Pharmakopöe

Pharmakopöe is an official publication that sets out the quality standards for medicines and their substances. It typically contains monographs for drug substances, dosage forms and excipients, as well as methods of analysis, acceptance criteria for identity, purity, strength and labeling. General chapters cover quality-control procedures, storage, packaging and criteria for testing. The purpose is to ensure uniform quality, safety and efficacy of medicines within a country or region.

In practice, pharmacopoeias serve as legal references for manufacturers, regulators and health professionals. Compliance with their monographs and methods is often required for marketing authorization and regulatory inspections. They underpin quality assurance across the pharmaceutical supply chain and guide laboratory testing, production, inspection and pharmacovigilance. National or regional pharmacopoeias may be complemented by an international standard to support international trade and cooperation.

Among the major pharmacopoeias are the European Pharmacopoeia (Ph. Eur.), the United States Pharmacopeia and National Formulary (USP–NF), the Japanese Pharmacopoeia (JP) and the British Pharmacopoeia (BP). Many countries maintain their own national pharmacopoeias (for example, the German Arzneibuch or the French Pharmacopée). The World Health Organization publishes the International Pharmacopoeia (Ph. Int.) to harmonize standards and provide guidance for countries that lack a national pharmacopoeia.

The concept originated in the early modern period as standardized references to ensure medicine quality. Today, pharmacopoeias continue to evolve, incorporating new substances, analytical techniques and regulatory requirements to support public health.