Molecular oxygen, reaction drug substance with

Oxidation. Oxidative studies are designed to reveal the primary oxidative degradation products due to oxidation. Oxidative degradants in drug substances and drug products normally are the result of reaction with molecular oxygen. As in the case of acid/base hydrolysis, appropriate controls are necessary. 

To perform an oxidative degradation study, the drug substance is dissolved in an appropriate solvent and transferred to a reaction vessel pressurized at 50-300 psi with molecular oxygen to increase the oxygen solubility in solution. Additionally, the system is heated to accelerate degradation. The temperature depends on the free radical initiator selected (Table 4). 

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