Analysis of potential genotoxic impurities in rabeprazole active pharmaceutical ingredient via Liquid Chromatography-tandem Mass Spectrometry, following quality-by-design principles for method development.
第一作者:
Katerina,Iliou
第一单位:
Laboratory of Pharmaceutical Analysis, Faculty of Pharmacy, National and Kapodistrian University of Athens, Panepistimioupoli Zografou GR, 157 71, Athens, Greece.
作者:
医学主题词
色谱法, 高压液相(Chromatography, High Pressure Liquid);药物污染(Drug Contamination);模型, 统计学(Models, Statistical);蒙特卡罗法(Monte Carlo Method);诱变剂(Mutagens);软件(Software);串联质谱法(Tandem Mass Spectrometry);工艺学, 制药(Technology, Pharmaceutical)
DOI
10.1016/j.jpba.2017.11.037
PMID
29154196
发布时间
2019-12-10
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