On the Possibility of Reducing the Sample Size for Microbiological Examination of Some Pharmaceutical Substances

The possibility of reducing the sample size for microbiological examination of some pharmaceutical substances is considered. Trypticase-soy agar was evaluated for the ability to detect yeast and mold fungi and to isolate the minimal amount of certain types of microorganisms. The minimal sample size...

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Bibliographic Details
Published in:Pharmaceutical chemistry journal 2021-12, Vol.55 (9), p.970-973
Main Authors: Roshchina, M. V., Gunar, O. V., Builova, I. A.
Format: Article
Language:English
Subjects:
Atazanavir
Darunavir
Insulin lispro
Medicine
Microbiology
Molds (Fungi)
Organic Chemistry
Pharmaceutical industry
Pharmacology/Toxicology
Pharmacy
Substance abuse
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Summary:The possibility of reducing the sample size for microbiological examination of some pharmaceutical substances is considered. Trypticase-soy agar was evaluated for the ability to detect yeast and mold fungi and to isolate the minimal amount of certain types of microorganisms. The minimal sample size for microbiological examination was 0.2 g (mL) for synthetic substances intended for the production of non-sterile drugs and 1.2 g (mL), for sterile drugs. Based on the experimental results, a scheme has been developed for microbiological examination of particular pharmaceutical substances using a reduced sample size
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-021-02524-8