Standardization of Drug Substances According to the  Purity  Section

Yu. V. Olefir; E. I. Sakanyan; T. B. Shemeryankina; S. P. Senchenko; S. A. Zaitsev; A. V. Barmin

doi:10.1007/s11094-018-1891-5

Standardization of Drug Substances According to the Purity Section

Authors: Olefir Y.V.¹, Sakanyan E.I.¹, Shemeryankina T.B.¹, Senchenko S.P.¹, Zaitsev S.A.¹, Barmin A.V.¹
Affiliations:
1. Scientific Center for Expert Evaluation of Medicinal Products
Issue: Vol 52, No 8 (2018)
Pages: 744-748
Section: Structure of Chemical Compounds, Methods of Analysis and Process Control
URL: https://journals.rcsi.science/0091-150X/article/view/245439
DOI: https://doi.org/10.1007/s11094-018-1891-5
ID: 245439

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Abstract

The current classification of impurities in chemical and mineral drug substances is presented. General approaches to standardization of chemical and mineral drug substances according to the Purity section are given depending on their origin and production technology and considering requirements of international and domestic pharmacopoeial practice