A compendial definition is a definition of a substance, product, or process that is provided by an official compendium or pharmacopoeia. Compendia are reference books or databases that provide information on the quality and standards of drugs, excipients, and other related substances.
Compendial definitions are established through a consensus process involving experts in the field, and they are widely accepted by regulatory agencies, manufacturers, and other stakeholders. They typically include information such as the chemical name, molecular formula, structural formula, physical and chemical properties, and analytical methods for testing the substance.
Examples of compendia include the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and the Japanese Pharmacopoeia (JP). These compendia are used by regulatory agencies around the world to establish standards for the quality, safety, and efficacy of drugs and other healthcare products.
