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Information × Registration Number 0224U033551, (0123U100229) , R & D reports Title Development of quality control methodology and standardization of the antiviral drug favipiravir popup.stage_title Розробка та валідація нових методик контролю якості ГЛЗ фавіпіравіру та вивчення біофармацевтичної еквівалентності препарата-генерика спектрофотометричним методом в порівняльних випробуваннях in vitro Head Yehorova Alla V., Доктор хімічних наук Registration Date 30-12-2024 Organization Physico-Chemical Institute O. Bogatsky National Academy of Sciences of Ukraine popup.description1 Experimental decision of the scientific task, which is manifested in the development, optimization and validation of quality control methods of prepared dosage product of favipiravir in accordance with the requirements of the State Pharmacopoeia of Ukraine, establishment of physicochemical properties of the active pharmaceutical ingredients and biopharmaceutical equivalence of the generic drug in comparative in vitro tests (study of dissolution profiles), necessary for the pharmaceutical dossier and industrial production. popup.description2  The object of the study is the drug FAVIPIRIVIR, film-coated tablets, 200 mg (antiviral drug). The subject of the study is the quality control methods of the drug FAVIPIRAVIR (determination of related substances, assay, dissolution, study of the biopharmaceutical equivalence of the generic drug in comparative in vitro tests). The methods of the study are molecular absorption spectroscopy in the UV and visible spectral regions, high-performance liquid chromatography (HPLC) with a UV detector. The main idea of the work was to experimentally resolve a scientific problem, which is manifested in the development, optimization and validation of quality control methods for the drug FAVIPIRAVIR in accordance with the requirements of the State Pharmacopoeia of Ukraine, and the establishment of the biopharmaceutical equivalence of the generic drug in comparative in vitro tests (study of dissolution profiles). Product Description popup.authors Yehorova Alla V. Aleksandrova Daria I. Scrypynets Yuliia V. Chebotarska Inna I. popup.nrat_date 2024-12-30 Close