farmakopéias

A pharmacopeia is an official publication containing a list of medicinal drugs and detailed instructions on how to test their quality. It also provides approved methods for the preparation of medicines and information on their physical and chemical properties. Pharmacopeias are developed by governmental agencies or professional organizations and serve as legal standards for drug quality. The primary purpose of a pharmacopeia is to ensure the quality, safety, and efficacy of pharmaceutical products available to the public. They are essential for regulatory bodies, pharmaceutical manufacturers, and healthcare professionals to maintain consistent standards in drug production and dispensing.

The content of a pharmacopeia typically includes monographs for individual drugs. Each monograph specifies the required purity, strength, and other quality attributes. It also outlines specific analytical procedures, such as tests for identification, assay, and impurities, that must be performed to verify that a drug meets the established standards. Compliance with pharmacopeial standards is often a legal requirement for drugs marketed in a particular country or region.

Major pharmacopeias include the United States Pharmacopeia (USP), the European Pharmacopoeia (Ph. Eur.), and the Japanese Pharmacopoeia (JP). These international standards aim to harmonize drug quality requirements globally, facilitating trade and ensuring access to safe medicines worldwide. Pharmacopeias are periodically updated to incorporate new scientific knowledge, analytical techniques, and emerging drug products.