
2. Sodium is preferentially removed from the renal filtrate or tubular fluid and in
the tubule cells, reacts with carbonic acid formed by the carbonic anhydrase
catalyzed reaction of carbon dioxide and water. This is sometimes called the
Na+–H+ exchange.
3. The sodium bicarbonate returns to the plasma and the proton enter the tubular
fluid, forming acids of the anions that originally were sodium salts.
 Acid excretion in the kidneys occur by three ways:
1. Bicarbonate reabsorption
2. New bicarbonate production (connected with H+ excretion)
3. Ammonium ion excretion.

1. Electrolytes are:
a. Minerals b. Amino acids
c. Vitamins d. None of the above
2. The body fluids found inside the cell is called:
a. Interstitial fluid b. Intracellular fluid
c. Plasma d. Extracellular fluid
3. Sodium chloride is used as:
a. Fluid and electrolyte replenisher b. Toxic agent
c. Pharmaceutical aid d. All of the above
4. Potassium chloride used for the treatment of:
a. Myasthenia gravis
b. Antidote in digitalis detoxification
c. Menieres syndrome
d. All of the above
5. Replacement therapy is required in the condition of:
a. Heavy loss of water b. Diarrhea
c. Both a and b d. None of the above
6. Water lost occurs through:
a. Kidney and lungs b. GI tract
c. Skin d. All of the above
7. Total output of the body fluid under normal conditions:
a. 1500 ml/day b. 250 ml/day
c. 2500 ml/day d. 4500 ml/day
8. ...... ions easily diffuses between intra- and extra-cellular compartments.
a. Chloride b. Potassium
c. Sodium d. Magnesium
9. In metabolic acidosis, ...... occurs.
a. Excess HCO 3– b. Deficit HCO 3–
c. Excess Cl– d. Deficit CO2
10. Calcium chloride is used as:
a. Electrolyte replenisher b. Toxic agent
c. Antacid d. All of the above
11. ...... is used as urinary acidifier:
a. NaHPO4 b. Sodium carbonate
c. Calcium chloride d. All of the above
12. Acute metabolic alkalosis may be corrected by:
a. KCl b. NaHCO3
c. NaCl d. All of the above
13. ...... can be caused due to extreme urine loss and metabolic acidosis.
a. Hypochloremia b. Hyponatremia
c. Metabolic acidosis d. All of the above
14. Calcium essential for ......
a. Myasthenia gravis b. Antioxidant
c. Blood clotting d. Hemostasis
15. Acute metabolic acidosis is treated by:
a. NaCl b. NaHCO 3–
c. KCl d. CaCl2

1. a 2. b 3. d 4. d 5. c 6. d 7. c 8. a 9. b 10. a 11. a
12. c 13. b 14. c 15. b

1. Electrolyte solution can be given by ...... and ......

2. Magnesium chloride lies in the category of ......
3. Excessive loss of CO2 can cause ......
4. ORS stands for ......
5. ...... is absorbed from upper part of small intestine.
6. Home-made ORS constitutes of ......
7. ...... therapy is not recommended in patients having impaired renal function and
acute dehydration.
8. Calcium gluconate is prepared from ...... and ......
9. The concentration of electrolytes expressed in ......
10. ...... are found in intracellular fluid.

1. Oral and IV
2. Magnesium replenisher
3. Acidosis
4. Oral rehydration salt
5. Calcium
6. One teaspoonful of salt, eight teaspoonful of sugar in one liter of water
7. Potassium
8. Gluconic acid CaCO3
9. Milliequivalents per liter
10. Potassium, magnesium and phosphate

1. Define major intra- and extracellular electrolytes.

2. Discuss physiological acid–base balance.
3. Define acidosis and alkalosis.
4. What do you understand the term replacement therapy?
5. What is the concentration of sodium, potassium, magnesium and calcium ion in
our body?
6. Write any two functions of sodium and potassium in our body.
7. Differentiate hypernatremia and hyponatremia.
8. Write the dietary sources of calcium and magnesium.

1. What are major intra- and extracellular electrolytes? Discuss the physiological
role of sodium.
2. Give the method of preparation, properties and uses of potassium chloride.
3. Write a detail note on physiological role of bicarbonate and chloride ions.
4. Write a short note on ORS.
5. Define replacement therapy. Explain any two ions used in replacement therapy.
6. Describe the preparation and uses of calcium gluconate.
7. Give the detail account of iron and phosphate ions.
 • Introduction • Calcium Carbonate
• Anatomy of Tooth • Desensitizing Agents
• Anticaries Agent • Zinc Chloride
• Role of Fluoride • Polishing Agents
• Role of Phosphate • Zinc Oxide Eugenol Cement
• Sodium Fluoride • Important Questions/Answers
• Dentrifrices

Dental hygiene is important to maintain oral hygiene on regular basis to prevent oneself
from oral diseases or dental disorders and other oral problems. The most common
dental disorders include tooth decay (cavities, caries) and gum disease (gingivitis,
periodontitis). One can keep the mouth clean and free from diseases by routinely
brushing the teeth twice a day and cleaning the teeth. A good dental health means to
maintain a health mouth, teeth, gums which in turn improve the quality of life and
appearance. Vitamin A and C are necessary for proper teeth formation. Deficiency of
these vitamins can affect the teeth.
The teeth are accessory organ of digestive system. It also called dentes. It is located
in oral or buccal of the mouth. Teeth are mainly used to bite and chew the food that is
also called mastication. Teeth cut, tear up the food with the help long, sharp canine
teeth while grind and mash up the food by wide, flat molar teeth. Then mixed with
saliva effectively and swallowed more easily. Teeth performed all actions mechanically
(as opposed to chemical).

Tooth consists of three major external regions: The crown, root and neck, and calcified
layers of tissue, namely:
1. Enamel: Crystalline calcium salts cover the crown to protect the tooth.
2. Dentin: Largest part of the tooth beneath the enamel and protect pulp.
3. Pulp: It consists of free nerve endings.
4. Cementum: Bone-like structure, cover the root and provide the attachment of the
tooth with periodontal ligaments.

Dental products are the substance which used to produce effect on teeth and in dental
cavity is called dental products. It is used to maintain dental hygiene.
 In order to prevent tooth decay, varieties of dental products are available in the
market. A large number of inorganic compounds are used to overcome the problems
associated with dental disorders. These dental products include:
• Anticaries agents
• Cleansing agents or dentifrices
• Desensitizing agent
• Polishing agents
• Oral antiseptic
• Mouthwashes
• Cements and fillers.

Dental caries or tooth decay involves demineralization (softening) of enamel and

dentin. It is caused by acid produced by the action of microorganisms or carbohydrates.
It is also called dental plaque. It is a biofilm or mass of bacteria that grows on surfaces
within the mouth. Initially, it is sticky colorless deposit then it is changes into brown
or pale yellow. It is characterized by decalcification of tooth by foul odor. If it is not
treated then microorganisms may invade the pulp which causes inflammation and
infection.
Dental caries or cavities are formed by the growth and implantation of
microorganism in teeth. The microbial flora present in the mouth act on carbohydrates
which produce acids especially lactic acid. Calcium salts are dissolved in acidic media
(demineralize the enamel) and the remaining organic matter digested by proteolytic
enzymes and cavities are formed. Initially, the demineralized enamel appears as chalky
white area and eventually becomes brown or yellow.
Dental caries can be prevented by dentifrices which help to maintain oral and dental
hygiene. Dentifrices are the products which enhance the removal of stain and tooth
decay by toothbrush. The most accepted approach to prevent caries includes flossing
and brushing accompanied by administration fluoride either internally or topically to
the teeth. Deprived nutrition of the mother during pregnancy may cause poor
architecture of the teeth that become susceptible to the development of caries in the
early age. Nowadays, dentist using newer devices to detect tooth decay in early stage
by laser technique which actually can be reversed most commonly used dental caries
is a liquid dye or stain. Dentist can spread the nontoxic dye into the teeth and rinse it
off. After rinsing, the healthy areas of teeth are free from stain but it sticks to the
decayed areas.
An agents or substances which are used to prevent dental caries are called anti-
caries agents.
Example of anticaries agent: Sodium fluoride, stannous fluoride, sodium mono-
fluorophosphate.

Fluoride ion is a trace element in the body. It is acquired from food and water in
adequate quantity. Fluoride is able to help in reducing and preventing dental caries.
An administration of small quantity (1 ppm) of fluoride containing salts or their use
in topical formulation on teeth to prevent caries. In some parts of the world, ground
water is completely lacking fluoride. In such cases, addition of fluoride to the municipal
water supply known as fluoridation and topical fluoride can also provide antimicrobial
action. However, excessive fluoride (more 2–3 ppm) intake during the period of tooth
development can cause dental fluorosis.

When a fluoride having salt or solution is taken internally, it is readily absorbed,

transported and deposited in the bone or developing teeth and remained get excreted
by kidneys. The deposited fluoride on the surface of teeth does not allow the action of
acids or enzymes that produce lesions. Fluoride is anticariogenic as it replaces the
hydroxyl ion in hydroxyapatite with the fluoride ion to form fluoroapatite in the outer
surface of the enamel. Fluoroapatite hardens the enamel and makes it more acid
resistant. It is also possible the fluorides may possess some antimicrobial activity and
help in remineralization of enamel.
It can be administered by two routes: (i) Orally and (ii) topically. Public water supply
containing 0.5–1 ppm (should not >1 ppm) which is sufficient and for topical application
2% solution is generally used on teeth.

Inorganic phosphate salts are also been found to useful in reducing the dental caries.
Generally phosphate ions are required for stronger bone as well as healthy teeth. Both
soluble and insoluble salts of phosphate ions are obtained from normal diets. It also
acts as a cleansing agent. Soluble inorganic salts phosphate ions such as 1% mixture of
sodium dihydrogen phosphate and disodium hydrogen phosphate is used to prevent
caries.

Molecular formula: NaF Molecular weight: 41.99

Category: Preventive for dental caries.
IP limit: Sodium fluoride contains not <98.5% and not >100.5% of NaF, calculated
with reference to the dried substance.

1. Neutralizing hydrofluoric acid with sod. carbonate

2HF + Na2CO3  2NaF + H2O + CO2
2. Double decomposition of calcium fluoride with sod. carbonate
CaF2 + Na2CO3  2NaF + CaCO3
Properties: A white powder or colorless crystals.
Solubility: Soluble in water practically, insoluble in ethanol (95%).
Storage: Store in tightly-closed containers.
Identification: Dissolve 2.5 gm in sufficient carbon dioxide-free water without heating
to produce 100 ml (solution A). To 2 ml of solution add 0.5 ml of calcium chloride solution;
a gelatinous white precipitate is produced which dissolves on adding 5 ml of ferric
chloride solution.
Acidity or alkalinity: Dissolve 2.5 gm of potassium nitrate in 40 ml of 2.5% w/v
solution, dilute to 50 ml with carbon dioxide-free water, cool to 0oC and add 0.2 ml of
dilute phenolphthalein solution. If the solution is colorless, not >1 ml of 0.1 M sodium
hydroxide is required to produce a red color that persists for not <15 seconds. If the
solution is red, not >0.25 ml of 0.1 M hydrochloric acid is required to change the color of
the solution. Reserve the neutralized solution for the test for fluorosilicate.
Clarity and color of solution: Solution A is clear and colorless.
Chloride: 40 ml of solution A complies with the limit test for chlorides (250 ppm).
Fluorosilicate: Heat to boiling the solution reserved in the test for acidity or
alkalinity and titrate while hot with 0.1 M sodium hydroxide until a red color is produced.
Not >1.5 ml of 0.1 M sodium hydroxide is required.
Sulfate: Dissolve 0.25 gm in 10 ml of a saturated solution of boric acid in distilled
water and add 5 ml of distilled water and 0.6 ml of 7 M hydrochloric acid. The solution
complies with the limit test for sulfates. Prepare the standard by mixing together 0.6 ml
of 7 M hydrochloric acid, 5 ml of sulfate standard solution (10 ppm SO4) and 10 ml of a
saturated solution of boric acid in distilled water (200 ppm).
Loss on drying: Not >0.5%, determined on 1 gm by drying in an oven at 130o for
3 hours.

Weigh accurately about 80 mg, add a mixture of 5 ml of acetic anhydride and 20 ml of

anhydrous glacial acetic acid and heat to dissolve. Cool, add 20 ml of dioxan and carry
out non-aqueous titration, using crystal violet solution as indicator, until a green color is
produced. Perform a blank determination and make any necessary correction. Each
ml of 0.1 M perchloric acid is equivalent to 0.004199 gm of NaF.
Action and uses: Sodium fluoride due to its fluoride ion is an important agent in
dental practice for retarding or preventing dental caries. Fluoridized teeth have been
resistant to microorganisms causing dental caries. It also decreases microbial acid
production.
Sodium fluoride in 2% aqueous solution is widely used topically; occasionally the
solution is applied to the surface of dry teeth periodically over several times in a year.
Application: 1.5–3 ppm (equivalent to 0.7–1.3 ppm of fluoride ion) in drinking water;
topically as a 2% solution to the teeth.

“A dentifrice is a substance used with a toothbrush for the purpose of cleaning the
accessible surface of the teeth”.

1. Cosmetic dentifrices: These must clean and polish teeth.

2. Therapeutic dentifrices: These must reduce disease process caries and sensitivity.
 Dentifrices are products that enhance the removal of stains and dental plaque by
the toothbrush. They are:
• Toothpastes
• Antiplaque agents
• Anticalculous agents
• Mouthwashes
• Cosmetic whiteners
• Desensitizing agents
• Disclosing agents.

1. It should not be harmful to the oral tissue and fluid.

2. It should not stain teeth.
3. It should not be scratching to the enamel surface of tooth.
4. If it is ingested it should not be harmful to the GIT.
5. It should have pleasant odor and taste.
Commercial dentifrices are available in the form of pastes, tooth powder and gels.
The main functions of dentifrices are removing stains; act as anticaries, minimizing
plaque build-up and as mouth freshener.

Dentifrices or toothpastes are responsible for decrease the incidence of dental caries,
reduce mouth odors and enhance personal appearance. The main ingredients of
toothpaste are:
1. Abrasives: Abrasives are responsible for physically removing plaque and debris,
e.g. silicates, sodium bicarbonate, dicalcium phosphate, sodium metaphosphate,
calcium pyrophosphate, calcium carbonate and aluminum oxides.
2. Surfactants/foaming agents: It is used due to their detergent action which helps
in removing debris, e.g. sodium lauryl sulfate, sodium dodecyl benzene sulfonate.
3. Humectants: Humectants are incorporated into toothpastes to prevent loss of
water and subsequent hardening of the preparation upon exposure to air, e.g.
sorbitol, glycerin, propylene glycol.
4. Suspending agents: Suspending agents will add thickness to the product, e.g.
methylcellulose, tragacanth, karaya gum.
5. Therapeutic agent: The majority of dentifrices contain therapeutic agents such as
fluoride salts. Fluoride salts inhibit caries. Common fluoride salt, which are used
in the paste are sodium monofluoride phosphate (SMFP), monofluorophosphate
(MFP), stanous fluoride, triclosan.
6. Pyrophosphates: Pyrophosphates are found in tartar control toothpastes. They
prevent tartar formation. They are water softening agents that remove calcium
from saliva thus preventing their deposition on teeth to form tartar.
7. Flavoring agent: Flavoring agent provide a smooth pleasant flavor both during
brushing and as aftertaste, e.g. spearmint, peppermint, wintergreen or cinnamon-
mint.
8. Sweetening agents: Most frequently used synthetic sweetener is saccharin.
 9. Preservatives: Preservatives are used to inhibit bacterial proliferation in the
preparation, e.g. benzoic acid, esters of p-hydroxybenzoic acid.
10. Coloring agent: Red, green or blue coloring agents are used.
11. Water.

Molecular formula: CaCO3 Molecular weight: 100.086

Synonym: Precipitated chalk, precipitated calcium carbonate.
It is used as an ingredient in our toothpaste since 1975. It is a common substance
found in rocks. It is most common natural forms are chalk, limestone, and marble. It is
also a component of harder organic materials like the shells of clams and eggshells.
Calcium carbonate is a mild abrasive which helps to safely remove plaque when
brushing and gently polishes away surface stains. Some alternatives include hydrated
silica gels, hydrated aluminum oxides, magnesium carbonate, phosphate salts and
silicates. While excess calcium from supplements, fortified food and high-calcium diets,
is known to cause milk-alkali syndrome under certain circumstances. There is no known
toxicity or associated risk in using calcium carbonate toothpaste.

Calcium carbonate is obtained by mixing the boiling solutions of calcium chloride and
sodium carbonate and allowing the resulting precipitate to settle down.
CaCl2 + Na2CO3  CaCO3 + 2NaCl
The precipitate is collected on calico filter, and washed with boiling water, until it
becomes free from chloride ions. Finally, the precipitate is dried.
Properties: It is a white, odorless powder or colorless crystals.
Solubility: Practically insoluble in water. Slightly soluble in carbonated water,
soluble in dil. hydrochloric acid.

Weigh accurately about 0.1 gm and dissolve in 3 ml of dilute hydrochloric acid and
10 ml of water. Boil for 10 minutes, cool, dilute to 50 ml with water. Titrate with 0.05 M
disodium edetate to within a few ml of the expected endpoint, add 8 ml of sodium hydroxide
solution and 0.1 gm of calcon mixture and continue the titration until the color of the
solution changes from pink to a full blue color. Each ml of 0.05 M disodium edetate is
equivalent to 0.005004 gm of CaCO3.

Precipitated chalk, which is having a fine powdery texture, is used in dentifrice, both
powders and pastes. It furnishes both abrasive and antacid effect in the mouth. If
forms a common ingredients of tooth powder and toothpaste. It is having a tendency
to cause constipation and hence it is usually administered alternatively or along with
magnesium salts. It is rapidly acting non-systemic antacid. It neutralizes gastric acid
and forms calcium chloride.
Teeth are somewhat sensitive to hot and cold especially during teeth decay or in
toothache. Therefore, some desensitizing agents are used in dental preparations so as
to reduce sensitivity of teeth to hot and cold.

Exact mechanism of action of desensitizing agent is not known with certainty. However,
they act probably like local anesthetic, e.g. strontium chloride and zinc chloride.

Strontium chloride forms a barrier and blocks the openings of dentinal tubules, thus
not allowing fluid movement within the tubules.

Dental floss, or tooth floss, is a cord of thin filaments used to remove food and dental
plaque from spaces between teeth where a toothbrush is unable to reach.

Molecular formula: ZnCl2 Molecular weight: 136.29

Synonym: Butter of zinc.
Category: Desensitizing agent
IP limit: It contains not <95% and not >100.5% of ZnCl2, calculated with reference
to the dried substance.

1. It is prepared by heating metallic or granulated zinc with hydrochloric acid. When

evolution of hydrogen ceases, the solution is filtered and evaporated to dryness.
Zn + 2HCl  ZnCl2 + H2
2. It can also be prepared by treating zinc carbonates or zinc oxide with HCl.
ZnCO3 + HCl  ZnCl2 + H2O + CO2

It occurs as white crystalline granules or powder. It is odorless and deliquescent. It is

soluble in water, freely soluble in alcohol and glycerine.

As it is deliquescent and absorbs carbon dioxide, it should be stored in tightly closed

container.

It is used as desensitizer in dental preparations and also acts as powerful astringent

and mild antiseptic.
One of the important constituents of good dentifrice is good abrasive or polishing
agent to have polish effect on teeth which is achieved by abrasive action. It provides
whiteness of teeth. Besides that some desensitizing agents are added to the dentifrices
for reducing sensitivity of teeth in hot and cold condition. The numbing effect is of
short duration like that local anesthetic. Astringent type of compounds shown this
property so it can be incorporated in dental products.

There are some inorganic substances which can be safely used as antiseptics in oral
cavity. For oral hygiene purpose some products having inorganic chemicals may be
used due to their antiseptic and astringent action, e.g. hydrogen peroxide, magnesium
peroxide and sodium perborate.

There are very few inorganic substances are used in mouthwashes. Zinc sulfate used
due to its mild antiseptic and astringent action or zinc chloride due to its deodorant
and desensitizing action or KMnO4 for its anti-infective and astringent action or sodium
bicarbonate due to its antacid property or sodium chloride for irrigation.

Dental cements are used to cover protect areas temporarily and then undergo operation
as in dental surgery. The cementing material is applied as paste which gets hardened
in a short duration and forming a protective layer. After healing, dentist removed the
hardened cement. The temporary cement is also medicated, usually with eugenol,
which is antiseptic and local anesthetic. Additives are used controlled the consistency
of the cement. A cement of suitable consistency finds uses temporary filler for cavities.
More often metal and their alloys used as permanent filling materials for cavities.
Gold and silver find used as permanent filling materials, e.g. zinc oxide.

• It should be strong and hard

• It is able to protect pulp
• It should be insoluble in saliva and liquids taken in mouth
• It should be dimensionally stable
• It should be adhesive
• It should be non-porous
• It should be biocompatible and non-irritant
• Co-efficient of thermal expansion should be equal to the tooth structure
• It should not be affected by thermal changes and moisture
• It should be easy to manipulate.

Cements are classified into four types:

• Type I: Used for temporary cementation
• Type II: Used for long-term cementation of fixed prosthesis
 • Type III: Used for temporary filling/thermal insulating base
• Type IV: Intermediate restorations and cavity liners.

It is compatible with the hard and soft tissues of the mouth and extensively used in
dentistry since 1890s. It is a least irritant of all the dental materials. It has poor strength
when compared to zinc phosphate. It has sedative effect on exposed dentin.

Powder Nature Quantity in % Liquid Nature Quantity in %

ZnO Principal 69 Eugenol Reacts with ZnO 85
ingredient
White resin Brittleness of 29.3 Olive oil Plasticizer 15
set cement
Zn acetate Accelerator, up to 1 Acetic acid/ To accelerate
improve alcohol setting up to 1
strength
MgO Modifier Traces Water Initiator Traces
Zn stearate Plasticizer 0.7 – – –

Properties: It has low strength, low abrasive resistance and low flow after setting.
So, it is used for temporary filling not more than few days. It has adhesive effect on
exposed dentin.

In powder:
1. Zinc powder 80%
2. Poly methyl-methacrylate 20% (bond to other components)
3. Zinc stearate-traces (accelerator)
4. Zinc acetate
5. Thymol and hydroxyquinoline—traces (antimicrobial agent).
In liquid:
1. Eugenol 85%
2. Olive oil 15% (as plasticizer, masks irritating effect of eugenol).

In powder:
1. ZnO
2. Aluminum oxide/other mineral fillers 20–30%
3. Polymeric reinforcing agent (polymethyl methacrylate)
4. Barium sulfate—radiopacity.
 In liquid
1. O-ethoxybenzoic acid 50–60%
2. Eugenol 40–50%

It is used as protective, sedative lining in deep cavities, used in temporary filling. It is

also used for temporary cementing, pulp capping and root canal filling.

1. Dentifrices are used for:

a. Cleaning of teeth and gums b. To control caries
c. Reduce hypersensitivity d. All of the above
2. Precipitated chalk is:
a. Sodium carbonate b. Sodium fluoride
c. Calcium carbonate d. Zinc chloride
3. Vitamin which is essential for tooth formation:
a. Vitamin C b. Vitamin A
c. Vitamin D d. All of the above
4. Commonly used desensitizing agents are:
a. ZnCl2 b. SrCl2
c. Both a and b d. None of the above
5. Dental caries is defined as:
a. Tooth decay c. Removing stains
b. Cleaning agent d. Polishing action
6. Phosphate is used as:
a. Anticaries agent b. Cleansing agent
c. Removing stains d. Polishing action
7. Which one in anticaries agents:
a. Stannous fluoride c. Sodium fluoride
b. Both a and b d. None of the above
8. Ideal properties of dental cement is:
a. It should be insoluble in saliva and other oral fluids
b. It should be adhesive
c. It should be non-porous d. All of the above
9. Fluoride inhibits the carries formation by:
a. Antimicrobial action b. Remineralization of enamel
c. Downward acid solubility of tooth enamel
d. All of the above
10. Zinc oxide eugenol cement used for:
a. Bacterial inhibition
b. Cavity lining, pulp capping and root canal filling
c. Sensitivity d. All of the above
 1. d 2. c 3. d 4. c 5. a 6. b 7. c 8. d 9. d 10. b

1. Toothpaste containing ...... should be used to prevent dental caries.

2. ...... is a substance used with brush for cleaning purpose.
3. Dental plaque is due to combined action of ...... and ......
4. The polishing effect is achieved by its ......
5. Basically setting is a ...... reaction.
6. Soluble salts of phosphate are ......
7. Calcium carbonate is prepared by using ...... and ......
8. ...... are used in treating dental caries.
9. Setting time of zinc eugenol cement is ......
10. Agents which are used to reduce sensitivity of teeth to heat and cold is known as
......

1. Sodium fluoride
2. Dentifrices
3. Periodontal disease, Streptococcus mutans
4. Abrasive
5. Acid–base
6. NaHPO4, NaH2PO4
7. Slaked lime and CO2
8. Fluorides
9. 4–10 minutes
10. Desensitizing.

1. What are anticaries? Discuss anyone of its official compound.

2. Discuss the role of fluoride with mechanism of action.
3. Name any two inorganic compounds as dental products.
4. Define dentifrices.
5. How is stannous fluoride prepared?

1. Discuss the preparation and uses of sodium fluoride.

2. Write a detail note on preparation, assay and uses of calcium carbonate.
3. Describe the composition of toothpaste.
4. What are the ideal requirements of dental cement?
5. Define polishing agents and desensitizing agents with examples.
6. Explain in detail about zinc oxide eugenol cement.
 • Introduction • Secretion of Gastric Juice/HCl
• Stomach

Digestive tract or gastrointestinal tract consists of group of organs. GI tract includes

the stomach, small intestine, large intestine (colon), rectum and terminates at the anus.
GI tract consists of structures that aid in the ingestion and digestion of food by means
of enzymatic breakdown/biochemical process. Ingestion is the process of consuming
something and taking it into the body, whereas digestion is a mechanical and chemical
breaking down of food into smaller components to a form that can be absorbed.
Disfunctioning of anyone of the GIT compartments may lead to human illness and
discomfort.

It is made-up of 5 layers of smooth muscles. The mucus lining of the stomach

protects the stomach walls from the action of stomach acid. The walls of the stomach
are lined with parietal cells that secrete mucus, gastric juice [pepsin (an enzyme) or
pepsinogen and HCl]. The digestion of protein takes place in acidic medium. Pepsin
is most effective in the very acidic condition of the stomach (pH 2). It became inactive
at higher pH. Thus, HCl present in the gastric juice [secreted by the oxyntic (or parietal)
cells of the stomach] is acidifies the food, kills many microbes which may be harmful
to the body, and provides the acid environment needed for effective digestion by
pepsin.

Hydrochloric acid secretion is under the control of bases, i.e. acetylcholine, histamine,
and gastrin (a 17 amino acids substance heptadecapeptide) through an interlinked
mechanism and by respective receptor sites. The release of gastric acid (i.e. intracellular
hydrogen ions) occurs through H+–K+ ATPase pump. Inadequate secretion of HCl
causes achlorhydria or hypochlorhydria. Excessive secretion of HCl takes place in the
stomach causes the imbalance of acid-enzyme in stomach it leads to hyperacidity and
ulcers. In large intestine, insufficient absorption of fluids causes diarrhea and
insufficient peristaltic movement causes constipation.
 Agents or substances which are used to treat gastrointestinal disorders are known
as gastrointestinal agents. Various inorganic agents used to treat GIT disorders include:
• Acidifying agents
• Antacids
• Protectives and adsorbents
• Saline cathartics or laxatives.
 • Introduction • Ammonium Chloride
• Dilute Hydrochloric Acid • Important Questions/Answers

Acidifiers are inorganic chemicals that either produce or become acid. These chemicals
increase the level of gastric acid in the stomach when ingested, thus decreasing the
stomach pH. The pH of stomach is 1.5–2 when empty and rises to pH 5–6 when food
is ingested.
These are many types of acidifiers but the main four types are:
i. Gastric acidifiers, used in controlling pH in stomach.
ii. Urinary acidifiers, used in controlling pH in urine.
iii. Systemic acidifiers, used in controlling pH in all the parts of body.
iv. Acids.

Drugs which are used to increase the acidity of the stomach in patients suffering from
achlorhydria or hypochlorhydria.

In patients suffering from achlorhydria, there is deficient secretion of HCl in stomach.

The pH of stomach is so low because of the secretion of HCl. Gastric HCl act by
destroying the bacteria in the ingested food and drinks. It softens the fibrous food and
promotes the formation of the proteolytic enzyme pepsin. This enzyme is formed
from pepsinogen at acidic pH (>6). Pepsin helps in the metabolism of proteins in the
ingested food. Therefore lack of HCl in the stomach can cause achlorhydria.
Two types of achlorhydria are known:
1. Where the gastric secretion is devoid of HCl, even after stimulation with
histamine phosphate.
2. Where gastric secretion is devoid of HCl, but secreted upon stimulation with
histamine phosphate.
The cause of achlorhydria initially may be subtotal gastrectomy, atrophic gastritis,
carcinoma, gastric polyp, etc. while in later case it may be chronic nephritis,
tuberculosis, hyperthyroidism, chronic alcoholism, sprue, pellagra, etc. The symptoms
vary with associated disease but they generally include mild diarrhea or frequent
bowl movement, epigastric pain and sensitivity to spicy food. It can be treated by
various acidifying agents like ammonium chloride, dilute HCl, calcium chloride, etc.

Drugs that are used to remove acidic urine from the body or in controlling pH in
urine, e.g. many bacteria grown badly in acidic urine as far as concerned. When the
urine is acidic, hexamine only act as antiseptic. However, hexamine itself break-up
into ammonia and formaldehyde in acidic media.

Systemic acidifiers are those which act by reducing the alkali reserve in the body
especially blood or to maintain pH of all parts of the body and are also useful in
reducing metabolic alkaloids. It is used to treat systemic alkalosis and given usually
by injection.

It is used in the preparation of medicaments as pharmaceutical aids.

Molecular formula: HCl Molecular weight: 36.5

IP limit: It contains not <9.5% and not >10.5% w/w of HCl.
The acid should be diluted with 25–50 volumes with water or juice and sipped
through a glass tube to prevent reaction upon dental enamel. It is taken during or
after meals given in conjunction with iron therapy in hyperchromic anemia.

It is prepared by mixing 274 gm of HCl and 726 gm of purified water.

1. It possesses pungent odor.

2. It is colorless liquid.

1. When added to KMnO4 with dilute nitric acid, chlorine is evolved.

2KMnO4 + 16HCl  2MnCl2 + 2KCl + 8H2O + 5Cl2
2. To acidified solution add silver nitrate solution, shake and allow to stand, curdy
white precipitate is formed, which is insoluble in HNO3 but soluble after being
washed with water in ammonium hydroxide from which it is re-precipitated by
the addition of HNO3.

Weigh accurately 6 gm, add 30 ml of distilled water mix and titrate with 1N NaOH
using methyl red as indicator. Each ml of 1N NaOH is equivalent to 0.03646 gm of
HCl.
It is stored in well-closed glass container at room temperature.

Used as pharmaceutical aid.

Molecular formula: NH4Cl Molecular weight: 53.49

Synonym: Sal ammoniac, solutions of ammonium chloride are mildly acidic.
Physical properties: White solid, hygroscopic, odorless, free soluble in water and
glycerol, sparingly soluble in alcohol.

1. Ammonium chloride prepared through the Solvay process

CO2 + 2NH3 + 2NaCl + H2O  2NH4Cl + Na2CO3
2. Ammonium chloride is prepared commercially by combining ammonia (NH3)
with either hydrogen chloride (gas) or hydrochloric acid (water solution)
NH3 + HCl  NH4Cl

Ammonium chloride appears to sublime upon heating but actually decomposes into
ammonia and hydrogen chloride gas
NH4Cl  NH3 + HCl
Ammonium chloride reacts with a sodium hydroxide (strong base) and release
ammonia gas.
NH4Cl + NaOH  NH3 + NaCl + H2O
Similarly, ammonium chloride also reacts with alkali metal carbonates at elevated
temperatures giving ammonia and alkali metal chloride
2NH4Cl + Na2CO3  2NaCl + CO2 + H2O + 2NH3

Dissolve 1 gm of ammonium chloride in 20 ml of water and add a mixture of 5 ml of

formaldehyde solution with few drops of phenolphthalein solution. After 1–2 minutes,
titrate slowly with 1 M sodium hydroxide. 1 ml of 1 M sodium hydroxide is equivalent
to 53.49 mg of NH4Cl.
In this ammonium chloride undergoes hydrolysis and yield ammonium hydroxide
and HCl. This reaction is facilitated by formaldehyde by fixing ammonia as hexamine.
Indicator is colorless in acid and pink in alkaline medium.

1 to 2 gm (as systemic acidifier), 0.3–0.5 gm (expectorant)

Store in highly closed container.

1. It is used as an expectorant in cough medicine.
2. It is used as a systemic acidifying agent in treatment of severe metabolic alkalosis.
3. The main application of ammonium chloride is as a nitrogen source in fertilizers.
4. It is used as a flux in preparing metals to be tin coated, galvanized or soldered.

1. Hydrochloric acid is also known as:

a. Spirit of salt b. Muriatic acid
c. Epsom salt d. Both a and b
2. Which one is the symptom of achlorhydria:
a. Pain in stomach b. Frequent bowel moment
c. Diarrhea d. All of the above
3. Inorganic compounds, used to increase or produce acid in GI tract, are called:
a. Antacid b. Absorbents
c. Acidifier d. None of the above
4. ...... in the stomach can cause achlorhydria.
a. Lack of HCl b. Presence of H2SO4
c. Presence of HCl d. All of the above
5. Drugs which are used to neutralize the alkaline body fluids are known as:
a. Systemic acidifies b. Acids
c. Urinary acidifier d. Gastric acidifier

1. d 2. d 3. c 4. a 5. a

1. Define acidifiers or acidifying agents. Write the classification of acidifies.

2. What do you understand by the term systemic acidifier?
3. Differentiate systemic and urinary acidifier.
4. What is achlorhydria?
5. Describe the preparation, properties and uses of ammonium chloride.
6. Give the methods of preparation and assay of dil. HCl.
 • Introduction • Magnesium Oxide
• Ideal Properties of Antacids • Calcium Carbonate
• Combination of Antacids • Magnesium Hydroxide
• Sodium Bicarbonate • Important Questions/Answers
• Aluminum Hydroxide Gel

Antacids are the substances which reduce gastric acidity resulting in an increase in
the pH of stomach. Antacids are alkaline bases used to neutralize the excess gastric
HCl associated with gastritis or peptic ulcer. Gastric acidity occurs due to excessive
secretion of HCl in stomach due to various reasons.
When hyperacidity occurs the outcome can range from:
1. Gastric ulcer (stomach)
2. Peptic ulcer or esophageal ulcer (lower end of esophagus)
3. Gastritis (a general inflammation of gastric mucosa)
4. Duodenum ulcers.
Peptic ulcers occur due to defective esophageal sphincter as in hiatal hernia. Gastric
ulcers occur in lesser curvature and are found in first portion of duodenum.

• The antacid should buffer in the range of pH 4–6

• The antacid should not be absorber/or cause systemic alkalosis
• It should not be a laxative or constipative
• It should exert effect rapidly and over a long period of time
• The reaction of antacid with gastric HCl should not cause large evolution of gas
• It should probably inhibit pepsin.

• Sodium containing antacids are problem for patients on sodium restricted diet
• Some antacids cause constipation while others have laxative effect
• If pH raises too high rebound acidity to neutralize the alkali occurs
• Antacids which absorbed systemically exert alkaline effect on body’s buffer
system.
Systemic antacids are antacids which get systemically absorbed, e.g. sodium carbonate
is water soluble and potent neutralizer, but it is not suitable for the treatment of peptic
ulcer because of risk of ulcer perforation due to production of carbon dioxide in the
stomach.

They are insoluble and poorly absorbed systemically, e.g. magnesium carbonate,
magnesium hydroxide, aluminum hydroxide, calcium carbonate.

Among various antacids every single compound has some side effect especially when
used for longer period or in elderly patients. Combinations of antacids are used to
avoid certain side effects associated with antacids such as:
i. Magnesium and calcium containing preparation where one is laxative and the
another is constipative in nature
ii. Magnesium and aluminum containing preparation, e.g. magnesium hydroxide a
fast-acting antacid with aluminum hydroxide which is a slow-acting antacid.

Molecular formula: NaHCO3 Molecular weight: 84.01

Synonym: Baking soda, sodium hydrogen carbonate.
IP limit: It contains not <99% and not >101% of NaHCO3
Properties: White crystalline powder, odorless, slight alkaline taste, stable in dry
air, freely soluble in water, insoluble in alcohol.

1. Solvay process: By passing strong brine (NaCl) containing high concentrations of

ammonia through a carbonating tower where it is saturated with carbon dioxide
under pressure. The ammonia and carbon dioxide reacts to form ammonia
bicarbonate which is allowed to react with NaCl to precipitate NaHCO3 and
separated by filtration.
NH3 + H2O + CO2  NH4HCO3
NH4HCO3 + NaCl  NaHCO3
2. It can also be prepared by covering sodium carbonate crystals with water and
passing carbon dioxide to saturation.
Na2CO3 + H2O + CO2  NaHCO3

To 5 ml of 5% w/v solution in carbon dioxide free water add 0.1 ml phenolphthalein

solution a pale pink color is obtained. On heating a gas is evolved and the solution
turns red.
For sodium: To sample solution add 15% w/v potassium carbonate, heat, no
precipitate is obtained add potassium antimonite solution heat to boiling, cool and if
necessary scratch the inside of test tube with a glass rod, a dense white precipitate is
produced.
For bicarbonate: To sample add magnesium sulfate no precipitate is produced. On
boiling a white colored precipitate is formed.

Weigh accurately 1 gm and dissolve in 20 ml of water, titrate with 0.5 N sulfuric acid
using methyl orange as indicator. Each ml of 0.5 N sulfuric acid is equivalent to 0.0425
gm of NaHCO3.

It is used as antacid and electrolyte replacement.

Molecular formula: Al(OH)3 Molecular weight: 78.0

Synonym: Aluminum hydroxide powder.
Aluminum hydroxide is a white, light odorless, tasteless amorphous powder. It is
an aqueous suspension of hydrated aluminum oxide with different amounts of basic
aluminum carbonate and bicarbonate. It is soluble in dilute mineral acids but practically
insoluble in water. It forms gel on prolonged contact with water at pH
5.5–8. The aluminum hydroxide gels are ideal buffers in the pH 3–5 range due to its
amphoteric nature.
IP limit: It contains not <3.5% and not >4.4% of Al2O3.

It is prepared by dissolve sodium carbonate in hot water and filters the solution. Add
clear solution of alum (aluminum salt, chloride or sulfate) to the filtrate in water with
constant stirring. Add more of water and remove all gas. The aluminum hydroxide
precipitate out, collect the precipitate, wash and suspend in sufficient purified water
flavored with 0.01% peppermint oil to strengthen aluminum hydroxide gel and
preserve with 0.1% sodium benzoate.
Al2 (SO4)3 + 3Na2CO3 + 3H2O  2Na2SO4 + Al(OH)3 + 3CO2
Aluminum hydroxide is a weak and slow reacting antacid. The aluminum ions
relax smooth muscles and cause constipation. It absorbs pepsin at pH >3 and releases
it at lower pH. It also prevents phosphate absorption. Major disadvantage of this gel
is that losses antacid properties on aging.

It should be stored in an airtight container.

Accurately weigh 5 gm and dissolve in 3 ml HCl by warming on water bath, cool to

below 20°C and dilute to 100 ml with water. To 20 ml of this solution add 40 ml of
0.05 M disodium EDTA, 80 ml water, 0.15 ml methyl orange/red and neutralize by
the dropwise addition of 1 M sodium hydroxide. Again warm on water bath for
30 minutes, add 3 gm hexamine and titrate with 0.05 M lead nitrate using 0.5 ml xylenol
orange as indicator. Each ml of 0.05 M disodium EDTA = 0.002549 gm of Al2O3.

It is used as antacid in the management of peptic ulcer, gastritis, gastric hyperacidity.

It is also used as skin protectant and mild astringent.

Molecular formula: MgO Molecular weight: 40.3

Synonym: Magnesia
IP limit: It contains not >98% of magnesium oxide
It occurs in nature as mineral periclase. There are two varieties; heavy magnesium
oxide and light magnesium oxide.

It can be prepared by heating gently magnesium carbonate to redness.

(MgCO3)4 Mg(OH)2 5H2O  MgO + CO2 + H2O

Both heavy and light magnesium oxides are odorless, slightly alkaline taste, practically
insoluble in water yield a solution which is alkaline. It readily dissolves in dilute acids
with slight effervescence. In presence of acid, the oxide forms the magnesium
hydroxide.

To the sample solution of sample add dilute nitric acid solution a white precipitate is
produced which is re-dissolved by adding 1 ml of 2 M ammonium chloride, add
0.25 M disodium hydrogen phosphate, a white crystalline precipitate is produced,
shows presence of magnesium.

It is used as antacid and laxative. It is ingredient of universal antidote along with

tannic acid and charcoal. It is used for compounding and preserving fluid extract
because of its absorptive power.

Molecular formula: CaCO3 Molecular weight: 100.09

Synonym: Precipitated chalk
It is found in nature as limestone, marble, calcite, vaterite, aragonite and shell of
sea animals. Precipitated chalk is prepared as a fine precipitate by adding a solution
of ammonium carbonate and ammonia or sodium carbonate to a solution of calcium
nitrate.
 1. It can be prepared by mixing and boiling calcium and sodium carbonate solution
and allowing the resulting precipitate to settle. The precipitate is collected,
washed with boiling water until free from chloride and dried.
CaCl2 + Na2CO3  CaCO3 + 2NaCl
2. By passing carbon dioxide through lime water
CaO + CO2 + H2O  CaCO3

It occurs as a white, odorless tasteless microcrystalline powder which is stable in air.

It is practically soluble in air. It exists in two crystal form and both are commercial
importance, one aragonite and other is calcite.

Dissolve substance in 5 M acetic acid and add 0.5 ml of potassium ferrocyanide solution.
The solution remains clear. Add ammonium chloride white crystalline precipitate is
formed. It shows the presence of calcium.
For carbonate: Suspend sample in 2 ml water in a test tube, add 2 M acetic acid
close the tube immediately with a stopper fitted with a glass tube bent at two right
angles, heat gently and collect the gas in 5 ml of 0.1 M barium hydroxide a white
precipitate is formed which is dissolves on addition of excess of dilute HCl.

It is a potent antacid with rapid acid neutralizing capacity, but on long-term use, it
can cause hypercalcemia, hypercalciuria and formation of calcium stone in kidney. It
is used in calcium deficiency, dentifrices and in combination with magnesium
containing antacids due to its constipative properties.

Molecular formula: Mg(OH)2 Molecular weight: 58.31

Synonym: Milk of magnesia

It can be prepared by combining a solution of magnesium salts with basic water induces
precipitation of solid magnesium hydroxide.
Mg2+ + 2OH  Mg (OH)2

It occurs as a white powder and odorless. It is insoluble in water, ethanol and soluble
in dilute mineral acids.

It is used as laxative and also used to treat gastrointestinal ailments such as heartburn,
stomach upset and indigestion.
 1. Antacids are used:
a. To maintain gastric pH 3.5–7 b. Increase the concentration acid
c. Decrease the concentration acid d. Both a and c
2. Dried aluminum hydroxide gel consists of:
a. Hydrated aluminum oxide
b. Basic aluminum carbonate and bicarbonate
c. Both a and b
d. None of the above
3. Simethicone is used as:
a. Astringent b. Antacid
c. Antiseptic d. Both a and c
4. Aluminum hydroxide gel is used as:
a. Astringent b. Gastritis
c. Peptic ulcer d. All of the above
5. Ideal properties of antacids are:
a. Should probably inhibit pepsin
b. Should not be cause systemic alkalosis
c. Should exert effect rapidly and over a long period of time
d. All of the above
6. Antacid acts by which of the following mechanisms:
a. Increase the volume of gastric HCl contents
b. Neutralizing the gastric HCl contents
c. Inhibit Na/K ion exchange d. All of the above
7. Side effects of antacid therapy:
a. Constipation c. Both a and b
b. Systemic alkalosis d. None of the above
8. Antiflatulents are used to:
a. Decrease the volume of gastric HCl contents
b. Prevent the formation of HCl
c. Synergistic effect
d. Decrease the surface tension of bubbles in the stomach
9. Which one is the example of systemic antacid.
a. Sodium bicarbonate b. Magnesium hydroxide
c. Calcium carbonate d. Magnesium carbonate
10. Combinations of antacids are used to:
a. Avoid absorption of antacid
b. Counteract the constipative effect
c. Synergistic effect d. All of the above

1. d 2. c 3. b 4. d 5. d 6. b 7. c 8. d 9. a 10. b
 1. ...... are the substances which reduce gastric acidity.
2. Gastric acid is secreted from ...... in the stomach
3. Systemic antacids are systemically ...... while a non-systemic antacid does not
exert any ......
4. Sodium bicarbonate is also known as ......
5. Antacids are administered to ...... excess HCl.
6. ...... is a systemic antacid.
7. Magnesium oxide is also known as ......
8. Antacid neutralizing capacity expressed as ......
9. ...... containing aluminum salt as antacid.
10. ...... can be prepared by heating gently magnesium carbonate to redness.

1. Antacids
2. Parietal cell
3. Absorbed, systemic effect
4. Baking soda
5. Neutralize
6. Sodium bicarbonate
7. Magnesia
8. Milliequivalents of HCl
9. Aluminum hydroxide gel
10. Magnesium oxide.

1. What are antacids? Discuss anyone of its official compound?

2. Classify antacids. Write the ideal requirements of an antacid.
3. Discuss the preparation, properties and uses of calcium bicarbonate.
4. How would you prepare magnesium oxide?
5. Explain neutralizing capacity of antacid.

1. Discuss the preparation, assay and uses of aluminum hydroxide gel.

2. Write a detail note on magnesium containing salt as antacids.
3. Discuss the preparation, properties and uses of sodium bicarbonate.
 • Introduction • Protectives and Adsorbents
• Saline Cathartics • Bismuth Subcarbonate
• Magnesium Sulfate • Bismuth Subgallate
• Sodium Orthophosphate • Kaolin
• Sodium Potassium Tartrate • Activated Charcoal
• Bentonite • Important Questions/Answers

Constipation is generally defined as infrequent and/or unsatisfactory defecation fewer

than 3 times per week. Patients may define constipation as passing hard stools or
straining, incomplete or painful defecation.
Drugs that relieve constipation and promote defecation, i.e. empty stomach (push
out the excreta from the body through the anus). Laxatives are called aperients. These
laxative drugs produce peristalsis (movement of the intestines) and promote
evacuation of the bowel to relieve constipation. More powerful laxatives are called
purgatives. Even more powerful purgatives are called cathartics.
The order of effectiveness is described as follows:
• Aperients—to smooth and soft
• Evacuant—to empty
• Purgative—to clean
• Cathartic—to completely clean
Laxative should only be used for short-term therapy as prolonged use may lead to
loss of spontaneous bowl rhythm upon which normal evacuation depends, causing
patient to become dependent on laxatives, the so-called laxative effect. It could not be
used on a regular basis because it may cause imbalance of water and electrolytes of
our body.
Constipation is the infrequent or difficult evacuation of the feces. It may be due to
a person resisting the natural urge to defecate, causing the fecal material which remains
in the colon to lose fluid and to become relatively dry and hard. Constipation can also
be due to intestinal atony, intestinal spasm, emotions, drugs and diet. Many a time
constipation can be helped by eating food such as natural laxatives or food with large
roughages. Cathartics or purgatives generally act by four different mechanisms which
are described as various types of laxatives.
Stimulants are drugs or substances which act by local irritation on the intestinal tract
which increase peristaltic activity. They include phenolphthalein, aloin, cascara extract,
rhubarb extract, senna extract, podophyllin, castor oil, bisacodyl, calomel, etc.

These are substances which are used to increase the bulk of intestinal contents, i.e.
increased bulk provides stimulation of bowels (peristalsis). They are made from
cellulose, sodium carboxyl methyl cellulose and karaya gum.

The emollient laxatives act either as lubricants facilitating the passage of compacted
fecal material or as stool softeners, e.g. d-octyl sodium sulfosuccinate, an anionic surface
active agent.
Substances such as liquid paraffin, glycerin, mineral, oil, etc. act as lubricants which
cause smooth clearance of fecal tool. It increases the fluid level in the small intestine
by coating of lubricants which in turn decreases the absorption of water and enhances
the water level in small intestine. This effect could increase the flow of stool by lubricants
from intestine and help to clearing the bowels.

Saline cathartics or purgatives are agents that quicken and increase evacuation from
the bowl. Laxatives are mild cathartics. Cathartics are used:
• To ease defecation in patients with painful hemorrhoids or other rectal disorders
and to avoid excessive straining and concurrent increase in abdominal pressure
in patients with hernias
• To relieve acute constipation
• To remove solid material from intestinal tract prior to certain roentgenographic
studies
• To avoid potentially hazardous rise in BP during defecation in patients with
hypertension, cerebral coronary or other arterial disease.

These substances act by increasing the osmotic load of the GIT by absorbing large
quantity of water and stimulating peristalsis. They are salts of poorly absorbable anions
–H 2 PO –4 (biphosphate), –H 2 PO 2–
4 (phosphate), sulfates, tartrates and soluble magne-
sium salt.
Saline cathartics are water soluble and are taken with large quantities of water.
This prevents excessive loss of water from body fluids and reduces nausea and vomiting
if a too hypertonic solution should reach the stomach. They act in the intestine and a
full cathartic dose produces a water evacuation within 3–6 hours. Because of their
quick onset of action they are given early in the morning before breakfast. They are
used for bowel evacuation before radiological, endoscopic and surgical procedures
and also to expel parasite and toxic materials.
 Small amounts of these drugs may be absorbed in the systemic circulation (blood)
causing occasional toxicity. The absorption of magnesium may cause marked CNS
depression while that of sodium worsens the existing congestive cardiac failure (CCF).
Following compounds are used as saline cathartics.

Molecular formula: MgSO47H2O Molecular weight: 246.47

Synonym: Epsom salt, bitter salt.
IP limit: It contains not <99% and not >100.5% of magnesium sulfate, calculated
with reference to dried substance.
Properties: It forms colorless prismatic crystals. It dissolves in water, is practically
insoluble in alcohol. It has cooling saline bitter taste. It is soluble in water and sparingly
soluble in alcohol. It efflorescences in warm dry air.
It forms double salt of ammonium and magnesium phosphate when preparation is
reacted with disodium hydrogen phosphate in presence of ammonium chloride.

1. It can be prepared by neutralizing hot dilute sulfuric acid with magnesium or its
oxides or carbonate. The solution is filtered; the filtrate is concentrated and
recrystallized.
MgCO3 + H2SO4  MgSO4 + H2O + CO2
MgO + H2SO4  MgSO4 + H2O
2. On commercial scale it is manufactured by reacting sulfuric acid with dolomite.
Magnesium sulfate so formed is dissolved in the solution and the sparingly
soluble calcium sulfate is deposited. The liquid is filtered, the filtrate is
concentrated and crystallized.
MgCO3·CaCO3 + 2H2SO4  MgSO4 +CaSO4 + 2H2O + CO2
Dolomite

For magnesium: To solution of sample add dilute nitric acid solution a white
precipitate is produced that is re-dissolved by adding 1 ml of 2 M ammonium chloride,
add 0.25 M disodium hydrogen phosphate, a white crystalline precipitate is produced.
For sulfate: To 5 ml of sample solution add 1 ml of dilute HCl and 1 ml barium
chloride solution white precipitate. Add 1 ml of iodine solution to the suspension, the
suspension remains yellow (distinction from sulfites and dithionites) but decolorize
on adding stannous chloride (distinction from iodates).

Weigh accurately about 6.3 gm of sample dissolve in 50 ml of water, add 10 ml of

strong ammonia ammonium chloride solution and titrate with 0.05 M disodium EDTA
using 0.1 gm of moderate black II mixture as indicator until blue color is obtained.
Each ml of 0.05 M disodium EDTA = 0.00602 gm of MgSO4.
It is used as osmotic (saline) laxative, in treatment of electrolyte deficiency, in wet
dressing in boils, treatment of cholecystitis (inflammation of gallbladder), sea sickness,
hypertension, etc.
Its excessive use may cause hypermagnesemia, gastrointestinal irritation and watery
diarrhea.

Molecular formula: Na2HPO412H2O Molecular weight: 358.14

Synonym: Disodium hydrogen phosphate, phosphor soda
IP limit: It contains 98–101% of Na2HPO4 calculated with reference to the dried
substance.

It occurs as colorless, odorless, crystalline powder and very efflorescent. It is readily

soluble in water and insoluble in alcohol.

1. It is prepared by reaction of orthophosphoric acid calculated quantity of sodium

hydroxide.
2NaOH + H3PO4  Na2HPO4 + 2H2O
Phosphoric acid
2. From bone ashes or mineral phosphorite, which is treated with sulfuric acid.
3. It is also obtained from calcium phosphate treated with calculated quantity of
sulfuric acid yields mono basic calcium phosphate. Then the mixture is filtered
and the filtrate is treated with sodium bicarbonate when dibasic calcium
phosphate gets deposited leaving sodium phosphate in solution.
2H2SO4 + Ca3(PO4)2  Ca2(H2PO4)2 + 2CaSO4
Ca2(H2PO4)2 + Na2CO3  Na2HPO4 + CaHPO4 + H2O + CO2

Weigh accurately 4 gm of substance and dissolve in 25 ml of water add 25 ml 1 N HCl

and titrate potentiometrically with 1 M NaOH to first inflection point of the pH curve
(n1) continue titration until second modulation of curve is reached. The total volume
of NaOH required is n2 ml and calculate percent content from the expression.
1420 (25 – n1)/w (100 – d) where d is percentage of water content.

Widely used as saline cathartic and orally as antihypercalcemic. It is used as

pharmaceutical aid and buffering agent.

Molecular formula: COONaCH(OH)·CH(OH)COOK 4H2O Molecular weight: 282.22

Synonym: Potassium sodium tartrate, Seignette’s salt, Rochelle’s salt.
 IP limit: It contains not <99% and not >102% of C4H4KNa calculated on the
anhydrous basis.

It is prepared by boiling a solution of sodium carbonate and potassium bitartrate for

some time and allowing the reaction mixture to stand at 60°C. The solution is filtered,
concentrated and crystallized.

It occurs as colorless, odorless, white crystalline powder. It is soluble in water and

practically insoluble in alcohol. It is having a cooling saline taste.

For potassium: To 1 ml of solution add 1 ml dilute acetic acid and 1 ml of 10% w/v
sodium cobalt nitrite a yellow color produced.
For sodium: To 2 ml of solution of 2 ml of 15% w/v of K2CO3 heat to boil, no
precipitate is produced. Add 3 ml of potassium antimonite solution and heat to boil.
Allow to cool in ice and if necessary scratch the inside of the test tube with glass rod
white precipitate is produced.
For tartrate:
1. Warm the substance with sulfuric acid charring occurs and carbon monoxide
which burns with blue flame is evolved.
2. To 5 ml of sample solution add 1% w/v solution of ferrous solution and 0.05 ml
of hydrogen peroxide (10 vols) a transient yellow color is produced. After color
disappears add 2 M NaOH intense blue color is produced.

Accurately weighed quantity 2 g of substance is heated in a silica crucible until

carbonized, cool and boil the residue with 50 ml of water and 0.5 N sulfuric acid
(15 ml). It is filtered and the residue washed with water. The filtrate and washing are
titrated with 0.5 N NaOH using methyl orange as indicator. Each ml of 0.5 N H2SO4 =
0.07056 gm of NaKC4H4O6·4H2O.

It is used as laxative, food additive, as stabilizer in cheese and meet products.

Molecular formula: Al2O3·4SiO2·H2O Molecular weight: 422.29

Synonym: Clay
It is a natural, colloidal and is an absorbent aluminum phyllosilicate clay consisting
mostly of montmorillonite. It may also contain magnesium, calcium and iron. It is
prepared by removing grit and non-swelling content of the ore. The most common
type is volclay bentonite, composed of about 90% montmorillonite (Al2Si4O10(OH)2·
nH2O) and feldspar (K2O·Al2O3·6SiO2) and aluminosilicate containing SiO2, Al2O3,
Fe2O3, CaO, MgO and some Na and K.

It occurs as very fine odorless, cream colored to greyish white powder. It is insoluble
in water and soluble in organic solvents. It is slightly earth in taste. The special
properties of bentonite are an ability to form thixotropic gels with water, an ability to
absorb large quantities of water with an accompanying increase in volume of as much
as 12–15 times its dry bulk, and a high cation exchange capacity. It is stored in tightly
closed containers.

It is used as filler in pharmaceuticals, and due to its absorption/adsorption functions,

it allows paste formation. Such applications include industrial protective creams,
calamine lotion, wet compresses and anti-irritants for eczema. In medicine, bentonite
is used as an antidote in heavy metal poisoning. Personal care products such as mud
packs, sunburn paint, baby and face powders and face creams may all contain bentonite.

These are chemically inert substances which are used in the treatment of mild diarrhea
or dysentery. Diarrhea is defined as the frequent passage of watery tools as liquid
feces due to improper absorption of food or by bacterial infections and chemical toxins.
As a result increased motility in colon, the stool may contain blood, pus, mucus or
excess quantity of fats. It may be mild or chronic diarrhea while chronic diarrhea is
due to GI disturbance, absorption and inflammation. This also results in electrolyte
imbalance or dehydration due to excessive discharge of fluid. Dysentery is a frequent
elimination of watery fluid with or without mucus or blood due to infection of small
protozoa like ameba.
Many chemical agents are used to treat diarrhea and their main action is protection
and adsorbent in nature. They are:
i. Bismuth subcarbonate
ii. Bismuth subgallate
iii. Kaolin, activated charcoal
iv. Bentonite.
Following compounds are used as protectives and adsorbents.

Molecular formula: (BiO)2CO3H2O Molecular weight: 518.98

IP limit: It contains 90–92% of bismuth calculated with reference to dried substance.

To a solution of bismuth nitrate an excess of 20% sodium carbonate solution is added

with constant stirring and the solution is allowed to stand for some time. Filter the
solution and wash the residue till washings are neutral. The solid is collected and
dried at about 50°C
2Bi + 8HNO3   2Bi (NO3)2 + 2NO2 + 4H2O
Na 2 CO 3
2Bi (NO3)2   (BiO)2 CO3

It occurs as white or pale yellowish and tasteless powder. It should be stored in air-
tight container when ignited it gets decomposed into bismuth trioxide. It is insoluble
in water and soluble in hydrochloric acid and nitric acid.

For bismuth: To 0.5 gm sample add 10 ml 2 N HCl and heat to boiling for 1 minute,
cool and filter, if necessary. To 1 ml add 20 ml of water a white or slightly yellow
precipitate is formed which on addition of 0.05–0.1 ml of sodium sulfate solution turns
brown.
For carbonate: Suspend sample in 2 ml water in a test tube, add 2 M acetic acid
close the tube immediately with a stopper fitted with a glass tube bent at two right
angles, heat gently and collect the gas in 5 ml of 0.1 M barium hydroxide, a white
precipitate is formed, which is dissolves on addition of excess of dilute HCl.

Weigh accurately 0.5 gm of sample and dissolve in 3 ml HNO3 and dilute with 250 ml
of H2O. Add strong ammonia solution until cloudiness is first observed; add 0.5 ml of
HNO3 and heat to 70°C maintain the solution at this temperature till it becomes clear.
Add about 50 mg of xylenol orange mixture and titrate with 0.1 M disodium EDTA
until color changes from pinkish violet to lemon yellow. Each ml of 0.1 M disodium
EDTA = 0.02090 gm of bismuth.

Topically as protective in lotions and ointments, internally as astringent and absorbent.

It is also used as adsorbent in enteritis, diarrhea, dysentery, ulcerative colitis, in wound
dressing.

Molecular formula: Bi(OH)2C7H5O5 Molecular weight: 412.13

Synonym: Bismuth oxygallate
IP limit: It contains not <52% and not >57% of bismuth trioxide calculated with
reference to the substance dried to constant weight at 105°C.

It is prepared from bismuth nitrate and gallic acid in acetic acid medium. The acetic
acid can be replaced by mannitol or glycol.

Bismuth subgallate is a basic salt of bismuth. It is amorphous, bright yellow powder,

odorless, tasteless. Practically insoluble in water, ether, ethanol but readily dissolves
in hot mineral acids with decomposition and in solution of alkali hydroxides.
To 0.5 gm sample add 10 ml 2 N HCl and heat to boiling for 1 minute, cool and filter,
if necessary. To 1 ml add 20 ml of water a white or slightly yellow precipitate is formed
which on addition of 0.05–0.1 ml of sodium sulfate solution turns brown.

Dry about 1 gm at 105°C to constant weight, add nitric acid dropwise with stirring
and warm until solution is complete. Evaporate the solution to dryness and carefully
ignite the residue to constant weight. The residue represents the quantity if Bi2O3 in
the weight of substance taken.

It is used as astringent, antacid and protective.

It is a suspension which is prepared by using bismuth hydroxide and bismuth

subcarbonate in water. It is also known as ‘Bismuth magma’ or ‘Bismuth cream’. Milk
of bismuth mainly used as astringent and antacid rather than protective adsorbent. It
is usually given in 4–5 ml dose.

Molecular formula: Al2O3·2SiO2·2H2O Molecular weight: 258.16

Synonym: China clay, porcelain clay, white bole.
Heavy kaolin is purified natural hydrated aluminum silicate of variable composition.
Light kaolin is native hydrated aluminum silicate free from most of its impurities by
elutriation and dried. It may contain a suitable dispersing agent.

Kaolin is widely distributed in nature contaminated with ferric oxides. It is prepared

when the rock is mined, evacuated and the impurities are washed with water and
then powdered. The rock is elutriated with water and large sized particles are separated.
The turbid liquid is allowed to settle; heavy kaolin containing large particles and
colloidal kaolin containing particles of small size are separated and dried. For
pharmaceutical use it is purified by treatment with HCl and H2SO4 or both and then
washed with water.

Fuse 2 gm of substance with 4 gm anhydrous sodium carbonate. Warm residue with

water and filter, acidify the filtrate with HCl evaporate to dryness and warm the residue
with dilute HCl, residue of silica is obtained and the acid solution after neutralization
gives reaction for aluminum.
For aluminum: To 0.5 gm in a metal crucible add 1 gm HNO3 and 3 gm anhydrous
sodium carbonate, heat to melt and allow cool, adding 20 ml of boiling water to this
residue and filtering. To filtrate add 1 ml of 10 M NaOH and filter. To filtrate add 3 ml
of ammonium chloride solution a gelatinous white precipitate is obtained.
 For silicate: Fuse 1 gm of substance with 2 g anhydrous sodium carbonate and
warm the residue with 10 ml of water, filter, wash with water and reserve the residue.
To combined filtrate and washings add 3 ml of HCl a gelatinous precipitate is obtained.

It is used as adsorbent in diarrhea caused by agents capable of being absorbed, e.g.

due to food poisoning and also used in chronic ulcerative colitis. As poultice, dusting
powder, clarifying and decolorizing medium, as filtering medium, as tablet diluent.

Absorbing power should not be <40% of weight of phenazone calculated with reference
to the dried substance.

Decolorizing charcoal is obtained from magnesium matter by suitable carbonization

process intended to confer a high absorbing power.

When heated to redness burns slowly without flame.

To 0.3 gm of substance add 25 ml of freshly prepared 1% w/v solution of phenazone,

shake thoroughly for 15 minutes filter the solution and discard the first 5 ml of the
filtrate. To 10 ml of the filtrate add 1 gm potassium bromide, 20 ml of 2 M HCl and
titrate with 0.0167 M potassium borate using 0.1 ml of ethoxychrysoidine HCl solution
as indicator. The endpoint is change of color from reddish pink to yellow pink. Repeat
the titration with phenazone only using 10 ml of phenazone. Calculate the % of
phenazone absorbed using expression
2.353 (a – b)/w
where w = weight in gm of sample
a = volume consumed during first titration
b = volume consumed by phenazone only

1. Laxatives are called:

a. Mild cathartics b. Protective
c. Stimulants d. All of the above
2. Magnesium sulfate is known as:
a. Blue vitriol b. Epsom salt
c. Clay d. None of the above
3. Cathartics are used to ......
a. Reduce GI irritation b. Induce vomiting
c. Evacuation of bowl d. All of the above
 4. Mild diarrhea caused due to:
a. Hypersensitivity b. Intentional poisoning
c. Accidental poisoning d. All of the above
5. When the rock is mined ..... is prepared.
a. Mild cathartics b. Bentonite
c. Kaolin d. Ammonium chloride
6. ...... are chemically inert substances which are used in the treatment of mild
diarrhea or dysentery.
a. Mild cathartics b. Protectives and absorbents
c. Antacids d. None of the above
7. Purgatives are ......
a. Mild cathartics b. Protective
c. Strong cathartics d. All of the above
8. ...... is defined as the frequent passage of watery stools as liquid feces.
a. Mild cathartics c. Stimulants
b. Diarrhea d. All of the above
9. Milk of bismuth is also known as:
a. Bismuth magma b. Bismuth cream
c. Both a and b d. None of the above
10. ...... is used as food additive.
a. Bentonite b. Sodium potassium tartrate
c. Kaolin d. Ammonium chloride

1. a 2. b 3. c 4. d 5. b 6. b 7. c 8. b 9. c 10. b

1. Molecular formula of kaolin ......

2. Saline cathartics should not be used in patients’ with ......
3. Major side effect of saline cathartics is ......
4. Emollient laxatives act either as ...... or ......
5. Kaolin is used as ......
6. Sodium potassium tartrate is also known as ......
7. Kaolin is ......
8. ...... can be prepared by neutralizing hot dilute sulfuric acid with magnesium or
its oxides or carbonate.
9. Mineral oil is ...... laxative.
10. ...... can be prepared from solution of bismuth nitrate an excess of 20% sodium
carbonate solution.

1. Al2O32SiO2·2H2O
2. Low sodium diet
3. Excessive loss of body fluids as watery stools
 4. Lubricants, stool softeners
5. Adsorbents
6. Rochelle’s salt
7. Natural hydrated aluminum silicate
8. Magnesium sulfate
9. Lubricant
10. Bismuth subcarbonate.

1. Define the following terms.

a. Purgative
b. Laxative
c. Cathartics
2. Discuss various types of laxatives.
3. Write the method of preparation of magnesium sulfate.
4. How would you prepare bismuth subcarbonate?
5. Define diarrhea. What are the causes of diarrhea?
6. Differentiate light and heavy kaolin.
7. What is milk of magnesia?
8. What are protectives and adsorbents?
9. What are side effects of MgSO4 when excessive amount consumed?
10. Write the method of preparation of bismuth subcarbonate.

1. Write a note on saline cathartics.

2. Briefly discuss the preparation, properties, assay and uses of magnesium sulfate.
3. Describe in detail about the method of preparation, properties and uses of sodium
potassium tartrate.
4. Discuss in detail about the method of preparation, properties and uses of bismuth
subcarbonate.
5. Briefly discuss the kaolin.
6. Explain in detail about the bentonite.
7. Write a short note on bismuth subgallate.
8. Give a detailed note on official compound sodium orthophosphate.
 • Introduction • Hydrogen Peroxide
• Mechanism of Action • Chlorinated Lime
– Classification • Iodine and its Preparation
• Boric Acid • Povidone–Iodine
• Potassium Permanganate • Important Questions/Answers

An antimicrobial is an agent that kills or stops the growth of microorganisms. The

word antimicrobial was derived from the Greek words ‘anti’—against, ‘mikros’—little
and bios—life. Antimicrobial substances are either destroying (microbiocidal) or
inhibiting the growth of microorganisms (microbiostatic) especially pathogenic
organism such as bacteria, fungi or protozoans. The most common targets for
antimicrobial drug actions are fall into five basic categories:
i. Inhibition of cell wall synthesis
ii. Inhibition of nucleic acid synthesis
iii. Inhibition of protein synthesis
iv. Inhibition of unique metabolic steps
v. Effects on cell membrane sterols (antifungal agents).
These are mainly classified into antiseptics, disinfectants, germicides, bacteriostatics
and sanitizers.
1. Antiseptics: Antiseptic(s) (from Greek anti: ‘against’ and septikos: ‘putrefactive’)
are antimicrobial substances which are applied to living tissue/skin to reduce or
arrests the possibility of infection, sepsis, or putrefaction. These are the chemical
substances used in destroying disease causing microorganism (also called
pathogens) externally on wound or taken internally to treat infection. All
antiseptics or protein denaturants and act on enzymes in the bacteria. They can
be applied to all tissues of the body and may be use in the form of mouthwashes,
soaps, deodorants, throat and nasal spray, e.g. Dettol, tincture of iodine, boric
acid, cetrimide.
2. Disinfectants: These are the drugs or substances which are applied to the surface
of non-living objects to destroy microorganisms that are living on the objects.
Disinfection does not necessarily kill all microorganisms, especially resistant
bacterial spores; it is less effective than sterilization. These are commonly used in
houses, disinfection of surgical instruments, hospital sanitation and sputum
 containers on floor. They are bactericidal and rapidly produce irreversible lethal
effects. Some chemical disinfectants are too irritant to the skin, e.g. cresol and
phenol.
3. Germicides: These are substances which kill microorganisms. More specific
terminology like ‘bactericide’ (against bacteria) ‘fungicide’ (against fungi),
‘viricide’ (against virus), etc. signifies exact action. Potency of germicide is
expressed by phenol coefficient. It mainly acts by denaturation of bacterial
enzymes and proteins, by oxidation of bacterial protoplasm and by increasing
bacterial cell membrane permeability.
4. Bacteriostatics: These are substances which primarily function by inhibiting the
growth of bacteria. Thus, bacteriostatic drugs or agents do not kill but inhibit the
growth of bacteria.
5. Sanitizers: It is the process of rendering sanitary by decreasing the number of
bacterial contaminants. Disinfectants that are used to maintain general public
health standards, are termed sanitizers. Sanitizers are mainly concerned with
cleaning or washing away the organic matter.

Based upon the mechanism of action inorganic antimicrobial agents can be divided
into three general categories:
1. Oxidation
2. Halogenation
3. Protein precipitation.

Convert sulfhydryl into a disulfide bridge, thus altering the conformation of the
protein and thereby alter its function. Nonmetals and certain types of anions function
through oxidative mechanisms, e.g. H2O2, KMnO4, iodine solution, povidone-iodine.

Hypohalides can react with amide hydrogen to form N-chloro derivatives. This is a
reaction occurring with antiseptics of the hypohalite type, e.g. sodium hypochlorite.
Since these types of compounds can serve as reagents in the chlorination of primary
and secondary amides, e.g.

It is expected that a similar reaction can take place under appropriate conditions
with the peptide linkage between the amino acid groups comprising the protein
molecule.
The complex of protein precipitants results in a radical change in the properties of the
proteins and them ‘tie-up’ important functional groups at the active site of enzymes
resulting in antimicrobial activity, e.g. AgNO3, mild silver protein, mercury, yellow
mercuric oxide, ammoniated mercury.
A non-selective antimicrobial agent causes most destructive effect on the majority
of microorganisms (antiseptics and disinfectants). The chemical agents must possess
following properties to treat as antiseptics and disinfectants:
• Must have a broad-spectrum and rapid onset of action
• Should have a small latency period and high activity
• Must be chemically resistant and low toxicity
• High availability and low cost
• Lack of local irritant or allergic effects on tissues
• Minimal absorption from the place of their application.

Classification of antiseptics and disinfectants (according to chemical structure):

Antimicrobial agents are classified according to their chemical structure.

Molecular formula: H3BO3 Molecular weight: 61.83

Synonym: Ortho boric acid, hydrogen borate, acidum boricum, boracic acid.
Boric acid widely distributed in sea water, plants, fruits and also available in
combined form as its largest natural resource. As per IP boric acid contains 99.5–100.5%
of H3BO3 on the dry basis.
 1. Boric acid may be prepared by reacting borax (sodium tetraborate decahydrate)
with a mineral acid, such as hydrochloric acid or sulfuric acid.
Na2B4O7·10H2O + 2HCl  4H3BO3 + 2NaCl + 5H2O
2. It is also formed as a by-product of hydrolysis of boron trihalides and diborane.
B2H6 + 6H2O  2B(OH)3 + 6H2O
Diborane
BX3 + 3H2O  B(OH)3 + 3 HX (X = Cl, Br, I)
Boron
trihalides

It occurs as white crystalline solid or granular, odorless, sparingly soluble in water

and slightly soluble in alcohol. When heated above 100°C, it dehydrates, forming
metaboric acid (HBO2) and when metaboric acid heated at 160°C it converted into
tetraboric acid or pyroboric acid (H2B4O7) and when pyroboric acid is heated above
200°C it decompose into boron trioxide (B2O3).
100°C 160°C 200°C
H 3 BO 3 
–H O
 HBO 2 
–H O
 H 2 B 4 O7 
–H O
 B2 O 3
2 2 2
Boric acid Metaboric Tetraboric Boron
acid acid trioxide

Boric acid is weak acid but when boric acid dissolve in glycerin it gives glyceroboric
acid and has ionization constant is 10,000 times greater than that of boric acid.

B(OH)3 + 2H2O  B(OH)–4  H 3 O 

Boric acid reacts with alcohols to form borate esters [B(OR)3] where R is alkyl or
aryl.
B(OH)3 + 3ROH  B(OR)O3 + 3H2O

i. Boric acid can be used as an antiseptic for minor burns or cuts. It is also used as
weak bacteriostatic, fungistatic and astringents.
ii. It is also used in preservation of grains such as rice and wheat.
iii. Boric acid is applied in a very dilute solution as an eyewash.
iv. Dilute boric acid can be used as a vaginal douche to treat bacterial vaginosis due
to excessive alkalinity.
v. It is also used as mouthwashes, skin lotion for local anti-infective action.
vi. It also used as an insecticide.
vii. The boric acid-borate system can be useful as a primary buffer system.
viii. Boric acid is used in some nuclear power plants as a neutron poison.
 It should be stored in well-closed container and kept in a cool place. Adverse effects
on ingestion are vomiting, abdominal cramps, etc.

Molecular formula: KMnO4 Molecular weight: 158.03

Synonym: Condy’s crystals, permanganate of potash, hypermangan
IP limit: As per IP, it contains 99–100.5% w/w of KMnO4.

It is prepared by heating potassium hydroxide with manganese dioxide in presence of

air or potassium nitrate/potassium chlorate (oxidizing agent).
2MnO2 + 4KOH + O2  2K2MnO4 + 2H2O
(Potassium
manganate)

2K2MnO4 + 2H2O  2KMnO4 + 2KOH + H2

Potassium manganate can be oxidized by chlorine, it gets converted into KMnO4
2K2MnO4 + 2Cl2  2KMnO4 + 2KCl
Potassium manganate when treated with hydrochloric acid
3K2MnO4 + 4HCl  2KMnO4 + 4KCl + 2H2O + MnO2
Potassium manganate when treated with carbon dioxide
3K2MnO4 + 2CO2  2KMnO4 + 2K2CO3 + MnO2
The above solution is filtered to separate the precipitated KMnO4 from MnO2 and
then concentrated and cooled to crystallize potassium permanganate.

It occurs as dark purplish or brownish black crystals or granular powder. It is odorless,

has metallic lusture. It is sweet with astringent taste and freely soluble in water and
alcohol. As it is strong oxidizing agent, it decomposes with a high-risk of explosion in
contact with certain organic substances. It is stable in air when it is heated it decomposes
at about 240°C with evolution of oxygen.
Potassium permanganate acts as strong oxidizing agents. Iodides are oxidized to
iodate by alkaline or neutral solution.
KMnO4 + KI + H2O  2MnO2 + KIO3 + KOH
2KMnO4 + 10KI + 8H2SO4  2MnSO4 + 6K2SO4 + 5I2 + 8H2O
Potassium permanganate oxidizes aldehydes to carboxylic acids
5C6H13CHO + 2KMnO4 + 3H2SO4  5C6H13COOH + 3H2O + 2MnSO4 + K2SO4
(n-heptanal) (heptanoic acid)
Even an alkyl group (with benzylic hydrogen) on an aromatic ring is oxidized, e.g.
toluene to benzoic acid.
5C6H5CH3 + 6KMnO4 + 9H2SO4  5C6H5COOH + 14H2O + 6MnSO4 + 3K2SO4
(Toluene) (Benzoic acid)
When heated solid potassium permanganate decomposes.
2KMnO4  K2MnO4 + MnO2(s) + O2
 1. It possesses strong oxidizing properties and oxidizes proteins and other
bioorganic substances so it is used as disinfectant and deodorant.
2. It is also used as astringents, anti-infective and bactericidal.
3. It was used as a bleaching agent and extensively used in the water treatment.
4. It finds used in the treatment of urethritis. Its solutions are used to clean the ulcer
or abscesses as wet dressing and in baths in eczematous conditions and acute
dermatitis.
5. It finds use as an antidote for poisoning by barbiturates, chloral hydrate and many
alkaloids.

Store in well-closed container and kept in a cool place.

Molecular formula: H2O2 Molecular weight: 34.01

Synonym: Dioxidane, oxidanyl, perhydroxic acid.
It is a nonplanar molecule with twisted symmetry. Although the O—O bond is a
single bond, the molecule has a relatively high rotational barrier. The molecular
structures of gaseous and crystalline H2O2 are significantly different. This difference
is attributed to the effects of hydrogen bonding, which is absent in the gaseous state.
IP limit: As per IP, hydrogen peroxide solution (20 vol/100 vol) is an aqueous
solution of H2O2. It contains a suitable stabilizing agent. Hydrogen peroxide solution
(20 vol) contains 5–7% of H2O2 which corresponds to about 20 times its volume of
available oxygen while hydrogen peroxide solution (100 vol) contains 26–28% of H2O2
which corresponds to about 100 times its volume of available oxygen.

1. From barium peroxide: When aqueous cream of barium peroxide treated with cold
dilute sulfuric acid forms hydrogen peroxide.
BaO2 + H2SO4  BaSO4 + H2O2
It is also obtained by decomposing barium peroxide treated with phosphoric acid
forms hydrogen peroxide.
3BaO2 + 2H3PO4  Ba3(PO4)2 + 3H2O2
2. When carbon dioxide is passed slowly through ice-cold paste of barium peroxide,
then hydrogen peroxide produced:
BaO2 + H2O + CO2  BaCO3 + H2O2
3. From sodium peroxide: In laboratory it is prepared by Merck’s process. Sodium
peroxide decomposed by addition of cold dilute (20%) solution of sulfuric acid
forms hydrogen peroxide.
Na2O2 + H2SO4  Na2SO4 + H2O2
It is a clear, colorless and odorless liquid or may have an odor related to that of ozone
unstable liquid. It is bitter in taste, caustic to skin, acidic to litmus. It is miscible with
water, dissolves in ether, immiscible in pet ether. It rapidly decomposes in contact
with oxidizable matter and metals. It is a good oxidizing agent.
It should be stored in a paraffin wax coated with glass, plastic or Teflon bottles
partially filled container having stabilizing agent and small vent in a closure at
8–15°C. It should be protected from light. It should not be stored in glass containers
due to metal oxides present in the containers catalyzes its decomposition. A small
quantity of acid, alcohol, glycerol and phosphoric acid is often used as a stabilizing
agent to check its decomposition.

1. Decomposition: Pure hydrogen peroxide decomposes slowly, but when heated at

100°C it liberates oxygen.
H2O2  2H2O + O2
2. Oxidation properties: Hydrogen peroxide is a strong oxidizing agent and react
many organic materials.
PbS + 4H2O2  PbSO4 + 4H2O
Lead Lead
sulfide sulfate
2KI + H2O2  2KOH + I2
Potassium
iodide
2FeSO4 + H2SO4 + H2O2  Fe2(SO4)3 + 2H2O
Ferrous Ferric
sulfate sulfate
3. Reduction properties: Hydrogen peroxide behaves as reducing agents towards
other oxidizing agents.
Ag2O + H2O2  2Ag + 2H2O + O2
Silver
oxide
2KMnO4 + 3H2SO4 + 5H2O2  K2SO4 + 2MnSO4 + 8H2O + 5O2
4. Acidic in nature: Hydrogen peroxide is slightly acidic in nature through in dilute
solution it is neutral towards litmus.
2NaOH + H2O2  Na2O2 + 2H2O
Sodium
peroxide
Ba(OH)2 + H2O2  BaO2 + 2H2O
Barium Barium
hydroxide peroxide
2Na2CO3 + H2O2  Na2O2 + CO2 + H2O
Sodium
peroxide

Assay of hydrogen peroxide based on the oxidation-reduction (redox) titration. 10 ml

of H2O2 is diluted with 10 ml distilled water, then add 10 ml of 5 N sulfuric acid and
then titrated with 0.1 N potassium permanganate solution, until a faint pink color is
obtained. Each ml of 0.1 N KMnO4 = 0.001701 gm of H2O2.
3KMnO4 + 3H2SO4 + 5H2O2  K2SO4 + 2MnSO4 + 8H2O + 5O2

1. In Medical:
• Used as an antiseptic, germicidal and disinfectant.
• Can be used for the sterilization of various surfaces, including surgical tools
and may be deployed as a vapor (VHP) for room sterilization.
• Demonstrates broad-spectrum efficacy against viruses, bacteria, yeasts, and
bacterial spores. In general, greater activity is seen against gram-positive than
gram-negative bacteria.
• Was used for disinfecting wounds.
• Effective antidote for phosphorus and cyanide poisoning.
2. Cosmetic applications:
• Diluted H2O (between 1.9% and 12%) mixed with ammonium hydroxide is
used to bleach human hair, wool, feather, ivory, etc.
• Also used for tooth whitening. It can be found in most whitening toothpastes
• May be used to treat acne
• It finds use in deodorants.
3. Propellant: High-concentration H2O is referred to as “high-test peroxide” (HTP).
It can be used either as a monopropellant (not mixed with fuel) or as the oxidizer
component of a bipropellant rocket.
4. Explosives: Used for creating organic peroxide-based explosives, such as acetone
peroxide, for improvised explosive devices.
5. Industrial:
• Used for pulp and paper-bleaching
• Manufacture of sodium percarbonate and sodium perborate which are used
as mild bleaches in laundry detergents
• Used as an antichlor
• Aerating agents in production of sponge rubber.

Store in cool and dark place and light resistant container.

Molecular formula: Ca(ClO)2 Molecular weight: 142.98

Synonym: Hypochlorous acid, bleaching powder, calcium oxychloride, calcium
hypochlorite.
Bleaching powder is not a simple mixture of calcium hypochlorite, calcium chloride,
and calcium hydroxide. Instead, it is a mixture consisting principally of calcium
hypochlorite [Ca(OCl)2], dibasic calcium hypochlorite [Ca3(OCl)2(OH)4], and dibasic
calcium chloride [Ca3Cl2(OH)4]. It is made from slightly moist slaked lime.
Calcium hypochlorite is produced industrially by treating slaked lime [Ca(OH)2] with
chlorine gas.
2Cl2 + 2Ca(OH)2  Ca(OCl)2 + CaCl2 + 2H2O

It is a dull, dry, white powder, contains not <30% w/w of chlorine. It is slightly soluble
in water and alcohol. It has strong odor of chlorine. On exposure to air, it becomes
moist and rapidly decomposes to release hypocholorus acid. Carbon dioxide being
absorbed and chlorine gas is evolved. Its aqueous solution is strongly alkaline. It is
stored in well-closed containers at dry, cool place and away from organic materials
and metals. The hydrated form is safer to handle.

1. Calcium hypochlorite reacts with carbon dioxide to form calcium carbonate and
release dichlorine monoxide
Ca(ClO)2 + CO2  CaCO3 + Cl2O
2. A calcium hypochlorite solution is basic. This basicity is due to the hydrolysis
performed by the hypochlorite ion, as hypochlorous acid is weak, but calcium
hydroxide is a strong base. As a result, the hypochlorite ion is a strong conjugate
base, and the calcium ion is a weak conjugate acid:
OCl– + H2O  HOCl + OH–
Similarly, calcium hypochlorite reacts with hydrochloric acid to form calcium
chloride, water and chlorine.
Ca(OCl)2 + 4HCl  CaCl2 + 2H2O + 2Cl2
3. Treatment of chlorinated lime with dilute sulfuric acids liberates hypochlorous
acid which behaves as oxidizing and bleaching agents.
2Ca(OCl)2 + 4H2SO4  CaCl2 + CaSO4 + 2HClO
HClO  HCl + [O]
4. On treatment with excess of dilute acid or CO2, the whole of chlorine is liberated.
Ca(OCl)2 + H2SO4  CaSO4 + H2O + Cl2

It has rapid bactericidal action. It kills most of bacteria, some fungi, yeast, algae, viruses
and protozoa. It is commonly used to sanitize swimming pools in combination with
cyanuric acid stabilizer which reduces the loss of chlorine due to UV radiation and
disinfect drinking water. It is also used for sugar industry for bleaching sugar cane
juice before its crystallization. It is a general oxidizing agent. It is used for bleaching
cotton and linen. In the preparation of surgical chlorinated soda solution (Dakin’s
solution) it is employed as a wound disinfectant. A mixture of chlorinated lime and
boric acid solution (Eusol) is used as a disinfectant lotion and wet dressing.
Molecular formula: I2 Molecular weight: 253.8
It is a dark violet non-metallic halogen element.
IP limit: As per IP, it contains 99.5–100.5% w/w of iodine.

1. From seaweeds: By reacting keep (seaweed ash) with water, sulfuric acid and
hydrogen peroxide
2I– (aq) + 2H+ (aq) + H2O2 (aq)  2H2O (l) + I2 (aq)
2. It is prepared by heating KI or NaI with dil. H2SO4 and manganese dioxide.
2KI + MnO2 + 3H2SO4  I2 + 2KHSO4 + MnSO4 + 2H2O

It occurs as grayish violet colored crystalline powder with irritant odor. It has pungent
taste. It is sparingly soluble in water, soluble in ethanol and freely soluble in ether. It
is volatile in nature.

It should be stored in well-closed amber colored container with a glass stopper at a

cool place.

It is incompatible with hypophosphite, sulfate, some metal, reducing agent, alkalis

and alkali carbonates.

It is used as topical agent, antimicrobial agent and the solution used as germicide and
fungicide. It is used in the treatment of thyrotoxicosis and antidote for alkaloidal
poisoning. It is also used as counterirritant. It is used in the manufacture of dye stuffs
and drugs.

It is mainly of three types:

It contains 5% w/v of iodine and 10% w/v of potassium iodide in water. It is a trans-
parent brown colored liquid and has a smell of iodine.
Composition:
Sr. Ingredient Qty.
no.
1. Iodine 50 gm
2. Potassium iodide 100 gm
3. Purified water 1000 ml qs
It contains 2% w/v of iodine and 2.5% w/v of potassium iodide in water. The required
volume is made by adding sufficient alcohol (90%). Its alcoholic content is 45–48% v/v
as per IP. It is a transparent brown colored liquid and has smell of alcohol.
Composition:
Sr. Ingredient Qty.
no.
1. Iodine 20 gm
2. Potassium iodide 25 gm
3. Alcohol 50% (qs) 1000 ml

It consists of 15 ml strong iodine solution, 6 ml purified phenol, 165 ml of glycerin and

sufficient water to make up the volume up to 1000 ml.

It is used as topical antimicrobial agent and used for disinfection of skin before surgery.
Dilute solution used to apply on wounds and cuts also used as amebicidal agent.

Povidone-iodine is an iodophor, i.e. complex of iodine with povidone (a polymer/

polyvinyl pyrolidone). Iodophors class of compounds is complexes of iodine with
carrier organic molecules serving as a solubilizing agent. These complexes slowly
liberate iodine in solution. It is less irritating iodine product without losing antibacterial
effectiveness.
Povidone-iodine (PVP I) is a stable chemical complex of polyvinyl pyrolidone
(povidone, PVP) and elemental iodine. It contains from 9–12% available iodine,
calculated on a dry basis.

It is a yellowish brown colored amorphous powder and having slight characteristic

odor. It is soluble in water and ethanol. Its aqueous solution is acidic in nature.

It should be stored in well-closed airtight container at a cool place.

It is having non-irritating effect on tissues and comparatively low oral toxicity. It is

soluble in water. Low iodine vapor pressure making it stable to possible iodine loss. It
is non-staining and can be washed clear from skin and clothing.

It is used as a topical agent as a broad-spectrum antiseptic. It is also used as gargles

and mouthwashes (to treat oral cavity infection). It is used as a disinfectant.
 1. ...... is an agent that kills or stops the growth of microorganisms.
a. Antimicrobials b. Antacids
c. Protectives d. All of the above
2. Antimicrobial agents act by ...... mechanism.
a. Oxidation b. Protein precipitation
c. Halogenation d. All of the above
3. ...... is an effective antidote for phosphorus and cyanide poisoning.
a. KMnO4 b. H2O2
c. Borax d. Calcium chloride
4. Chlorinated lime is also known as ......
a. Clay b. Dioxidane
c. Bleaching powder d. Calcium chloride
5. ...... is a dark violet non-metallic halogen element.
a. Hypochlorite b. Iodine
c. Zinc sulfate d. Mercury
6. Strong iodine solution is also known as:
a. Aqueous iodine solution b. Lugol’s solution
c. Both a and b d. None of the above
7. Povidone iodine is an:
a. Oxadione b. Pyrazine
c. Both a and b d. Polyvinyl pyrolidone
8. ...... is produced industrially by treating slaked lime with chlorine gas.
a. Calcium hypochlorite b. Calcium carbonate
c. KMnO4 d. Polyvinyl pyrolidone
9. Hydrogen peroxide should be stored in a paraffin wax coated with ...... bottles.
a. Glass b. Plastic
c. Teflon d. All of the above
10. ...... acts as strong oxidizing agents.
a. Titanium dioxide b. Potassium permanganate
c. Magnesium sulfate d. All of the above

1. a 2. d 3. b 4. c 5. b 6. c 7. d 8. d 9. d 10. b

1. ...... are the substances which are applied to the surface of non-living objects to
destroy microorganisms.
2. ...... is the process of rendering sanitary by decreasing the number of bacterial
contaminants.
3. ...... are substances which kill microorganisms.
4. Molecular formula of borax ......
 5. Boric acid is a ...... acid.
6. ...... is used as astringents, anti-infective and bactericidal.
7. Hydrogen peroxide is used as ......
8. ...... is used as an anti-hyperthyroid.
9. ...... and ...... are examples of disinfectants.
10. Povidone iodine is an ......

1. Disinfectants
2. Sanitization
3. Germicides
4. Na2B4O7·10H2O
5. Weak
6. KMnO4
7. Antiseptics
8. Iodine
9. Cresol, phenol
10. Iodophor

1. Write the method of preparation of iodine in laboratory.

2. Define antimicrobials. Discuss the mechanism of action of antimicrobial.
3. Classify antimicrobials on the basis of mode of action with examples.
4. Classify antimicrobials on the basis of chemical structure with examples.
5. Define the following terms:
a. Germicide
b. Bacteriostatic
c. Sanitizers
6. Differentiate antiseptics and disinfectants.
7. Discuss the method of preparation and properties of boric acid.
8. What are the pharmaceutical uses of boric acid.

1. Explain the method of preparation, properties and uses of hydrogen peroxide.

2. Discuss in detail about the method of preparation, properties and uses of
potassium permanganate.
3. Describe in detail about the method of preparation, properties and uses of
chlorinated lime.
4. Give a detail note on iodine and its preparations.
 • Introduction • Ammonium Chloride
• Classification of Expectorants • Important Questions/Answers
• Potassium Iodide

A cough is a sudden expulsion of air through the large breathing passages that can
help clear them of fluids, irritants, foreign particles and microbes. Cough due to
irritation from lack of sufficient demulcent respiratory tract fluid below the epiglottis.
As a protective reflex, coughing can be repetitive with the cough reflex following
three phases: an inhalation, a forced exhalation against a closed glottis, and a violent
release of air from the lungs. Cough can be the irritant and productive. Irritative cough
is a dry cough which may be produced by cold or inhalation of irritant foreign particles
or gases and produce no sputum. Whereas productive cough produces a phlegm or
sputum (mucus) and producing cough which is associated with asthma and bronchitis.
It should not be suppressed and clears mucus from the lungs.
Expectorants are drugs that help in removing sputum from the respiratory tract
either by increasing the fluidity (or reducing the viscosity) of sputum or increasing
the volume of fluids that have to be expelled from the respiratory tract by coughing.
Expectorants derived from the latin word ‘Expectorate’ means ‘to drive from the chest’.
These are medicinal substances which enhance the secretion of the sputum by the
air passages so that it is easier to remove the phlegm through coughing. They are
used in cough mixtures for this purpose they act either by increasing the bronchiole
secretion or by making it less viscous (mucolytic agents). In case of dry cough, many
of the expectorants act reflexly irritate the lining of the stomach which stimulates the
production of sputum by the glands in the bronchial mucous membrane.
Commonly used expectorants are Guafensin is commonly available in many cough
syrups. Drugs such as ipecacuanha in small doses act as stimulant expectorants. Volatile
oils are direct expectorants. Potassium iodide stimulates the gastric mucosa which
increases the bronchiole secretion and liquify mucus. Ammonium chloride acts like
potassium iodide but it is less potent. Antimony potassium tartrate also used as
expectorant.
According the their mechanism of action it is classified into two categories.

These are stomach irritant expectorants which are able to produce their effect through
stimulation of gastric reflexes, e.g. bitter drugs—ipecac, senega, Indian squill and
inorganic compounds such as antimony potassium tartrate, ammonium chloride,
sodium citrate, potassium iodide, etc.

These are the expectorants which bring about a stimulation of the secretory cells of
the respiratory tract directly or indirectly. Since these drugs stimulate secretion, more
fluid produced in respiratory tract and sputum is diluted, e.g. eucalyptus, lemon,
anise.

Molecular formula: KI Molecular weight: 166.0

Synonym: Kalii iodidum, potide.
IP limit: As per IP it contains 99–101.5% of potassium iodide with reference to a
dried basis.
Category: Antithyroid, antifungal, expectorant.

1. In laboratory, it is prepared by treating a hot aqueous solution of potassium

hydroxide with iodine in slight excess to form a mixture of potassium iodide and
iodate. The obtained pale yellow solution is evaporated and the residue (iodate)
is heated with charcoal to reduce iodate to iodine.
6KOH + 3I2  KIO3 + 5KI + 3H2O
KIO3 + 3C  KI + 3CO
2. On large scale, it is prepared by treating iron fillings with potassium carbonate.
Iron fillings are agitated in the iodine solution to form ferro ferric iodide (FeI2.
FeI3) solution of which is further boiling with concentrate potassium carbonate
gives potassium iodide.
4Fe + 5I2  2FeI2·FeI3
FeI2·FeI3 + 4K2CO3  8KI + FeO·Fe2O3 + 4CO2
3. Its prepared by the reaction of a potassium base with hydroiodic acid, e.g.:
HI + KHCO3  KI + H2O(l) + CO2(g)
4. Alternatively iron (II) iodide, prepared using scrap iron and iodine (made from
iodide rich brines or from Chile saltpeter, can be treated with potassium
carbonate:
FeI2 + K2CO3  2KI + FeCO3

It occurs as cubic crystals, white granular powder. It is soluble in water, alcohol and
freely soluble in glycerine. Its taste is saline and slightly bitter. It is slightly hygroscopic
in nature, on exposure to air; it becomes yellow due to liberation of iodine. It should
be stored in airtight container protected from light and moisture.

As expectorant, 250–500 mg.

1. Iodine gets readily dissolves in aqueous solution of KI, forming a dark brown
solution of potassium triiodide.
KI + I2  KI3
2. It reacts with silver nitrate gives yellow precipitate of silver iodide.
2I–  I2 + 2e–
3. Iodine ion readily gets oxidized by treating with oxidizing agents like nitric acid,
copper, chlorine, etc.
KI + AgNO3  AgI + KNO3
Yellow

It is based upon oxidation–reduction method using iodometric method. Dissolve

accurately weighed 350 mg of potassium iodide in about 10 ml of water, and add
35 ml of hydrochloric acid and 5 ml of chloroform. Titrate with 0.05 M potassium
iodate until purple color of iodine disappears from the chloroform. The last portion of
the iodate solution is added dropwise and the solution is agitated continuously and
vigorously. It is then allowed for 5 minutes; if any color develops in the chloroform
layer then the titration is continued. Each ml of 0.05 M potassium iodate is equivalent
to 16.60 mg of KI.
KIO3 + 2KI + 6HCl  3KCl + 3I2 + 3H2O

A 10% w/v solution in carbon dioxide-free water (solution A) gives the reactions of
potassium salts, and of iodides.

Add mercuric chloride solution to 1 ml of sample solution a dark red precipitate is

obtained which is slightly soluble in excess of this reagent and completely soluble in
excess of potassium iodide solution by forming potassium mercuri iodine precipitate.
2KI + HgCl2  HgI2 + 2KCl
2KI + HgI2  K2HgI4

To 10 ml of solution A add 0.2 ml of 0.01 M sulfuric acid; no color is produced on

addition of a drop of phenolphthalein solution.

Solution A is clear and colorless.

 1. Arsenic: Dissolve 5 gm in 50 ml of water and 12 ml of stannated hydrochloric acid
AsT. The resulting solution complies with the limit test for arsenic (2 ppm).
2. Heavy metals: Not >10 ppm, determined on 2 gm by Method A.
3. Iron: Solution A complies with the limit test for iron (20 ppm).
4. Cyanide: Warm 5 ml of solution A, add one drop of ferrous sulfate solution and
0.5 ml of sodium hydroxide solution and acidify with hydrochloric acid; no blue
color is produced.
5. Iodate: Dissolve 0.5 gm in 10 ml of carbon dioxide-free water and add 0.15 ml of
dilute sulfuric acid and a drop of iodide-free starch solution; no blue color is
produced within 2 minutes.
6. Sulfate: 1 gm dissolved in 15 ml of water complies with the limit test for sulfates
(150 ppm).
7. Loss on drying: Not >1%, determined on 1 gm of the powdered substance by
drying in an oven at 105oC for 3 hours.

Incompatible with salts of mercury, bismuth, lead, iron, potassium chlorate, chloral
hydrate, other oxidizing agent and dilute hydrochloric acid.

It is used as mild expectorants (dose of 300 mg in 4 times a day), treatment of

hypothyroidism, used as a source of iodine, in cough preparation, to stabilize in
preparation of solutions of iodine. It is also used as antifungal in veterinary practices.

Molecular formula: NH4Cl Molecular weight: 53.49

Synonym: Salmiac, amchlor, ammonium muriate.
IP limit: As per IP it contains not <99.5% of ammonium chloride with reference to
a dried basis.

1. Ammonium chloride is made by reacting hydrochloric acid with ammonia and

the resulting solution is evaporated to dryness. The product is purified by
recrystallization or by sublimation.
2NH3 + HCl  NH4Cl
2. It is also prepared by treating ammonium sulfate with sodium chloride.
2NaCl + (NH4)2SO4  2NH3 + 2HCl + 2Na2SO4
2NH3 + 2HCl  2NH4Cl

It is a white crystalline salt, odorless and has cooling saline taste. It is freely soluble in
water but slightly soluble in alcohol. It is hygroscopic. On heating it sublimes without
melting. It should be stored in tightly closed containers.
 1. In its vapor form, it dissociates in ammonia and hydrochloric acid.
NH4Cl  NH3 + HCl
2. It reacts with strong base such as sodium hydroxide to release ammonia gas.
NH4Cl + NaOH  NH3 + NaCl + H2O
3. It also reacts with alkali metal carbonates at elevated temperatures to give alkali
metal chlorides and ammonia gas.
2NH4Cl + Na2CO3  2NaCl + CO2 + H2O + NH3

It is assayed by acid–base titration method. Formaldehyde, previously neutralized is

added to the solution of the substance. It fixes the ammonia in ammonium chloride as
hexamine. The liberated hydrochloric acid is titrated against 0.1 M sodium hydroxide,
using phenolphthalein as indicator. Each 1 ml of 0.1 N sodium hydroxide is equivalent
to 0.005439 gm of ammonium chloride.
NH4Cl + HCHO  CH2NH + HCl + H2O
HCl + NaOH  NaCl + H2O

It gives reactions with ammonium salts and chlorides. It is heated with sodium
hydroxide solution releases ammonia gas which is recognized by its odor and its action
on moist litmus paper.
NH 4 + OH–  NH3 + H2O

It is tested for the following impurities.

1. Arsenic should not be >2 ppm.
2. Heavy metals should not be >10 ppm.
3. Iron should not be >20 ppm.
4. Sulfate should not be >150 ppm and calcium not >200 ppm.
5. Loss on drying should not be >1%.
pH: Between 4.5 and 6, determined in a 5% w/v solution.

A 10% w/v solution is clear and colorless.

Incompatible with alkalies, alkali metal carbonates, lead and silver salts.

It is used as expectorant, diuretic and systemic acidifiers in treatment of severe

metabolic alkalosis. It is used as a thickening agent in shampoos and also used as
flavoring agent. It is used in textile and leather industry in dying, tanning and textile
printing. In fertilizers, it is a nitrogen source.
 1. Ammonium chloride is also known as:
a. Ammonium murriate b. Ammonical oxide
c. Amalgam d. Blue vitriol
2. Potassium iodide is used for:
a. Emetics b. Expectorant
c. Analgesic d. Antithyroid agent
3. Productive cough produces:
a. Amalgam b. Vomiting
c. Dehydration d. Mucus
4. Cough is a physiological protective reflex occurs due to:
a. Inhalation of foreign particles b. Cold and infection
c. Chemical irritant d. All of the above
5. Which cough does not produce mucus?
a. Productive cough b. Non-productive cough
c. Both a and C d. None of the above

1. a 2. b 3. d 4. d 5. b

1. Ammonium chloride is prepared by ......

2. Molecular formula for potassium iodide ......
3. Expectorants are mainly used for ......
4. The latin word ‘expectorate’ means ......
5. Ammonium chloride is ...... in nature.
6. Cough is a ...... reflex.
7. ...... is used as nitrogen source in fertilizers.
8. Ammonium chloride solutions are highly ......
9. Inorganic sedative expectorant is ......
10. Potassium iodide is prepared by treating ...... and ......

1. Solvay process
2. KI
3. Removal of secretions
4. To drive from the chest
5. Hygroscopic
6. Protective
7. Ammonium chloride
8. Soluble in water
9. Ammonium chloride
10. Iron fillings and iodine
1. Discuss in detail about cough.
2. How does expectorant acts on the respiratory tract?
3. Define expectorant. Classify the expectorants.
4. Discuss in detail about preparation, properties and uses of ammonium chloride.
5. Give a note on official compound potassium iodide.
 • Introduction • Antimony Potassium Tartrate
• Mechanism of Action • Copper Sulfate
• Sodium Potassium Tartrate • Important Questions/Answers

Emetic is derived from the word emesis it means vomiting. Vomiting is defined as
involuntary, forceful expansion of the contents in the stomach through mouth
sometimes nose. Emetics are the drugs which give rise to forced regurgitation (emesis)
by which the contents of the stomach get expelled through the oral cavity. Vomiting
center is situated in medulla oblongata which is known as area postrema. It is
administered orally or injection to induce vomiting.

The emetics act by two types:

By local irritation of gastric mucosa, e.g. ammonium bicarbonate, ipecacuanha.

Directly on the chemoreceptor trigger zone (CTZ) in the floor of IVth ventricle in
medulla, e.g. apomorphine and morphine.
In ancient times, salt water and mustard water used as emetic. It is added in cough
preparation in small dose to stimulate the flow of respiratory tract secretion. They are
very important in cases of poisoning as antidotes that are given before absorption of
poison into intestines so it may help to expel out the toxic substance from the body.
Strong coffee is one of the best domestic stimulants, especially after a narcotic poison.
Emetics should not be given to children, in the early pregnant women, corrosive
poisoning, in conditions like CNS depressions, unconscious or coma.
Inorganic substances include antimony potassium tartrate, zinc sulfate, copper
sulfate and sodium chloride. The most common side effects of emetics are dehydration
so the person must be kept hydrates by continuous administration of fluid and
electrolytes.
Molecular formula: C4H4KNaO6 Molecular weight: 210.16
Synonym: Rochelle salt, seignette salt.
It is the double salt of sodium and potassium of tartaric acid.

It is prepared by boiling the solution of potassium bitartrate and sodium carbonate

and allowed the reaction mixture to remain at 60°C for some time.
2KHC4H4O6 + Na2CO3  2KNaC4H4O6 + CO2 + H2O

It is a colorless to white crystalline powder with a cool and saline taste. It has a pH
value of 6.5–8.5. It has a large piezometric effect which makes it widely useful in
sensitive vibrational and acoustic devices. It is soluble in hot water and insoluble in
alcohol. It should be stored in airtight containers.

It is used as an emetic because of its irritant action on GI mucosa. It is used as a

laxative and food additive in the form of stabilizer in cheese and meat products. It is
used in the silvering of mirrors. It is one of the ingredients in Fehling’s solution and
used in the electroplating process. It is used in cigarette paper. It is one of the ingredients
in biuret reagent to measure the concentration of protein. It is used as a common
precipitant in protein crystallography.

Molecular formula: C4H4KO7Sb Molecular weight: 333.93

CHOHCOO(SbO)
|
CHOHCOOK
Synonym: Emetic tartar, tartarised antimony.
It is the double salt of potassium and antimony of tartaric acid.
Category: Expectorant, diuretic, systemic acidifier.

It is obtained by mixing 5 parts of antimony trioxide (Sb2O3) with 6 parts of potassium

acid tartrate in a fine paste. Keep this paste aside for a day. Boil it with water for
15 minutes with constant stirring. The liquid is then filtered and left for crystallization.
2KHC4H6O6 + Sb2O3  2K (SbO)C4H4O6 + H2O

It occurs as colorless transparent crystals, odorless having a sweetish taste. On exposure

to air crystals are efflorescence. It is soluble in water, glycerol but insoluble in alcohol.
It should be stored in well-closed container at a cool place.
40–140 mg daily.

Initially, it is used as an emetic due to its irritant action on mucosa. It is administered

by IV and should never be given by IM or subcutaneous because it causes severe pain
and necrosis. It is also used in the treatment of schistosomiasis and leishmaniasis.

Molecular formula: CuSO4. 5H2O Molecular weight: 249.7

Synonym: Blue vitriol, cupric sulfate.
IP limit: As per IP it contains 98.5–101% of copper sulfate.

1. It is prepared by treating granulated copper in presence of air with sulfuric acid.

The oxygen of air assists the reaction.
2Cu + 2H2SO4 + O2  2CuSO4 + 2H2O
2. In laboratory, it is also prepared by dissolving cupric oxide or cupric carbonate or
cupric hydroxide in dil. H2SO4
CuO + 2H2SO4  CuSO4 + H2O
Cu(OH)2 + H2SO4  CuSO4 + 2H2O
CuCO3 + H2SO4  CuSO4 + H2O + CO2
3. Copper granules are heated with sulfur a mixture of copper sulfate and cupric
oxide is obtained. The residue of CuO is again treated with dil. H2SO4 to convert
it to copper sulfate.
3Cu + S + 3O2  CuSO4 + 2CuO
2CuO + H2SO4  2CuSO4 + H2O

It is a hydrated salt exist in the form of deep blue crystals. It shows effervescence in
dry air slowly. It is soluble in water but insoluble in alcohol. It is acidic in nature. It
should be protected from air, moisture and heat.

1. On heating at 100°C it loses two molecule of water, at 140°C it loses one molecule
of water and at 200°C, white anhydrous salt is formed.
100 C 140C 200 C
CuSO 4  5H2 O   CuSO 4  3H 2 O  2H 2 O   CuSO 4  2H2 O  H 2O   CuSO 4
2. On further heating at high temperature it decomposes into cupric oxide and
sulfur dioxide gas.
2CuSO4  2 CuO + SO2 + O2
3. Reaction with KI: KI reduces CuSO4 to cuprous iodide which appears as white
ppt while KI is oxidized to I2.
 4. Reaction with NH3: When NH3 is added to CuSO4 solution, a bluish white ppt of
Cu(OH)2 is formed which dissolves in excess ammonia forming tetra-amine
copper (II) sulfate which is commonly known as Schweizer’s reagent.
CuSO4 + NH4OH  Cu(OH3)4SO4
Bluish
white
CuSO4 + NH4OH + (NH4)2SO4  [Cu(NH3)4]SO4 + 4H2O
Tetra-amine copper
(II) sulfate
(deep blue)
5. Action of water: CuSO4 gives acidic salt solution due to hydrolysis of Cu++ ion as
it is salt of weak base and strong acid.
CuSO4(aq)  Cu++ + SO4
Cu++ + 2H2O  Cu (OH)2 + 2H

It is assayed by the principle of oxidation–reduction reaction of iodine/thiosulfate. A

solution of copper sulfate is first treated with potassium iodide and acetic acid. Cuprous
iodide (CuI) is formed with iodine and the liberated iodine is titrated with 0.1 N sodium
thiosulfate using starch as an indicator. The titration is continued until blue color
persists. Each ml of 0.1 N sodium thiosulfate is equivalent to 0.02497 gm of copper
sulfate.
2CuSO4 + 4KI  2 CuI2 + 2K2SO4
2CuI2  Cu2I2 + I2
2Na2S2O3 + I2  Na2S2O6+ 2 NaI
2Cu2I2  2CuCNS + 2KI
Uses: It is used as an emetic in a dose of 300 mg in 30 ml water. It is used as a
germicide and insecticide in agriculture. A mixture of copper sulfate and lime,
commonly known as Bordeaux mixture, is used as fungicide. It is used as electrolyte
in purification of copper and electroplating of Cu. It is used in making Schweizer’s
reagent used for manufacturing of paper. It is an ingredient for Fehling’s and Benedict’s
solution. It is considered to be chemical antidote for phosphorus poisoning.

1. Emetics are used to produce:

a. Dehydration b. Vomiting
c. Alkalosis d. All of the above
2. ...... is used as emetic in ancient times.
a. Salt water b. Sugar solution
c. KI d. None of these
3. Which official compound is used as emetic?
a. KI b. NH4Cl
c. Potassium antimony tartrate d. Potassium chloride
4. Emetics acts by:
a. On lungs
b. Decrease fluid viscosity
c. Decrease bronchial secretion
d. Stimulate the chemoreceptor trigger zone
5. Copper sulfate is also called ......
a. Blue vitriol b. Yellow vitriol
c. Green vitriol d. None of the above

1. b 2. a 3. c 4. d 5. a

1. Copper sulfate is used as antidote for ...... poisoning.

2. Sodium potassium tartrate is also known as ......
3. Antimony potassium tartrate is also known as ......
4. ...... is used as emetic in veterinary practices.
5. Sodium potassium tartrate acts an emetic due to ......

1. Phosphorus
2. Rochelle
3. Emetic tartrate
4. Hydrogen peroxide
5. Irritant action GI mucosa.

1. Define emetics. How they are useful in poisoning?

2. Differentiate vomiting and emetic.
3. Write a detail note on sodium potassium tartrate.
4. Discuss the preparation, properties, assay and uses of copper sulfate.
5. Write a note on antimony potassium tartrate.
 • Introduction • Ferrous Gluconate
• Iron • Important Questions/Answers
• Ferrous Sulfate

Hematinics are the substances which are required in the formation of blood and also
used in the treatment of anemias. A hematinic is a nutrient required for the formation
of blood cells in the process of hematopoiesis. The main hematinics are iron, vitamin
B12 and folate ions. These agents increase the number of erythrocytes or hemoglobin
content in the blood. Anemia is a condition in which there is a deficiency of red cells
or of hemoglobin in the blood, resulting in pallor and weariness.
Anemia occurs when balance between production and destruction of RBCs are
disturbed by blood loss (acute or chronic), impaired cell formation due to deficiency
of essential factors, such as iron, vitamin B12 and folic acid, bone marrow depression
(hypoplastic), erythropoietin deficiency and increased cell destruction (hemolytic).

Iron is one of the essential elements for the body. Total body iron content in an adult
is 3.5 gm (average) which is found 50 mg/kg in men and 38 mg/kg in women. Iron is
distributed in the body in form of 66% hemoglobin, 25% of ferritin and hemosiderin,
3% of myoglobin and 6% in parenchymal iron (in enzymes-cytochromes, peroxidases,
catalases).
Hemoglobin is a protoporphyrin molecule which consists of four iron containing
haeme residues as prosthetic group and four globin chain as apoprotein. It has 0.33%
of iron, thus loss of 100 ml of blood means loss of 50 mg elemental iron. To raise 1 gm/
dl about 200 mg elemental iron is required. It is stored only in ferric form (Fe3+) and in
combination with apoferritin. The daily iron requirement of an adult is 0.5–1 mg for
men and 1.5–2 mg/day for women.
Iron is very important component of metabolic processes which is responsible for
the transport of molecular oxygen from respiratory chain. It is an essential constituent
of blood cells and tissues. It is associated with types of proteins, such as hemoprotein,
iron storage and transport proteins. Iron forms the nucleus of iron-porphyrin haem
ring, which together with globin chains forms hemoglobin. Hemoglobin binds oxygen,
transporting it from lungs to tissues.
 1. The primary function of iron is to form hemoglobin.
2. It is necessary for the formation and maturation of RBC.
3. Its responsible for the transport of oxygen in the form of oxyhemoglobin.
4. Cytochrome is an iron containing enzyme. It is concerned with the oxidation of
metabolites in the cell.
5. Myoglobin of muscle is an iron containing chromoprotein. It combines with O2
and acts as an oxygen store for muscle.
6. The chromatin of the nucleus contains iron and thus helps in the functioning of
nuclei.
Dietary sources of iron are wheat, vegetables, fruits, dry fruits, dry beans, egg yolk,
liver and oyster. Medium sources of iron are meat, chicken, fish, spinach and apple.
Poor sources of iron are milk and milk products. Iron deficiency occurs due to
malnutrition, congenital atransferrinemia (inability to release iron from transferrin).

Iron absorption occurs mainly in the duodenum and upper jejunum and is influenced
by many factors. Dietary iron must first be released from protein complexes by acid
and proteases in the stomach. Solubilizing agents such as sugars and ascorbic acid
enhance absorption, and phosphates and phytates in cereals form insoluble complexes
with iron which inhibit its absorption. Iron that is of animal origin (haem iron) is more
readily absorbed than non-haem iron found in cereals, and the ferrous (Fe2+) form is
more soluble than the ferric (Fe3+) form. Iron uptake occurs both by active transport
and passive diffusion and can be increased to 20–30% in iron deficiency or pregnancy.
Iron overload decreases absorption by an unknown mechanism.
For absorption, iron is converted into ferrous form in presence of ferroreductase.
Absorbed by two mechanisms:
1. On luminal surface of intestinal epithelial cells, divalent metal transporter 1
(DMT 1) is present, through which ferrous form of iron is actively transported.
This new iron along with that splits from haem, are transported to blood across
basolateral membrane by ferroprotein (ferriportin 1). It is then oxidized to ferric
form by ferro-oxidase.
2. Haem iron (present in meat) is absorbed without conversion to elemental form.

If body requirements are low, iron is stored inside intestinal mucosal cells in form of
ferritin. Ferritin is water-soluble complex consisting of a core of ferric hydroxide
covered with a shell of specialized storage protein, apoferritin. If body requirements
are high, more iron is transported across basolateral membrane to blood. In plasma, it
binds transferrin, a globulin which binds to ferric iron. Transferrin-iron complex is
carried to different organs including spleen, liver, and bone marrow. Transferrin
acceptors (TFA) are present in these organs and as a result iron is internalized by
these organs, and transferrin receptor complex are recycled to plasma.

Factors facilitating iron absorption

1. Acid: Acid enhances dissolution and reduction of ferric iron.
2. Reducing substances: Ascorbic acid reduces ferric iron and forms absorbable
complexes.
3. Meat: Meat also facilitates iron absorption by increasing HCl secretion.
4. Pregnancy/menstruation: Due to increased iron requirement.

1. Phosphates: Phosphates are present in egg yolk.

2. Phytates: Phytates occur in wheat and maize.
3. Alkalies: Alkalies form non-absorbable complexes as well and oppose the
reduction.
4. Tetracyclines: Tetracyclines impede absorption.
5. Presence of other foods in stomach.

Transport occurs by transferrin, a -globulin that binds two molecules of ferric iron,
forming transferrin–iron complex. This complex binds transferrin receptors present
in large number of erythroid cells. They bind and internalize the complex by receptor
mediated endocytosis. In endosomes, ferric iron is released, and is reduced to ferrous
form. It is then transported by DMT 1 into cells, used:
1. For Hb synthesis
2. Stored as ferritin
 Transferrin-transferrin receptor (TfR) complex is recycled to cell membrane.
Transferrin dissociates and returns to plasma. Increased erythropoiesis leads to
increased number of transferrin receptors on cells. Iron deficiency leads to increased
concentration of serum transferrin (Tf).

The released iron is utilized for hemoglobin synthesis or other purposes. Tf and TfR
are returned to the cell surface to carry fresh loads.
It is stored into reticuloendothelial cell in liver, spleen, bone marrow, hepatocytes
and myocytes.

Trace amounts of iron are lost in feces, urine, bile and sweat. Less than 1 mg/day of
iron is lost.

Iron deficiency anemia manifests as hypochromic, microcytic anemia, in which:

1. Erythrocyte mean cells volume is low (MCV <80 fl).
2. Mean cell Hb concentration is low (MCHC <30%).
Infants, children during rapid growth, pregnant and lactating women and patients
of chronic kidney disease (due to increased loss during hemodialysis) required
increased iron requirements. Inadequate iron absorption has seen in gastrectomy.

Oral and parenteral preparations can be used. Oral preparation is present in the form
of salts like:
• Ferrous gluconate
• Ferrous sulfate
• Ferrous fumarate.
Both are equally effective but oral therapy is preferred. Parenteral preparations are
given only in:
• Chronic anemia
• Impaired GI absorption
• Patients of chronic kidney disease undergoing dialysis
• Patients who cannot tolerate oral iron.

Only ferrous salts are used because iron is absorbed only in ferrous form.

Iron salts Tablet size Iron in Adult Iron salts

tablet (dose/day)
Ferrous sulfate (hydrated 325 mg 65 mg 3–4 Ferrous sulfate (hydrated
chocolate colored) chocolate colored)
Ferrous sulfate (desiccated) 200 mg 65 mg 3–4 Ferrous sulfate (desiccated)
Ferrous gluconate 325 mg 36 mg 3–4 Ferrous gluconate
Ferrous fumarate 100 mg 33 mg 6–8 Ferrous fumarate
50–100 mg iron can be incorporated into Hb daily. 25% of oral iron as ferrous salt can
be absorbed. So, 200–400 mg/day elemental iron should be given.
Adverse effects of oral administration: Mainly GIT—nausea, gastric irritation,
abdominal discomfort, altered bowel habits, black staining of stools (can mask GIT
bleeding).

A colloid containing particle is made with a core of iron oxyhydroxide surrounded by

a shell of carbohydrate (e.g. dextran polymers). In this way, bioactive iron is released
slowly from stable colloid particles.

Parenteral administration of free inorganic ferric iron produces serious dose-dependent

toxicity which limits the dose of iron.

Iron dextran: Iron dextran can be given IM or IV. It is a stable combination of ferric
hydroxide with low molecular weight dextran containing 50 mg elemental iron/ml of
solution.
Iron sucrose and sodium ferric gluconate complex: Iron sucrose and iron sodium
gluconate complex are two compounds given IV, however, they are less antigenic and
allergic manifestations are less commonly encountered.

Dose of iron in grams = 0.25 × (normal Hb – patients Hb)

Iron requirement (mg) = 4.4 × body weight (kg) × Hb deficit (g/dl)
[Hb = hemoglobin]
Iron levels should be monitored in parenteral therapy as it is not subjected to normal
regulatory mechanism (as in oral therapy).

Painful (especially IM injection of dextran), abdominal discomfort, nausea, vomiting,

allergic manifestations, dizziness, headache, fever, arthralgia, urticarial and
bronchospasm.

It is used in:
1. Iron deficiency anemia: Nutritional deficiency, chronic blood loss (GIT—ulcers
and hookworm).
2. Megaloblastic anemia.
3. As astringent: Ferric chloride.
Iron poisoning can be generally treated by gastric lavage, followed by giving sodium
bicarbonate and sodium dihydrogen phosphate which are able to convert iron into
insoluble iron salts.
There are several types and classifications of anemia. The occurrence of anemia is due
to the various red cell defects such as:
• Production defect (aplastic anemia)
• Maturation defect (megaloblastic anemia)
• Defects in hemoglobin synthesis (iron deficiency anemia)
• Genetic defects of hemoglobin maturation (thalassemia)
• Due to the synthesis of abnormal hemoglobin (hemoglobinopathies, sickle cell
anemia and thalassemia)
• Physical loss of red cells (hemolytic anemias)
• The size of red blood cells is smaller than normal size (microcytic)
• Size of red blood cells larger than normal (macrocytic).

Molecular formula: FeSO4·7H2O Molecular weight: 278.01

Synonym: Green vitriol
IP limit: As per IP it contains 98–105% of ferrous sulfate.
Pernicious anemia occurs in old people for lack of intrinsic factor which is essential
for absorption of vitamin B12.

1. It is obtained from the reaction between elemental iron and sulfuric acid, to yield
ferrous sulfate and hydrogen gas.
Fe + H2SO4  FeSO4 + H2
2. The commercial grade of this salt is made by pilling in pyrites (FeS2) in heaps and
exposing it to atmospheric oxidation. The mass is leached with water and the
dilute solution of ferrous sulfate is run into large vats. The liquid is concentrated
by crystallization.
2FeS2 + 7O2 + 2H2O  FeSO4 + 2H2SO4

It is a bluish green crystalline powder, odorless and metallic in taste. On exposure to

moist air, the crystals rapidly oxidize and become brown. It shows effloresces in dry
air. It is soluble in water but insoluble in alcohol. It should be stored in airtight
containers.

1. Ferrous sulfate reacts with aluminum under displacement reaction forming

aluminum sulfate and metallic iron.
2Al + 3FeSO4  Al2(SO4)3 + 3Fe
 2. Ferrous sulfate reacts with potassium permanganate in the presence of sulfuric
acid forms ferric sulfate, manganese sulfate, potassium sulfate, and water.
10FeSO4+ 2KMnO4 + 8H2SO4  5Fe2(SO4)3 + 2MnSO4 + 8H2O + K2SO4
3. When it is treated with ceric ammonium sulfate in acidic medium, it reduces ceric
ion.

Gives reaction of ferrous salts and the reaction of sulfates.

Between 3 and 4, determined in a 5% w/v solution.

Dissolve 2.5 gm in carbon dioxide-free water, add 0.5 ml of 1 M sulfuric acid and
dilute to 50 ml with water. The solution is not more opalescent than opalescence
standard.

Dissolve 5 gm in 10 ml of water, add 15 ml of stannated hydrochloric acid and distil

20 ml. To the distillate add a few drops of bromine solution, remove the excess of
bromine with a few drops of stannous chloride solution AsT and add 40 ml of water.
The resulting solution complies with the limit test for arsenic (2 ppm).

Make 25 ml of solution B alkaline with dilute ammonia solution, add 1 ml of potassium

cyanide solution and sufficient water to produce 50 ml. Add 0.1 ml of sodium sulfide
solution; the solution is not more intensely colored than a mixture of 10 ml of
hydrochloric acid, 0.5 ml of nitric acid, 5 ml of lead standard solution (20 ppm Pb), 0.1
ml of sodium sulfide solution and sufficient water to produce 50 ml (50 ppm).

Dissolve 2.5 gm in carbon dioxide-free water, add 0.5 ml of 1 M sulfuric acid and
dilute to 50 ml with water. Take 20 ml of solution complies with the limit test for
chlorides (250 ppm).

The assay is based on redox titration method. Dissolve 2.5 gm of sodium bicarbonate
in a mixture of 150 ml of water and 10 ml of sulfuric acid. When effervescence ceases,
add 0.5 gm of the substance being examined, accurately weighed, shake gently to
dissolve and titrate with 0.1 M ceric ammonium nitrate using 0.1 ml of ferroin solution
as indicator, until the red color disappears. Each ml of 0.1 M ceric ammonium nitrate
is equivalent to 0.02780 gm of FeSO4·7H2O.
It is used as hematinic agent in the treatment of anemia. It is also used to dye fabrics
and in tanning leather.

Molecular formula: C12H22FeO14·H2O Molecular weight: 446.14 (anhydrous)

Synonym: Ferrous di (D-Gluconate), iron (II) gluconate
IP limit: As per IP it contains 95–102% of ferrous gluconate.

1. It is prepared by double decomposition reactions between barium gluconate/

calcium gluconate and ferrous sulfate.
C12H22BaO14 + FeSO4  C12H22FeO14 + BaSO4
C12H22CaO14 + FeSO4  C12H22FeO14 + CaSO4
2. The gluconate solution is first produced by the fermentative oxidation of glucose.
The solution of gluconic acid is then treated with barium carbonate. The barium
gluconate treated with ferrous sulfate and filtered. From the filtrate, the ferrous
gluconate is crystallized. The salt contains one molecule of water of
crystallization.

It occurs as yellowish grey or pale greenish yellow fine powder or granules, odor,
similar to burnt sugar. It is soluble in water but insoluble in alcohol. It should be
stored in airtight containers and protected from light.

Prophylactic, 600 mg daily; therapeutic, 1.2 to 1.8 gm daily, in divided doses (300 mg
of ferrous gluconate is approximately equivalent to 35 mg of ferrous iron).

Between 4 and 5.5, determined in a solution prepared by dissolving 5 gm in carbon

dioxide-free water at 60o, cooling and diluting to 50 ml with the same solvent (solution
A), and measured 3–4 hours after preparation.
Dilute 2 ml of solution A to 10 ml with water. When examined against the light, the
resulting solution is clear.

To 5 gm add 15 ml of water and 15 ml of stannated hydrochloric acid, distil 22 ml and

add to the distillate 40 ml of water and 0.2 ml of stannous chloride solution AsT. The
resulting solution complies with the limit test for arsenic (2 ppm).

Not >20 ppm, determined by method A, on a solution prepared in the following

manner. Warm 2 gm gently with 10 ml of nitric acid until reaction begins and allows
to stand until the evolution of nitrous fumes subsides. Boil gently to complete oxidation,
adding a further 5 ml of nitric acid, if necessary, and continue boiling until the volume
is reduced to about 5 ml. Add 20 ml of hydrochloric acid, boil gently for 1 minute, cool
and extract with three quantities, each of 20 ml, of ether. If the acid solution is still
more than faintly yellow, extract with a fourth quantity of 20 ml of ether and discard
the ether extracts. Transfer the acid solution to a narrow-necked flask, rinse the
separator with 5 ml of water, and add the rinsing’s to the flask. Heat the solution to
remove the dissolved ether and part of the hydrochloric acid. Cool and dilute to 50 ml
with water. Use 25 ml for the test.

0.4 gm complies with the limit test for chlorides (625 ppm).

0.3 gm complies with the limit test for sulfates (500 ppm).

Between 5% and 10%, determined on 1 gm by drying in an oven at 105o.

It is used as iron source for treatment of various anemias.

1. Absorption of iron is inhibited by:

a. Antacids
b. Phosphates and tetracycline
c. Bicarbonates
d. All of the above
2. On which condition iron requirement increases:
a. Growth b. Lactation
c. Pregnancy d. All of the above
 3. Ferrous sulfate is incompatible with:
a. Silver salts b. Carbonates
c. Alkalies d. All of the above
4. Ferrous sulfate crystals are ...... in color:
a. Blue b. Red
c. Green d. White
5. Which of the following enzymes having iron:
a. Catalase b. Peroxidase
c. Both a and b d. None of the above
6. Iron poisoning can be treated by:
a. Gastric lavage b. Deferroxamine
c. Both a and b d. None of the above
7. In adult, total iron content in our body:
a. 2.5–5 gm b. 6–7 gm
c. 1–2 gm d. 8–10 gm
8. Iron preparation can cause:
a. Nausea, vomiting b. Staining of teeth
c. Constipation d. All of the above
9. ...... is a condition in which there is a deficiency of red cells or of hemoglobin in
the blood.
a. Emetic b. Anemia
c. Abdominal irritation d. None of the above
10. Ferrous sulfate is also known as:
a. Blue vitriol b. Green vitriol
c. Yellow vitriol d. White vitriol

1. d 2. d 3. d 4. c 5. c 6. c 7. a 8. d 9. d 10. b

1. ...... are the substances which are required in the formation of blood and also used
in the treatment of anemias.
2. For absorption, iron is converted into ...... form in presence of ......
3. Iron absorption occurs mainly in the ...... and ......
4. ...... of iron can be incorporated into Hb daily.
5. Dietary sources of iron are ......, ...... and ......

1. Hematinics
2. Ferrous, ferroreductase
3. Duodenum, upper jejunum
4. 50–100 mg
5. Wheat, vegetables, fruits.
1. Define hematinics. Discuss the compounds used in hematinics.
2. What do you understand the term anemia? Classify various types of anemia.
3. Discuss the absorption and transportation of iron in our body.
4. Describe the preparation, properties, assay and uses of ferrous sulfate.
5. Write a detail note on iron.
6. Explain the factors affecting absorption of iron and storage regulation of iron.
7. Write a detail note on preparation, properties and uses of ferrous gluconate.
 • Introduction • Activated Charcoal
• Sodium Thiosulfate • Important Questions/Answers
• Sodium Nitrite

A poison may be defined as any substance that when introduce into or absorbed by a
living organism causes illness or death. The diagnosis of poisoning is often difficult.
Poisoning occurs in many ways, such as occupational, accidental, criminal or suicidal,
using recreational substances (cannabis, opiates, etc.) and intentional behavior.
The poisoning may be either accidental or intentional requires immediate support
and symptomatic management. It means removal of poison from the body by emesis
induction. The perfect support management and treatment mainly depends upon the
identification of ingested poison or corrosive substance so that exact antidote can be
used to counteract the poison.
Poisoning may be classified into:
1. Intentional poisoning: A person consumes the substance with intension of
causing harm to that person, e.g. suicide.
2. Unintentional poisoning: If the person consumes the substance without knowing
its toxic effects, e.g. accidental.
3. Undetermined: When the circumstances is not clear whether it is intentional or
unintentional, e.g. poisoning due to pesticides or insecticides.
Other common causes are:
1. Due to overdose of drug.
2. Intentionally cyanide poisoning.
3. Poisoning of heavy metals which may occur metallic contamination of food and
water by leaching process.

Nausea, vomiting, diarrhea, muscle cramps, increased or decreased heart rate,

decreased breath rate, partial consciousness and dilated pupils.

“Antidote is a chemical especially a drug that limits the effects of a poison”, or “A

way of preventing or acting against something bad”.
 It is an agent which counteracts as poisons. The term antidote is a Greek word
‘Antididonai’ meaning ‘given against’.
According to WHO, “Antidote was defined as a therapeutic substance used to
counteract the toxic action(s) of a specified xenobiotic.” It reduces the overall burden
of health service in managing of poisoning cases:

Antidotes act by different mechanism. The mechanisms of action of antidotes are given
below:
1. Complex formation.
2. Metabolic conversion.
3. Prevention of toxic metabolite formation.
4. By changing the physiochemical nature of toxicant.
5. Antidote returns to normal function by repairing a defect.

Antidotes are classified into three types according to mode of action.

Producing opposite effects to that poison. They are also called antagonists, e.g. sodium
nitrite in cyanide poisoning, which converts hemoglobin into methemoglobin in order
to bind cyanide.

Prevent absorption of poison into the body or expel out the poison from the body by
emesis or eliminate through urine, e.g. activated charcoal absorbs the poison prior to
the absorption of intestinal wall.

Change chemical nature of poison by converting the poison into inactive or harmless
substance, e.g. sodium thiosulfate in cyanide poisoning which converts the toxic
cyanide into nontoxic thiocyanate, EDTA (chelating agent for heavy metal poisoning).

1. In cyanide poisoning: Sodium nitrite and sodium thiosulfate

2. In lead poisoning: Sodium calcium edetate and dimercaprol.

Cyanide is a rapidly acting lethal agent. Its effects are very fast and can cause death
within a few minutes. Hydrogen cyanide (formonitrile) is a gas. Hydrocyanic acid
(liquid form) is a colorless or pale blue at the normal room temperature). It is volatile
and flammable, diffuse either by air and explosives, very easy to mix with water.
Other forms are sodium cyanide and potassium cyanide.
It takes place intentionally or accidentally to commit suicide. It may occur by
inhalation of fumes of hydrocyanic acid, ingestion of cyanide inorganic salt or cyanide
releasing substances like cyanide, cyanogen, bitter almond, peach of apricot,
photographic chemical and silver polishes. Consumption of 300 mg of potassium
cyanide may cause death.
Cyanide is hazardous by:
• Inhalation: Rapid onset of action (seconds to minutes)
• Ingestion: Delayed onset (15–30 minutes)
• Skin contact: Delayed onset (15–30 minutes)
Death occurs in 6–8 minutes after inhalation of a high concentration (2–5 mg/kg
of it is lethal).

It is available in
• Low-dose in nature and in every product that we usually eat or use
• Cyanide can be produced by bacteria, fungi and algae
• Cyanide is found in cigarettes, motor vehicle fumes, food and the synthetic
product
• Cyanide in seed plants, especially grains (cassava wild, wild tubers, intersection
buffoonery, wild cherry, plum, apricot, wild amigdalin, jetberry bush, etc.).

1. It produces cellular hypoxia by binding to ferric iron specially that present in

cytochrome oxidase system. When it bind to this enzyme complex electron
transport is inhibited (ATP will not produce) this is result in decrease cellular
utilization of oxygen (hypoxia).
2. It inhibits cellular respiration (cytochrome a–a3).
3. Tissues cannot utilize oxygen.
4. Arterialization of venous blood.

• In CNS: Headache, dizziness, seizures, coma

• In cardiovascular: Hypertension, bradycardia, hypotension, later in course,
cardiovascular collapse
• In pulmonary (lung): Dyspnea, tachypnea, pulmonary edema, apnea
• In gastrointestinal: Nausea, vomiting, caustic effects.

Sodium nitrite and sodium thiosulfate injections both antidotes one by one are
administered to counteract this poisoning.
Sodium nitrite is used for this purpose because it has very weak vasodilator action.
Nitrite generates ferrous ion of hemoglobin to the ferric ion of methemoglobin that
has high affinity to cyanide radicals to form cyanomethemoglobin. This may again
dissociates to release cyanide. Then sodium thiosulfate is administered to form sodium
thiocyanate which is poorly dissociable and excreted through urine.
 • Sodium nitrite (300 mg IV)
–0.33 ml/kg of 10% solution
• Sodium thiosulfate (12.5 gm IV)
–1.65 ml/kg of 25% solution

Poisoning of the body is due to various reasons. Heavy metal poisoning occurs due to
intake of salts of arsenic, lead, mercury, iron and cadmium. It occurs because of
overdose intake or incomplete metabolism in the body. Depending upon the content
and type of heavy metal and the toxic effects can be seen in the patients. Most widely
heavy metal antagonist used which will be able to form chelate or complex with the
substance.

Initially activated charcoal is given for absorbing heavy metals or poison followed by
administration of compounds which are able to produce emesis to eliminate any poison
left in the stomach or being absorbed in the circulation. Some inorganic compounds
precipitate the heavy metals and prevent the absorption in blood circulation, e.g.
activated charcoal, light kaolin, copper sulfate, magnesium sulfate and sodium
phosphate.

Lead is a health hazard for all humans and important toxic heavy element in the
environment. Especially children under the age of six are most at risk for lead poisoning.
Lead toxicity causes hematological, gastrointestinal and neurological dysfunction. Lead
inhibits some enzymes, alters cellular calcium metabolism. It stimulates synthesis of
binding proteins in kidney, brain, bone and slows down nerve conduction. Acute lead
poisoning is relatively infrequent and results from ingestion of acid soluble lead
compounds or inhalation of lead vapors but chronic exposure to low levels of the
metal is still a public health issue. Both occupational and environmental exposures to
lead remain a serious problem in many developing and industrializing countries and
a public health problem of global dimensions.
Lead is considered as a potent occupational toxin and toxicological manifestations
are well known. In case of severe lead poisoning, dimercaprol, sodium calcium edetate
are widely used and chelation therapy has also been used.

Firstly remove the source of the lead. In more severe cases, chelation therapy can be
used. This treatment binds to lead that has accumulated in the body. The lead is then
excreted through urine. Dimercaprol is more effective than sodium calcium edetate as
chelating which lead from the soft tissues. Sodium calcium edetate leads from the
bone and extracellular space and then expel out from the urine.

It is used as an antidote when the exact cause of poisoning is unknown. It is a mixture

of compounds. A mixture contains two parts of activated charcoal, one part tannic
acid and one part magnesium oxide intended to be administered to the person who
consumed poison. The mixture is ineffective and no longer used but activated charcoal
is used as universal antidote for many poisons.

Molecular formula: Na2S2O3·5H2O Molecular weight: 248.17

Synonym: Sodium hyposulfate
Category: Antidote to cyanide poisoning.
IP limit: As per IP, sodium thiosulfate contains 99–101% w/w of Na2S2O3,5H2O.

1. The solution of sodium sulfite treated with powdered sulfur wetted with small
amount of ethanol and gently boiled under reflux for an hour. The obtained
solution is filtered. The filtrate is evaporated to concentrate and cooled to 30°C
and if any unchanged sodium sulfite is left it will separate as a crystal meal which
is to be filtered off. The solution is left at room temperature in a crystallizing dish
until an abundant crop of crystals is obtained.
Na2SO3 + 5H2O + S  Na2S2O3·5H2O(s)
2. It can be obtained by mixing sulfide liquors with sodium carbonate by passing
SO2 gas.
Na2CO3 + 2Na2S + 4SO2 3Na2S2O3 + CO2

It occurs as large colorless crystals or coarse crystalline powder, odorless, having

alkaline taste, deliquescent in moist air and effloresces in dry air at temperature above
33o. It dissolves in its water of crystallization at about 49o.

Very soluble in water; practically insoluble in ethanol (95%).

It should be stored in tightly-closed containers.

Between 6 and 8.4 of 10% w/v solution in carbon dioxide-free water.

When sodium thiosulfate acidified with HCl, it decomposes to give sulfur dioxide,
water and sulfur.
Na2SO3 + 2HCl  H2S2O3 + 2NaCl
H2SO3  H2O + SO2 + S

10% w/v solution in carbon dioxide-free water is clear, and colorless.

Dissolve 5 gm in 50 ml of water and add 10 ml of stannated hydrochloric acid AsT.

The resulting solution complies with the limit test for arsenic (2 ppm).

Not >20 ppm, determined by method A.

To 12.5 ml of 10% w/v solution in carbon dioxide-free water add 15 ml of 2 M nitric

acid, boil gently for 3–4 minutes, cool and filter. The filtrate complies with the limit
test for chlorides (200 ppm).

To 10 ml of 10% w/v solution in carbon dioxide-free water add 0.05 ml of a freshly

prepared 5% w/v solution of sodium nitroprusside; the solution does not become
violet.

Dilute 2.5 ml of 10% w/v solution in carbon dioxide-free water to 10 ml with distilled
water. To 3 ml of this solution add 2 ml of iodine solution and gradually add more
iodine solution and dilute to 15 ml with distilled water. The resulting solution complies
with the limit test for sulfates (0.2%).

Weigh accurately about 0.5 gm, dissolve in 20 ml of water and titrate with 0.05 M
iodine using starch solution, added towards the end of the titration, as indicator. Each
ml of 0.05 M iodine is equivalent to 0.02482 gm of Na2S2O3ÿ 5H2O.

It is used as antidote for cyanide poisoning and titrant for titrimetry. It is also used to
treat parasitic skin diseases. It is used as a fixer in photographic work as hypo solution.

Molecular formula: NaNO2 Molecular weight: 68.99

Synonym: Nitrous acid sodium salt.
Category: Antidote to cyanide poisoning.
 1. Sodium nitrate and elemental lead are heated with constant stirring using an iron
spatula. After the reaction is complete, the mass is cooled. The sodium nitrite is
extracted with hot water. To precipitate the lead which has gone into the solution,
carbon dioxide is passed for a few minutes. The solution is filtered and
neutralized cautiously with a very little dilute nitric acid. The solution is
evaporated to a small volume to obtain crystals, filtered, washed with alcohol.
NaNO3 + Pb  NaNO2 + PbO
2. It is prepared by strongly heating sodium nitrite.
2NaNO3  2NaNO2 + O2

It is an odorless, colorless to yellowish white crystalline solid. Its taste is saline.

Soluble in water; practically insoluble in ethanol (95%).

Store in tightly-closed containers.

1. Sodium nitrite acts as a reducing and oxidizing agent. It is readily oxidized by

KMnO4 or KClO3.
KClO3 + 3HNO2  3HNO3 + KCl
When nitrites react as oxidizing agents, the reduced product will be nitric oxide.
HNO2 + KI + 3 H2SO4  I2 + NO + H2O + K2SO4
2. It is easily decomposed by acidification with dil. H2SO4.
2NaNO2 + H2SO4  Na2SO4 + HNO2

It is used as an
• Antidote to cyanide poisoning
• Food additive
• Inhibition of lipid oxidation
• Inhibition of microbial growth.

Charcoal is a dark grey residue. It consists of carbon and any remaining ash obtained
by removing water and other volatile constituent from animal and vegetable
substances.
 1. Activated charcoal is simply burnt wood that has had all the oxygen removed
through controlled oxidation and or processing by steam. The obtained residue
consists of nearly pure carbon.
2. It is prepared from vegetable matter by suitable carbonization processes.
3. Activation of charcoal: It is having high adsorption power. Due to its absorptive
power, it could be extremely increased by treating it with various substances,
such as air, steam, CO2, oxygen, sulfuric acid, zinc chloride, phosphoric acid or
combination of these substances at 500–900°C. In this process, the activating
substance presumably removes previously absorbed substances on charcoal and
breaking down the granules of carbon into smaller ones.

It occurs as a light balck powder, free from grittiness and odorless. It should be stored
in airtight container and protected from moisture.

Internally as an antidote and remedy, charcoal works by binding drugs and poisons
within the gastrointestinal tract. This allows their transfer out of the body in a harmless
form. Charcoal absorbs like a sponge, and renders poisons harmless. It can do varied
tasks because of its amazing ability to attract other substances to its surface and hold
onto them until they exit the body.
Charcoal used as an antidote however how charcoal work with drug or aspirin
poisoning.
• The most common drug poisoning is from aspirin. Charcoal should be given
within the first 30 minutes of an overdose.
• Powdered charcoal reaches its maximum rate of absorption rapidly, within
1 minute. The sooner it is given the better the chances of successful treatment.
• Charcoal given after 1 hour of fast absorbing drugs, like aspirin, is usually only
about 10% effective.
Common side effects of charcoal antidotes are: Black stools (severe), diarrhea (less
severe), throwing up (less severe).
Rare side effects of charcoal antidotes are: Stomach cramps (severe), swelling of the
abdomen (less severe).

1. As an antidote, activated charcoal is mainly known both for its use in drug
overdoses and chemical poisonings.
2. Charcoal acts to purify and cleanse the body due to its amazing ability to attract
poisons to itself.
3. Charcoal has a wide range of absorption. Heavy metals, viruses, bacterial and
fungal toxins, etc. are all absorbed effectively.
4. Activated charcoal often absorbs more than its own weight of injurious materials.
5. It is used in overdose of aspirin.
6. It is used as protective and adsorbent.
 7. It is used to filter toxin from blood and kidney diseases.
8. It is also used as burning fuel.

1. An antidote is used to:

a. Absorb the poison b. To counteract the poison
c. Reduce hypersensitivity d. All of the above
2. Poisoning occurs in:
a. Accidental b. Insecticides
c. Recreational substances d. All of the above
3. Cyanide poisoning is treated by combine use of:
a. Sodium nitrite, sodium thiosulfate
b. Sodium nitrite, sodium bicarbonate
c. Sodium nitrite, sodium carbonate
d. Sodium nitrite, sodium chloride
4. Which therapy is used for lead poisoning?
a. Occupational therapy b. Inhalation therapy
c. Chelation therapy d. None the above
5. Which one is the physiological antidote?
a. Sodium chloride b. Sodium bicarbonate
c. Zinc chloride d. Sodium nitrite
6. ...... is used to absorb the poison.
a. Activated charcoal b. Potassium iodide
c. Zinc sulfate d. None of the above
7. Mechanism of antidotes is:
a. Neutralize the effect of poison b. It inhibits cellular respiration
c. Tissues cannot utilize oxygen d. All of the above
8. Symptoms of poisoning are include:
a. Trouble in breathing b. Paralysis
c. Confusion d. All of the above
9. Heavy metal poisoning is treated by:
a. Administration of compounds which are able to produce emesis
b. Activated charcoal
c. Both a and b
d. None of the above
10. Sodium thiosulfate is also known as:
a. Sodium hyposulfate b. Sodium monosulfite
c. Sodium hyposulfite d. None of the above
11. Which one is the mechanical antidote:
a. Magnesium sulfate b. Copper sulfate
c. Activated charcoal d. All of the above
12. Antidote for lead poisoning:
a. Dimercaprol b. Atropine
c. Ethanol d. All of the above
13. Cyanide poisoning has a characteristic odor of ......
a. Fruit b. Bitter almonds
c. Lemon d. Wheat
14. ...... is prepared from vegetable matter by suitable carbonization processes.
a. Sodium nitrite b. Activated charcoal
c. Sodium sulfate d. Magnesium sulfate
15. Which type of antidote reduces the poison across the intestine?
a. Physiological antidote b. Mechanical antidote
c. Chemical antidote d. None of the above

1. b 2. d 3. a 4. c 5. d 6. a 7. d 8. d 9. c 10. a 11. d
12. a 13. b 14. b 15. b

1. The poisoning may be either accidental or intentional requires immediate ..... and
.......
2. Molecular formula for sodium thiosulfate .......
3. Assay of sodium thiosulfate is based on ...... titration method.
4. ...... is used as a fixer in photographic work as hyposolution.
5. ...... is the first choice of antidote when the cause of poisoning is unknown.
6. Cyanide poisoning kit contains ...... and ......
7. Sodium nitrite acts as a ...... and ...... agent.
8. ...... antidotes act by producing opposite effects to that poison.
9. ...... is used as a food additive.
10. ...... is a substance that when introduce into or absorbed by a living organism
causes illness.

1. Supportive therapy, symptomatic management

2. Na2S2O3ÿ 5H2O
3. Iodimetry
4. Sodium thiosulfate
5. Activated charcoal
6. Sodium nitrite, sodium thiosulfate
7. Oxidizing and reducing
8. Physiological
9. Sodium nitrite
10. Poison.
1. What are antidotes? Classify antidotes with examples.
2. Differentiate poison and antidote.
3. Differentiate between mechanical and physiological antidote.
4. Which antidote is used for cyanide poisoning? Explain with its mechanism of
action.
5. Explain universal antidote.
6. Discuss the role of activated charcoal in poisoning.

1. Define antidotes and discuss its mechanism of action.

2. Give a detail note on heavy metal poisoning and its treatment.
3. Discuss the preparation, properties, assay and uses of sodium nitrite.
4. Explain the preparation and uses of sodium thiosulfate.
5. Write a note on lead poisoning and its treatment.
 • Introduction • Potash Alum
• Zinc Sulfate • Important Questions/Answers

Astringent is substance that causes the contraction or shrinkage of tissue that dry up
secretions. Astringent acts as protein precipitant and arrest discharge by causing
shrinkage of tissue. It forms protective layer on the surface and stops bleeding by
constricting the blood vessels. Astringent is applied to skin, mucous membrane and
does not destruct the tissue. The word ‘astringent’ is derived from Latin word
‘adstringere’ means ‘to bind fast’. A small quantity of astringent applied to wound to
stimulate the growth of new tissues while in larger quantity produces irritation.
Zinc oxide and calamine are astringents used in lotions, powders and ointments.
It is used in much diluted form and is used topically.
1. If suffer from oily skin, astringent can help improve your skin’s appearance by
minimizing pores and drying up oily skin.
2. Astringent is usually applied after cleansing, but before moisturizing.
3. The alcohol based product can also help remove bacteria and leftover traces of
cleanser or make-up.
4. An astringent is also used to improve blood circulation and tighten the skin
besides. One such example is the Stolin Gum Astringent aimed at total oral
hygiene.
5. Used to treat hemorrhoids.

Skin made up of lipids and proteins which contain peptides. Transition metal cations
have protein precipitation action. If very dilute solution of this cation is used over a
tissue, it causes shrinkage on surface of the skin this is known as astringent action. It
means atoms which are capable to form metallic bonds, i.e. chelation of metal with
protein. The complexation of important functional groups at the protein site of action
causes a drastic change in the properties of proteins. It hardens the epidermis of the
akin and makes barrier against infection.
Inorganic astringents are salt of iron, zinc, manganese, iron and bismuth, aluminum
sulfate, alum, zinc chloride, zinc sulfate, zirconium oxide and zirconium silicate.
 • Styptic to arrest minor bleeding by coagulation of blood
• Anti-perspirant to reduce perspiration by constricting pores of skin
• Anti-inflammatory action
• At high concentration to remove unwanted tissue growth
• Internally they can use in diarrhea
• As cosmetic as skin tone and bring out the hardening effect
• In dental products it can promotes hardening the gums
• It reduces the cell permeability.

Molecular formula: ZnSO4·7H2O Molecular weight: 287.54

Synonym: White vitriol.
Category: Astringent
IP limit: As per IP, zinc sulfate contains not <99% and not >104% of ZnSO4·7H2O.

1. By the reaction of zinc oxide with sulfuric acid

ZnO + H2SO4  ZnSO4 + H2O
2. Small quantity of zinc carbonate adds to the sulfuric acid at a time, stirring
between additions and allowing any effervescence to die away before adding
more. Filter the solution into an evaporating basin. Slowly evaporate the solution
until it is about one-fifth of its original volume. Allow the concentrated solution
to cool until crystals form. Filter off the crystals and put the filter paper and
crystals on a watch glass and dab dry with another piece of filter paper. Cover
them with a piece of clean filter paper and leave them to dry at room temperature.
ZnCO3(s) + H2SO4(aq)  ZnSO4(aq) + H2O(l) + CO2(g)

It occurs as colorless, transparent crystals or white, crystalline powder, odorless,

efflorescent and astringent taste.

Very soluble in water; practically insoluble in ethanol (95%).

Store in tightly-closed, non-metallic containers.

Between 4.4 and 5.6, determined in 5% w/v solution.

5% w/v solution is clear, and colorless.

Dissolve 1 gm in 50 ml of water and add 10 ml of stannated hydrochloric acid AsT.
The resulting solution complies with the limit test for arsenic (10 ppm).

2 ml of 5% w/v solution diluted to 10 ml with water complies with the limit test for
iron (100 ppm). Use 0.5 ml of thioglycolic acid in the test.

20 ml of 5% w/v solution complies with the limit test for chlorides (250 ppm).

It is incompatible with carbonates, hydroxides and with astringent infusions and

decocations.

Weigh accurately about 0.5 gm and dissolve in 5 ml of 2 M acetic acid and dilute to
50 ml with water. To the resulting solution add about 50 mg of xylenol orange triturate
and sufficient hexamine to produce violet-pink color. Add a further 2 gm of hexamine
and titrate with 0.1 M disodium edetate until the color changes to yellow. Each ml of
0.1 M disodium edetate is equivalent to 0.02875 gm of ZnSO4·7H2O.

It is widely used as an astringent and emetic. Water-soluble zinc is used as supplements

for zinc deficiency. It is also used as topical agent and mild germicidal. It is used in
preparation of bandages and adhesive tapes. It also has local styptic action. It is also
used as ophthalmic astringents (0.25% aqueous solution). It is used in narcotic poisoning
as a reflex emetic.

Molecular formula: KAlSO4·12H2O Molecular weight: 474.37

Category: Astringent.

Potash alum is prepared by dissolving an equimolar mixture of hydrated aluminum

sulfate and potassium sulfate in minimum amount of water containing a little of sulfuric
acid and then subjecting the resulting solution to crystallization, when octahedral
crystals of potash alum separate out.
K 2 SO 4 + Al 2 (SO 4 )3  18H 2 O + 6H 2 O 
 K 2 SO 4  Al 2 (SO 4 )3  24H 2 O
Potassium Aluminum sulfate (666) Potash alum
sulfate (174)

It occurs as colorless granular crystalline powder, odorless and sweet astringent taste.
Soluble in water, soluble in glycerin, insoluble in alcohol.

It should be stored in well-closed container at a cool place.

Alum precipitates proteins and is most powerful topical astringent. It also has local
styptic action. It is used as antiseptics and preparation of toxoids.

1. Astringent acts by:

a. Protein precipitation c. Harden the skin
b. Constriction of capillaries d. All of the above
2. Astringent causes ...... on surface of the skin.
a. Shrinkage c. Harden the skin
b. Elongation d. All of the above
3. Zinc sulfate is also known as ......
a. Blue vitriol c. Green vitriol
b. White vitriol d. Yellow vitriol
4. Potash alum is used as:
a. Antidote c. Topical astringent
b. Antacid d. All of the above
5. Topical astringents are used to ......
a. Firm up the skin c. Skin permeation
b. Skin irritation d. All of the above
6. Zinc sulfate is prepared by the action of ...... with sulfuric acid.
a. Zinc carbonate c. Aluminum sulfate
b. Zinc oxide d. All of the above
7. ...... astringent is used in the treatment of narcotic poisoning.
a. Zinc chloride c. Zinc sulfate
b. Zinc oxide d. All of the above
8. Zinc sulfate is stored in ...... containers.
a. Metallic c. Plastic
b. Glass d. Non-metallic

1. d 2. a 3. b 4. c 5. a 6. b 7. c 8. d

1. Disodium edetate is a ...... agent.

2. In assay of zinc sulfate ...... is added to maintain the pH 5–6.
3. ...... and ...... are astringents used in lotions, powders and ointments.
4. ...... used as topical agent and mild germicidal.
5. Potash alum is prepared by dissolving an equimolar mixture of hydrated ...... and
......
6. Taste of alum is ......

1. Complexing agent
2. Hexamine
3. Zinc oxide, calamine
4. Zinc sulfate
5. Aluminum sulfate and potassium sulfate
6. Sweet astringent taste.

1. Define astringent. Discuss the mechanism of astringents.

2. Write any two pharmaceutical uses of alum.
3. Write down the incompatibility of zinc sulfate.
4. Explain preparation, properties, assay and uses of zinc sulfate.
5. Describe the preparation and uses of potash alum.
6. Explain in detail about uses of astringent.
 • Introduction • Storage, Handling and Precautions of
• Radioactivity and Rays Radioactive Material
• Isotopes • Radiopaque Contrast Media
• Radioactive Decay • Barium Sulfate
• Units of Radioactivity • Sodium Iodide (131I)
• Radioactive Dosimetry • Pharmaceutical Applications of Radioactive
• Half-life Substances
• Detection Methods of Radioactivity • Important Questions/Answers
• Measurement of Radioactivity

An atom is the smallest particle of the substance which can be identified from the
element. An atom consists of central nucleus surrounded by electrons. Group of atom
joined together are called molecules. The nucleus containing positively charged protons
and neutrons (no charge).
Radiopharmaceutical is a branch of science that deals with the study of the
radioactive compounds which are used for the diagnosis and therapeutic treatment of
human diseases. It is used to treat tumors, diagnose thyroid and other metabolic
disorders including brain function. Radioactive substances are those substances which
emit continuous radiation spontaneously by itself, to decompose to stable nuclei. The
emission of radiation is not depending by pressure, temperature and catalyst.

In 1895, Wilhelm Roentgen discovered that invisible rays were emitted when electrons
bombarded the surface of certain materials and can darken photographic plates and
the invisible high-energy emissions named X-rays. In 1896, the French scientist Henry
Becquerel accidentally discovered that certain minerals were constantly producing
energy rays that could penetrate matter. Becquerel determined that:
1. All the minerals that produced these rays contained uranium
2. The rays were produced even though the mineral was not exposed to outside
energy.
He called them uranic rays because they were emitted from minerals that contained
uranium (like X-rays) but not related to phosphorescence. Then Marie Curie discovered
few more radioactive elements like polonium and radium.
Isotopes are atoms of the same element that have different numbers of neutrons.
Isotopes of atoms with unstable nuclei are called radioisotopes. Radioisotopes showed
radioactive phenomena, i.e. radioactivity. The phenomenon of spontaneous emission
of certain kind of invisible radiation by certain substances is called radioactivity.
Substances which contain radioisotopes and emit such radiation are called radioactive
substance. It is a natural and spontaneous process by which the unstable atom of one
element emits or radiates excess energy in the form of particles or waves. The emitted
particles or waves are called ionizing radiations due to their ability to remove electrons
from the atom of any matter they interact with.

Radioactive radiations are composed of three different rays which differ very much in
their nature and properties. The most common form of radiations emitted has been
traditionally classified as -rays, -rays, -rays.

1. These -rays are the positively charged particles as they are produced when the
heaviest element decay.
2. As a particle contains two protons and two neutrons, having a mass of 4 amu and
these are similar to helium atom.
4
2H or  -particle
3. These particles are large and heavy in nature, so cannot penetrate but easily get
absorbed.
4. Due to less penetration of -particles, elements which emit them do not find any
use in biological application as they cannot penetrate tissues.
5. When a radioactive element emits -particles, the resulting nucleus will have
its atomic number <2 and mass number will be <4 units as compared to the
original.
226
88 Ra  226
 4
88 Rn  2 He ( )
6. It travels 2.5 cm in air and penetrate skin only 0.3 mm.
7. They get deflected in electric and magnetic field and they produce fluorescence
and phosphorescence in some materials such as zinc sulfide.
8. Their energy is about 6 MeV.
9. They ionize the gas through which they pass, e.g. isotope of thorium 234 from
uranium 238. Here two protons and two neutrons lost from uranium 238 and
these protons and neutrons are leave as an -particle.
238
92 U  234
 4
90 Th  2 He

1. These rays or particles are negatively charged, much lighter energy particles and
have less ionizing power than -particles.
2. During the emission of -particles from element does not alter the atomic mass
and atomic number increases by one unit, e.g. isotope of carbon 14 and iodine 131.
14
6U  147 Th  –


The -particle that is emitted during  decay has high energy and can penetrate
human skin and damage cells.
3. -Particles are smaller (8000 times) than the -particles, having negligible masses,
higher speed and thus these particles are much more penetrating than
-particle.
4. They have less ionizing power than -particle
5. Their energy ranges from 2–3 MeV.
6. It travels 4.5 m in air and penetrates skin only 4 mm.
-Particles can be classified into two types.

Positron is a type of -particle, in which a proton inside a radionuclide nucleus is

converted into a neutron and as they are short lived. Positron has a charge of +1 e and
negligible mass (anti-electron) and similar to -particles in their ionizing and
penetrating ability. When an atom loses a positron from the nucleus, its mass number
remains the same and atomic number decreases by 1 unit. Positrons result from a
proton changing into a neutron. Isotopes which undergo this decay and thereby emit
positrons are include iodine 121, nitrogen 13, oxygen 15, carbon 11, aluminum 26,
sodium 22 and fluorine 18.
11
6C  115 B  10


These are emitted by unstable nuclei in which neutrons are transformed into protons
with  emission.
1 0
0n  11p 
 –1

where the released proton particle has the same mass as that of original atom while
the -particle has charge as an electron.
It occurs when an inner orbital electron is pulled into the nucleus and there is no
particle emission. But it changes atom and same result as positron emission. Proton
combines with the electron to make a neutron, its mass number stays the same and
atomic number decreases by one.

92 0 92
44 Ru  –1 e 
 43 Tc

92 92
44 Ru 
 43 Tc

 Emission—neutron changing into a proton

1 0
0n  11p 
 –1

Positron emission—proton changing into neutron

1 0
1p  10 n 
 –1

Electron capture—proton changing into neutron

1 1 0
1 p  –1e 
 1n


-Rays are high energy photons of light. They do not have any charge or mass on
them. It travels with the same velocity of light. It has shorter have shorter wavelength
than the visible light. Like X-rays. It has least ionizing, but most penetrating power.
When -rays are emitted from a radioactive element, no change or loss of atomic mass
or number takes place, only there is lowering of nuclear energy. It produces heat on
the surface on which they fall and knock out electrons from it. So, they can produce
nuclear reaction (Table 5.1).

-Radiation: High-energy
electromagnetic
wave
 Table 5.1: Properties of -, -, and -radiations
Property Type of radiation
  
Charge Positive (+1) Carry 1 unit They are neutral (no
of negative (–1) charge – 0)
Mass (each particle has) 4 amu (6.64 × 10–24 g) 5.5 × 10–4 amu Negligible mass
Relative penetrating Small 100 times that 10000 times that of
power of -rays -rays
4
Nature of radiation 2 He nuclei Electron High-energy photons
Velocity 3 × 107 ms–1 2.97 × 108 ms–1 3 × 108 ms–1

Nucleus contains protons and neutrons and electron circles the nucleus in orbits.
Protons are having +1 charge with mass number (MN) of 1 and neutrons do not carry
charge (0) with MN of 1, whereas electrons carry negative (–1) charge with MN nearly
zero.
Isotopes are having same number of protons but different number of neutrons; or
Isotopes are having same atomic number but different mass numbers.
The nucleus of an isotope is called nuclides. Nuclides have same number of protons
but different number of neutrons. They are chemically same but have physical
properties are different due to different number of neutrons, e.g. hydrogen has three
isotopes which are shown below.

Isotopes are classified into two types.

Isotopes which are stable in nature and do not emit any kind of radiation. e.g. 13C,
35Cl, 1H (protium), 2H (deuterium).

Radioactive isotopes are also called radioisotopes. These are naturally occurring or
artificially created radioactive isotope of a chemical element. A version of a chemical
element that has an unstable nucleus and emits radiation during its decay to a stable
form reached. The original nuclide is called the parent (undergoes decay) and the
product is termed daughter nuclide. The stable end product is a non-radioactive isotope
of another element. This phenomenon of nuclear changes is termed disintegration or
radioactive decay, e.g.
b Emit radiation b– 4
aX 
 a– 2 X   -rays
Parent Daughter
nuclei nuclei (stable
or unstable)

Radioactive isotopes are of two types:

1. Naturally occurring: It occurs in nature.
Examples: U235 (uranium), Ra226 (radium), Rb87 (rubidium), K40 (potassium)
2. Artificial radionuclides: These radionuclides are produced in nuclear reactions.
It is created by bombardment of atoms of specific element with radiation particles,
e.g. bombarding aluminum with -particles to produce radioactive isotope of
phosphorus
27
13 Al  24He  30
 15 P  10n

The naturally occurring nuclides have a particular ratio of protons and neutrons in
most of the elements. If more neutrons are added to the nucleus and the ratio will get
disturbed so the nuclide becomes unstable. Any deviation in this ratio alters the atomic
number and causes unstability of nucleus.
An isotope can be unstable if:
• It is too heavy (>83 protons).
• Its n0 (N) to p+ (Z) ratio is too high.
• Its n0 (N) to p+ (Z) ratio is too low.

Radioactivity describes an atom which undergoes radioactive decay. It releases

radiation from the nuclei of radioactive isotopes. Radioactive decay is when an unstable
atom of an element emits radiations in the form of electromagnetic waves or subatomic
particles; to stabilize it.
According to the law of radioactive decay, the quantity of radioelement which
disappears in unit time is directly proportional to the amount present. It is independent
of temperature so its activation energy is zero. Each radionuclide, whether natural or
artificial get disintegrated by the emission of energy.
Carbon 12 and carbon 13 are stable, but carbon 14 is radioactive.
6p+ and 6n0 6p+ and 7n0 6p+ and 8n0
Identification of radioactive element depends upon disintegration rate, decay
constant, half-life and type of radiation emitted.

Various forms of equation for radioactive decay are

Rate of disintegration = –dN/dt  N
or –dN/dt = KN
where K is amount of proportionality which is called disintegration or decay
constant
–dN/N = K·dt (i)
Integrating equation (i) over limit 5A0 and N (for the left hand side) and 0 and t (for
the right hand side), we get:
N dN t
N 0 N
 –  Kdt
0

ln N/N0 = –Kt (ii)

On simplification of equation (ii)
N/N0 = e–Kt
N = N0e–Kt (iii)
where K = Disintegration or decay constant
N0 = Initial number of atoms of the nuclei at time 0
(N0 – N) = the amount of substance that gets disintegrated into another after time t.

The standard unit of radioactivity is Curie (Ci) or (C).

It defined as mass of radioactive elements that produces 3.7 × 1010 disintegration per
second. This is approximately the amount of radioactivity emitted by 1 gram (1 gm) of
radium = 226.
1Ci = 3.7 × 1010 disintegrations or nuclear transformations per second
But nowadays, the unit curie is replaced by Rutherford.

The quantity of a radioactive material that have one transformation per second or one
decay per second
Bq = one transformation per second
or 1Ci = 3.7 × 1010 Bq = 37 GBq
or 1Bq  2.703 × 10–11Ci
= 27 pCi

It is a non-SI unit of radioactive decay. It is defined as the activity of a quantity of

radioactive material in which one million nuclei decay per second.
1 Rd = 106 decay/second
or 1 Rd = 106 Bq
or 1 Rd = 2.703 × 10–5 Ci
Original measuring unit for expressing the absorption of all types of ionizing radiation
(, , , neutrons, etc. into any medium. One rad is equivalent to the absorption of 100
ergs of energy per gram of absorbing tissue. Pharmaceutical dosage forms are described
in terms of rad units.
1 rad = 10–2 J/kg (SI system)
Pharmaceutical dosage forms are described in terms of rad units.

It is the measurement of energy produced by  or X-ray radiation in a cubic centimeter

of air.
1R = 2.58 × 10-4 C kg–1 (C = Couloumb)

It is a measurement that correlates the dose of any radiation to the biological effect of
that radiation. This expresses the relative effects of radiations (,  and ) on the
biological system.

Dosimetry is the measurement of radiation dose. It can be calculated only if bio-

distribution and clearance rate are known. Bio-distribution is the amount of activity
within the organ, while the clearance rate is the rate at which the drug is eliminated
from the body with respect to time.

Gray (Gy): It is a derived unit of ionizing radiation dose in the International Standard
(SI) of Units. One gray is the absorption of one joule of energy, in the form of ionizing
radiation, per kilogram of matter.
1 Gy = 100 rad
Sievert (Sv): It is a measure of the health effect of low levels of ionizing radiation
on the human body. The Sievert is of importance in dosimetry and radiation protection,
and is named after Rolf Maximilian Sievert, a Swedish medical physicist renowned
for work on radiation dose measurement and research into the biological effects of
radiation.
1 Sv = 100 rem
Radiopharmaceuticals used in majority of diagnostic studies in adults ordinary result
in organ dose of <5 rad, within dose to the whole body of <0.2 rad. Radiation dose
below 1 rad is considered to be in ‘low dose’ range.
Radiation dose level is estimated using average activities administered to adults
(Table 5.2).
 Table 5.2: Radiation dose level
Radiation dose Diagnostic use
131
High dose (>5 rads) I- Sodium iodide for thyroid imaging
99m
Tc-DMSA (dimercaptosuccinic acid) for renal imaging
m
I-iodocholesterol for adrenal imaging
201
Medium dose (1–5 rads) Tl-chloride for heart imaging
67
Ga-citrate for tumor and abscess imaging
99m
Tc-pertechnetate for brain imaging
99m
Tc-gluceptate for brain and kidney imaging
99m
Low dose (<1 rad) Tc (Technetium)-red blood cells for blood pool imaging
131
I-hippuran for kidney function studies

The half-life of a radioactive nuclide is the time taken for half the nuclei present to
disintegrate or it is the time required for a radioactive isotope to decay to one half of
its original value at any given point of time.
If the half-life is represented by T1/2, then when t = T1/2, N = No/2, and therefore by
equation
N = N0e–Kt
N0/2 = N0e – Kt1/2
t1/2 = 0.693/K
where K = disintegration constant
Each radioactive isotope has its own characteristic half-life (t1/2). The half-life period
for any given radioelement remains unchanged under varying conditions of
temperature, pressure and chemical environment. This is because radioactivity is a
nuclear property and remains unaffected by changes in the outer electron arrangement.
An element having shorter half-life, greater is the number of disintegrating atoms
hence greater its radioactivity. It is widely varied from fraction of seconds to millions
of years.
For example, initially 64 micro curies of radioactivity occur in a given sample of
ferric citrate (59Fe) solution on a particular date. It was observed that radioactivity is
reduced to 4 micro curies (1/6th of its original) value after 4th half-life.
The reciprocal of the radioactive constant or decay constant is called average half-
life period. It is denoted by  (tau).
 = 1/K
In calculating the dose of any radiopharmaceutical, i.e. t1/2 calculation needs to be
considered (Table 5.3).
Table 5.3: Application of radioisotopes with half-life
Name Half-life Application
131
Sodium iodide ( I) 8.06 days Thyroid scanning and study of thyroid uptake
Sodium phosphate (32P) 14.2 days Treatment of polycythemia (overproduction of RBCs)
injection
Ferric citrate (59Fe) solution 45 days Study of iron metabolism and RBC formation
Calcium chloride (45Ca) 160 days Study of calcium metabolism disorder, bone cancer
Radioactivity was discovered by Becquerel because it left marks on photographic film.
The equipment used for detection or measurement of radiation generally utilizes some
type of material or substance which responds to the radiation. Various detection
methods are as follows.

A photographic film when knocked with radiation gave picture. The more radiation
exposure, the more blackening of the film.

A crystal such as LiF containing Mn as an impurity is used. The impurity causes traps
in the crystalline lattice where, following irradiation, electrons are held. When the
crystal is warmed, the trapped electrons are released and light is emitted. The amount
of light is related to the dose of radiation received by the crystal.

Radiation results in the formation of positive and negative ions in a gas as well as in
all other materials. Ionization can be used both for Bq measurements as well as for
dose measurement.

A number of compounds have the property that they will emit light when exposed to
radiation. The intensity of the emitted light depends on the radiation exposure and
the light intensity is easily measured.

Radiation produces an electric current in semiconductors that can be measured.

Radiation produces a class of chemical species known as free radicals. Although they
are very reactive, they can trap in some solid materials. The number of trapped free
radicals is a measure of the radiation dose.

Radiation either reduces (by electron addition) or oxidizes (by electron abstraction)
the absorbing molecules. Although these changes are initially in the form of unstable
free radicals, chemical reactions occur which ultimately result in stable reduction and
oxidation products.
There are three types of commonly used radiation detectors are electroscope, cloud
chamber and ionization chamber.

Radiations are interact with matter, i.e. charged particles, electrons and photons which
can directly ionize or excite the atoms. Therefore, measurement of radiation and
detection is an important aspect in the identification of type of radiations (a, b, g).
Emitted radiations are identified on the basis of their properties. Suitable detectors
are also needed to assay the radioisotope emitting the radiation.
Ionization effect is measured in ionization chamber, proportional counter and
Geiger-Müller counter. The scintillation effect of radiation is measured using
scintillation detector and the photographic effect is measured by autoradiography.

All the detectors are based on the principle that the radiation deposits its energy
through the formation of charge carriers, either directly or indirectly in the detector
which results in the flow of current or a voltage pulse. The ions created in the detector
can be collected by applying the electric field within the detector and the current flowing
through the detector can be measured using an electrometer.

1. Ionization chamber (Fig 5.1): An ionization chamber consists of a chamber filled

with gas volume (like argon, helium or air, etc.) and fitted in an electric field
between two electrodes kept at different electric potential (50–100 V) and a
measuring device to indicate the flow of current. Radiation entering this volume
results in the formation of ions. The positive ions will be attracted to the negative
electrode, and negative ions will be attracted to the positive electrode. It works
on the principle which is based on the collection of all the charges created by direct
ionization of the gas molecules through the application of electric field.

Fig. 5.1: Ionization chamber

2. Proportional counters: It is the modified form of ionization chamber. In this
instrument the voltage across the electrodes is adjusted to let the number of ions
that reach the electrodes be equal or proportional to the number of ions induced
by the radiation. Thus, the pulse size reflects the energy deposited by the incident
radiation in the detector gas.
If the electric field gradient between the cathode and anode is increased by
increasing applied voltage, the electron produced in primary ionization further
ionize the gas molecule and number of ion pairs is multiplied. For each primary
 electron liberated, larger numbers of additional electrons are liberated and the
current pulse gets amplified. The voltage range over which ionization occurs is
called proportional region and counters working in this region is called
proportional counter.
The gas used in the counters is usually a noble gas (mainly argon). For special
purposes other mixtures of gases have been used, such as a tissue equivalent gas
mixture consisting of 64.4% methane, 32.4% carbon dioxide and 3.2% nitrogen.
For neutron detection He3 and BF3 (boron trifluoride) are the most commonly
employed gases.
3. Geiger-Müller counter (Fig. 5.2):
In 1928, Geiger and Müller was
developed GM counter in
Germany. It is the oldest radia-
tion detector due to its low cost,
simplicity; it is the best detector
among all. It does not require use
of any high gain amplifier and
easily can detect -, -, -
radiations.

Fig. 5.2: Geiger-Müller counter

The counter consists of a GM tube having sensing element which detects the radiation
and processing electronics which shows the result. The GM tube is filled with an inert
gas at low pressure, to which a high voltage (450–500 V) is applied. The tube conducts
electrical charge when a particle or photon of incident radiation makes the gas
conductive by ionization. The ionization considerably amplified within the tube to
produce easily measured detection pulse, which is fed to processing electronics and
display the result.

It consists of a cylinder made-up of stainless steel or glass coated with silver on inner
side which acts as cathode. A tungsten wire is suspended internally which is mounted
at one end with a glass bead, act as anode. Cylinder is filled mixture of gas (argon or
neon and helium generally used) which also contain a small amount of quenching
vapors.
Quenching vapors are used to prevent the false pulse and to absorb photons emitted
by exciting atoms and molecules returning to their ground state. Chlorine, bromine,
ethanol are commonly used as quenching agents. The counter consists of a gas volume
with two electrodes that have a high voltage between them. Very often the detector
element is cylindrical in shape with the cylinder wall serving as the negatively charged
(ground) electrode and a thin metal rod running along the middle axis serving as the
positively charged electrode.
Ionizing radiation passing through the gas volume produces ions in the gas. The
voltage is high enough for each electron attracted to the central electrode to make a
cascade of new ions. This results in a pulse which is detected by a counter system.
 Different counters are used depending on purpose such as:
1. In order to count the radioactive solid source, the end window type GM counter
has been used and window has been made-up of aluminum alloy or mica.
2. For counting radioactive liquids, the counter having 3% solution of uranium salt
is used and the capacity of 10 cm3.
3. To count radioactive gases, counter having lead or copper cathode have been
used.
4. For counting - and -particles, thin glass walled counters may be used and tube
is coated on inside with graphite to form cathode.

A GM counter cannot differentiate between different types of radiation and their

energy. However, the multiplication factor is a big advantage in simple radioactive
counting.

The scintillation counter is based on the principle that light is emitted when a scintillator
is exposed to radiation. When high energy radiation or photons is incident on certain
substance, a flash of light is emitted by the phenomenon called fluorescence or
phosphorescence.
Several organic compounds, such as benzene and anthracene can be used. Crystals
of certain substances, e.g. cesium fluoride, cadmium tungstate, anthracene and sodium
iodide emit small flashes of light when bombarded by -rays. The most commonly
used phosphor in scintillation counters is NaI with a minute quantity of thallium added.
The light pulse produced when radiation interacts with the scintillators is recorded
by a photomultiplier tube. It multiplies and amplifies even a small signal so it becomes
possible to measure -, - or -radiation.
The light emitted when the crystal is irradiated is proportional to the -energy
deposited. Consequently these counters are suited to measure the energy of -radiation
and, therefore, can be used to identify -emitting isotopes.

Fig. 5.3: Scintillation detector

Both organic and inorganic scintillations can be used as detector. The incident light
should be proportional to light produced on detectors. It has high scintillation
efficiency. Inorganic scintillation detectors like alkyl halides are most common
compounds, e.g. sodium iodide, cesium iodide, lithium iodide. Organic scintillators
like plastic scintillators have good scintillation property but stilbene have low
scintillation property. Short decay time of the induced fluorescence can be increased
by dynodes which are made-up of phosphor or fluor which multiplies the electrons
when strike to them. Hence, various inorganic and organic scintillation detectors can
be used to measure the incident radiation.

A large, clean and almost perfect semiconductor is ideal as a counter for radioactivity.
The released electric charge is closely related to the radiation energy. These counters
are employed to measure the energy of the radiation and for identification. The crystals
are made of silicon or germanium. However, it is difficult to make large crystals with
sufficient purity. The semiconductor counters have, therefore, low efficiency, but they
do give a very precise measure of the energy. In order to achieve maximum efficiency
the counters must operate at the very low temperatures of liquid nitrogen (–196°C).
It is a diode of n (electron rich) and p (electron deficient) semiconductors. In a
semiconductor the band gap is very small and large numbers of electron hole pairs
are formed. The absorption of incident radiations results in the formation of electron
and hole pairs which move under the influence of applied electric field. The collection
of electrons at the electrode produces a voltage pulse, which is proportional to the
intensity of the incident radiation.

Fig. 5.4: Semiconductor detector

A care should be taken to protect the people and personal from its harmful effects
during in handling and storage of radioactive materials.
1. The radioactive materials are stored in remote areas and it should be away from
exposure to human beings.
2. The area of radioactive material should be tested for intensity of radioactivity.
3. - and -emitters are stored in thick glass such that shielding effect is provided,
while -emitters are stored in lead containers.
4. Lead shielding is required while handling with radioactive substances.
5. Exposure to radioactive radiation can cause blood cancer to persons.
 The following precautions are taken while working with radioassays, radio-
detectors, radioelements, radioisotopes and other radioactive materials.
1. These materials should be handled by means of forceps and never be touched
with hands.
2. Area of where these materials stored and used should be monitored properly.
3. Sufficient protective clothing or shielding must be used while handling the
material.
4. Food contaminated with radioactive material which can cause serious injury to
internal organs, so avoid any food intake, drinking and smoking within the
laboratory.
5. Radioactive material should be kept in labeled containers and must be shielded
by lead bricks.
6. Final disposal of radioactive material should be done with great care.

The label of radiopharmaceutical preparations should be appropriate and the following

details are to be mentioned on the label:
• Name of radionuclide
• Route of administration
• Date of manufacture
• Date of expiry
• Date of calibration
• A statement ‘caution-radioactive material’
• Dosage calculation
• Correction to be made for radioactive decay
• The half-life of radioactive nuclei.

Radiopaque agents such as iodine or barium compounds are used for X-ray
examinations of kidney, liver, heart, brain and blood vessels.

Radiopaque contrast media are the chemical compounds having the capacity to absorb
and block the passage of X-rays and they are used as a diagnostic aid in radiology
which emits X-rays. X-rays are capable of passing through most of the tissues. When
a photographic film is placed opposite to the X-rays through patient’s body organ, the
film is darkened in the amount of X-rays that have been passed. All radiopaque
materials are not radiopharmaceuticals. Various radiopaque contrast media are used
in X-ray examination of GIT, gallbladder, bile duct, kidney, ureter, fallopian tubes,
liver, heart and brain. Radiopaque contrast media do not produce any pharmaco-
logical effect.

Molecular formula: BaSO4 Molecular weight: 233.39

Synonyms: Barium meal, shadow meal
 IP limit: It contains not <90% and not >110% of the labeled amount of barium sulfate.

1. It is prepared from barium hydoxide and barium chloride by the action of sulfuric
acid and the precipitates formed are filtered and dried.
BaCl2 + H2SO4  BaSO4 + 2HCl
Barium Sulfuric Barium Hydro-
chloride acid sulfate chloric
acid
Ba(OH)2 + H2SO4  BaSO4 + 2H2O
Barium Sulfuric Barium
hydroxide acid sulfate
2. It can also be prepared by the action of sulfuric acid on barium sulfide.
BaS + H2SO4  BaSO4 + H2S
Barium Sulfuric Barium Hydrogen
sulfide acid sulfate sulfide

It is a fine, heavy, white, odorless, bulky powder which is free from grittiness. It is
insoluble in water and organic solvents but soluble in hydrochloric acid and nitric
acid. Suspension of barium sulfate is susceptible to barium emitting microorganisms
so in suspension is permitted to contain suitable preservatives. It is also soluble in
sulfuric acid by forming bisulfate salt.
BaSO4 + H2SO4  Ba(HSO4)2
Barium Sulfuric Barium
sulfate acid bisulfate

Oral dose: 60–450 gm in suspension, rectal dose: 150–750 gm in suspension.

1. 0.5 gm of barium sulfate is mixed with 2 gm each of anhydrous sodium carbonate

and potassium carbonate. The mixture is heated in a crucible until fusion is
completed; the fused mass is treated with hot water and filtered. The filtrate is
acidified with H2SO4 to meet the requirement of test for sulfates.
2. Dissolve a portion of well-washed residue from the above identification test in
6 N acetic acid; the solution meets the requirement for the test of barium.

The following tests are carried out to test the purity of sample:
1. pH 3.5–10 in 60% w/v aqueous suspension.
2. Loss on drying at 105°C for 4 hours: it should not lose >1% of its weight.

Take a mixture sodium carbonate and potassium carbonate (0.6 gm) and heat it at
1000°C for 15 minutes. It is cooled, water is added, filtered by decantation and residue
is washed with sodium carbonate solution. Then dil. HCl, ammonium acetate,
potassium dichromate and urea are added to the residue, heated in an oven at 80–
85°C for 16 hours, filtered, the precipitates are washed with potassium dichromate
and finally with water and dried at 105°C.
1 gm of the residue  0.213 gm of BaSO4

It is used as radiopaque contrast media for X-ray examination and diagnosis for
GI tract. It is used primarily as a whitening agent in industrial applications. Barium
ion stimulates smooth muscles causing vomiting, severe cramps, hemorrhage and
diarrhea.

Molecular formula: NaI Molecular weight: 153.90

Synonym: Radioactive iodine, natrii radioiodidum.
Among all radioactive isotopes of iodine, 131I is most frequently used. It is used
as an aqueous solution of sodium iodide having sodium thiosulfate as a reducing
agent.

It should not contain <90% and not >110% of labeled amount of Iodine-131 as iodide
which is expressed in microcuries or millicuries at the time indicating in the labeling.

In 1949, the first production of Iodine-131 took place in France at the Fort de Chatillon,
the site of the first Zoe atomic reactor. Since 1942, the isotope has been used in the
treatment of thyroid cancer.
Most 131I is prepared in nuclear reactor by neutron-irradiation of a natural tellurium
target. Irradiation of natural tellurium produces almost entirely 131I as the only
radionuclide with a half-life longer than hours. Finally in 8.02 days it gets converted
into Xenon-131 (stable isotope).
(n, y)  –
( – ,  )
Te130  Te131   131I  Xe131

It is a clear and colorless solution. 131I undergoes decay by emitting - and -radiations
with a half-life of 8.02 days. Its solution is having pH range of 7.5–9. It easily solubilizes
in water and alcohol.

Iodide inhibits the release of thyroid hormone and it is used in hyperthyroidism. All
the isotopes of iodine are rapidly taken up by thyroid follicles. Radioactive iodine, i.e.
131I is available as Na131I solution and is administered orally.

The absorption of 131I leads to highly localized destruction of thyroid follicles due
to -particles emission. This property has promoted radioactive iodine as a therapeutic
alternative in surgical removal of the gland. The radioiodine therapy is considered
advantageous over surgery because of the simplicity of its procedure, its applicability
to patients, avoidance of surgical risks and complications.

Sodium iodide (131I) is suitable for both oral and IV administration. The solution is
clear and colorless, but during the time passes both the solution and glass may get
darken due to the effect of radiation.
For injection, a suitable preservative such as benzyl alcohol and reducing agent
such as sodium thiosulfate is also added to the solution, to prevent the oxidation of
sodium iodide in aqueous solutions. Potassium salt, iodide and iodate have been acting
as a carrier for iodide ions and for iodate ions present in the 131I solution.
Sodium iodide (131I) capsules are prepared by evaporating an alcoholic solution of
sodium radioiodide directly on the walls of the capsule or on inert capsule filling
material.

The spectrum of 131I has been complex but the most abundant type of photon is having
energy of 0.364 MeV. The -ray scintillation spectrum of 131I solution has been found
to be identical to that of specimen of 131I of known purity, which exhibits major
photoelectric peak, having energy of 0.365 MeV.

It should be stored in single or multiple dose containers that have been treated
previously to prevent absorption.
131I solution should be first of all rinsed with a solution having approximately 0.8%

of sodium bisulfate and 0.25% of sodium iodide and then water until the last rinsing
has been neutral to litmus.

It is possible to determine its activity, using suitable counting equipment by comparison

with a standardized 131I solution or by measurement of an instrument calibrated with
the aid of such solutions. Iodine-131 has been emitting both - and -particles in its
decay process. Radioactivity has to be recorded on a counting assembly which is having
either a Geiger-Müller counter or a scintillation detector used as a sensing unit and an
electronic sealing device.

Radioactive iodine is mainly used for the diagnosis of disorders of thyroid function. It
is mainly used in the treatment of hyperthyroidism. It is also used in the treatment of
thyrotoxicosis and radiotherapy of thyroid cancer. Radioactive iodine is also used in
the treatment of Graves’ disease (toxic diffused goiter).

Nowadays, radiation and radioactive substances have been widely used in medicine,
mainly for diagnosis and treatment of various health ailments.
 In diagnosis:
1. Sodium iodide (131I) injection is used to study the functioning of thyroid gland.
2. Iodinated ( 131I) human serum albumin injection finds the use to investigate
cardiovascular functions.
3. Chromium in the form of sodium chromate attaches strongly to the hemoglobin
of red blood cells. Chromium-151 isotope is also useful for determining the
lifetime of RBC, which can be of great importance in the diagnosis of anemia.
4. Colloidal gold (198Au ) has been used in studying the blood circulation in liver.
5. Radioactive cobalt (Cobalt-59 or Cobalt-60) is used to study defects in vitamin B12
absorption.
6. Cyanocobalamin (57Co) is used for measuring glomerular filtration rate.
7. Ferric citrate (59Fe) injection finds the use in hematological disorders.
In treatment: The therapeutic use of radioisotopes depends on the ability of their
ionization. These are useful to destroy or weaken malfunctioning cells. It is -radiation
that causes the destruction of damaged cells. An ideal therapeutic radioisotope should
be a strong -emitter with just enough  to enable imaging, e.g.
1. Iodine-131 is used to treat the thyroid for cancers and abnormal conditions such
as hyperthyroidism.
2. Yttrium-90 is used for the treatment of cancer particularly liver cancer and it is
being used more widely including for arthritis.
3. Lead-212 can be attached to monoclonal antibodies for cancer treatment.
In research: Excellent biological and medicinal study can be carried out with
radioactive isotopes as radiotracers. Generally carbon-14 and tritium are most
commonly used.
In sterilization: Thermolabile substances like vitamins, hormones, antibiotics can
be safely sterilized by strong radiation sources, e.g. cobalt-60 or cesium-137 may be
used for sterilizing surgical instrument. In agriculture, -rays are used to kill
pests and induce genetic mutations in a plant. Californium-252 is used for neutron
activation analysis, to inspect airline luggage for hidden explosives. It is also used for
various analytical purposes such as radioimmunoassay (RIA) and solubility
determination.

Table 5.4: Some commonly used radioisotopes for various therapeutic and diagnostic appli-
cations
Radioisotope Applications/Uses
Iodine-123 (-emitter) Diagnose thyroid imaging
Iodine-125 Used in diagnosis of clotting by fibrinogen scan
Iodine-131 Used to treat thyroid disorders
Calcium-44, 45 (Ca-44, 45) Study of bone structure and bone cancer
Cesium 147 Used to treat cancerous tumors
Sodium-22,24 (Na-22, Na-24) Used in estimation of extracellular fluid, body circulation rate,
excretion and distribution of water
Xenon-133 Used in nuclear medicine for lung ventilation and blood flow
studies
(Contd.)
Radioisotope Applications/Uses
Carbon-14 (C-14) Used in medical and pharmaceutical research
Strontium-90 (Sr-90) Used in radiotherapy of superficial carcinoma
Cobalt-60 (Co-60) radiotherapy, sterilization of heat labile substances, study of
vitamin B12
Cobalt-57 (Co-57) Used in diagnosis of pernicious anemia
Hydrogen- 2H, 3H Used to determine total body water content
Iron-59 (Fe-59) Used to study iron absorption, lifespan of red blood cells
Phosphorus-32 In the treatment of polycythemia and related disorders
Radium-223 (-emitter) In the treatment of metastatic cancer in bone
Selenium-75 (-emitter) Investigation of adrenal gland imaging and bile salt absorption
Fluorine-18 Used in investigation of tumor imaging, bone imaging, myo-
cardial imaging
Nitrogen-13, 15 (N-13, N-15) Used in investigation of amino acid and protein metabolism
Oxygen-17, 18 (O-17, O-18) To study organic reactions and photosynthesis
Oxygen-15 (O-15) Cerebral and myocardial blood flow imaging
Gallium-67 (-emitter) Tumor imaging and inflammation/infections imaging
Gallium-68 Prostate cancer imaging
Sodium chromate (Cr-51) It finds use in measuring red cell volume and its survival time
Cr-51 EDTA For glomerular filtration rate estimation
Dysprosium-165 (165Dy) In arthritis treatment

1. Radioactivity was discovered by:

a. Louis Pasteur b. Becquerel
c. William Crookes d. Benjamin Franklin
2. 1 curie is equivalent to:
a. 3.7 × 108 Becquerel b. 3.7 × 1012 Becquerel
-8
c. 3.7 × 10 Becquerel d. 3.7 × 1010 Becquerel
3. Radioactive decay undergoes ...... order of reaction.
a. Second c. First
b. Zero d. Third
4. Positron emission results in:
a. -Decay b. +-Decay
c. -Decay d. -Decay
5. ...... is used as quencher in Geiger-Müller counter.
a. CCl4 b. Chloroform
c. Methanol d. Ethanol
6. ...... device used for the measurement of radioactivity.
a. Geiger-Müller counter b. NMR spectroscopy
c. Cyclotron d. Nuclear reactor
 7. Iodine 131I is produced from the neutron bombardment of ......
a. Indium-111 b. Xenon-133
c. Tellurium-132 d. Tellurium-130
8. Gamma rays are:
a. No charge
b. No penetrating power
c. High penetrating power than  and 
d. Less penetrating power than  and 
9. ...... is gas filled detector.
a. Ionization chamber b. GM counter
c. Both a and b d. None of the above
10. Beta rays are:
a. Negatively charged b. Positively charged
c. Neutral d. None of the above
11. Isotopes are having:
a. Same atomic number and same mass number
b. Same atomic number but different mass number
c. Sum of number of protons and neutrons
d. None of the above
12. Alpha rays are:
a. Negatively charged b. Positively charged
c. Neutral d. None of the above
13. Radioactivity undergoes ...... reaction.
a. Spontaneous reaction b. Statistical process
c. Chemical reaction d. None of the above
14. Radioactivity is due to:
a. Stable nucleus c. Cosmogenic
b. Electronic configuration d. Unstable nucleus
15. In PET ...... is used as a tracer.
a. Sodium-24 b. Fluorine-18
c. Phosphorus-32 d. Tellirium-132
16. The units of ...... are the Sievert (Sv) and the roentgen equivalent man (rem).
a. Dose equivalent c. Half-life
b. -Emitted d. None of the above
17. Atomic number is equivalent to:
a. Number of electrons b. Number of neutrons
c. Number of protons d. None of the above
18. ...... is the commonly used quenching agent.
a. Argon b. Methane
c. Hydrogen d. Bromine and chlorine
19. Which of the following detectors is not used in medicine?
a. -Particle emitters b. -Particle emitters
c. -Particle emitters d. All of the above
20. The standard unit of radioactivity is:
a.  b. Ci
c.  d. All of the above

1. b 2. d 3. c 4. b 5. d 6. a 7. b 8. c 9. c 10. a 11. b
12. b 13. a 14. d 15. b 16. a 17. c 18. d 19. a 20. b

1. Dynodes are used in ...... detectors.

2. Half-life period of radioactive is calculated by ......
3. The function of quenching vapor is ......
4. P-10 gas is a mixture of ...... and ......
5. Proportional counter has a basic cylindrical geometry with a central wire made
up of tungsten acting as ......
6. ...... is the measurement of radiation dose.
7. ...... is the time required for a radioactive isotope to decay to one half of its original
value at any given point of time.

1. Scintillation counter
2. t 1/2 = 0.693/K
3. To prevent false pulses
4. 90% argon and 10% methane
5. Anode
6. Dosimetry
7. Half-life

1. Define radioactivity. Discuss about radioactive rays.

2. Differentiate -, - and -rays.
3. Define the following terms:
a. Half-life
b. Isotope
c. Units of radioactivity
4. How to label radioactive material?
5. What are the uses of radiopaque contrast media?
6. List any two radioisotopes with their applications.
7. Write a note on storage conditions and precautions of radioactive substance.

1. Discuss the construction, working and principle of Geiger-Müller counter with a

neat and labeled diagram.
2. Discuss the preparation, properties and uses of 131I and barium sulfate.
3. What are the different modes of decay of a radioisotope, also discuss in detail of
the half-life.
4. Explain the properties of -, - and -particles and also write the applications of
radioisotopes.
5. Give a detail note on scintillation counter.
6. Describe methods of measurement of radioactivity. What are the standards and
units of radioactivity?
7. Discuss the diagnostic and therapeutic applications of radioisotopes in detail.
 Bentonite 91
Absorbed dose 157 -Rays 152
Achlorhydria 76 Bicarbonate 52
Acid–base balance 58 Bismuth
Acidifiers 76 subcarbonate 92
Acidity 66 subgallate 93
Acids 29 Boric acid 100
theories of 30 British Pharmacopoeia 7
Activated charcoal 95, 140 Bronsted-Lowry theory 30, 31
Adsorbents 92
Buffer
Alkalinity 66
action 32, 34
-Rays 151
Aluminum mechanism of 32
chloride 78, 114 capacity 36
hydroxide gel 82 solutions 38
Anemia 128 types of 33
types of 128 acidic 33
Antacid 80 basic 33
combination of 81 Buffered isotonic solutions 39
non-systemic 81 Bulk forming cathartics 88
properties of 80
systemic 81
therapy 80
side effects of 80 Calcium 49
Anticaries agent 64 carbonate 68, 83
Antidotes 134 gluconate 56, 57
classification of 135 preparations of 57
mechanism of action of 135 Cathartics 87
Antimicrobials 98 Cements 70
Antimony potassium tartrate 119 Charcoal 141
Antiseptics 98 mechanism of 141
Arrhenius theory 30 Chemical buffer system 59
Arsenic 22 Chloride 16, 18, 51
apparatus 24 limit test for 16
limit test for 22 modified limit test for 18
Astringents 145
Chlorinated lime 105
Cleansing agents 66
Barium sulfate 164 Compound sodium chloride injection 55
Bases 29 Conjugate acid–base pair 31
theories of 30 Copper sulfate 120
Cryoscopic method 41 Fluid balance 47
Cyanide 136 Fluid electrolyte concentrations 47
antidote kit 137 Fluoride 64
clinical effects of 136 role of 64
poisoning 135 Formulation 57
sources of 136 composition of 57
treatment 136 Free radicals 159

Decay constant 155 -Rays 153

Dental Gastric acidifiers 76
Gastric juice 74
cements 70
secretion of 74
properties of 70
Gastrointestinal agents 74
floss 69
Geiger-Müller counter 161
products 63
Germicides 99
Dentifrice 67
Gray (Gy) 157
ideal properties of 67
types of 66
cosmetic 66
Heavy metal poisoning 137
therapeutic 66
Heavy metals 20, 131
Desensitizing agents 69
limit test for 20
Detectors 160
Hematinics 123
types of 160
Henderson-Hasselbalch equation 30
Dilute hydrochloric acid 77 Hydrogen peroxide 103
Disinfectants 98 Hyperkalemia 49
Hypermagnesemia 51
Hypernatremia 48
Electrolyte dissociation 30 Hyperphosphatemia 53
Arrhenius theory of 30 Hyperthyroidism by 131I 166
Electrolyte in body 48 treatment of 166
role of 48 Hypokalemia 49
Electrolyte replacement therapy 53 Hypomagnesemia 51
Electron Hyponatremia 48
capture 153 Hypophosphatemia 53
emission 152
Electronic theory 30
Emetics 118 Impurities 13
centrally acting 118 effect of 13
locally acting 118 sources of 13
European Pharmacopoeia 9 Indian Pharmacopoeia 3
Expectorants 111 salient features of 6
classification of 112 Inorganic antidotes 135
sedative 112 Interstitial fluid 46
stimulant 112 Intracellular fluid 46
Extracellular fluid 46 Iodine 107
Ionization 159
chamber 160
Ferrous Iron 123
gluconate 130 absorption of 124
sulfate 128 physiological functions of 124
Fillers 70 transport of 125
Iron deficiency 126 Pharmacopeia 2
treatment of 126 history of 3
Isoelectric point 39 Pharmacopeia internationals 9
Isosmotic solutions 39 Phosphate 65
Isotonic role of 65
buffers 43 Phosphate 52
solution 39 Plasma 46
Isotopes 154 Poisoning 134
stability of 155 intentional 134
types of 154 sign and symptoms of 134
radioactive 154 undetermined 134
stable 154 unintentional 134
Polishing agents 70
Positron emission 152
Kaolin 94 Potash alum 147
Kidneys 59 Potassium 49
chloride 55
iodide 112
Laxatives 87 permanganate 102
Lead 25 Povidone–iodine 108
limit test for 25 Proportional counters 160
Lead poisoning 137 Protectives 92
Lewis theory 30 Protein precipitation 145
Lubricants (stool softener) cathartics 88 mechanism of 145
Proton transfer theory 30, 31
Purgatives 87
Magnesium 50
hydroxide 84
oxide 83 Radiation dose level 158
sulfate 89 Radioactive
Mouthwashes 70 decay 155
dosimetry 157
identification 167
material 163
Negatrons 152
storage, handling and precautions of 163
preparations 164
labeling on 164
Oral rays 151
antiseptics 70 substances 167
iron therapy 126 pharmaceutical applications of 167
rehydration salt 57 Radioactivity 150, 159
Osmolality 39 detection methods of 159
Osmosis 39 discovery of 150
Osmotic (saline) cathartics 88 measurement of 159
units of 156
Becquerel (Bq) 156
Particle changes 153 Curie (Ci) 156
Pharmaceutical substances 1 radiation absorbed dose (RAD) 157
impurities in 1 Roentgen (R) 157
Pharmaceutical system 37 Roentgen equivalent man (REM) 157
buffers in 37 Rutherford (Rd) 156
Radioisotopes with half-life 158 limit test for 17
application of 158 modified limit test for 19
Radiopaque contrast media 164 Systemic acidifiers 77
Radiopharmaceuticals 150, 164
Rapid initial replacement 53
Redox products 159 Thermoluminescence dosimetry (TLD) 159
Respiratory system 59 Tonicity 39
Ringer injection 55 methods of adjustment of 41
methods used for the measurement of 40
hemolytic 40
Saline cathartics 88 types of 39
Scintillation 159 Tooth 63
detector 162 anatomy of 63
Semiconductor detector 163 Toxicity 136
Semiconductors 159 mechanism of 136
Sievert (Sv) 157 Transcellular fluid 47
Slight temperature difference 40
determination of 40
Sodium 48 United States Pharmacopeia 9
bicarbonate 81 Universal antidote 138
chloride 54 Urinary acidifiers 77
hypertonic injection 55
injection 54
preparations of 54 Vascular fluid 46
fluoride 65
iodide 166
nitrite 139
White-Vincent method 42
orthophosphate 90
potassium tartrate 90, 119
thiosulfate 138
Sprowls method 43 Zinc
Stimulants 88 chloride 69
Subsequent replacement 53 oxide eugenol cement 71
Sulfate 17, 19 sulfate 146