静脉输液袋系统中可萃取物和可浸出物分析检测方案(气质联用仪)

To ensure the safety of pharmaceutical products, the monitoring of potentially harm-ful contaminants originating from the product itself or its packaging is necessary. In this study, IV bag components were analyzed for extractables using direct thermal desorption/thermal extraction combined with unit resolution GC/MS system. The results were compared to those obtained for leachables by stir bar sorptive extrac-tion of an aqueous solution stored in the exact same type of IV bag, again combined with GC/MS determination of the leached compounds. In addition, a high resolution GC/Q-TOF mass spectrometer was used to confirm or refute some of the analyte identifications obtained using commercial library searches with the unit resolution MSD system.