Determination of Organic Impurities in Combination Drugs
- Авторы: Matveeva O.1, Kovaleva E.1
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Учреждения:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- Выпуск: Том 51, № 2 (2017)
- Страницы: 126-129
- Раздел: 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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Аннотация
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.
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Об авторах
O. Matveeva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Автор, ответственный за переписку.
Email: matveeva@expmed.ru
Россия, Moscow, 127051
E. Kovaleva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: matveeva@expmed.ru
Россия, Moscow, 127051