At RSSL, we apply forced degradation conditions - temperature, pH, redox, light, humidity and shear stress - to accelerate this process. This enables the production of enough drug degradation products (5-20%) to be useful in stability indicating method development and validation.
In addition to conducting the studies, our technical experts can also build a robust regulatory compliant data package to support your regulatory submission.
Forced degradation studies are used to:
- To identify natural degradation pathways and mechanisms (early phase work)
- To identify stability indicating characteristics
- To produce degraded material for impurity identification, assay testing and validation
- To gain additional information about the drug molecule
To identify the optimal conditions, each drug will require a tailored forced degradation protocol. This optimisation is performed using a robust feasibility study resulting in the development of a bespoke method capable of achieving suitable drug degradation levels.