Zobrazeno 1 - 8
of 8
pro vyhledávání: '"M. V. Roshchina"'
Autor:
O. V. Gunar, N. G. Sakhno, E. S. Novik, G. M. Bulgakova, L. V. Kolosova, I. A. Buylova, M. V. Roshchina
Publikováno v:
Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 1, Pp 15-18 (2018)
The article presents the review of the national regulatory documents on drug testing for microbiological characteristics, such as «Sterility», «Microbiological Purity» etc. It discusses the history of the establishment of characteristics and the
Externí odkaz:
https://doaj.org/article/ecb6a36d0ad4433384d191b52faa25fe
Autor:
M. V. Roshchina, O. V. Gunar
Publikováno v:
Pharmaceutical Chemistry Journal. 54:834-837
An informational-analytical review of alternative microbiological methods for quality testing of pharmaceutical products is presented. The expediency and peculiarities of implementing these methods in pharmacy practice for routine testing are conside
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b329f0cbad35563fbf7a0e05aac8131d
https://doi.org/10.1007/s11094-020-02283-y
https://doi.org/10.1007/s11094-020-02283-y
Publikováno v:
Pharmaceutical Chemistry Journal
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5a345ffbd3e77cf99c1a29f8e2b3aa65
https://pubmed.ncbi.nlm.nih.gov/34873351
https://pubmed.ncbi.nlm.nih.gov/34873351
Publikováno v:
Pharmaceutical Chemistry Journal. 52:569-572
Important features of the isolation of anaerobic microorganisms were examined. The detection limit and frequency and time for isolating several anaerobic bacteria by direct inoculation on thioglycollate medium and by a BacT/ALERT 3D automated system
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::e3bae40abde64eafb82f277bf97fdbf6
https://doi.org/10.1007/s11094-018-1861-y
https://doi.org/10.1007/s11094-018-1861-y
Publikováno v:
Farmaciya (Pharmacy). 68
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::067de431988f8519166b9bad9c6a27a3
https://doi.org/10.29296/25419218-2019-08-01
https://doi.org/10.29296/25419218-2019-08-01
Publikováno v:
Pharmaceutical Chemistry Journal. 51:1045-1048
The aim of the present work was to examine the applicability of an alternative method for detecting CO2 using an automated BacT/ALERT 3D colorimetric microbiological detection system and analytical parameters for sterility testing of medicinal prepar
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f0b66964ae9e650a01608b8be91af50d
https://doi.org/10.1007/s11094-018-1737-1
https://doi.org/10.1007/s11094-018-1737-1
Publikováno v:
Pharmaceutical Chemistry Journal. 50:47-51
We present an information-analytical review of methods for evaluating the sterility of solid drug formulations. Current normative documentation regulating the quality of parenteral drugs is analyzed and the main limitations of the test method for thi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::05f26e2aec46d55b06f115f197600db6
https://doi.org/10.1007/s11094-016-1397-y
https://doi.org/10.1007/s11094-016-1397-y
Publikováno v:
Pharmaceutical Chemistry Journal. 51:508-510
The use of compendial and alternative methods for drug sterility testing, the most important characteristic of which is the limit of detection (LOD), i.e., the minimum amount of viable microorganisms that can be found in the examined sample, is curre
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a7f929b47c99d000257de9bb585d8403
https://doi.org/10.1007/s11094-017-1644-x
https://doi.org/10.1007/s11094-017-1644-x