Determination of Organic Impurities in Combination Drugs
- 作者: Matveeva O.1, Kovaleva E.1
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隶属关系:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- 期: 卷 51, 编号 2 (2017)
- 页面: 126-129
- 栏目: 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
如何引用文章
详细
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.
作者简介
O. Matveeva
Scientific Center for Expert Evaluation of Medicinal 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, Moscow, 127051
E. Kovaleva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: matveeva@expmed.ru
俄罗斯联邦, Moscow, 127051