Pharmacopoeia, Indian Pharmacopoeia, Other pharmacopoeias, Monographs,

1. Pharmacopoeia
Abhishek B Rai

2. PHARMACOPOEIA
• Originated from Greek pharmakopoeia ie. Making of Drugs; made of pharmakon ie healing
medicine/drug/poison and poiein ie. to make.
• A national Pharmacopoeia is a compendia issued under the authorities of the government and
contains a list of drugs and formulae for medicinal substances and preparations with
description, tests for these substances and the standards to which they must confirm.
• E.g., Indian Pharmacopoeia, British Pharmacopoeia, United states Pharmacopoeia etc.
• As per WHO there are as many as 40 pharmacopoeias published around the world.
• Major role of pharmacopoeias is in quality control and harmonization of standards.

3. INDIAN PHARMACOPOEIA
• Bengal dispensatory was published in 1841
• Bengal pharmacopoeia was published in 1844.
• First pharmacopoeia was published in 1868 under the authorities of her Majesty’s secretary of
state for India in Council It was divided into sections on vegetable, animal and inorganic
materia medica and a separate section on products of fermentation and distillation. A
supplement to Pharmacopoeia of India was published in 1869 which was a catalogue of Indian
synonyms of the medicinal plants, products, inorganic and organic substances included in
Pharmacopoeia of India with explanatory and descriptive remarks in 14 Indian languages in
addition to English.
• Official Indigenous Drugs of India in 1902 by Bose and its enlarged edition in 1932 as
Pharmacopoeia Indica.

4. INDIAN PHARMACOPOEIA
• Indian Pharmacopoeial List was published in 1946 by Govt. of India containing mainly crude
drugs with their preparations and few synthetic pharmaceuticals like Urea stibamine which
were of special interest to India.
• In 1948 National Pharmacopoeial Committee was appointed to prepare a National
Pharmacopoeia for India.
• First edition of Indian Pharmacopoeia(IP) was published in 1955.
• Supplement to the 1st edition of IP in 1960 to provide standards for some new drugs introduced
into the market.
• 2nd edition was published in 1966 and its supplement in 1975.
• 3rd edition appeared in 1985 with 2 addenda in 1989 and 1991.
• 4th edition was published in 1996 with 3 addendum in 2000, 2002 (and one Veterinary
addendum) and 2005.
• 5th edition appeared in 2007 with addendum in 2008.

5. INDIAN PHARMACOPOEIA
• 6th edition was published in 2010 with addendum in 2012.
• 7th edition came in 2014 and there were 2 addendums to it in 2015 and 2016.
• 8th edition came in 2018 which is the latest one.
• In addition to IP, Govt. of India also publishes the Ayurvedic Pharmacopoeia and Homeopathic
Pharmacopoeia.
• Exclusive list of books legally recognized, pertaining to various medicinal systems including
Allopathic system has been given as Schedule 1 of Drugs and cosmetics Act 1940.

6. INDIAN PHARMACOPOEIA
Indian Pharmacopoeia Commission
• Mission: To promote public health in India by bringing out authoritative and officially
accepted standards for quality of drugs including active pharmaceutical Ingredients, excipients
and dosage forms used by health professionals, patients and consumers.
• Vision: To promote the highest standards of drugs for use in humans and animals within
practical limits of the technologies available for manufacture and analysis.

7. INDIAN PHARMACOPOEIA
• Salient features of 8th edition:
• 8th edition is in 4 volumes and contains 220 new monographs (170 chemical monographs, 18
biological monographs, 15 herbal monographs, 03 radiopharmaceutical monographs and 14
veterinary non-biological monographs.), 366 revised monographs and 7 omisions.
• New chapters added in 8th edition include Test for biological reactivity In-vitro, test for
biological reactivity in vivo, monocyte activation test, microbiological assay of Calcium
pantothenate, microbiological assay of Vitamin B12 activity, Odour and taste, dimension of
hard cellulose capsule shell, viral safety evaluation of biotechnology products derived from cell
lines of human or animal origin and approximate pH of solutions.
• General chemical tests and thin layer tests for identification almost eliminated with emphasis
on more specific IR and UV spectrometry and HPLC tests.
• Use of chromatographic methods greatly extended for increased specificity in assay and in
assessing the nature and extent of impurity.
• Assays and identifications test methods upgraded to Liquid chromatographic methods for
harmonization with international standards.

8. INDIAN PHARMACOPOEIA
• Salient features of 8th edition:
• Assays and identifications test methods upgraded to Liquid chromatographic methods for
harmonization with international standards.
• Pyrogen test replaced by Bacterial Endotoxin test (BET) for evaluation of parenteral
preparations.
• Index is incorporated in Vol. I along with Vol. IV to make it user friendly.
• 53 new fixed dose combinations monographs included where 25 being included first time in
any pharmacopoeia.
• General chapters on Volumetric glass wares, conductivity, Dissolution test, disintegration test,
dimensions of Hard gelatin capsule shells etc. revised.
• General chapter on maintenance, Identification, Preservation and disposal of micro-organism
revised.

9. BRITISH PHARMACOPOEIA
• In 1684 Pharmacopoeia Londinensis was published.
• In 1699 First Edinburgh Pharmacopoeia was published in Scotland and in 1807 first Dublin
Pharmacopoeia was published.
• All three were fused and resulted into British Pharmacopoeia who’s first edition appeared in
1864.
• After that it was revised in 1867, 1885,1898, 1914 and 1932.
• In 1947 General Medical Council passed resolution to publish BP every 5 years with 7th edition
in 1947. This continued till 1973.
• 13th edition came in 1980 and 14th in 1988, 15th in 1993 and 16th in 2000.
• British Pharmacopoeia is reissued every year now.
• Current edition has 6 volumes and more than 4000 monographs.

10. UNITED STATES PHARMACOPOEIA
• First edition of United States Pharmacopoeia (USP) was published in 1820 under the authority
of USP Convention Inc. It was started by physicians to serve as a therapeutic guide to the
medical profession.
• In 1856 APA was established.
• In 1888 1st edition of US NF was published.
• 9th edition was given title USP VIII to indicate that it was 8th revision.
• USP 1900 was published in 1905. It adopted average doses, the Purity Rubric, and 250c as the
standard temperature for specific gravity and solubility standards.
• USP IX added for first time biological assays. Biological products etc and a chapter on the
methods of analytical determination.

11. INTERNATIONAL PHARMACOPOEIA
• 1st edition of Pharmacopoeia International (PhI) was published by WHO in two volumes 1st in
1951 and 2nd in 1955.
• 2nd edition “Specifications for the Quality Control of Pharmaceutical Preparations” appeared in
1967.
• 3rd edition was published in 3 vol. in 1979, 1981 and 1988.
• 4th edition in 2006 in 5 vol.
• 5th edition in 2015 in 2 vol.

12. MONOGRAPH
Monograph provides information regarding titles, chemical formulae, description,
solubilities, identification and purity tests, methods of assays, storage conditions, labelling,
preparations, action and uses and doses.
• Titles: The names of the pharmacopoial drugs, preparations, substances and process are given
with capital initial letters in English.
• Synonyms: Common names, if any of the substances.
• Chemical Formulae: at the beginning of the monograph the graphic and molecular formulae
and molecular weight are given.
• Chemical Names: IUPAC names of the substances are given in the monographs are given.
• Molecular weights: On the basis of atomic weights as adopted by IUPAC, molecular weights
are given.
• Category: Application of drug’s pharmacological activity and the medical or pharmaceutical
basis for recognition in the pharmacopoeia.

13. MONOGRAPH
• Dose: Given for general guidance and unless otherwise stated, gives average adult oral dose.
• Usual Strength: Strength of the product usually marketed; not binding to manufacturer.
• Description: Statements on color, odour, taste and crystalline/amorphous nature are provided
for identification during preliminary evaluation of the integrity of an article.
• Solubility: Solubility if otherwise mentioned means solubility at 15-30*c and STP.
Status of solubility Vol (ml) of solvent per mg of solute
Very soluble Less than 1
Freely soluble 1 to 10
Soluble 10 to 30
Sparingly soluble 30 to 100
Slightly soluble 100 to 1000
Very slightly soluble 1000 to 10000
Practically insoluble More than 10000

14. MONOGRAPH
• Standards: Minimum qualitative and quantitative standards a compound should follow in
order to be called as official drug/preparation. Standards of purity and strength in the
monograph of all official substances are given. To be deemed as a substance of standard
quality, it must compile with the requirements described under “standard” of its monograph.
• Identification: Specific and non-specific tests of the substance. Viz.
IR absorption spectra
UV visible spectra max values
Melting/boiling point
Simple chemical tests. Characterized by color or precipitate formation.
Acidity/alkalinity: Compounds which are acidic or basic in nature, the pH of the solution with specific
strength is given.

15. MONOGRAPH
• Test for Purity: Dedicated tests to check purity of the compounds and identify and quantify
impurities viz. boiling and melting points, limit tests for common impurities like chlorides,
sulphates, iron, arsenic, lead, heavy metals, pH of the solution, loss on drying, specific optical
rotation, HPLC, etc.
• Assay: It provides analytical method for the determination of the percentage content of a
particular chemical in the given test sample.
• Storage conditions: In order to prevent any degradation and/or contamination official
drugs/preparations, IP provides for the storage conditions. Specific conditions regarding
Temperature, atmosphere, moisture, heat and sunlight are given.
Eg: Store in a dry place at a temperature not exceeding 30*c, Store in refrigerator (2 to 8*c). Do not
freeze, Store in a freezer (-2 to -18*c), Store in a deep freezer (below -18*c), Store protected from light,
Store protected from light and moisture.

16. MONOGRAPH
• Container: Vehicle in which drugs are kept should not undergo any reaction physically or
chemically immediately as well as till the self life of the drug. Design should be such that the
drugs can be withdrawn without any inconvenience for the intended purpose.
• Labelling: Labelling statements which may appear on the container, the package as a leaflet
must accompany the package or a certificate of analysis including the article as decided by
competent authority (Drugs and cosmetic Act 1940 and rules 1945.)

17. APPENDICES
• Appendix-I: Apparatus required for different tests and assays.
• Appendix-II: Biological tests and assays.
• Appendix-III: Details of various tests and assays.
• Appendix-IV: Microbiological tests and assays.
• Appendix-V: Physical tests and determinations viz. loss on drying, pH, melting range etc.
• Appendix-VI: Directions on cleaning glasswares.
• Appendix-VII: Reagents and solutions required for different tests and assays.
• Appendix-VIII: Reference substances.
• Appendix-IX: Names and symbols used in pharmacopoeia and their atomic weights.

18. THANK YOU