Applicability of an Alternative Method for Sterility Testing of Medicinal Preparations
- 作者: Roshchina M.1, Gunar O.1, Sakhno N.1
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隶属关系:
- Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
- 期: 卷 51, 编号 11 (2018)
- 页面: 1045-1048
- 栏目: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244906
- DOI: https://doi.org/10.1007/s11094-018-1737-1
- ID: 244906
如何引用文章
详细
The aim of the present work was to examine the applicability of an alternative method for detecting CO2 using an automated BacT/ALERT 3D colorimetric microbiological detection system and analytical parameters for sterility testing of medicinal preparations (MPs) that were selected, justified, and harmonized with leading global pharmacopoeias. The tests used microorganisms and samples of 38 MPs and compared the results with defined criteria for pharmaceutical microbiology. The experimental results showed that the alternative method did not cause discrepancies and was suitable for MPsterility testing. However, the lack of regulations for validation standard procedures in the RF currently limits replacing routine methods by alternative ones.
作者简介
M. Roshchina
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: chem@folium.ru
俄罗斯联邦, 8/2 Petrovskii Blvd., Moscow, 127051
O. Gunar
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: chem@folium.ru
俄罗斯联邦, 8/2 Petrovskii Blvd., Moscow, 127051
N. Sakhno
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: chem@folium.ru
俄罗斯联邦, 8/2 Petrovskii Blvd., Moscow, 127051