Methods of Microbial Identification During Drug Quality Analysis and Applicability Assessment
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Rapid and correct identification of microorganisms is an essential part of pharmaceutical analysis. Several phenotypic, genotypic, and proteotypic methods, each of which has its own advantages and limitations, are currently used to identify microorganisms. The aim of the present work was to reveal features and validate the operation of a Vitek 2 Compact 30 bacteriological analyzer (bioMerieux, France), which was based on determining the biochemical properties of microorganisms. The applicability of this method was determined using accuracy, precision, and robustness. Correct results were found in 86% of 396 cases. Results obtained under repeatability and intermediate precision conditions showed no differences. Approaches to molecular and genetic identification of microorganisms isolated from preparations in addition to automated biochemical identification were discussed.
Keywordspharmaceutical products microorganism identification
The work was performed in the framework of State Task for SCEEMP, Ministry of Health of Russia, No. 056-00023-18-02 for applied scientific research (State Contract No. NIR AAAA-A18-118021590049-0).
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