Email this article Comparative Analysis of Quality Assessment Requirements for Gelatin Used in Drug Production (Review)
- Authors: Mironova M.M.1, Kovaleva E.L.1
-
Affiliations:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- Issue: Vol 50, No 12 (2017)
- Pages: 820-825
- Section: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://journals.rcsi.science/0091-150X/article/view/244487
- DOI: https://doi.org/10.1007/s11094-017-1540-4
- ID: 244487
Cite item
Open Access
Access granted
Subscription Access
Abstract
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.
About the authors
M. M. Mironova
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Author for correspondence.
Email: SmirnovaM@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
E. L. Kovaleva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: SmirnovaM@expmed.ru
Russian Federation, 8/2 Petrovskii Blvd., Moscow, 127051
