| 气相色谱法检测泊洛沙姆188中环氧化物杂质 |
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| 引用本文： | 段梦茹,何东升,孙会敏,熊晔蓉,涂家生. 气相色谱法检测泊洛沙姆188中环氧化物杂质[J]. 药学研究, 2020, 39(6): 331-335,340 |
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| 作者姓名： | 段梦茹 何东升 孙会敏 熊晔蓉 涂家生 |
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| 作者单位： | 中国药科大学药学院,药用辅料及仿创药物研发评价中心,江苏 南京210009;中国食品药品检定研究院,国家药品监督管理局药用辅料质量研究与评价重点实验室,北京100050 |
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| 基金项目： | 国家科技重大专项-重大新药创制（No.2017ZX09101001-006-002）；国家药典委员会-药品医疗器械审评审批制度改革专项课题（No.ZG2017-5-03） |
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| 摘 要： | 目的 利用气相色谱法建立泊洛沙姆188中环氧乙烷、环氧丙烷及1,4-二氧六环的含量检查方法。方法 以超纯水作为溶剂，采用顶空气相色谱法检测泊洛沙姆188中环氧乙烷、环氧丙烷及1,4-二氧六环含量。结果 该方法的系统适用性、专属性、线性、精密度和准确度均符合规定，9批泊洛沙姆样品中均未检出环氧乙烷，环氧丙烷及1,4-二氧六环。结论 该方法简便、准确、可靠，可用于泊洛沙姆188中环氧乙烷、环氧丙烷及1,4-二氧六环含量检测。
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| 关 键 词： | 泊洛沙姆188 顶空气相色谱法 环氧乙烷 环氧丙烷 1 4-二氧六环 |
Determination of Epoxide Impurity in Poloxamer 188 by Gas Chromatography |
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| DUAN Mengru,HE Dongsheng,SUN Huimin,XIONG Yerong and TU Jiasheng. Determination of Epoxide Impurity in Poloxamer 188 by Gas Chromatography[J]. Journal of Pharmaceutical Research, 2020, 39(6): 331-335,340 |
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| Authors: | DUAN Mengru HE Dongsheng SUN Huimin XIONG Yerong TU Jiasheng |
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| Abstract: | Objective To establish the method for the determination of ethylene oxide, propylene oxide and 1,4-dioxane in poloxamer188 by gas chromatography.Methods Using ultrapure water as solvent, the content of ethylene oxide, propylene oxide and 1,4-dioxane in poloxamer188 was determined by headspace gas chromatography.Results The gas chromatography validation results for system suitability,specificity,linearity,precision,recovery,all met the requirement. Ethylene oxide, propylene oxide and 1,4-dioxane were not detected in the 9 batches of poloxamer samples.Conclusion The method is simple, accurate and reliable, and can be used for the detection of ethylene oxide, propylene oxide and 1,4-dioxane in poloxamer188. |
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| Keywords: | Poloxamer188 Headspace gas chromatography Ethylene oxide Propylene oxide 1,4-dioxane |
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