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Trace determination of mutagenic alkyl toluenesulfonate impurities via derivatization headspace-GC/MS in an active pharmaceutical ingredient of a candidate drug

文献类型：期刊论文

作者Liu, Xue-Wei1,2; Zhang, Wen-Peng1,2; Han, Hai-Yun1; Sun, Ling1; Chen, Dong-Ying1,2
刊名JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
出版日期2018-06-05
卷号155页码:104-108
关键词Mutagenic impurities Alkyl toluenesulfonate Derivatization Headspace GC/MS
ISSN号0731-7085
DOI10.1016/j.jpba.2018.03.054
文献子类Article
英文摘要This study aims to optimize sodium iodide (Nal) derivatization headspace-GC/MS described in European Pharmacopoeia by using vitamin C as an alternative antioxidant for the determination of mutagenic alkyl toluenesulfonate impurities in an active pharmaceutical ingredient (API) of a candidate drug with an artemisinin derivative. Alkyl toluenesulfonates are transformed into their corresponding alkyl iodides (methyl iodide, ethyl iodide, propyl iodide, and isopropyl iodide) by utilizing the derivatization reagent Nal. Results show that the MS response of methyl iodide is a critical indicator of method robustness because of the deteriorating effects of methyl iodide on stability when sodium thiosulfate is used as an antioxidant originally described in the pharmacopoeia. With vitamin C as a newly developed antioxidant, the robustness of this method is improved significantly. The optimized method is further validated and applied successfully for the quality control and safety of the API of an artemisinin derivative. (C) 2018 Elsevier B.V. All rights reserved.
WOS关键词ESTER GENOTOXIC IMPURITIES ; MASS-SPECTROMETRY ; GAS-CHROMATOGRAPHY ; SULFONATE ; SUBSTANCE ; ACID ; MS
资助项目Shanghai Institute of Materia Medica, Chinese Academy of Sciences for Innovative Pharmaceutical Project[CASIMM0120163011]
WOS研究方向Chemistry ; Pharmacology & Pharmacy
语种英语
WOS记录号WOS:000433267700012
出版者ELSEVIER SCIENCE BV
源URL[http://119.78.100.183/handle/2S10ELR8/279715]  
专题药物质量控制与固体化学研究中心
通讯作者Chen, Dong-Ying
作者单位1.Chinese Acad Sci, Shanghai Inst Mat Med, Lab Pharmaceut Anal, 555 Rd Zuchongzhi,Zhangjiang Hitech Pk, Shanghai 201203, Peoples R China;
2.Univ Chinese Acad Sci, 19A Yuquan Rd, Beijing 100049, Peoples R China
推荐引用方式
GB/T 7714		 Liu, Xue-Wei,Zhang, Wen-Peng,Han, Hai-Yun,et al. Trace determination of mutagenic alkyl toluenesulfonate impurities via derivatization headspace-GC/MS in an active pharmaceutical ingredient of a candidate drug[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,2018,155:104-108.
APA Liu, Xue-Wei,Zhang, Wen-Peng,Han, Hai-Yun,Sun, Ling,&Chen, Dong-Ying.(2018).Trace determination of mutagenic alkyl toluenesulfonate impurities via derivatization headspace-GC/MS in an active pharmaceutical ingredient of a candidate drug.JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,155,104-108.
MLA Liu, Xue-Wei,et al."Trace determination of mutagenic alkyl toluenesulfonate impurities via derivatization headspace-GC/MS in an active pharmaceutical ingredient of a candidate drug".JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 155(2018):104-108.

入库方式： OAI收割

来源：上海药物研究所

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