Enviar artigo por via de e-mail Determination of Organic Impurities in Combination Drugs
- Autores: Matveeva O.1, Kovaleva E.1
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Afiliações:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- Edição: Volume 51, Nº 2 (2017)
- Páginas: 126-129
- Seção: 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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Resumo
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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Sobre autores
O. Matveeva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Autor responsável pela correspondência
Email: matveeva@expmed.ru
Rússia, Moscow, 127051
E. Kovaleva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: matveeva@expmed.ru
Rússia, Moscow, 127051
