All about Pharmacopoeia

A. What is Pharmacopoeia (British spelling)/ Pharmacopeia (American spelling)?

A pharmacopoeia, pharmacopoea, or pharmacopeia is a regulatory requirement of a country that benchmarks standards and obligatory quality requirements for drugs, starting materials used to formulate drugs, and the different pharmaceutical formulations or preparations.

The book contains a test for the identification of the drug and raw materials. The government authority publishes the book. In some cases, it is published by medical or pharmaceutical society with government permission. The requirements of pharmacopoeia are mandatory for all formulators and distributors of drugs.

Phar-ma-co-pe-ia was created from two Greek words: pharmakon means medicine, remedy, poison, or charm and poiein means to make or create.

The term Pharmacopoeia was observed initially as work published in Basel, Switzerland in 1561 by Doctor A. Foes. However, in the 17th century, it was utilized.

Up to the year 1617, the remedial medicines were provided by apothecaries. In this era, regulations on product quality and quantities were not enforced. In the early 16th century, work on medicines was published by various authorities in countries.

The Base document for the 1st British Pharmacopoeia (1864) was as follows:
i. Pharmacopoeia Londinensis (1618)
ii. Edinburgh Pharmacopoeia (1699)
iii. Dublin Pharmacopoeia (1807)

This was an outcome of The Medical Act that came into force in the year 1858. The act put stress on the harmonization of list compounds, medicines, and its preparations with accurate weight and measures.

2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, and 11th editions were made available in 1867 (addendum in 1874), 1885 (addendum in 1890), 1898, 1914, 1932, 1948, 1953, 1958, 1963 and 1968 respectively.

French Pharmacpoeia was available to use in 1818, and United States Pharmacopoeia was effective from the year 1820. On July 5, 1974, the combined publication form of USP an NF (national formulary was published).

In the year 1951, World Health Organization published Pharmacopoeia International with the objective of global uniformity of quality specifications for drugs, excipients, and dosage forms.

The first publication of Indian pharmacopoeia (IP) was made available in the year 1955 under the leadership of Dr. B. N. Ghosh.

B. What is Monographs?

The monograph in a pharmacopoeia is the compiled articles on drugs substance, other inactive starting materials, and dosage forms. The monograph contains quality expectations of materials such as description, tests to quantify potency and its limit, and details of other tests to meet the required standards.

The typical heading of the monograph are as follows:
1. Title
2. Chemical formulae
3. Atomic and molecular weight
5. Action and use
6. Definition
7. Characters: Appearance, Solubility
8. Identification
9. Assay
10. Impurities
11. Storage
12. Labeling

C. A list of pharmacopoeia, name, and years of first publication for different countries are given below:

D. References:

Index of world pharmacopoeias and pharmacopoeial authorities,
Working document QAS/11.453/Rev.10 January 2018 Original: English

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