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:
- Acid stress
- Base stress
- Oxidative stress
- Heat stress (dry and wet)
- Photolytic stress (ICH guideline option 2)
- Accelerated stability (elevated temperature, high humidity)
Contact us today to find out how we can help with forced degradation studies executed under cGMP regulations.