Forced degradation is synonymous with stress testing and plays a key role in the development of stability-indicating and analytical methods, establishing operative conditions and the design of formulations.
Purposeful degradation can be a useful tool in predicting the stability of a medicinal substance or product with effects on purity, potency and safety.
The nature of the stress testing depends on the individual medicinal substance and type of medicinal product involved (e.g. solid oral dosage forms, lyophilized powders, or liquid formulations).
Mérieux NutriSciences performs these studies on finished products, active pharmaceutical ingredients (APIs), and placebos if needed, evaluating the following stress conditions, in order to detect potential degradation products and validate the stability-indicating properties of the analytical procedure:
- Increased temperature;
- Acidic conditions;
- Alkaline conditions;
- Oxidative conditions;
- Light exposure.