Pharmakopöen

Pharmakopöen are official compendia of pharmaceutical standards used in many countries, providing uniform criteria for the quality, safety, and efficacy of medicines. The plural form indicates multiple pharmacopoeias, such as the European Pharmacopoeia (Ph. Eur.), the United States Pharmacopeia (USP), the British Pharmacopoeia (BP), and the Japanese Pharmacopoeia (JP). They serve as authoritative references for the manufacture, testing, and quality control of medicines.

A pharmacopoeia typically includes monographs for active pharmaceutical ingredients and for finished dosage forms, excipients, and often labeling and packaging requirements. Each monograph states the official name, description, identification methods, assay (strength), limits for impurities and contaminants, storage conditions, and sometimes specific tests for sterility, dissolution, or content uniformity. The pharmacopoeia also describes general chapters with analytical procedures and quality-control methods, sampling plans, and reference standards.

National pharmacopoeias are legally binding in their jurisdictions; manufacturers and compounding pharmacists reference them to ensure compliance and to support regulatory submissions. International pharmacopoeias provide harmonized standards and can facilitate cross-border trade. Updates and revisions are produced periodically to reflect new scientific findings, new substances, and post-market surveillance. Origins of pharmacopoeias trace to early apothecary practice, with major national editions established in the 19th and 20th centuries. While each pharmacopoeia serves its jurisdiction, many strive toward harmonization to reduce redundancy and improve access to high-quality medicines.