Enterosorbents: quality analysis by microbiological indicators and the risk of microbial contamination

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DOI: https://doi.org/10.29296/25419218-2021-06-01
Issue: 
6
Year: 
2021

O.V. Gunar, V.E. Grigoryeva, G.M. Bulgakova Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation, 8, Petrovsky Boulevard, Build. 2, Moscow 127051, Russian Federation

The paper analyzes the results of pharmaceutical testing of enterosorbents (ESBs), which was made in the Laboratory of Microbiology, Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation, in the period 2013–2019 according to the indicator «Microbiological purity». During the above-mentioned period, 38 series of ESBs made in Russia and foreign countries were analyzed. Only 3 (8%) of 35 (92% of the total number of the test Russian medicines did not comply with the requirements of regulatory documents. The revealed discrepancy was confirmed by an overestimated number of aerobic bacteria and microscopic fungi. Among the rejected samples, activated charcoal tablets are a higher-risk drug, which may be due to both the origin and properties of the drug and the characteristics of process technology.
Keywords: 
enterosorbents
microbiological purity
drug quality testing
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