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 ination is published after the seventeenth century. Some of the older pharmacopoeias are given in table below.

Pharmacopoeia	Published by	Year
Pharmacopoeia Angustana	Augsburg in Bavaria	1601
Pharmacopoeia Londinensis	College of physicians	1918
Edinburgh Pharmacopoeia	College of physicians	1699
Dublin Pharmacopoeia	College of physicians	1809

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.

Edition	Publishing year
1st edition	1864
5th edition	1879
10th edition	1914
15th edition	1963
20th edition	2000
21st edition	2002
22nd edition	2007
23rd edition	2013
24th edition	2016
25th edition	2020
26th edition	2024

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 11^th 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 ination 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 11^th edition is known as “The Pharmaceutical Codex”.

British national ulary (NF)

It is prepared and published by Pharmaceutical Society of Great Britain and British Medical Association. It has arranged the preparations as per pharmaceutical s and has importance to pharmacists. Pharmacological classification is given for the convenience of medical practitioners. It gives valuable ination 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 ination 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.

Edition	Publication year
1st edition	1820
10th edition	1920
15th edition	1955
20th edition	1980
25th edition	2002
30th edition	2007
35th edition	2012
40th edition	2017
45th edition	2020

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 s 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 edition	Publication year
1st edition	1955
2nd edition	1966
3rd edition	1985
4th edition	1996
5th edition	2007
6th edition	2010
7th edition	2014
8th edition	2018

The latest edition of IP 2018, contains a wide range of ination 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 s, pharmaceutical calculations and quality management systems.
• Monographs: Detailed specifications for the identity, purity, strength and quality of individual drugs and pharmaceutical substances. Monographs include ination 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 ination 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 s and instructions for preparation. Each monograph provides standardized ination 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 s, 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 s: Pharmacopoeias provide specifications and standards for various dosage s 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 s ensure uniity in drug ulation and help safeguard patient safety and efficacy.

Summary

Pharmacopoeia is a comprehensive reference book or official publication that contains ination 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.

For practice MCQ on above topic please visit: MCQs On Unit I Of Pharmaceutics I » PHARMACAREERS

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