Limit of Detection of Microorganisms in Drug Sterility Testing
- Авторы: Roshchina M.1, Gunar O.1, Sakhno N.1
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Учреждения:
- Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
- Выпуск: Том 51, № 6 (2017)
- Страницы: 508-510
- Раздел: Article
- URL: https://journals.rcsi.science/0091-150X/article/view/244683
- DOI: https://doi.org/10.1007/s11094-017-1644-x
- ID: 244683
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Аннотация
The use of compendial and alternative methods for drug sterility testing, the most important characteristic of which is the limit of detection (LOD), i.e., the minimum amount of viable microorganisms that can be found in the examined sample, is currently regulated abroad. The goal of the research was to determine experimentally and compare the LODs of microorganisms by direct inoculation and using a BacT/ALERT 3D Microbial Detection System automated bacteriological analyzer. Statistically significant differences between the results obtained by the different methods were not found.
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Об авторах
M. Roshchina
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Россия, 8/2 Petrovskii Blv., Moscow, 127051
O. Gunar
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Россия, 8/2 Petrovskii Blv., Moscow, 127051
N. Sakhno
Scientific Centre for Expert Evaluation of Medicinal Products, Ministry of Public Health of the Russian Federation
Email: chem@folium.ru
Россия, 8/2 Petrovskii Blv., Moscow, 127051