Compatibility of rubber stoppers for recombinant antitumor-antivirus protein injection by gas chromatography-mass spectrometry
- Author:
Zhaorui MENG
1
;
Xun GAO
;
Haifeng YU
;
Lan ZHANG
;
Xiangyong YU
;
Longshan ZHAO
Author Information
1. School of Pharmacy
- Keywords:
Compatibility;
Rubber stoppers;
Injection;
Fatty acids;
GC-MS
- From:
Journal of Pharmaceutical Analysis
2019;9(3):178-184
- CountryChina
- Language:Chinese
-
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, re-spectively. As these values were both below the permitted daily exposure, the migrants can be con-sidered as having low safety risk and do not affect the quality of the injection.
