An LC/MS/MS Method for the Sub-ppm Level Quantification of the Genotoxic Impurity 2-Hydroxypyridine N-oxide as Its Dansyl Derivative

摘要

1. An LC-MS/MS quantification method detecting HOPO as its dansyl derivative in three APIs was developed for HOPO at 0.1 - 25 ppm. The method w as validated for the assay of three different APIs. 2. A novel SRM-based procedure was also established for the confirmation of any HOPO analyte determined above the established TTC.