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

Autores: Olefir Y.V.¹, Sakanyan E.I.¹, Shemeryankina T.B.¹, Senchenko S.P.¹, Zaitsev S.A.¹, Barmin A.V.¹
Afiliações:
1. Scientific Center for Expert Evaluation of Medicinal Products
Edição: Volume 52, Nº 8 (2018)
Páginas: 744-748
Seção: 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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Resumo

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