Characterization of the impurities and isomers in cefetamet pivoxil hydrochloride by liquid chromatography/time-of-flight mass spectrometry and ion trap mass spectrometry

• Ten impurities and isomers in cefetamet pivoxil hydrochloride drug substance were separated and identified by HPLC-MSn (TOF and TRAP).
• Their fragmentation patterns and structural assignment were studied based on the HPLC-MSn data.
• Impurity VII was isolated by preparative HPLC, and its structure was confirmed by 1H NMR data.

Ten impurities and isomers in cefetamet pivoxil hydrochloride drug substance made in China were separated and identified by HPLC-MSn (TOF and TRAP). Their fragmentation patterns and structural assignment were studied based on the HPLC-MSn data. Among the ten impurities and isomers, impurity VII was isolated by preparative HPLC, and its structure was confirmed by 1H NMR data.

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