Modern Approaches to the Development of Standard Samples of Drugs

• Published in: Pharmaceutical chemistry journal Vol. 54; no. 7; pp. 761 - 765
• Main Authors: Shchepochkina, O. Yu, Gegechkori, V. I., Prokof’eva, V. I., Chepilo, D. A., Levko, A. A., Chadova, N. N., Shestakov, V. N.
• Format: Journal Article
• Language: English
• Published: New York Springer US 01-10-2020; Springer
• Subjects: Drugs; Medicine; Organic Chemistry; Pharmacology/Toxicology; Pharmacy; Political aspects; Quality control; normative documentation; medicinal products; standardization; standard samples; State Pharmacopeia of the Russian Federation
• ISSN: 0091-150X; 1573-9031
• DOI: 10.1007/s11094-020-02267-y

This review addresses the history of the creation of standard samples (SS) around the world and in Russia, along with studies of the current condition of the state system for standardization of medicinal products (MP) based on the use of SS. Standardization in the area of drugs is directed to guaranteeing the quality of the items standardized, which includes products (raw materials, other materials, ready MP, etc.), services, and processes. The continuing development of manufacturing technologies and the discovery of novel MP increases the need for standard samples, as drug quality control involves the use of complex, highly effective, specific, and precise physicochemical and biological analysis methods.