Reactive impurities, such as hydrogen peroxide in excipients, raise a great concern over the\nchemical stability of pharmaceutical products. Traditional screening methods of spiking impurities\ninto solid drug-excipient mixtures oversimplify the micro-environment and the physical state of\nsuch impurities in real dosage form. This can lead to an inaccurate prediction of the long-term\nproduct stability. This study presents the feasibility of using a polyvinylpyrrolidone-hydrogen\nperoxide complex (PVP-H2O2) as an oxidative agent for the solid state forced degradation of a\nselected drug, vortioxetine HBr. The PVP-H2O2 complex was prepared and characterized using\nFT-IR spectroscopy. The tablet compacts were made using a mixture of solid PVP-H2O2 complex\nand crystalline vortioxetine HBr powder. The compacts were exposed to 40 DegreeC/75% RH condition\nin open and closed states for different time intervals. The extent and the type of drug degradation\nwere analysed using LC and LC-MS. The extent of degradation was higher in the samples stored at\nthe open state as compared to the close state. The solution state forced oxidation was conducted to\nverify the peroxide induced degradation reactions. The results evidence the utility of the proposed\nsolid-state stressor and the method for screening the sensitivity of drugs to the excipient reactive\nimpurities involving peroxides in solid-state.
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