Study of the compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry

Publication date: Available online 15 October 2018Source: Journal of Pharmaceutical AnalysisAuthor(s): Zhaorui Meng, Xun Gao, Haifeng Yu, Lan Zhang, Xiangyong Yu, Longshan ZhaoAbstractA 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 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.
Source: Journal of Pharmaceutical Analysis - Category: Drugs & Pharmacology Source Type: research