Forced degradation studies are used to identify reactions that may occur that degrade a processed product. Usually conducted before final formulation, forced degradation uses external stresses to rapidly screen material stability.
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 Labs uses force degradation studies to qualify a method as a 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.
Applicable Standards
- USP <1025>
- ICH Q1B
- ICH Q2
- ICH Q14
