药包材中萃取物和浸出物检测方案(气质联用仪)

Extractables and Leachables Analysis of lVBag Systems 要： To ensure the safety of pharmaceutical products， the monitoring of potentially harmful contaminantsoriginating from the product itself or its packaging is necessary. In this study， IV bag components wereanalyzed for extractables using direct thermal desorption/thermal extraction combined with unitresolution GC/MS system. The results were compared to those obtained for leachables by stir barsorptive extraction of an aqueous solution stored in the exact same type of lV bag， again combinedwith GC/MS determination of the leached compounds. In addition， a high resolution GC/Q-TOF massspectrometer was used to confirm or refute some of the analyte identifications obtained usingcommercial library searches with the unit resolution MSD system o Agiler ilagim Agilent Technologies To ensure the safety of pharmaceutical products, the monitoring of potentially harmful 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 extraction 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