Регуляторные исследования и экспертиза лекарственных средств (Feb 2018)
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.