pharmacopoeia

A pharmacopoeia is an official compendium that establishes quality standards for medicines, active pharmaceutical ingredients, dosage forms, and related substances. It provides monographs with definitions, identity tests, purity criteria, potency, packaging, and storage requirements, along with official methods and reference standards. Pharmacopoeial standards aim to ensure safety, efficacy, and consistency of medicines throughout their lifecycle and are used by manufacturers, pharmacists, and regulatory authorities.

Pharmacopoeias arose in early modern Europe to codify medicinal knowledge. Notable historical works include the Pharmacopoeia Londinensis (1618) and subsequent national editions. In modern practice the principal pharmacopoeias are the United States Pharmacopeia and National Formulary (USP–NF), the British Pharmacopoeia (BP), and the European Pharmacopoeia (EP). Other significant compendia include the Japanese Pharmacopoeia (JP), Chinese Pharmacopoeia (ChP), and Indian Pharmacopoeia (IP). The EP operates as a regional standard adopted by many EU countries; national editions may adopt or align with EP standards.

Contents typically include monographs for substances and dosage forms, as well as general chapters on topics such as identity testing, impurities, dissolution, microbiological criteria, method validation, and packaging. Herbal medicines may have specialized chapters or monographs. Official reference standards and test methods are provided to support quality control and regulatory compliance.

Regulatory role: in jurisdictions where binding, pharmacopoeial compliance is required for product registration, manufacturing, and marketing. Manufacturers must verify identity, purity, strength, and quality using the pharmacopoeial methods, and updates to editions may require compliance with revised requirements.