1) IRLPL offers forced degradation and material compatibility studies to showcase the specificity of stability indicating methods and gather essential data for development, formulation, and packaging.
2) Our forced degradation and material compatibility studies assist in establishing the stability of the molecule and provide crucial data for selecting the appropriate formulation and packaging. Additionally, we can help determine proper storage conditions and shelf life, which are vital for regulatory documentation.
Why choose forced degradation studies from IRLPL?
We can assist you with:
1) Establishing degradation pathways of drug substances and products
2) Distinguishing degradation products related to drug products from those generated in a formulation
3) Elucidating the structure of degradation products
4) Determining the intrinsic stability of a drug substance in formulation
5) Revealing degradation mechanisms such as hydrolysis, oxidation, thermolysis, or photolysis
6) Establishing the stability-indicating nature of a developed method
7) Understanding the chemical properties of drug molecules
8) Formulating more stable products
9)Creating a degradation profile similar to formal stability studies under ICH conditions
10) Resolving stability-related issues
Contact us today to find out how we can help with forced degradation studies executed under cGMP regulations.