pharmacopeial

Pharmacopeial is an adjective relating to a pharmacopeia, an official compendium of drug standards published by a government or recognized authority. Pharmacopeias establish criteria for the quality of medicines, active ingredients, excipients, and related substances, and provide reference methods to test them. They are used by manufacturers, regulators, and quality-control laboratories to ensure consistency, safety, and efficacy.

Contents typically include monographs for individual substances and dosage forms, general chapters with standard procedures, and reference data on names and packaging. Monographs specify identity tests, purity criteria, impurity limits, assay methods, and storage or shelf-life requirements. General chapters describe validated analytical procedures and quality-control practices.

Global role: The leading pharmacopeias are the United States Pharmacopeia–National Formulary (USP–NF), the British Pharmacopoeia (BP), and the European Pharmacopoeia (Ph. Eur.). National pharmacopeias exist worldwide. Compliance with pharmacopeial standards is often legally required for manufacture, import, or sale of medicines, and pharmacopeial testing is central to regulatory submissions and post-market surveillance.

History and purpose: Pharmacopoeias emerged to standardize drug quality and facilitate trade. They evolve through revisions that reflect new science, safety concerns, and manufacturing practices. Harmonization efforts aim to align different pharmacopeial standards to reduce duplicative testing and improve global access to quality medicines.