Determination of 2-Hydroxypyridine-1-Oxide (HOPO) at sub-ppm levels using derivitization and gas chromatography with mass spectrometry detection (GCMS)

- Method developed for HOPO following categorization as a potential genotoxic impurity.
- Use of derivitization overcame challenges associated with direct analysis of HOPO.
- Method uses gas chromatography separation with mass spectrometry detection.
- Technology transferred for routine use in commercial API manufacturing.