Forced degradation studies are used to identify reactions which may occur to degrade a processed product. Usually conducted before final formulation, forced degradation uses external stresses to rapidly screen material stabilities.
Forced degradation studies are performed by means of various stressing agents such as pH, temperature, light, chemical agents (e.g., oxidizing), and mechanical stress to speed up the chemical degradation, physical degradation, or instability of a molecule. Forced degradation studies show the chemical behavior of the molecule which in turn helps the development of formulation and package.
Nelson Laboratories uses force degradation studies to qualify method as stability indicating method. Stability indicating methods are specifically designed to separate drug degradants from non-degraded drug. The forced degradation studies are performed usually at the development stage of the stability indicating method. After the development is completed, validation is performed.
- USP <1049>
- ICH Q1A