Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry

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	Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry
	Zhaorui Meng 2; Xun Gao 2; Haifeng Yu 3; Lan Zhang 3; Xiangyong Yu 1; Longshan Zhao 2
刊名	药物分析学报:英文版
	2019
卷号	9.0 期号:003 页码:178-184
关键词	Compatibility Rubber stoppers Injection Fatty acids GC-MS
ISSN号	2095-1779
其他题名	Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry
英文摘要	A simple, rapid, and sensitive gas chromatography-mass spectrometry (GC-MS) method was developed and validated for the simultaneous determination of two fatty acids, methyl hexadecanoate (MH) and methyl stearate (MS), to allow the evaluation of packaging-drug compatibility. The two migrants were quantified in selective ion-monitoring (SIM) mode, with limits of detection (LOD) of 0.0030 μg/mL and 0.0121 μg/mL. Linear calibration curves for MH and MS were obtained in the concentration ranges of 0.1011–5.0570 μg/mL and 0.2015–10.0740 μg/mL, respectively. The developed method was successfully applied to estimate the safety of the injection of recombinant antitumor-antivirus protein (RAAP). The results showed that the possible maximum daily intake was 3.0 ng and 12.1 ng for MH and MS, respectively. As these values were both below the permitted daily exposure, the migrants can be considered as having low safety risk and do not affect the quality of the injection.
语种	中文
CSCD记录号	CSCD:6521749
内容类型	期刊论文
源URL	[http://ir.imr.ac.cn/handle/321006/147562]
专题	金属研究所_中国科学院金属研究所
作者单位	1.中国科学院金属研究所 2.沈阳药科大学 3.Anshan Institute for Food and Drug Control, Anshan
推荐引用方式 GB/T 7714	Zhaorui Meng,Xun Gao,Haifeng Yu,et al. Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry[J]. 药物分析学报:英文版,2019,9.0(003):178-184.
APA	Zhaorui Meng,Xun Gao,Haifeng Yu,Lan Zhang,Xiangyong Yu,&Longshan Zhao.(2019).Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry.药物分析学报:英文版,9.0(003),178-184.
MLA	Zhaorui Meng,et al."Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry".药物分析学报:英文版 9.0.003(2019):178-184.