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
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
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
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
Publikováno v:
Farmaciya (Pharmacy). 68
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
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