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

IMR OpenIR

	Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry
其他题名	Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry
	Zhaorui Meng 1; Xun Gao 1; Haifeng Yu 2; Lan Zhang 2; Xiangyong Yu 3; Longshan Zhao 1
	2019
发表期刊	药物分析学报:英文版
ISSN	2095-1779
卷号	9.0 期号:003 页码:178-184
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.
其他摘要	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.
关键词	Compatibility Rubber stoppers Injection Fatty acids GC-MS
收录类别	CSCD
语种	中文
CSCD记录号	CSCD:6521749
引用统计	被引频次：1[CSCD] [CSCD记录]
文献类型	期刊论文
条目标识符	http://ir.imr.ac.cn/handle/321006/147563
专题	中国科学院金属研究所
作者单位	1.沈阳药科大学 2.Anshan Institute for Food and Drug Control, Anshan 3.中国科学院金属研究所
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.