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

V. A. Merkulov; E. I. Sakanyan; V. I. Klimov; T. B. Shemeryankina; V. A. Yashkir; A. V. Barmin

doi:10.1007/s11094-016-1369-2

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

Authors: Merkulov V.A.¹, Sakanyan E.I.¹, Klimov V.I.¹, Shemeryankina T.B.¹, Yashkir V.A.¹, Barmin A.V.¹
Affiliations:
1. Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
Issue: Vol 49, No 11 (2016)
Pages: 776-778
Section: Article
URL: https://journals.rcsi.science/0091-150X/article/view/244290
DOI: https://doi.org/10.1007/s11094-016-1369-2
ID: 244290

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Abstract
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Abstract

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.

Keywords

reference standards, pharmacopoeial reference standards, drug substances, pharmacopoeial monograph, regulation

About the authors

V. A. Merkulov

Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation