Modern Approaches to the Development of Reference Standards for Quality Assessment of Drug Substances

• DOI: 10.1007/s11094-016-1369-2
• Publication Date: 2016-02-16T04:50:53Z
• Authors: V. A. Merkulov; E. I. Sakanyan; V. I. Klimov; T. B. Shemeryankina; V. A. Yashkir; A. V. Barmin
• Keywords: Pharmacopoeia; Quality standard; Quality Assessment

Reference standards, including pharmacopoeial reference standards, are widely used for quality assessment of drug substances. Leading global pharmacopoeias contain monographs regulating the requirements for the classification, attestation, and use of reference standards. The drug standardization system in the Russian Federation, which includes drug substances, requires revision for the creation and attestation of national reference standards, including pharmacopoeial ones.