Diploma in pharmacy

1. INTRODUCTION TO PHARMACOPOEIAS
Prof.:-Sarika Vinayak Patil
M.Pharmacy (Q.A.)
Shree Panchavati Education Society
Institute of Pharmacy ,Nashik

2. 1) Definition:-
Pharmacopoeia is the official book published by
the government of that country. It contains the list of
drugs, formulae for medicinal preparations with detail
information with respect to tests, description for these
substances and their standard. The word
pharmacopoeia has been derived from Greek word
„Pharmacon‟ meaning drug and „Poeia‟ meaning to
make.

3. OBJECTIVES AND IMPORTANCE OF PHARMACOPOEIA
1. To provide list of medicinal substances, formulae together with
the description and standards.
2. To provide all information about the drug in monograph.
3. To improve and maintain the quality control and standard of
drugs.
4. To provide official standards for manufacturing of medicines.
5. To provide health care.
6. To solve dispute and conflict about drug and medicinal
products.
7. To provide standard product to the country following it.

4. Pharmacopoeia are revised regularly
-To update the monograph of certain drugs.
-To add new drugs.
-Removal of drugs monograph which are not in current use.
2)Official Substance:
The substance of which information is given in the pharmacopoeia is
known as official substance.

5. The first British Pharmacopoeia came into existence in
1864
In the United States, the first pharmacopoeia was published in
December 1820 both in English and in Latin. Later on a National
Formulary was also published in addition to U.S.P.
Objectives of U.S.P.:-
-To select substance which posses medicinal power.
-To convert them in to preparations of suitable composition in
order to enhance their power to the maximum advantage

6. The first International Pharmacopoeia was
published by the World Health Organization
(WHO) IN 1951(Volume-I) and in 1955(Volume -
II).
Objective:
-To provide uniform list which would avoid the
confusion caused by different national standards,
strengths and names especially for the use of
travelers who might need to use the same
prescription in different countries.

7. HISTORY OF THE PHARMACOPOEIA OF INDIA
Indian Pharmacopoeia: The official book published by
the government of India is known as Indian
pharmacopoeia.
HISTORY
First “Bengal Pharmacopoeia” was published in 1844.
(During pre-independence day it was referred as official
book.
But it had no legal status).
↓
26 January 1944: Government of India directed Drug
Technical Advisory Board to prepare list of drugs.
↓

8. Publication of List → in 1946
(List is misleading; list contains all the drugs of medicinal value and
their standards.
List contains: 180 monographs and number of appendices of which
100 monographs contain vegetable drugs and their galenicals)
↓
February 1947(Pharmaceutical and drugs
research committee decided to prepare
Brochure)

9. ↓
Government of India in 1948 appointed 11 members committee on 23rd Nov. to prepare pharmacopoeia
of India.
↓
First I.P. Published in 1955 (which contains very large no. of crude drug and their preparation).
↓
Supplement to 1st edition was published in 1960
(By Dr. B.N. Gosh and R.G. Kar)
(During publication of 2nd edition of I.P. 273 monograph of I.P.1955 was deleted of which 123 consisted
of crude drug and preparation of fixed oils.)
(And addition of new 93 drugs likes antibiotics, hormones and synthetic preparation.)
↓
Second edition of I.P. was published in 1966
↓
Supplement to 2nd edition published in 1975
↓
30th June 1979→ Committee constituted for 3 rd edition
↓
3rd edition of I.P. Published in 1985(with two volumes, under the chairmanship of Dr. Nityanand)
↓
Supplement to 3rd edition were published
Addendum I: Supplement in 1989
Addendum II: Supplement in 1991
↓
On 12th August 1991 reconstituted committee for 4 th edition
↓

11. Fourth edition of I.P. published in 1996.
(Which contains 1149 monographs, including 291 new monographs, 110 monographs deleted and
titles of 142 monographs has been changed.)
↓
(During publication of 5th edition of I.P. some obsolete or less used products monograph were delete
from I.P. 1996 and added monograph on systems of priorities based on therapeutic merits, medical
needs and extent of use)
Fifth edition of I.P. was published in 2007 By Indian Pharmacopoeia Commission,Ghaziabad.
(Which include those herbal drugs which had supporting definitive quality control standards) and
(Monographs on vaccines and immune seras for human use, Monograph on blood and blood related
products and Monograph on Biotechnological products were added)
↓
Sixth edition I.P., 2010
↓
7th edition of I.P. 2014 Addendum/Supplement2015
↓
2018

12. Salient Features of First Edition of Pharmacopoeia of India (1955)
1. The title- of monographs and abbreviated titles has been given in Latin
language.
2. The English title has also been given in below the abbreviation title.
3. Weights and measures have been given in metric system.
4. Doses are impressed in metric and English system.
5. A list of preparation has been given at the end of monograph.
6. The temperature has been expressed in Celsius thermometric Scale.
7. The descriptive terms like very soluble, slightly soluble etc. have been used
where the exact solubility of pharmacopoeial substance is not known.

13. Salient Features of Second Edition of Pharmacopoeia of India (1966)
1. The titles of monographs have been changed from Latin to English.
2. Titles have been transposed to give name of the drug first.e.g.Injection of
Aminophylline to Aminophylline Injection.
3. Doses are expressed in metric system only and solubility in part of solvent per
unit of solute.
4. Preparation of drug have been given after monograph of the parent drug.
5. Test for sterility have been modified.
6. New analytical techniques have been include e.g. Non aqueous titrimetry,
column chromatography, compleximetry etc.
7. A new subheading “Usual strength” has been given to represent strength of the
tablet or injection.

14. Salient Features of Third Edition of Pharmacopoeia of India (1985)
IP 1985 contained many additional standards
1. The analytical method included such as flame photometry, flurometery,
electrophoresis as official method.
2. Dissolution Test has been included for certain tablets.
3. Modified Disintegration test has been included.
4. Microbial limit test has been prescribed for certain preparations.
5. The Pyrogen Test was revised to make the test less time consuming.
6. Some drug have been renamed in this edition
e.g. Acetyl salicylic acid :Aspirin, Purified Talc:Talc
7. Many new broad spectrum antibiotics are included.
8. IUPAC System of nomenclature of organic chemical drugs has been used.
9. New Appendix „Water for pharmaceutical use‟ has been included and different
standards of water were given e.g. Purified water, Water for injection, sterile
water for injection etc.

15. Salient Features of Fourth Edition of Pharmacopoeia of India (1996)
1. It contains 1149 monograph and 123 appendices are available in two volumes.
2. The computer generated structural formulae have been introduced.
3. Some titles have been changed to include the more commonly accepted name in
India.
4. Infra-red and Ultra –red absorption spectrophotometric test for identification of
drug substances.
5. The infra-red reference spectra of a number of drug substances has been included
in an appendix.
6. The high performance liquid chromatography (HPLC) has been widely used as a
method of analysis for many formulations.
7. The test of Bacterial endotoxin as a more suitable substitute for the test for
pyrogen has been introduced.
8. A number of general monographs e.g. eye drops, pessaries, suppositories etc.
have been included.
9. The specific biological assays and test provided for vaccines, hormones, blood
products and enzymes have been transferred from an appendix to the individual
monograph.

16. NATIONAL FORMULARY:
Multiplicity of drugs, their effects and continuous flow of new drugs made
difficult for medical practitioners to choose the drug.
Thus to provide proper guidance to medical practitioners, medical students and
pharmacists in hospitals, National formulary has been made.
The first edition of National formulary was published in 1960 by Government of
India; Ministry of Health published many new drugs.
The second edition was published in 1966 under the chairmanship of Dr.B.B.Yodh
consulting physician.

17. MONOGRAPH:
Monograph is published report on one particular subject.
The information portion of monograph comprises of :
1. Title in English with synonyms.
2. Chemical names as per IUPAC
3. Atomic weight.
4. Category
5. Chemical formula or molecular formula.
6. Doses.
7. Usual strength of dosage.
8. Description.
9. Solubility parameters
10. Standards
11. Limit and tolerance with upper or lower limits.
12. Other requirements as may be specified.
13. Tests and assays
14. Packaging, storage, labeling.

18. List of Pharmacopoeias and Some of the Standard Reference Books of Common Use in
India
1. Indian Pharmacopoeia (I.P.)
2. British Pharmacopoeia (B.P.)
3. United States Pharmacopoeia (U.S.P.)
4. European Pharmacopoeia
5. International Pharmacopoeia
6. Japanese Pharmacopoeia
7. Martindale Extra Pharmacopoeia
8. British Pharmaceutical Codex.(B.P.C.)
9. Pharmaceutical Codex
10. Merck Index
11. British National Formulary
12. United States National Formulary
13. National Formulary (N.F.)
14. United States Dispensatory
15. Indian Pharmaceutical Codex (I.P.C.)