Ultra high performance liquid chromatography coupled with high resolution quantitation mass spectrometry method development and validation for determining genotoxic 2,5-dichlorobenzoyl chloride in MLN9708 drug substance.

Abstract

A novel reversed-phase ultra high performance liquid chromatography coupled with high resolution quantitation mass spectrometry (UHPLC/HRQMS) method was developed to quantify 2,5-dichlorobenzoyl chloride (DCBC), a genotoxic impurity, in MLN9708 drug substance. A surrogate strategy was utilized whereby DCBC was intentionally hydrolyzed to 2,5-dichlorobenzoic… (More)
DOI: 10.1016/j.jpba.2013.11.012

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