方案摘要
方案下载应用领域 | 制药/生物制药 |
检测样本 | 其他 |
检测项目 | 溶出物 |
参考标准 | - |
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.
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
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