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- Title
Limit of Detection of Microorganisms in Drug Sterility Testing.
- Authors
Roshchina, M.; Gunar, O.; Sakhno, N.
- Abstract
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.
- Subjects
DETECTION limit; EFFECT of drugs on microorganisms; DRUG use testing; BACTERIOLOGICAL apparatus; PHARMACEUTICAL industry; QUALITY control
- Publication
Pharmaceutical Chemistry Journal, 2017, Vol 51, Issue 6, p508
- ISSN
0091-150X
- Publication type
Article
- DOI
10.1007/s11094-017-1644-x