Autoxidation of drugs: prediction of degradation impurities from results of reaction with radical chain initiators.

Abstract

In the study of the degradation of drug substances by molecular oxygen, their specific reaction mechanisms must be taken into account. The rate-determining step is usually the reaction of the substrate with a radical chain initiator, which is often an unknown impurity. The reactivity and selectivity of autoxidation can be controlled better by using a radical chain initiator, such as AIBN, than by changing the temperature or the oxygen pressure. In this paper the products profiles of four pharmaceutical substances in a simple oxidation test with AIBN are compared with the results of long term natural stability tests or with already established stabilities.