Stability Solid-state forced degradation studies

Forced degradation studies are carried out either in the solution state and/or in the solid state. Usually the forced degradation testing is carried out on one batch of drug substance and/or one formulation blend (capsules and tablets). This forced degradation testing should not be part of a formal stability program. 

The temperature/humidity conditions used may be more severe than the typical accelerated stability testing conditions in order to generate potential degradation products in a reasonable time. The typical forced degradation conditions include thermolytic, hydrolytic, oxidative, photolytic (in excess of ICH conditions), high pH (alkaline conditions), and low pH (acidic conditions). Outlined in Table 9-25 and Table 9-26 are some solid-state and solution forced degradation studies, respectively, that could be conducted. In the following... 

Forced degradation studies of API and DP include appropriate solid-state and solution-state stress conditions (e.g., acid/base hydrolysis, heat/humidity, oxidation, and light exposure) in accordance with ICH guidelines (Figure 2, Steps 2 and 3). Forced degradation studies should be conducted whenever a stability-indicating... 

---