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Introduction To Quantitative Pharmaceutical Chemistry

1) Quantitative pharmaceutical chemistry involves analyzing drugs and chemicals for purity and quality, and analyzing chemical constituents in the human body related to disease states. 2) Quality control ensures drugs are free of impurities, physically and chemically stable, contain the proper amount of active ingredients, and provide optimal release of ingredients when administered. 3) The USP publishes legally recognized standards for drugs set by scientific experts, including assays and tests for strength, purity, and quality, and are revised every 5 years.

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523 views9 pages

Introduction To Quantitative Pharmaceutical Chemistry

1) Quantitative pharmaceutical chemistry involves analyzing drugs and chemicals for purity and quality, and analyzing chemical constituents in the human body related to disease states. 2) Quality control ensures drugs are free of impurities, physically and chemically stable, contain the proper amount of active ingredients, and provide optimal release of ingredients when administered. 3) The USP publishes legally recognized standards for drugs set by scientific experts, including assays and tests for strength, purity, and quality, and are revised every 5 years.

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Mrl Ashia
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MODULE 1:

Introduction to Quantitative
Pharmaceutical Chemistry
Quantitative Pharmaceutical Chemistry

• ​The application of the procedures of


quantitative analytical chemistry to:

– ​The analysis and determination of the purity


and quality of official drugs and chemicals
used in pharmacy.
– ​The analysis of chemical constituents found
in the human body whose concentrations
are altered during disease states.
– ​The analysis of medicinal agents and their
metabolites found in biological systems.
Quality as Applied to a Drug Product

• ​Sum of all factors which contribute directly or


indirectly to the safety, effectiveness and
reliability of the product.

• ​Properties that are built into products through


research and during the manufacturing
process by procedures known as quality
control.
Quality Control

• ​Guarantees within reasonable limits


that a drug product is:

– ​Free of impurities
– ​Physically and chemically stable
– ​Contains the amount of active ingredient/s
as stated on the label
– ​Provides optimal release of active
ingredient/s when the product is
administered
Standards
• ​These are set through a United States
Pharmacopoeial Convention, Inc. composed of
representatives from different colleges and
schools of pharmacy and medicine,
pharmaceutical and medical associations, other
national associations and other various
departments of the government.

• ​During revisions, drugs for inclusion are


selected by a committee composed of medical
experts. The standards for such drugs are then
set by pharmaceutical and medical scientists
who represent educational institutions,
government departments and industry.
The United States Pharmacopeial
Convention Inc.
• ​Publishes the USP/NF
• ​Legally recognize compendiums of
standards for drugs, which include
assays and tests for determination of
strength, quality and purity.
– ​Such compendiums are revised every 5
years and supplements are issued between
revisions in order to keep them as up-to
date as possible on matters pertaining to
drug quality.
Methods of Analysis in Quantitative
Pharmaceutical Chemistry

1.) Volumetric Analysis


Determination of the volume of a solution of
known concentration required to react with a
given amount of the substance to be
analyzed.

2.) Physicochemical Methods


Analysis based on some specific physical or
chemical properties of the substance to be
analyzed.
Methods of Analysis in Quantitative
Pharmaceutical Chemistry
3.) Gravimetric Analysis
Separation by extraction, precipitation or
other means, of the constituent to be
determined, either in the natural state or
in the form of a compound with definite
composition, known to the analyst, and
then weighing of the resulting product.

4.) Special Methods


Analysis which require a distinct type of
technique.
Official Pharmaceutical Assay Methods
• ​Exactly measure a substance’s purity when
combined with qualitative tests

• ​Hence, a complete analysis requires not


only quantitative determinations but also
qualitative tests to determine strength,
potency and purity of a drug or
pharmaceutical product.

• ​Mastery of theoretical considerations is


required and should be applied throughout
each step of analytical procedures.

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