Differential role of potential stressors, underlying degradation mechanism, characterization of degradants using LC-MS/MS, and establishment of a stability-indicating analytical method for duvelisib

This study is the first to report the structure of degradation impurities and the step-by-step degradation mechanism of DUV. This information will be useful for the scientific community and manufacturers in optimizing the formulation parameters and/or storage conditions. The validated method can be employed for analysis of stability study and routine quality control samples of newer DUV formulations in pharmaceutical industries. The identified impurities may serve as impurity standards for specifying their limits in the drug after required qualification studies.PMID:37852619 | DOI:10.1002/bmc.5760
Source: Biomedical Chromatography : BMC - Category: Biomedical Science Authors: Source Type: research