The development of microbiological methods for drug analysis
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 elaboration of the related general pharmacopoeia monog...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2018-02-01
|
| Series: | Регуляторные исследования и экспертиза лекарственных средств |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/6 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849395137724022784 |
|---|---|
| author | O. V. Gunar N. G. Sakhno E. S. Novik G. M. Bulgakova L. V. Kolosova I. A. Buylova M. V. Roshchina |
| author_facet | O. V. Gunar N. G. Sakhno E. S. Novik G. M. Bulgakova L. V. Kolosova I. A. Buylova M. V. Roshchina |
| author_sort | O. V. Gunar |
| collection | DOAJ |
| description | 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 elaboration of the related general pharmacopoeia monographs, as well as prospects for the development of methods in connection with the publication of the Russian State Pharmacopoeia XIII edition. There is a clear trend towards harmonization with the leading world pharmacopoeias, but the Russian State Pharmacopoeia maintains the individual characteristics of drug quality analysis in terms of microbiological characteristics, including the introduction of new technologies, process automation and taking into account the special features of individual drug groups. |
| format | Article |
| id | doaj-art-ecb6a36d0ad4433384d191b52faa25fe |
| institution | Kabale University |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| publishDate | 2018-02-01 |
| publisher | Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) |
| record_format | Article |
| series | Регуляторные исследования и экспертиза лекарственных средств |
| spelling | doaj-art-ecb6a36d0ad4433384d191b52faa25fe2025-08-20T03:39:44ZrusFederal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)Регуляторные исследования и экспертиза лекарственных средств3034-30623034-34532018-02-010115184The development of microbiological methods for drug analysisO. V. Gunar0N. G. Sakhno1E. S. Novik2G. M. Bulgakova3L. V. Kolosova4I. A. Buylova5M. V. Roshchina6Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsThe 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 elaboration of the related general pharmacopoeia monographs, as well as prospects for the development of methods in connection with the publication of the Russian State Pharmacopoeia XIII edition. There is a clear trend towards harmonization with the leading world pharmacopoeias, but the Russian State Pharmacopoeia maintains the individual characteristics of drug quality analysis in terms of microbiological characteristics, including the introduction of new technologies, process automation and taking into account the special features of individual drug groups.https://www.vedomostincesmp.ru/jour/article/view/6микробиологические показателистерильностьмикробиологическая чистотасодержание витаминовконцентрация микробных клетокэффективность консервантовmicrobiological characteristicssterilitymicrobiological purityvitamin contentconcentration of microbial cellspreservative effectiveness |
| spellingShingle | O. V. Gunar N. G. Sakhno E. S. Novik G. M. Bulgakova L. V. Kolosova I. A. Buylova M. V. Roshchina The development of microbiological methods for drug analysis Регуляторные исследования и экспертиза лекарственных средств микробиологические показатели стерильность микробиологическая чистота содержание витаминов концентрация микробных клеток эффективность консервантов microbiological characteristics sterility microbiological purity vitamin content concentration of microbial cells preservative effectiveness |
| title | The development of microbiological methods for drug analysis |
| title_full | The development of microbiological methods for drug analysis |
| title_fullStr | The development of microbiological methods for drug analysis |
| title_full_unstemmed | The development of microbiological methods for drug analysis |
| title_short | The development of microbiological methods for drug analysis |
| title_sort | development of microbiological methods for drug analysis |
| topic | микробиологические показатели стерильность микробиологическая чистота содержание витаминов концентрация микробных клеток эффективность консервантов microbiological characteristics sterility microbiological purity vitamin content concentration of microbial cells preservative effectiveness |
| url | https://www.vedomostincesmp.ru/jour/article/view/6 |
| work_keys_str_mv | AT ovgunar thedevelopmentofmicrobiologicalmethodsfordruganalysis AT ngsakhno thedevelopmentofmicrobiologicalmethodsfordruganalysis AT esnovik thedevelopmentofmicrobiologicalmethodsfordruganalysis AT gmbulgakova thedevelopmentofmicrobiologicalmethodsfordruganalysis AT lvkolosova thedevelopmentofmicrobiologicalmethodsfordruganalysis AT iabuylova thedevelopmentofmicrobiologicalmethodsfordruganalysis AT mvroshchina thedevelopmentofmicrobiologicalmethodsfordruganalysis AT ovgunar developmentofmicrobiologicalmethodsfordruganalysis AT ngsakhno developmentofmicrobiologicalmethodsfordruganalysis AT esnovik developmentofmicrobiologicalmethodsfordruganalysis AT gmbulgakova developmentofmicrobiologicalmethodsfordruganalysis AT lvkolosova developmentofmicrobiologicalmethodsfordruganalysis AT iabuylova developmentofmicrobiologicalmethodsfordruganalysis AT mvroshchina developmentofmicrobiologicalmethodsfordruganalysis |