Farmakopéi

Farmakopéi, or pharmacopoeia, is a legally recognized compendium of quality standards for medicines, active pharmaceutical ingredients, dosage forms, and related materials. It contains monographs that specify the identification, purity, potency, and quality of substances, as well as validated analytical procedures and requirements for packaging, labeling, storage, and stability. Monographs may cover substances (APIs and excipients), finished dosage forms, and sometimes radiopharmaceuticals, with limits for impurities, residual solvents, endotoxins, and microbial limits. General chapters provide approved methods of analysis and quality-control practices.

Pharmacopoeias serve as official reference texts for manufacturers and regulators. In jurisdictions where a pharmacopoeia is enacted by law, compliance is mandatory for medicines to be marketed; authorities use the pharmacopoeia to evaluate quality and to set standards in licensing, manufacturing, and surveillance. Pharmacopoeias are regularly updated to incorporate new substances and methods and to reflect advances in analytical technology and manufacturing.

Major national and regional pharmacopoeias include the United States Pharmacopoeia (USP), the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP), the Chinese Pharmacopoeia (ChP), and the Indian Pharmacopoeia. Some countries maintain their own official pharmacopoeias, while others adopt international standards or reference pharmacopoeias in addition to national texts.

Historically, pharmacopoeias emerged in early modern Europe as standardized references for medicines; over time they evolved into formal regulatory instruments guiding quality control, manufacturing, and pharmacovigilance.