Modern Approaches to Estimating the Content of Genotoxic Impurities in Drugs (a Review)
- Authors: Matveeva O.A.1, Kovaleva E.L.1
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Affiliations:
- Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
- Issue: Vol 49, No 11 (2016)
- Pages: 765-770
- Section: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://journals.rcsi.science/0091-150X/article/view/244288
- DOI: https://doi.org/10.1007/s11094-016-1367-4
- ID: 244288
Cite item
Abstract
This review considered international approaches to assessment of the content of genotoxic impurities (residual solvents and various inorganic and organic impurities) in drugs. Foreign and domestic regulations defining requirements for the classification, control, and toxicological risk assessment of potential genotoxic impurities in drug substances and drugs were compared. The use of highly sensitive and specific analytical methods for detecting genotoxic impurities in drugs was justified. The need to improve the domestic regulatory framework on the control of elemental genotoxic impurities (heavy metals) and to prepare guidelines on the assessment of potentially genotoxic organic impurities in drugs was demonstrated.
About the authors
O. A. Matveeva
Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
Author for correspondence.
Email: matveeva@expmed.ru
Russian Federation, 8 Petrovskii Blvd., Moscow, 127051
E. L. Kovaleva
Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
Email: matveeva@expmed.ru
Russian Federation, 8 Petrovskii Blvd., Moscow, 127051