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

Journal of Pharmaceutical and Biomedical Analysis(2014)

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摘要
•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.
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关键词
2-Hydroxypyridine-1-Oxide (HOPO),Derivitization,Gas chromatography,Mass spectrometry quantitification,Validation,Trace analysis
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