At FreeThink, we have considerable experience generating Stability Indicating Methods
“If a procedure …can detect changes in a quality attribute(s) of the drug substance and drug product during storage, it is considered a stability-indicating test.”
–Guidance for Industry, Analytical Procedures and Methods Validation for Drugs and Biologics, U.S. Department of Health and Human Services FDA, July 2015
We routinely carry out forced degradation studies.
We develop appropriate stability indicating methods using a systematic approach --mostly using HPLC. We have special expertise with fixed-dose combination drug products Download Dr. Lewis' presentation with FreeThink's case studies
Determining the chemical structure of degradation products can help with stabilization strategies and provide justification for increased specification limits. At FreeThink, we are experienced in identifying degradation products and proposing mechanisms for their formation. When needed, we can also synthesize authentic samples of degradation products for co-elution.