Determination of trace level genotoxic impurities in small molecule drug substances using conventional headspace gas chromatography with contemporary ionic liquid diluents and electron capture detection.

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作者： Tien D,Ho ^[1] ; Peter M,Yehl ^[1] ; Nik P,Chetwyn ^[1] ; Jin,Wang ^[1] ; Jared L,Anderson ^[2] ; Qiqing,Zhong ^[3]

作者单位： Genentech Small Molecule Pharmaceutical Sciences, 1 DNA Way, South San Francisco, CA 94080, USA. ^[1] Department of Chemistry and Biochemistry, The University of Toledo, Toledo, OH 43606, USA. ^[2] Genentech Small Molecule Pharmaceutical Sciences, 1 DNA Way, South San Francisco, CA 94080, USA. Electronic address: zhong.qiqing@gene.com. ^[3]

关键词 Alkyl/aryl halide Electron capture detector Genotoxic impurity Headspace gas chromatography Ionic liquid Nitro-aromatic compound

主题词色谱法, 气相(Chromatography, Gas);电子(Electrons);离子液体(Ionic Liquids);检测限(Limit of Detection);诱变剂(Mutagens);小分子化合物库(Small Molecule Libraries);温度(Temperature)

DOI 10.1016/j.chroma.2014.07.099

PMID 25151038

发布时间 2018-12-02

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