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 

• In formulation development 
• To predict how a molecule will behave in formal stability studies under ICH conditions 
• To provide a sensitive means of performing biosimilarity and comparability studies 

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.