Analytical Method Development for 19 Alkyl Halides as Potential Genotoxic Impurities by Analytical Quality by Design.

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作者： Kyoungmin,Lee ^[1] ; Wokchul,Yoo ^[2] ; Jin Hyun,Jeong ^[1]

作者单位： College of Pharmacy, Yonsei Institute of Pharmaceutical Sciences, Yonsei University, 85 Songdogwahak-ro, Yeonsu-gu, Incheon 21983, Korea. ^[1] Analytical Research Department, Central Research Institute, Hanmi fine Chemical, 59 Gyeongje-ro, Siheung-si 15093, Korea. ^[2]

关键词 (Q)SAR GC–MS alkyl halide analytical QbD analytical method development genotoxic impurity

主题词 DNA损伤(DNA Damage);药物污染(Drug Contamination);制药工业(Drug Industry);气相色谱-质谱法(Gas Chromatography-Mass Spectrometry);质谱分析法(Mass Spectrometry)

DOI 10.3390/molecules27144437

PMID 35889310

发布时间 2022-07-31

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