Forced Degradation Testing

Forced degradation studies are a regulatory requirement and scientific necessity during analytical method development. Chemical stability of pharmaceutical molecules affects the safety and efficacy of the drug product.

The ICH guideline states that stress testing is intended to identify the likely degradation products. This helps to determine the intrinsic stability of the molecule, establishing degradation pathways, and to validate the stability indicating procedures used. As a result, it has become mandatory to perform stability studies of new drug moiety before filing registration.

Our forced degradation and material compatibility studies help you to establish the stability of the molecule and provide the data you need to select the proper formulation and packaging. We can also help you determine proper storage conditions and shelf life, which are essential for regulatory documentation.

Why choose forced degradation and material compatibility studies from SGS?

We can help you to:

Establish degradation pathways of drug substances and drug products
Differentiate degradation products that are related to drug products from those that are generated from non-drug product in a formulation
Elucidate the structure of degradation products
Determine the intrinsic stability of a drug substance in formulation
Reveal the degradation mechanisms, such as hydrolysis, oxidation, thermolysis or photolysis of the drug substance and drug product
Establish stability indicating nature of a developed method
Understand the chemical properties of drug molecules
Generate more stable formulations
Produce a degradation profile similar to that of what would be observed in a formal stability study under ICH conditions
Solve stability-related problems

Comprehensive Forced Degradation and Material Compatibility Studies from a World-leading Expert

As a world-leader in inspection, certification, testing and verification, we offer you extensive expertise in all aspects of forced degradation and material compatibility studies. With our team of experienced and dedicated scientists, we provide you with a well-planned and designed study for forced degradation that will include: