gyógyszerkönyvi

Gyógyszerkönyvi is an adjective in Hungarian that describes substances, preparations, or processes that conform to the standards contained in an official pharmacopoeia. The term signals compliance with widely recognized quality specifications for pharmaceutical materials.

A pharmacopoeia is an official reference book that provides monographs for active pharmaceutical ingredients, excipients, dosage forms, and packaging, along with methods for testing quality, purity, strength, and labeling. Major modern pharmacopoeias include the European Pharmacopoeia (Ph. Eur.), the United States Pharmacopoeia (USP), and the Hungarian Magyar Gyógyszerkönyv. National authorities and harmonization bodies maintain and update these standards, often aligning with Ph. Eur. to facilitate trade within the EU.

In practice, gyógy­szerkönyvi specifications are used by manufacturers during validation, quality control, and regulatory submissions. Materials and finished products are tested against monographs; compliance is cited in production documentation and in official product licenses. When a substance or product is described as gyógyszerkönyvi, it signals adherence to its pharmacopoeial requirements, including identity, assay, impurities, dissolution (for dosage forms), and microbial limits where applicable.

The term underscores quality assurance and regulatory conformity, while pharmacopoeial standards evolve over time with new scientific information. In Hungary, the Magyar Gyógyszerkönyv operates alongside international pharmacopeias (notably Ph. Eur.), and non-compliance can affect market authorization and supply.