vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-32Research ArticleЭКСПЕРТИЗА ЛЕКАРСТВЕННЫХ СРЕДСТВEXPERT EVALUATION OF MEDICINESСтресс-исследования и фотостабильность как часть данных по фармацевтической разработке лекарственного средстваStress studies and photostability as a part of pharmaceutical drug development dataМитькинаЛ. И.Mit'kinaL. I.Mitkina@expmed.ruКовалеваЕ. Л.KovalevaE. L.noemail@neicon.ruПрокоповИ. А.ProkopovI. A.noemail@neicon.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationRussian Federation20151302201802912Copyright © Митькина Л.И., Ковалева Е.Л., Прокопов И.А., 20182018Митькина Л.И., Ковалева Е.Л., Прокопов И.А.Mit'kina L.I., Kovaleva E.L., Prokopov I.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/32

Стресс-исследования лекарственных средств проводят с целью установления продуктов деградации лекарственных веществ под действием стресс-условий. Характер стресс-исследований зависит от свойств действующего вещества. Используют факторы, ускоряющие химические реакции: температуру, свет, влагу, рН среды, кислород, углекислый газ. Представленные данные необходимы для разработки методик определения посторонних примесей и количественного определения, для выбора надлежащих условий производства и хранения лекарственных средств.

Drug stress studies are conducted in order to identify drug degradation products under the influence of stress conditions. The principles of stress studies depend on characteristics of an active substance. The following factors accelerating chemical reactions are being used: temperature, light, moisture, pH, oxygen, carbon dioxide. The obtained results are required for the development of impurity identification and assay methods as well as for the choice of appropriate conditions for drug manufacture and storage.

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The authors declare that there are no conflicts of interest present.