Stress studies and photostability as a part of pharmaceutical drug development data
Abstract
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.
About the Authors
L. I. Mit'kina
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
E. L. Kovaleva
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
I. A. Prokopov
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
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Review
For citations:
Mit'kina L.I., Kovaleva E.L., Prokopov I.A. Stress studies and photostability as a part of pharmaceutical drug development data. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(2):9-12. (In Russ.)
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