farmakopeja

Farmakopeja is a collection of official standards and specifications for medicinal drugs and their preparations. It serves as a guide for the quality control of pharmaceutical substances, ensuring their identity, purity, potency, and other essential characteristics. These standards are established by governmental bodies or professional organizations and are legally binding in many countries. The content of a farmakopeja typically includes monographs for individual drugs, detailing their chemical structure, physical properties, analytical methods for testing, and acceptable limits for impurities. It also provides general chapters on pharmacopoeial procedures, such as methods for assay, dissolution testing, and sterility.

The primary purpose of a farmakopeja is to safeguard public health by ensuring that medicines are safe, effective, and of consistently high quality. It provides a common reference point for manufacturers, regulatory agencies, and healthcare professionals, facilitating the global trade of pharmaceuticals and promoting international harmonization of drug standards. Different countries and regions often have their own farmakopejas, such as the United States Pharmacopeia (USP), the European Pharmacopoeia (Ph. Eur.), and the Japanese Pharmacopoeia (JP). These pharmacopoeias are regularly updated to incorporate new scientific knowledge and evolving regulatory requirements.