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1. By…
Mr. S. L. Khan
M. Pharm(PhD),
Assistant Professor,
Pharmaceutical Chemistry,
Rajarshi Shahu College of Pharmacy,
Buldhana, Maharashtra
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INTRODUCTION
Pharmacopoeia: the word derives from the ancient Greek word
Pharmakon means Drug & Poeia means to make.
It is a legally binding collection, prepared by a national or regional authority &
contains list of medicinal substances, crude drug & formulas for making
preparation from them.
The pharmacopoeia contain-:
 List of drug and other related substances
 Sources
 Description
 Tests
 Formulas for preparation actions
 Uses
 Doses
 Storage conditions

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 National Pharmacopoeia(s):
United States Pharmacopoeia (USP),
Indian Pharmacopeia(IP),
Pharmacopoeia of the People's Republic of China(PPRC),
German Pharmacopeia,
British Pharmacopoeia (BP),
Portugese Pharmacopoeia,
Mexican Pharmacopoeia,
French Pharmacopoeia,
Japanese Pharmacopoeia (JP) and
Argentinean Pharmacopoeia
 Regional Pharmacopoeia(s):
 European Pharmacopoeia.
 International Pharmacopoeia(s):
 International Pharmacopoeia.
Different Types of
Pharmacopoeia

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INDIAN PHARMACOPOEIA
 Indian Pharmacopoeia Commission (IPC) is an autonomous
institution of the Ministry of Health and Family Welfare which sets
standards for all drugs that are manufactured, sold and consumed in India
The set of standards are published under the title Indian
Pharmacopoeia (IP)
Vision: The IPC is committed to the promotion of the highest standards for
drugs for use in the prevention and treatment of diseases in human beings
and animals keeping in view the special features of the pharmaceutical
industry in India.
Objectives…?

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HISTORY & EDITIONS
The process of publishing the first Pharmacopoeia started in the year 1944 under
the chairmanship of R. N. Chopra
• In 1948 government of India appointed an Indian Pharmacopeia committee to prepare
‘Pharmacopeia of India’
• 1st edition I. P. 1955 was published in the official gazette. Dr. B. N. Ghosh, Chairman
– Supplement 1960
• 2nd edition I. P. 1966, Dr. B. Mukherji, Chairman, Shankar S.
– Supplement 1975
• 3rd edition I. P. 1985, Dr. Nityanand, Chairman
– I Addendum/Supplement 1989
– II Addendum/Supplement 1991

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• 4th Edition I. P. 1996 Dr. Nityanand, Chairman
– III Addendum/ Supplement 2000
– IV Addendum/ Supplement 2002
• 5th Edition I. P., 2007, Dr. Nityanand, Chairman
• 6th Edition I. P., 2010
• 7th Edition I. P. 2014
-- V Addendum/Supplement 2015
• 8th Edition I. P. 2018
-- IV Volumes
HISTORY & EDITIONS

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 The Indian Pharmacopoeia is the official book of standards and
medicines produced in India must comply with the specified standards
 Pharmacopoeial standards and acceptance criteria are set with the
intention that they be used only as compliance requirements and not as
requirements to guarantee total quality assurance
 Pharmacopoeial standards are the minimum ones with which a
manufacturer must comply before release of a product for sale or
distribution
 It is recognized that changes in quality may occur during storage and
distribution and the pharmacopoeial requirements are set to define
acceptable levels of change and to reject materials or products showing
unacceptable levels
OVERALL PHILOSOPHY

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It is the responsibility of the manufacturer to ensure that the product is
manufactured in accordance with current Good Manufacturing Practices and that
sufficiently stringent limits of acceptance are applied at the time of release of a
batch of material or product so that the compendial standards are met until the
expiry date under the storage conditions specified
Pharmacopoeial requirements for drug substances have been drawn up to provide
appropriate limits for potential impurities rather than to provide against all possible
impurities and adulterants
Material found to contain an impurity that cannot be detected by means of the
prescribed tests is to be considered as not of pharmacopoeial quality if the nature or
amount of the impurity found is not compatible with good manufacturing practices

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INDIAN PHARMACOPOEIA MONOGRAPH DEVELOPMENT
Normal Format
 Description. Physical form of the material, whether hygroscopic, odour, if
apparent and indication of polymorphism, if applicable
 Identification Tests usually including infrared spectrometry, if appropriate
 Non-specific purity tests, such as light absorption, optical rotation, sulphated
ash etc
 Impurities , both related substances and impurities that may be present as a
result of the method of manufacture or from degradation on storage
 Impurities other than related substances that may require control such as
heavy metals, inorganic impurities, residues of solvents and reagents used
during synthesis and purification

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Other tests such as loss on drying or water
Assay and limits for purity calculated on the anhydrous, dried or solvent-free
basis, as appropriate
To the extent possible, for assay, a robust and precise, though not specific
method is given rather than a specific stability-indicating and complex one. With
increasing emphasis on stability, the latter is often unavoidable
In the case of non-specific assay methods, control of impurities is provided
separately by means of specific impurity tests
Each monograph is designed to be considered as a whole and should provide a
reliable basis for judging the quality of the drug substance
INDIAN PHARMACOPOEIA MONOGRAPH DEVELOPMENT

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