Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry
查看参考文献25篇
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文摘
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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. |
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来源
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Journal of Pharmaceutical Analysis
,2019,9(3):178-184 【核心库】
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DOI
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10.1016/j.jpha.2018.10.002
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关键词
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Compatibility
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Rubber stoppers
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Injection
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Fatty acids
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GC-MS
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地址
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1.
School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, 110016
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Anshan Institute for Food and Drug Control, Anshan, 114006
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Shenyang Wellwolf Pharmaceutical Science and Technology Co., Ltd, Shenyang, 110022
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语种
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英文 |
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文献类型
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研究性论文 |
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ISSN
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2095-1779 |
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学科
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化学;药学 |
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文献收藏号
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CSCD:6521749
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