| Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry | |
| Alternative Title | Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry |
| Zhaorui Meng1; Xun Gao1; Haifeng Yu2; Lan Zhang2; Xiangyong Yu3; Longshan Zhao1 | |
| 2019 | |
| Source Publication | 药物分析学报:英文版
 |
| ISSN | 2095-1779 |
| Volume | 9.0Issue:003Pages:178-184 |
| Abstract | 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. |
| Other Abstract | 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. |
| Keyword | Compatibility Rubber stoppers Injection Fatty acids GC-MS |
| Indexed By | CSCD |
| Language | 中文 |
| CSCD ID | CSCD:6521749 |
| Citation statistics | |
| Document Type | 期刊论文 |
| Identifier | http://ir.imr.ac.cn/handle/321006/147563 |
| Collection | 中国科学院金属研究所 |
| Affiliation | 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 |
| Recommended Citation 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. |
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