Givinostat Acid Impurity (CAS 199657-47-1) is a structurally related process-related impurity of givinostat, consistent with oxidative or hydrolytic conversion of the parent hydroxamate side chain to the corresponding carboxylic acid derivative. With molecular formula C24H26N2O4 and molecular weight 406.47 g/mol, it retains the aromatic amine and ketone framework characteristic of this chemotype while lacking the hydroxamic acid functionality. It is not a nitrosamine, but its presence may reflect degradation or synthesis-associated side reactions. Characterization typically requires LC-MS/MS, high-resolution LC-MS, and orthogonal RP-HPLC with UV or PDA detection; structural assignment may be supported by NMR and accurate-mass fragmentation analysis.
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