Characterization of degradation products of idarubicin through LC-UV, MSn and LC-MS-TOF studies

- Forced degradation on idarubicin under ICH Q1A(R2) prescribed conditions conducted.
- Three new degradation products of idarubicin characterized through LC-MS-TOF studies.
- Acid hydrolyzed product characterized as deglucosaminyl idarubicin.
- Two oxidative products characterized as desacetyl idarubicin and desacetyl idarubicin hydroperoxide.
- Mechanistic explanation of idarubicin degradation discussed.