Methodological aspects of determining molecular mass distribution of dextrans by size-exclusion chromatography for various groups of medicines
The article analyses the results of quality evaluation of dextran substances and medicines produced thereof which was carried out by the Institution as part of pre-authorisation testing and involved the analysis of the «molecular mass distribution» parameter. The article gives recommendations on how...
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| Format: | Article |
| Language: | Russian |
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NEICON ISP LLC
2018-02-01
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| Series: | Ведомости Научного центра экспертизы средств медицинского применения |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/110 |
| _version_ | 1797199072354893824 |
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| author | R. S. Smirnov E. V. Ivanainen A. I. Lutseva O. A. Vaganova D. A. Orlov |
| author_facet | R. S. Smirnov E. V. Ivanainen A. I. Lutseva O. A. Vaganova D. A. Orlov |
| author_sort | R. S. Smirnov |
| collection | DOAJ |
| description | The article analyses the results of quality evaluation of dextran substances and medicines produced thereof which was carried out by the Institution as part of pre-authorisation testing and involved the analysis of the «molecular mass distribution» parameter. The article gives recommendations on how to present data on determination of dextran molecular mass distribution by size-exclusion chromatography in corresponding sections of product specifications with due consideration for specificity of the tested products and methods of their analysis, as well as on how to interpret the obtained results. It is suggested that particular attention should be paid to the creation of a calibration curve (choice of reference standards, type of experimental curve approximation) and testing of its suitability. The validation/verification (practical testing) of procedures used for determination of dextran molecular mass distribution which was carried out as part of pre-authorisation testing, made it possible to compile a list of documents that have to be submitted to the Institution for evaluation. |
| first_indexed | 2024-03-07T19:18:16Z |
| format | Article |
| id | doaj.art-92fa93e172a34c0ca2aac2cb701d161f |
| institution | Directory Open Access Journal |
| issn | 1991-2919 2619-1172 |
| language | Russian |
| last_indexed | 2024-04-24T07:09:56Z |
| publishDate | 2018-02-01 |
| publisher | NEICON ISP LLC |
| record_format | Article |
| series | Ведомости Научного центра экспертизы средств медицинского применения |
| spelling | doaj.art-92fa93e172a34c0ca2aac2cb701d161f2024-04-21T11:46:32ZrusNEICON ISP LLCВедомости Научного центра экспертизы средств медицинского применения1991-29192619-11722018-02-017138108Methodological aspects of determining molecular mass distribution of dextrans by size-exclusion chromatography for various groups of medicinesR. S. Smirnov0E. V. Ivanainen1A. I. Lutseva2O. A. Vaganova3D. A. Orlov4Scientific 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 analyses the results of quality evaluation of dextran substances and medicines produced thereof which was carried out by the Institution as part of pre-authorisation testing and involved the analysis of the «molecular mass distribution» parameter. The article gives recommendations on how to present data on determination of dextran molecular mass distribution by size-exclusion chromatography in corresponding sections of product specifications with due consideration for specificity of the tested products and methods of their analysis, as well as on how to interpret the obtained results. It is suggested that particular attention should be paid to the creation of a calibration curve (choice of reference standards, type of experimental curve approximation) and testing of its suitability. The validation/verification (practical testing) of procedures used for determination of dextran molecular mass distribution which was carried out as part of pre-authorisation testing, made it possible to compile a list of documents that have to be submitted to the Institution for evaluation.https://www.vedomostincesmp.ru/jour/article/view/110декстранымолекулярная массамолекулярно-массовое распределениеэксклюзионная хроматографияэкспертиза качестварегистрация лекарственных средствнормативная документацияdextransmolecular massmolecular-mass distributionsize-exclusion chromatographyquality evaluationmarketing authorization |
| spellingShingle | R. S. Smirnov E. V. Ivanainen A. I. Lutseva O. A. Vaganova D. A. Orlov Methodological aspects of determining molecular mass distribution of dextrans by size-exclusion chromatography for various groups of medicines Ведомости Научного центра экспертизы средств медицинского применения декстраны молекулярная масса молекулярно-массовое распределение эксклюзионная хроматография экспертиза качества регистрация лекарственных средств нормативная документация dextrans molecular mass molecular-mass distribution size-exclusion chromatography quality evaluation marketing authorization |
| title | Methodological aspects of determining molecular mass distribution of dextrans by size-exclusion chromatography for various groups of medicines |
| title_full | Methodological aspects of determining molecular mass distribution of dextrans by size-exclusion chromatography for various groups of medicines |
| title_fullStr | Methodological aspects of determining molecular mass distribution of dextrans by size-exclusion chromatography for various groups of medicines |
| title_full_unstemmed | Methodological aspects of determining molecular mass distribution of dextrans by size-exclusion chromatography for various groups of medicines |
| title_short | Methodological aspects of determining molecular mass distribution of dextrans by size-exclusion chromatography for various groups of medicines |
| title_sort | methodological aspects of determining molecular mass distribution of dextrans by size exclusion chromatography for various groups of medicines |
| topic | декстраны молекулярная масса молекулярно-массовое распределение эксклюзионная хроматография экспертиза качества регистрация лекарственных средств нормативная документация dextrans molecular mass molecular-mass distribution size-exclusion chromatography quality evaluation marketing authorization |
| url | https://www.vedomostincesmp.ru/jour/article/view/110 |
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