Introduction to Pharmacopoeia

Introduction

Pharmacopoeia is a book containing directions for the identification and evaluation of medicines, published by the authority of a government or a medical or pharmaceutical society. In a broader sense it is a reference book for pharmaceutical drug specifications. The word pharmacopoeia is derived from Greek language, pharmakon means drug and poieo means I make. in this article we will study introduction to pharmacopoeias of various countries and Indian pharmacopoeia with its subsequent editions.

Number of attempts have been made in the past, but official book containing drug information is published after the seventeenth century. Some of the older pharmacopoeias are given in table below.

PharmacopoeiaPublished byYear
Pharmacopoeia AngustanaAugsburg in Bavaria1601
Pharmacopoeia LondinensisCollege of physicians1918
Edinburgh PharmacopoeiaCollege of physicians1699
Dublin PharmacopoeiaCollege of physicians1809

British Pharmacopoeia (BP)

In 1855, college of physicians in collaboration with pharmaceutical society, published a revised edition of London Pharmacopoeia. After the medical act 1858, this book renamed as British Pharmacopoeia by General Council of Medical Education and Registration. The pharmacopoeial committee and pharmaceutical society served as foundation of first British Pharmacopoeia which was published in 1864. The latest edition of British Pharmacopoeia is published in 2023 and effective from 01/01/2024. Its previous editions are tabulated below.

EditionPublishing year
1st edition1864
5th edition1879
10th edition1914
15th edition1963
20th edition2000
21st edition2002
22nd edition2007
23rd edition2013
24th edition2016
25th edition2020
26th edition2024

The latest British Pharmacopoeia edition was published in 2024. It includes 4000 monographs which are legally enforced by the Human Medicines Regulations 2012. It incorporates new monographs from both the British Pharmacopoeia and European Pharmacopoeia (Ph Eur). Additional features of BP 2024 are,

  • 27 new BP monographs, 17 new Ph Eur monographs
  • 93 amended BP monographs
  • All monographs from the Ph Eur 11th edition

British pharmaceutical codex (BPC)

First edition of BPC was published in 1907, to provide authoritative guidance to the persons engaged in the medical practice (physicians) and pharmacists in British Empire. BPC used to serve as a supplement for the information in British Pharmacopoeia in several aspects like actions of drugs, undesirable effects, standard uses, etc. In 1979, BPC edition revised with desired changes and its 11th edition is known as “The Pharmaceutical Codex”.

British national formulary (NF)

It is prepared and published by Pharmaceutical Society of Great Britain and British Medical Association. It has arranged the preparations as per pharmaceutical forms and has importance to pharmacists. Pharmacological classification is given for the convenience of medical practitioners. It gives valuable information about actions, uses, dosage of drugs and adverse reactions of drugs are also given. British National Formulary does not give any standards for drugs or their preparations.

United States Pharmacopoeia (USP)

United States Pharmacopoeia (USP) is a compendium of drug information including standards for identity, strength, quality and purity of medicines, dietary supplements. It is published by the United States Pharmacopoeial Convention, a nonprofit organization.  Its first edition was published in 1820. Its subsequent editions are given in table below.

EditionPublication year
1st edition1820
10th edition1920
15th edition1955
20th edition1980
25th edition2002
30th edition2007
35th edition2012
40th edition2017
45th edition2020

Indian Pharmacopoeia (IP)

Indian Pharmacopoeia (IP) is an official document published by the Indian Pharmacopoeia Commission (IPC), under the Ministry of Health and Family Welfare, Government of India. It contains authoritative standards for drugs manufactured, distributed and consumed in India as well as for pharmaceutical substances and dosage forms not covered by any other Pharmacopoeia. The first edition of Indian Pharmacopoeia was published in 1955. Its subsequent editions are given in table below.

IP editionPublication year
1st edition1955
2nd edition1966
3rd edition1985
4th edition1996
5th edition2007
6th edition2010
7th edition2014
8th edition2018

The latest edition of IP 2018, contains a wide range of information relevant to the pharmaceutical industry in India. Some of the key contents include,

  • General notices: Introduction, scope and definitions used throughout the pharmacopoeia.
  • General chapters: These chapters cover topics such as dosage forms, pharmaceutical calculations and quality management systems.
  • Monographs: Detailed specifications for the identity, purity, strength and quality of individual drugs and pharmaceutical substances. Monographs include information on tests, reference standards and acceptance criteria.
  • Tests and reference standards: Methods for testing the quality of pharmaceuticals, including analytical procedures and reference standards.
  • Additional features: Commentary, appendices, and supplementary information relevant to the interpretation and application of pharmacopoeial standards.

Important components of Pharmacopoeia

  • Monographs: Monographs are the detailed descriptions of individual drugs or substances, including their physical and chemical properties, identification tests, purity tests, dosage forms and instructions for preparation. Each monograph provides standardized information to ensure consistency in the manufacturing and quality control of pharmaceutical products. Monographs also include specifications for impurities and limits for acceptable concentrations.
  • General chapters: General chapters cover various aspects of pharmaceutical manufacturing, quality control and testing procedures. General chapters may include chapters such as dosage forms, analytical methods, microbiological testing, packaging requirements and storage conditions. They provide guidelines and standards for pharmaceutical manufacturers to follow in order to ensure product quality and safety.
  • Reference standards: Pharmacopoeias often include reference standards, which are authenticated substances used for comparison and quality control purposes. These standards help to ensure the accuracy and relatability of analytical methods and testing procedures used in pharmaceutical laboratories. Reference standards may include chemical reference substances, biological reference preparations and physical reference standards.
  • Tests and assays: Pharmacopoeias contain standardized tests and assays for evaluating the quality, purity and potency of pharmaceutical substances and products. These tests may include physical tests, chemical tests, chromatographic methods and biological assays.
  • Dosage forms: Pharmacopoeias provide specifications and standards for various dosage forms including tablets, capsules, injections, ointments, creams and solutions. These standards cover some aspects like composition, labelling, packaging, stability and storage conditions. Pharmacopoeial requirements for dosage forms ensure uniformity in drug formulation and help safeguard patient safety and efficacy.

Summary

Pharmacopoeia is a comprehensive reference book or official publication that contains information about the standards or drugs and pharmaceutical substances. It serves as a guide for the preparation, quality control and use of medicines. Pharmacopoeias are essential tools for pharmacists, pharmaceutical companies, regulatory agencies and healthcare professionals to ensure the safety, efficacy and quality of medications. Each country (most of the) has their own pharmacopoeia. They serve as authoritative references for healthcare professionals, regulators and manufacturers worldwide.

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