Novel Sensitive Determination Method for a Genotoxic Alkylating Agent, 4-Chloro-1-butanol, in Active Pharmaceutical Ingredients by LC-ICP-MS Employing Iodo Derivatization

An alkylating agent, 4-chloro-1-butanol, is a genotoxic impurity (GTI); it may be generated during the synthesis of active pharmaceutical ingredients (APIs). For the trace-level detection of GTIs in APIs, usually, gas chromatography–mass spectrometry (GC-MS) or liquid chromatography–mass spectrometr...

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Veröffentlicht in:	Analytical Sciences 2014/03/10, Vol.30(3), pp.377-382
Hauptverfasser:	HARIGAYA, Koki, YAMADA, Hiroyuki, YAKU, Koji, NISHI, Hiroyuki, HAGINAKA, Jun
Format:	Artikel
Sprache:	eng
Schlagworte:	3-iodobenzoyl chloride 4-Chloro-1-butanol active pharmaceutical ingredient Analytical Chemistry Chemistry Chlorobutanol - analogs & derivatives Chlorobutanol - analysis Chromatography, High Pressure Liquid - instrumentation Chromatography, High Pressure Liquid - methods genotoxic impurity LC-ICP-MS Mass Spectrometry - instrumentation Mass Spectrometry - methods Pharmaceutical Preparations - chemistry trace analysis
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