Ambe Durga Educations Society’s

DADASAHEB BALPANDE COLLEGE OF DIPLOMA

IN PHARMACY
Near Swami Samarth Dham Mandir, Besa, Nagpur

SUBJECT—PHARMACEUTICS-I
CHAPTER—INTRODUCTION TO
PHARMACOPOEIA

By : Mrs. Deepali Vikas Chaudhary

 Pharmacopoeia
 Pharmacopoeia: Pharmakon means “a drug” and
poein means “to make”.
 Pharmacopoeia is defined as a compressive book
which is issued under the authority of government and
contains a list of drug and formulae used for medicinal
preparation with description and the tests for those
substances and the standards to which they must
confirm.
History of Indian Pharmacopoeia:

 The government of India directed the Drugs Technical

Advisory Board to list the drugs that are used in India, which
are not mentioned in British Pharmacopoeia and also
 recommend the standards to be prescribed to maintain
uniformity and the chemical tests to be used to establish
identity and purity.
 The Government of India published the Indian
Pharmacopoeial List in 1946 as a supplement to British
Pharmacopoeia.
 list in the title was ‘misleading’ in that, the book not only
contained a list of drugs which were of substantial
medicinal value but also laid down standards.
 The Indian Pharmacopoeial List contained about 180
monographs and a number of appendices prepared on
the lines of the British Pharmacopoeia.
 Approximately 100 monographs were on vegetable
drugs growing in India and on their galenicals.
 `The drugs of plant origin such as artemesia, bael,
berberis, cannabis, ispaghula, kaladana, kurchi,
myrobalan,picrorhiza, punarnava, rauwalfia,
vasakaetc.were included in it.
 Similarly several oils such as ajowan,cassia, chaulmoogra,
neem and pudina were included it. The appendices gave
detail for a number of determinations referred to in the
monographs.
 The Pharmaceuticals and Drugs Research Committee of the
Council of Scientific and Industrial Research decided in
February 1947 to compile a ’Brochure’ to highlight the
information and clinical users of the important indigenous
drugs of India.
 Later on it was decided to prepare a ’Codex’ instead of
Brochure on the lines of the British Pharmaceutical Codex.
 The first Indian Pharmaceutical Codex published in 1953.The Codex
consisted of two parts.
 The part carried about 190 general monographs on natural product and
drugs of vegetable and animal origin, and a few chemicals.
 The second part consisted of formulary of galenicals and other
preparations.
 After the publications of the Indian Pharmacopoeial List the Government
of India, constituted an eleven member Indian Pharmacopoeial
Committee in 1948, in their notification No. F.1-1/48-DS dated 23rd
November, 1948, for preparing the Pharmacopoeia of India.
 The tenure of the office of the members of the Committee was five years.
It was extended by one year vide Government notification no F.6-10/53-
DS dated 21st November 1953.
 In compiling the monographs of the first Pharmacopoeia of
India, help was taken from all available established scientific
data in the modern Pharmacopoeia, such as British
Pharmacopoeia, the United States Pharmacopoeia, and the
international Pharmacopoeia and from scientific institutions
interested in drugs and Pharmaceuticals products.
 The first edition of Pharmacopoeia of India was compiled and
then published in 1955.
 Salient features
 First Edition
 Second Edition
 Third Edition
 Fourth Edition
 Fifth Edition
 Sixth Edition
 Seventh Edition
 Eighth Edition
 Salient features of First Edition of I.P. (1955)
By the Controller of publications, Delhi on the behalf
of GOI, Ministry of Health and Family Welfare.
1. Official Titles of monographs : Latin language.
2. Written in English
3. Weight and measures :Metric system
4. Doses : Metric system and Imperial system
5. Preparation List : At the end of monograph
6. Temperature: Celsius Thermometer scale.
7. Solubility(not known exactly): Descriptive terms are
used
The work related to I.P. Compilation and revision was
taken –up simultaneously under chairmanship of Dr. B.
N. Ghosh.
 Salient features of Second Edition of
I.P. (1966)
1. Title: English language.
2. Words of Title changed to give name of the drug first
3. Weight and measures :Metric system
4. Doses : Metric system only
5. Preparation List : Immediately of monograph
6. Sterility test: modified for detection of fungi
7. Solubility: Parts of solvents per part of solute
8. New analytical tech: non- aqueous titrimetry, column
chromatography.
9. Tablets and Injection monograph: “Usual Strength”
Salient features of Third Edition of I.P.
(1985)
1. New analytical tech: Flame photometry, Flurometry,
Electrophoresis, photometric Heamoglobinometry.
2. Dissolution test: certain tablets
3. Disintegration test : modified the design of the apparatus and
method.
4. A microbial limit test : Pharmaceutical prep and oral liquid
preparation
5. Pyrogen Test: Revised to decrease time.
6. GLC: Determination of alcohol concentration
7. Viscosity Test: Ostwald Viscometer
8. New Appendix: on “Water for Pharmaceutical Use”
9. Some drugs renamed: Acetyl salicylic acid to Aspirin.
10. Many drugs omitted and many new drugs are added.
 The first edition of Pharmacopoeia of India --------------- 1955.
 The second edition of Pharmacopoeia of India ------------1966.
 The third edition of Pharmacopoeia of India -------- ------1985.
 The fourth edition of Pharmacopoeia of India--------- 1996.
 The fifth edition of Pharmacopoeia of India ------------2007.
 The sixth edition of Pharmacopoeia of India------------2010.
 The seventh edition of Pharmacopoeia of India ---------2014.
 The eighth edition of Pharmacopoeia of India ---------2018.
 List of Pharmacopoeias

 Indian Pharmacopoeia –I.P.

 British Pharmacopoeia –B.P.
 United State Pharmacopoeia –U.S.P.
 European Pharmacopoeia –E.P.
 International Pharmacopoeia
 British Pharmaceutical Codex—B.P.C.
 National Formulary—N.F.
 Indian Pharmaceutical Codex—I.P.C.
 National Formulary of India —N.F. I.
 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.
Fourth edition of BP was published in 1898.
Fifth edition of BP was published in 1914.
Eighth edition of BP was published in 1953.
In this edition titles of drugs & preparations were in English instead of
Latin and metric system.
It has been published annually.
In BP 2007 monographs has been introduced for material specifically used
in preparation of Traditional Chinese medicines.
Term „Prolonged release‟ has been replaced the term „Slow‟ and the term
„Gastro-resistant‟ has been replaced with „Enteric coated‟ in number of
monographs.
 BP 2008 contains approximately 3100 monographs for
substances, preparations and articles used in practice.
It has been made effective from 1st January 2008.
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.
THE BRITISH PHARMACOPOEIA 2010 TSO (The Stationery Office), on
behalf of the British Pharmacopoeia Secretariat, part of the Medicines and
Healthcare products Regulatory Agency (MHRA), has published the British
Pharmacopoeia (BP) 2010.
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 standards in the BP 2010 are legally effective in the UK from 1 January
2010. 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.
 THE BRITISH PHARMACOPOEIA (BP) 2013 The BP 2013 package includes: Six volume printed
edition including the BP (Veterinary) 2013 New for 2013: 41 new BP monographs 40 new
European Pharmacopoeia monographs 619 amended monographs 6 new and 1 amended Infrared
Reference Spectra
 THE BRITISH PHARMACOPOEIA 2014 The only official source of British pharmaceutical
standards Produced by the British Pharmacopoeia Commission Secretariat of the Medicines and
Healthcare Products Regulatory Agency, and updated annually, the British Pharmacopoeia (BP) is
the official, authoritative collection of standards for UK medicinal substances for human and
veterinary use.
 The 2014 edition includes almost 3500 monographs which are legally enforced by the Human
Medicines Regulations 2012. Global standards Now used in over 100 countries, the BP remains an
essential reference for all individuals and organisations working within pharmaceutical research
and development, manufacture and testing around the globe.
 Flexible access options The BP 2014 package comprises five volumes of the British Pharmacopoeia
2014 and a single volume of the British Pharmacopoeia (Veterinary) 2014, along with a fully
searchable CD-ROM and online access to provide you with flexible resources. New for 2014
Legally effective from 1 January 2014 40 new BP monographs 272 amended monographs Three
new Supplementary Chapters Four new BP (Vet) monographs One new BP (Vet) Supplementary
Chapter
UNITED STATE Pharmacopoeia
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.
First National Formulary of the united state appeared in 1888.
USP21-NF16 have eight supplements.
First appeared in January 1985 & last in November 1988.
USP22-NF17, 1990 is the third revision that consolidates USP & NF
into a single volume.
Electronic version of USP-NF on floppy disks was introduced in 1992.
USP23-NF18, was published in Mumbai as an Asian edition at the end
of 1994.
 USP23 has ten supplements.
 First supplement was published in January 1995 & Last in May 1999.
 USP24-NF19, appeared from first January 2000.
 USP30-NF25, appeared from May 2007.
 It contains Scientific standards for drugs, dietary substances, biological
products & Excipients used in dosage forms.
 It contains 4,100 monographs and 200 general chapters.
 It has been printed in three volume set.
 Volume I contains general chapters & Volume II & III contains
monographs.
 First supplement to USP30-NF25, appeared from August 2007 &
second supplement from November 2007 which will be considered
official from May 2008.
 From 2006, Spanish edition of USP is also being published.
 History
• The first edition of the British Pharmacopoeia was published in 1864 and
was one of the first attempts to harmonize pharmaceutical standards
• A Commission was first appointed by the General Medical Council
(GMC) under the Medical Act 1858 for producing a British Pharmacopoeia
on a national basis.
• In 1907 the British Pharmacopoeia was supplemented by the British
Pharmaceutical Codex, which gave information on drugs and other
pharmaceutical substances not included in the BP, and provided standards
for these.
Editions
• The current edition of the British Pharmacopoeia comprises six volumes
which contain nearly 3,000 monographs for drug substances, excipients
and formulated preparation
• Items used exclusively in veterinary medicine in the UK are included in
the BP
THANK
YOU