Pharmacopoeias

PHARMACOPOEIAS
Ronald Peter
Assistant Professor
Dept. of Pharmaceutics

• Derived from Greek word ‘Pharmakon’ means drug and ‘Poiein’ means to make.
• Legal and official book issued by recognized authorities - appointed by Government
of each country.
United States Pharmacopeial Convention
Indian Pharmacopoeia Commission
• Comprises - list of pharmaceutical substances, formula along with their description
and standards.
• List of Pharmacopeias:
Lisie College of Pharmacy, Kochi
a) British
b) Chinese
c) European
d) French
e) German
f) Indian
g) International
h) Italian
i) Japanese
j) United state

 The term pharmacopoeia – first used in 1580 – in a book on drug standards
 Later – many pharmacopoeia appeared – made many confusions – due to many
irregularities.
 To overcome this – 1864 – first BP published.
 In Dec 1820 – USA – first US Pharmacopoeia – Latin and English
 In addition to USP – National Formulary (NF) – published - 1888
 In 1951 – WHO – first International Pharmacopoeia (Vol I)
 In 1955 – WHO – first International Pharmacopoeia (Vol II)

Indian Pharmacopoeia (journey till now)
 Gov. India – 26th Jan. 1944 – directed DTAB – list the drugs used in India – which are
not mentioned in BP.
 Also recommended – to maintain various standards – chemical tests –
identification and purity
 1946 – Gov. India – PHARMACOPOEIAL LIST – supplement to BP.
 Committee under chairmanship of Sir R. N. Chopra along with other nine members
prepared, The Indian “Pharmacopoeial list”
 It was published by Dept. of Health, Govt. of India - 1946.
 The term “List” – misleading. (because - not only contained list, but also standards)

Pharmacopoeial list
 180 monographs & number of appendices based on BP.
 Out of which – almost 100 monographs – vegetable drugs in India and their
galenicals.
 Pharmaceuticals and drug research committee of CSIR – Feb 1947 – to prepare a
Brochure – highlighting – information and clinical uses of indigenous drugs of India.
 Later – decided – instead to brochure – prepare “Codex” – similar to “British
Pharmaceutical Codex”
 “Indian Pharmaceutical Codex” – published – 1953
 Indian Pharmaceutical Codex – two parts
First part – 190 monographs on natural products & drugs of veg. and animal origin
Second part – formulary of Galenicals and other preparations.

 First edition of IP (1955)
• In 1948 – Gov. of India appointed an Indian Pharmacopeia committee, of eleven
members, for preparing “Pharmacopeia of India”
• Tenure of this committee was five years which was extended by one more year.
• Indian Pharmacopeia committee under chairmanship of Dr. B. N. Ghosh Published
first edition of IP in 1955.
• It was written in English & official titles of monographs given in Latin.
• It covers 986 monographs.

Salient features of 1st edition (IP 1955)
1. Title of monographs – Latin.
2. Abbreviated titles for use in prescription – given immediately below Latin title.
3. English title – also given below – abbreviation title.
4. Weighs and measures – metric system
5. All statements in monographs – considered as constitute standards.
6. Doses – expressed – Metric and English system
7. List of preparations – given at end of some monographs
8. Temperature – expressed in Celsius
9. Descriptive terms (very soluble, freely soluble etc) used- solubility is unknown.

• The tenure of 1st Indian Pharmacopoeia committee – expired in 1954.
• Reconstituted – chairmanship – Dr. B N Ghosh
• The committee – compiled a supplement to first edition – published – 1960.
• The IPC decided to publish the second edition of IP.
• The Indian Pharmacopoeial Committee appointed various sub committees – assist
in compilation work.
• A coordination sub committee – formed – coordinate the work of sub committees.
• Working group – formed – examine the comments on draft monograph.
• Second edition of IP – published – 1966 and later its supplement in 1975.

Salient features of 2nd edition (IP 1966)
1. Title of monographs – changed from Latin to English.
2. Title – name of the drug given first
(injection of Paracetamol Paracetamol injection)
3. Doses – in metric system only
4. Solubility – in “parts of solvent per unit part of solute”

5. Preparations of a drug – given immediately after the parent drug
(paracetamol injection, paracetamol tablet, paracetamol suspension etc given
immediately after paracetamol)
6. Test for sterility – modified (to detect fungi in addition to bacteria)
7. New analytical techniques - Non-aqueous titrimetry, column chromatography
included
8. In case of tablets and injections – usual strength – included.

• In 1979 – Gov. of India – reconstituted Indian Pharmacopoeia committee – for 5
years – for preparing 3rd edition of IP.
• The committee was as follows;
o Chairman
o Members – 13 (from academic, research and industry)
o Member secretary
o Assistant secretary
• Committee appointed – various subcommittees and working group
• Monographs, Appendices and General Notes – prepared by working group –
finalised by committee – published third edition of IP - 1985

Salient features of 3rd edition (IP 1985)
1. New analytical techniques – Flame photometry, Flurometry, Electrophoresis and
Photometric Haemoglobinometry – introduced as official methods for chemical
analysis.
2. Dissolution test introduced
3. Disintegration test – amended – by modifying design of apparatus and method of
testing
4. Microbial limit test – introduced
5. Pyrogen test – revised – to make less time consuming

6. Gas liq. chromatography – recognised as an alternative – for det. alcohol conc.
7. Introduced various methods for determining viscosity – using Ostwald viscometer.
8. Introduced new appendix – “Water for Pharmaceutical Use” – clearly indicating
official standards for – purified water, water for injection and sterile water for
injection.
9. Some drugs are renamed (Acetylsalicylic acid to Aspirin)
10. Many drugs are omitted and many new drugs where introduced.

• In 1991 August 12th – Gov. of India – reconstituted Indian Pharmacopoeia
committee – for 5 years – for preparing 4th edition of IP.
• The committee was as follows;
o Chairman
o Members – 18 (from academic, research and industry)
o Member secretary
o Assistant secretary
• Committee appointed – various subcommittees and working group
• Monographs, Appendices and General Notes – prepared by working group –
finalised by committee – published fourth edition of IP - 1996

Salient features of 4th edition (IP 1996)
1. Contained 1149 monographs & 123 appendices – in 2 volumes
2. Computer generated structural formulae – introduced
3. Some titles changed to more accepted names in India.
(Hyoscine Hydrobromide for Scopolamine Hydrobromide)
4. Infra red and Ultra red absorption spectrophotometric tests – introduced
5. HPLC has been widely used as a method to analyse many formulations.

6. Test for bacterial endotoxins has been introduced instead of test for pyrogen for
some articles.
7. Number of general monographs – introduced (eye drops, eye ointments, nasal
preparations, oral liquids etc.)
8. Quantitative test for determining particulate matter has been replaced by
qualitative test.
9. Certain bioassay and tests for vaccines, hormones, blood products and enzymes –
transferred from appendix to individual monographs
10. In monographs of ORS – ORS Bicarbonate has been removed (due to stability
issues), whereas ORS Citrate has been retained as recommended by WHO.

• Rapid development in field of pharmaceutical science and technology – became a
necessity to update the IP frequently.
• After the publication of fourth edition of IP – an addendum – published – 2000 and
in 2002.
• The numbering of pages where continuous form IP 1996 to 2000 and 2002.
• The following changes were made;
1. A number of tests and standards were amended.
2. Test on bacterial endotoxins replaces the pyrogen tests.
3. A new appendix on “residual solvents” – introduced
4. Appendix on HPLC – replaced by revised version covering ion
chromatography.
5. Monographs on antiretroviral activities – introduced
6. Monographs on vaccines for Hepatitis B and Rabies - revised

• In 2005 March 22nd – Gov. of India – reconstituted Indian Pharmacopoeia
commission (IPC)
• The commission has a 3 tier structure, as follows;
o General Body – 19 members
o Governing Body – 8 to 10 members
o Scientific Body – 15 to 23 members
• Commission appointed – various expert committees o prepare various
monographs.
• The 5th edition of IP – published – 2007 and its addendum in 2008

Salient features of 5th edition (IP 2007)
1. IP 2007 – presented in 3 volumes.
 Vol. I – general notes, preface, structure of IPC, introduction and general chapters
 Vol. II – general monographs on drugs, dosage forms and pharmaceutical aids
 Vol. III - general monographs on drugs, dosage forms and pharmaceutical aids cont
general monographs on vaccines and immunosera for human use, herbs
and herbal products, blood and blood related products, biotechnology
products and veterinary products.
2. General chemical tests – eliminated and IR and UV spectrophotomeric tests -
included

3. Test for pyrogen – involving animal tests – eliminated and bacterial endotoxin
introduced.
4. Test for abnormal toxicity – confined to certain vaccines only
5. Use of chromatographic methods – extended to many more products.
6. Labelling and storage – given – at end of monographs.

7. General monographs for dosage forms of active pharmaceutical ingredients are
grouped at beginning of Vol. II – followed by monographs of active
pharmaceutical ingredient, pharmaceutical aid, individual dosage form (all in
alphabetical order)
8. Monographs for other special articles – vaccines and immunosera, herbs and
herbal products, blood and blood related products etc – separate section in Vol. III
9. Limit of bacterial contamination – included
10. Analytical methods – closely related – internationally accepted methods.

Find out the full form and what they are..........
1. IP
2. BP
3. USP
4. BPC
5. NF
6. IPC
7. NFI

• 6th edition of IP is published in 2010 and its addendum in 2012.
• The Indian Pharmacopoeia 2010 is presented in three volumes.
• Volume I – Notices, Preface, the Structure of the IPC, Acknowledgements,
Introduction, and the General Chapters.
• Volume II – General Notice, General Monographs on Dosage Forms and
Monographs on drug substances, dosage forms and pharmaceutical aids (A to M).
• Volume III – Monographs on drug substances, dosage forms and pharmaceutical
aids (N to Z). Followed by Monographs on Vaccines and Immunosera for Human
use, Herbs and Herbal products, Blood and blood related products, Biotechnology
products and Veterinary products.

• 7th edition of IP is published in 2014 and its addendum in 2015 & 2016.
• The Indian Pharmacopoeia 2014 is presented in four volumes.
• The IP 2014 incorporates 2550 monographs of drugs out of which 577 are new
monographs consisting of APIs, excipients, dosage forms and herbal products
biotechnology product, radiopharmaceuticals etc.

• 8th edition of IP is published in 2018 and its addendum in 2019.
• The Indian Pharmacopoeia 2018 is presented in four volumes.

Edition Year No of volumes Addendum (yr)
1st 1955 - 1960
2nd 1966 - 1975
3rd
4th
5th
6th
7th
8th

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