farmakopöad

Farmakopöad, in Icelandic contexts, refers to the pharmacopoeia, an official publication that contains the quality standards for medicines, their ingredients, dosage forms, and methods of analysis. It serves as a legal and technical reference to ensure the safety, efficacy, and consistency of pharmaceutical products.

A pharmacopoeia includes monographs for substances and finished dosage forms, specifying identification tests, purity criteria, potency, assay procedures, and permissible impurity levels. It also provides requirements for packaging, labeling, storage, and handling. General chapters cover topics such as sampling, reference standards, analytical methods, and quality control practices.

Historically, pharmacopoeias emerged in medieval and early modern Europe to standardize medicines. Notable examples include the London Pharmacopoeia (established 1618) and the United States Pharmacopeia (1820). In Europe, the European Pharmacopoeia, established in 1968 by the Council of Europe, serves as a harmonized standard used by many member states.

Today, pharmacopoeias are maintained as national and regional standards. Major examples include the United States Pharmacopeia (USP), the British Pharmacopoeia (BP), the Japanese Pharmacopoeia (JP), the Indian Pharmacopoeia (IP), and the European Pharmacopoeia (EP). Many pharmacopoeias are accessible online, and regulatory authorities such as the FDA and EMA require compliance with these standards for medicine approval and market authorization. They underpin quality control in manufacturing and testing laboratories and complement broader regulatory frameworks like Good Manufacturing Practice.

Users of pharmacopoeias include pharmacists, chemists, regulators, and quality-control professionals who rely on standardized tests and specifications to ensure product quality and patient safety.