Email this article Determination of Organic Impurities in Combination Drugs
- Authors: Matveeva O.A.1, Kovaleva E.L.1
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Affiliations:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- Issue: Vol 51, No 2 (2017)
- Pages: 126-129
- Section: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://journals.rcsi.science/0091-150X/article/view/244517
- DOI: https://doi.org/10.1007/s11094-017-1570-y
- ID: 244517
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Abstract
Methodological approaches to the control of organic impurities in drugs containing two and more active pharmaceutical ingredients are reviewed. Approaches of leading foreign pharmacopoeias (British, USA, Japanese) to assessing impurity profiles in combination drugs are analyzed. The methods for assessing impurities that carry the largest safety risks for combination drugs are determined. It is demonstrated that a unified approach to the control of organic impurities in combination drugs is needed.
About the authors
O. A. Matveeva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Author for correspondence.
Email: matveeva@expmed.ru
Russian Federation, Moscow, 127051
E. L. Kovaleva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: matveeva@expmed.ru
Russian Federation, Moscow, 127051
