LC and LC-MS/MS Analysis for Characterization of Novel Degradation Products of Ivosidenib: Exploration of Degradation Pathways and In Silico Predictions.

ABSTRACT: Ivosidenib (ISB) is an anticancer drug used to treat acute myeloid leukemia and cholangiocarcinoma. In order to determine and describe the degradation products (DPs) of ivosidenib, the International Conference on Harmonization (ICH) guidelines (Q1A, R2) suggest conducting stress degradation studies by subjecting the drug to acidic, alkaline, neutral hydrolysis, thermal, photolytic, and oxidative conditions. These studies are crucial for understanding the stability of the drug and ensuring its safe use. Liquid chromatography (LC) and LC-MS/MS are essential for identifying and characterizing these DPs. Ivosidenib is sensitive to degradation under acidic, alkaline, photolytic, and oxidative conditions at room temperature but is stable under neutral hydrolysis and thermal conditions. The separ

SUBMITTER: Foudah AI 

PROVIDER: S-EPMC11800010 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature