Integrated Analytical Quality by Design and In Silico Modeling for Stability‐Indicating Ultra‐High‐Performance Liquid Chromatography Method Development and Validation for Impurity Profiling of Gilteritinib Fumarate
Impurity profiling of targeted anticancer agents is essential to ensure product quality, patient safety, and regulatory compliance. Despite the clinical importance of gilteritinib fumarate, a potent FMS‐like tyrosine kinase 3 inhibitor used for relapsed or refractory acute myeloid leukemia, existing chromatographic...