farmacopéias

A pharmacopeia is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society. Pharmacopeias are legal or legal-binding documents that establish official standards for the quality, purity, strength, and identity of medicines. These standards are crucial for ensuring that medicines are safe and effective for public use.

The standards outlined in a pharmacopeia cover various aspects of drug quality, including specifications for raw materials, active pharmaceutical ingredients (APIs), and finished drug products. They detail the methods and criteria for testing these substances, such as tests for assay, impurities, dissolution, and uniformity of dosage units. Pharmacopeias also provide information on the nomenclature, chemical structure, and physical properties of drugs.

Major pharmacopeias include the United States Pharmacopeia (USP), the European Pharmacopoeia (Ph. Eur.), and the Japanese Pharmacopoeia (JP). These are often harmonized to some extent to facilitate international trade and the global accessibility of medicines. Regulatory agencies in different countries rely on pharmacopeial standards to approve and monitor pharmaceutical products. Adherence to pharmacopeial standards is a legal requirement for manufacturers of pharmaceuticals in many jurisdictions, and non-compliance can lead to regulatory action.