Drug products degradation studies

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. 

The culmination of degradation studies is the preparation of a degradation pathway. A degradation pathway will show all the possible degradation products beginning with the drug substance. An example is shown in Figure 9. 

A short-term stability study is conducted under stressed conditions to increase the rate of chemical and physical degradation of the drug product. The classical statistical procedure to establish a preliminary shelf life is based on regression techniques, which are used to estimate the parameters of the Arrhenius equation. 

---