REFERENCE STANDARDS OF ACTIVE INGREDIENTS OF POTENT ANALGESIC DRUGS

• Main Authors: A. V. Sosnov, S. S. Golubev, B. S. Punkevich, S. V. Sadovnikov, E. M. Zagrebin, I. S. Rodina, F. M. Semchenko, A. A. Sosnova
• Format: Article
• Language: Russian
• Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
• Series: Разработка и регистрация лекарственных средств
• Subjects: reference standards; pharmaceutical substances; metrology; potent controlled substances; analgesics; anesthetics; narcotic drugs; psychotropic drugs; quantitative analysis; industrial safety; quality of pharmaceuticals; chemical safety and security
• Online Access: https://www.pharmjournal.ru/jour/article/view/243

The article describes acute problem - absence of reference standards (Federal Reference Standards) of controlled ingredients of some potent pharmaceuticals (especially narcotic and psychotropic substances) in Russia. Authors present an algorithm for solving this task. According to regulatory documents providing traceability and technical regulation in Russian Federation requires use of the Federal Reference Standards for any official quantitative studies of narcotic and psychotropic substances. Lack of the reference standards does not allow provide: legally meaningful assessment of quality of medical products; to ensure industrial safety of work with substances belonging to list of dangerous goods; to conduct quantitative forensic analysis using instrumental methods, etc. Development of the Federal Reference Standards should be organized in the framework of technological cooperation of organizations (laboratories) which has necessary licenses. Production of the highest quality standards should be organized on a specialized facility where Federal S&T Center "Inversiya" has already made Federal Reference Standards of toxic chemicals. Creation and introduction in practices Federal Reference Standards of the controlled substances will provide scientific, technical and methodological foundations in development and implementation technologies for production of potent pharmaceutical ingredients in Russian Federation and solutions in the field of criminology and chemical safety and security.