Email this article Validation of Qualitative Microbiological Methods of Pharmaceutical Analysis
- Authors: Gunar O.V.1, Builova I.A.1
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Affiliations:
- State Scientific Center for Expertise in Medical Products, Ministry of Health of the Russian Federation
- Issue: Vol 51, No 1 (2017)
- Pages: 68-70
- Section: Structure of Chemical Compounds, Methods of Analysis and Process Control
- URL: https://journals.rcsi.science/0091-150X/article/view/244507
- DOI: https://doi.org/10.1007/s11094-017-1560-0
- ID: 244507
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Abstract
We present here the results of validation of qualitative microbiological methods, particularly a modified method for determining the microbiological purity of medicines. The parameters required for validating qualitative microbiological methods and criteria for evaluating them were identified. Experimental data from validation studies demonstrate the value of using improved methods for determining microbiological purity using smaller sample sizes, and confirm that this is possible.
About the authors
O. V. Gunar
State Scientific Center for Expertise in Medical Products, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow
I. A. Builova
State Scientific Center for Expertise in Medical Products, Ministry of Health of the Russian Federation
Email: chem@folium.ru
Russian Federation, Moscow
