COMPARATIVE ANALYSIS OF REQUIREMENTS FOR QUALITY CONTROL OF ETHINYL ESTRADIOL AND LEVONORGESTREL CONTAINING MEDICINAL PRODUCTS
The article compares test methods and levels of requirements laid out in the world’s leading pharmacopoeias and in manufacturers’ specifications with regard to the quality of levonorgestrel and ethinyl estradiol containing medicinal products used as oral contraceptives. The study analysed medicines...
| Những tác giả chính: | , , , , |
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| Định dạng: | Bài viết |
| Ngôn ngữ: | Russian |
| Được phát hành: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2018-03-01
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| Loạt: | Регуляторные исследования и экспертиза лекарственных средств |
| Những chủ đề: | |
| Truy cập trực tuyến: | https://www.vedomostincesmp.ru/jour/article/view/157 |
| _version_ | 1826566747528888320 |
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| author | V. I. Seredenko A. V. Korolev L. G. Maslov T. Yu. Belova N. N. Dolgushina |
| author_facet | V. I. Seredenko A. V. Korolev L. G. Maslov T. Yu. Belova N. N. Dolgushina |
| author_sort | V. I. Seredenko |
| collection | DOAJ |
| description | The article compares test methods and levels of requirements laid out in the world’s leading pharmacopoeias and in manufacturers’ specifications with regard to the quality of levonorgestrel and ethinyl estradiol containing medicinal products used as oral contraceptives. The study analysed medicines containing a combination of levonorgestrel and ethinyl estradiol (Vezantra, Melleva, Microgynon, Minisiston, Modelle Libera etc.) that were tested at the FSBI «SCEEMP» of the Ministry of Health of the Russian Federation as part of premarketing evaluation. The comparison of the obtained data revealed that the test methods recommended by foreign pharmacopoeias and manufacturers’ specifications for quality control of medicines containing levonorgestrel and ethinyl estradiol are in line with the current trends in the pharmaceutical analysis and make it possible to adequately assess the quality of this group of medicines that are authorised in the Russian Federation. Manufacturers’ specifications include additional parameters, such as «Related impurities», «Microbiological purity», and, in some cases, «Identification of colouring agents» (titanium dioxide, iron oxide), «Average weight», «Disintegration», «Water», and «Residual organic solvents». The study showed that the requirements included into manufacturers’ specifications meet the requirements of the world’s leading pharmacopoeias or even exceed them, as in the case of the «Assay» parameter. |
| first_indexed | 2024-03-07T19:17:46Z |
| format | Article |
| id | doaj.art-17d07a1d24ed4955b8938b3e422c5322 |
| institution | Directory Open Access Journal |
| issn | 3034-3062 3034-3453 |
| language | Russian |
| last_indexed | 2025-03-14T10:56:34Z |
| publishDate | 2018-03-01 |
| 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-17d07a1d24ed4955b8938b3e422c53222025-03-02T10:46:40ZrusFederal 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 средств3034-30623034-34532018-03-0181616510.30895/1991-2919-2018-8-1-61-65155COMPARATIVE ANALYSIS OF REQUIREMENTS FOR QUALITY CONTROL OF ETHINYL ESTRADIOL AND LEVONORGESTREL CONTAINING MEDICINAL PRODUCTSV. I. Seredenko0A. V. Korolev1L. G. Maslov2T. Yu. Belova3N. N. Dolgushina4Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationThe article compares test methods and levels of requirements laid out in the world’s leading pharmacopoeias and in manufacturers’ specifications with regard to the quality of levonorgestrel and ethinyl estradiol containing medicinal products used as oral contraceptives. The study analysed medicines containing a combination of levonorgestrel and ethinyl estradiol (Vezantra, Melleva, Microgynon, Minisiston, Modelle Libera etc.) that were tested at the FSBI «SCEEMP» of the Ministry of Health of the Russian Federation as part of premarketing evaluation. The comparison of the obtained data revealed that the test methods recommended by foreign pharmacopoeias and manufacturers’ specifications for quality control of medicines containing levonorgestrel and ethinyl estradiol are in line with the current trends in the pharmaceutical analysis and make it possible to adequately assess the quality of this group of medicines that are authorised in the Russian Federation. Manufacturers’ specifications include additional parameters, such as «Related impurities», «Microbiological purity», and, in some cases, «Identification of colouring agents» (titanium dioxide, iron oxide), «Average weight», «Disintegration», «Water», and «Residual organic solvents». The study showed that the requirements included into manufacturers’ specifications meet the requirements of the world’s leading pharmacopoeias or even exceed them, as in the case of the «Assay» parameter.https://www.vedomostincesmp.ru/jour/article/view/157levonorgestrelethinyl estradioloral contraceptivesquality controlcomparative analysis |
| spellingShingle | V. I. Seredenko A. V. Korolev L. G. Maslov T. Yu. Belova N. N. Dolgushina COMPARATIVE ANALYSIS OF REQUIREMENTS FOR QUALITY CONTROL OF ETHINYL ESTRADIOL AND LEVONORGESTREL CONTAINING MEDICINAL PRODUCTS Регуляторные исследования и экспертиза лекарственных средств levonorgestrel ethinyl estradiol oral contraceptives quality control comparative analysis |
| title | COMPARATIVE ANALYSIS OF REQUIREMENTS FOR QUALITY CONTROL OF ETHINYL ESTRADIOL AND LEVONORGESTREL CONTAINING MEDICINAL PRODUCTS |
| title_full | COMPARATIVE ANALYSIS OF REQUIREMENTS FOR QUALITY CONTROL OF ETHINYL ESTRADIOL AND LEVONORGESTREL CONTAINING MEDICINAL PRODUCTS |
| title_fullStr | COMPARATIVE ANALYSIS OF REQUIREMENTS FOR QUALITY CONTROL OF ETHINYL ESTRADIOL AND LEVONORGESTREL CONTAINING MEDICINAL PRODUCTS |
| title_full_unstemmed | COMPARATIVE ANALYSIS OF REQUIREMENTS FOR QUALITY CONTROL OF ETHINYL ESTRADIOL AND LEVONORGESTREL CONTAINING MEDICINAL PRODUCTS |
| title_short | COMPARATIVE ANALYSIS OF REQUIREMENTS FOR QUALITY CONTROL OF ETHINYL ESTRADIOL AND LEVONORGESTREL CONTAINING MEDICINAL PRODUCTS |
| title_sort | comparative analysis of requirements for quality control of ethinyl estradiol and levonorgestrel containing medicinal products |
| topic | levonorgestrel ethinyl estradiol oral contraceptives quality control comparative analysis |
| url | https://www.vedomostincesmp.ru/jour/article/view/157 |
| work_keys_str_mv | AT viseredenko comparativeanalysisofrequirementsforqualitycontrolofethinylestradiolandlevonorgestrelcontainingmedicinalproducts AT avkorolev comparativeanalysisofrequirementsforqualitycontrolofethinylestradiolandlevonorgestrelcontainingmedicinalproducts AT lgmaslov comparativeanalysisofrequirementsforqualitycontrolofethinylestradiolandlevonorgestrelcontainingmedicinalproducts AT tyubelova comparativeanalysisofrequirementsforqualitycontrolofethinylestradiolandlevonorgestrelcontainingmedicinalproducts AT nndolgushina comparativeanalysisofrequirementsforqualitycontrolofethinylestradiolandlevonorgestrelcontainingmedicinalproducts |