Modern Approaches to Estimating the Content of Genotoxic Impurities in Drugs (a Review)
- 作者: Matveeva O.1, Kovaleva E.1
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隶属关系:
- Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
- 期: 卷 49, 编号 11 (2016)
- 页面: 765-770
- 栏目: 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
如何引用文章
详细
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.
作者简介
O. Matveeva
Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
编辑信件的主要联系方式.
Email: matveeva@expmed.ru
俄罗斯联邦, 8 Petrovskii Blvd., Moscow, 127051
E. Kovaleva
Scientific Center for Expertise of Medical Products, Ministry of Public Health of the Russian Federation
Email: matveeva@expmed.ru
俄罗斯联邦, 8 Petrovskii Blvd., Moscow, 127051