Introduction to Pharmacopoeia’s

Prepared By:
Shivani Singh
Associate Professor
Lloyd Institute of Management and Technology
• The term Pharmacopoeia comes from the
Greek word
“Pharmakon” meaning ‘drug’ and
‘Poiein’ meaning ‘make’
and the combination means any recipe or
formula or other standard required to make or
prepare a drug.
• Pharmacopoeia is a legally binding collection
prepared by a national or regional authority, of
standards and quality specifications for medicines used
in the country or region. A quality specification is
composed of a set of appropriate tests that will confirm
the identity and purity of the product, ascertain the
strength(amount) of the active substance and when
needed its performance characteristics.
• Reference substances i.e. Highly characterized
physical specimens are used in testing to help ensure
the quality such as identity, strength and purity of
medicines.
• The text covers pharmaceutical starting materials,
excipients, intermediates and finished pharmaceutical
products.
• Pharmacopoeia’s are of two types:
1. National Pharmacopoeia
2. International pharmacopeia
Pharmacopoeia are also defined as book
recognized by the government as legal
authority for standardization of drugs.
These books are revised from time to time so
as to introduce the latest information
available as early as possible after they
become established.
• Pharmacopoeia’s are also known as Formularies and collectively
these books are known as drug COMPENDIA.
• Compendia’s are of two types:
1. Official Compendia
2. Non official Compendia

MONOGRAPH- The descriptive material pertaining to any of the

drugs in the pharmacopoeia is known as the monograph. It
includes (Non proprietary name of substance, chemical formula,
molecular weight, category, doses, standards, physical properties,
solubility, identification test, test of purity(m.p, b.p etc), method of
assay* and storage.

Assay: It is the qualitative and quantitative estimation of a substance.

 OFFICIAL COMPENDIAS
• These are combinations of drugs and other
related substances which are recognised as
legal standards of purity, quality and strength
by government agency of respective countries
of their origin. E.g.
-Indian Pharmacopoeia
-British Pharmacopoeia
-European Pharmacopoeia
 NON OFFICIALCOMPENDIAS
• Books other than official drug compendia
which are used as secondary reference
sources for drugs and other related
substances are known as non official drug
compendias. E.g.
-Merck Index
-Remington’s Pharmaceutical Sciences
 Indian Pharmacopoeia
• In 1946 Govt. of India issued one list known as
“The Indian Pharmacopoeial List” under the
chairmanship of sir RN Chopra. It was
prepared by Dept. Of Health, Govt of India,
New Delhi.
• In 1948, Govt. Of India appointed an Indian
Pharmacopoeial Committee for preparing
pharmacopoeia of India. Tenure of this
committee was 5 years.
 First Edition 1955; supplement 1960
• Indian Pharmacopoeial Committee under the
chairmanship of Dr. BN Ghosh published the first
edition of IP in 1955
• It was written in English.
• Official titles of monographs* were given in Latin.
• It contained 986 monographs
* A drug monograph describes the properties, claims,
indications and conditions of use of the drug and
contains any other information that may be required
for optimal, safe and effective use of the drug
Second Edition 1966; Supplement -1975
• It came under the chairmanship of Dr. B
Mukherjee.
• Official titles of monograph were given in English.
• Doses were expressed in metric system.
• For tablets and injections “usual strength” have
been given.
• Formulation of drugs were just given after their
monograph.
• 274 monographs of IP 1955 were deleted and 93
new were added.
 Third Edition: 1985
• It came in 2 volumes and 9 Appendices
• 261 new monographs have been added and 450 old
were deleted.
Fourth Edition: 1996
• It has 2 volumes and came under the chairmanship of
Dr. Nityanand.
• It covered 1149 monographs and 123
appendices(explain the additional information of the
topic).
• 294 new monographs were added and 110 old were
removed.
 Fifth edition: 2007
• It came in 3 volumes:
• Volume I
Contains general notices and general chapter.
• volume II and Volume III
They contain general monographs on drug
substances, dosage forms and pharmaceutical aids
 Sixth Edition:2010
• It was published by IPC ghaziabad.
• It is also available in 3 volumes.
Volume I: it contains notices, preface,
acknowledgements, introduction and general
chapters
Volume II: it contains general monographs on
dosgae forms and monographs on drug
substances, dosage forms and pharmaceutical
aids (A to M).
• Voulme III: it contains monographs on drug
substance, dosage forms, pharmaceutical aids
from (N to Z).
It also includes the products of
biotechnology, indigenous herbs and herbal
products, veterinary vaccines and additional
antiretroviral drugs.
Standards for new drugs and drugs used in
National Health Programmes are also added.
 Seventh Edition: 2014
• Published by IPC on behalf of Govt. Of India,
Ministry of Health and Family Welfare.
• It is available in 4 volumes
• It contains 2550 monograph among which 577
are new consisting of API’S, excipients, dosage
forms and herbal products.
• It also contain 19 New radiopharmaceutical
Monograph.
• It contains additional anticancer drugs,
antiretroviral drugs and formulations, products of
biotechnology, veterinary vaccines.
 Eighth Edition:2018
• It is orange in colour
• It has 4 volumes.
• 170 new chemical mongraphs,15 herbal monographs and 10
monographs on blood and blood related products are added
new.
• 53 New Fixed Drug Combinations monographs have been
included.
• Pyrogen test have been replaced by Bacterial Endotoxin Test
in parentral preparations.
 Ninth Edition:2022
• IP 2022 came under the chairmanship of Dr. Mansukh Mandaviya, Union Minister for Health
and Family Welfare and Chemicals and Fertilisers,
• It is orange in colour and came in 4 volumes.
• It contains a total of 92 new monographs, including:
60 Chemicals,
21 Vitamins, Minerals, amino acids, fatty acids, etc.,
3 biotechnology-derived therapeutic products,
4 human vaccines,
2 blood and blood-related products,
2 herbs and herbal-related products,
7 phytopharmaceutical ingredient category monographs.
• This has led to the total number of 3,152 monographs in the current edition of IP. In addition,
12 new general chapters have also been introduced.
• Chitrak and Siri are newly added herbs and herbal products to IP 2022.
• Anti-D blend (IgM + IgG) monoclonal reagent and anti-D (IgG) monoclonal reagents have also
been added to the IP under the category of blood and blood related products.
• 3 new biotechnology derived therapeutic products added to the IP are rituximab, rituximab
injection, teriparatide concentrated solution.
• A *new category “the quality of raw materials” has been created in IP 2022
 BRITISH PHARMACOPOEIA
• The responsibility of preparing and publishing
the British pharmacopoeia has been upon the
Pharmacopoeia commission by the General
medical council.
• Pharmacopoeial commission is reconstituted
from time to time for a period which
corresponds to the period during which a new
edition of pharmacopoeia is prepared and
published.
BRITISH Pharmacopoeia
First edition of BP was published in 1864.
It consist of two sections
Part I:- Materia Medica & Part II:- Preparation & compounds.

Second edition of BP was published in 1867.

• Third edition of BP was published in 1885.
Fourth edition of BP was published in 1898.
Fifth edition of BP was published in 1914.

Eighth edition of BP was published in 1953.

1. In this edition titles of drugs & preparations were in English instead
of Latin and metric system.
2. It has been published annually.

BP 2007 -2009 were given in Six Volumes i.e. Volume I to Volume VI.
Volume I & II contains medicinal substances.
Volume III contains formulated preparations, blood related products,
immunological products, radiopharmaceutical preparations, surgical
materials & homoeopathic preparations.
Volume IV contains supplementary chapters, IR spectra etc.
Volume V contains veterinary.
Volume VI contains CD ROM version.
The British Pharmacopoeia (BP) is the official collection of
standards for UK medicinal products and pharmaceutical
substances.
Published annually, the BP contains monographs for
pharmaceutical substances, formulated preparations and
other articles used in the practice of medicine.

The BP has been providing authoritative, official standards

for pharmaceutical substances and medicinal products since
1864. Today, it is used in almost 100 countries worldwide
and remains an essential reference for any individual or
organisation working within pharmaceutical research and
development, manufacturing and testing across the globe.
 UNITED STATE PHARMACOPOEIA

• It is the official pharmacopoeia of united states and many other

nation.
• It contains the recognized standards of identity, strength,
purity, quality, packaging and labeling of drug substances,
dosage forms and other therapeutic products including
nutritional and dietary supplements.

First edition of United state Pharmacopeia was published on

15th December 1820 in both Latin & English.

From 1820 to 1942 it was published at Ten years intervals.

From 1942 to 2000 it was published at Five years intervals.
From 2002 it was published annually.
• It is a compendium of quality control for drugs
and excipients to be introduced into medicinal
preparations and include method of
identification, assay and purity determination
of drug substance and excipients.
 NATIONAL FORMULARY
• It is a manual containing a list of medicines
that are approved for prescription throughout
the country. It includes key information on the
composition, description, selection,
prescribing, dispensing and administration of
medicines
 USP-NF
• The USP is published dually with the National
Formulary as the USP-NF by United States
Pharmacopoeial Convention (USPC). It is a non
profit organization that owns the trademark
and copyright to the USP-NF and publishes it
every year.
• Prescription and OTC medicines and other
health care products sold in the United States
are required to follow the standards in the
USP-NF. USP also sets the standards for food
ingredients and dietary supplements.
• USP purchased the National Formulary in
1975 and combined the two publications
under one cover creating USP-NF.
• USP-NF is a book of public pharmacopoeial
standards. It contains standards for medicines,
dosgae forms, drug substances, excipients,
medical devices and dietary supplements
 EXTRA PAHRMACOPOEIA/ MATRINDALE:
The Complete Drug Reference
• It was first produced in 1883 by william Matrindale.
It is authorised reference book on drugs and used
throughout the world.
• It provides information on drugs in clinical use
worldwide, disease treatment reviews, selected
investigational and veterinary drugs, herbal
medicines, pharmaceutical excipients, vitamins and
nutritional agents, vaccines, radio pharmaceuticals,
diagnostic agents, medicinal gases, drugs of abuse,
disinfectants or pesticides.
• It provides latest information on medicine and
drugs whether official, unofficial and
proprietary that are currently used in
pharmacy to practicing pharmacist and
doctors.
THANK YOU