Validation of Methods and Procedures in Pharmacopoeial Monographs in the Framework of a Drug Standardization Program

Yu. V. Olefir; E. I. Sakanyan; A. I. Luttseva; L. G. Babeshina; T. B. Shemeryankina

doi:10.1007/s11094-019-1919-5

Validation of Methods and Procedures in Pharmacopoeial Monographs in the Framework of a Drug Standardization Program

Authors: Olefir Y.V.¹, Sakanyan E.I.¹, Luttseva A.I.¹, Babeshina L.G.¹, Shemeryankina T.B.¹
Affiliations:
1. Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Issue: Vol 52, No 10 (2019)
Pages: 873-877
Section: Article
URL: https://journals.rcsi.science/0091-150X/article/view/245519
DOI: https://doi.org/10.1007/s11094-019-1919-5
ID: 245519

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Abstract

Experimental validation of methods and procedures featured in draft general pharmacopoeial and pharmacopoeial monographs is an important task for Russian compendial science and practice. These studies provide a basis for adopting state compendial drug quality standards. They enable both manufacturers and quality-control organizations to perform independent quality control of drug substances and medicinal preparations that helps to protect public health.