Отправить статью по E-mail Comparative Analysis of Quality Assessment Requirements for Gelatin Used in Drug Production (Review)
- Авторы: Mironova M.M.1, Kovaleva E.L.1
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Учреждения:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- Выпуск: Том 50, № 12 (2017)
- Страницы: 820-825
- Раздел: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://ogarev-online.ru/0091-150X/article/view/244487
- DOI: https://doi.org/10.1007/s11094-017-1540-4
- ID: 244487
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Аннотация
Gelatin is usually used as an excipient in drug preparations and more rarely as an active ingredient. Domestic quality standards regulating gelatin used in drug production were enacted over 20 years ago. A comparative analysis of quality requirements for gelatin in domestic and foreign pharmacopoeias seemed timely in order to justify national pharmacopoeial quality requirements for gelatin (quality parameters, analysis methods, norms) and to compose a pharmacopoeial monograph for gelatin in the RF State Pharmacopoeia.
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M. Mironova
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Автор, ответственный за переписку.
Email: SmirnovaM@expmed.ru
Россия, 8/2 Petrovskii Blvd., Moscow, 127051
E. Kovaleva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: SmirnovaM@expmed.ru
Россия, 8/2 Petrovskii Blvd., Moscow, 127051
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