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.
We can help you to:
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:
Contact us today to find out how we can help with forced degradation studies executed under cGMP regulations.
2nd Floor Alegria Office Building. 2229 Chino Roces Avenue,
1223,
Makati, Metro Manila, Philippines