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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Detalles Bibliográficos
Autores principales: Roshchina, M. V., Gunar, O. V., Builova, I. A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2021
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8635761/
https://www.ncbi.nlm.nih.gov/pubmed/34873351
http://dx.doi.org/10.1007/s11094-021-02524-8
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author Roshchina, M. V.
Gunar, O. V.
Builova, I. A.
author_facet Roshchina, M. V.
Gunar, O. V.
Builova, I. A.
author_sort Roshchina, M. V.
collection PubMed
description 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
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spelling pubmed-86357612021-12-02 On the Possibility of Reducing the Sample Size for Microbiological Examination of Some Pharmaceutical Substances Roshchina, M. V. Gunar, O. V. Builova, I. A. Pharm Chem J Article 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 Springer US 2021-12-02 2021 /pmc/articles/PMC8635761/ /pubmed/34873351 http://dx.doi.org/10.1007/s11094-021-02524-8 Text en © Springer Science+Business Media, LLC, part of Springer Nature 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Article
Roshchina, M. V.
Gunar, O. V.
Builova, I. A.
On the Possibility of Reducing the Sample Size for Microbiological Examination of Some Pharmaceutical Substances
title On the Possibility of Reducing the Sample Size for Microbiological Examination of Some Pharmaceutical Substances
title_full On the Possibility of Reducing the Sample Size for Microbiological Examination of Some Pharmaceutical Substances
title_fullStr On the Possibility of Reducing the Sample Size for Microbiological Examination of Some Pharmaceutical Substances
title_full_unstemmed On the Possibility of Reducing the Sample Size for Microbiological Examination of Some Pharmaceutical Substances
title_short On the Possibility of Reducing the Sample Size for Microbiological Examination of Some Pharmaceutical Substances
title_sort on the possibility of reducing the sample size for microbiological examination of some pharmaceutical substances
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8635761/
https://www.ncbi.nlm.nih.gov/pubmed/34873351
http://dx.doi.org/10.1007/s11094-021-02524-8
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