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Extractables and Leachables Analysis of IV Bag Systems using Direct Thermal Extraction of the Materials and Stir Bar Sorptive Extraction of Aqueous Solutions coupled with Thermal Desorption Gas-Chromatography with Unit Mass and High Resolution Mass Spectrometric Detection


Keywords: Pharmaceutical, Packaging, IV bags, intravenous delivery systems, Extractables, Leachables, Single Quad Mass Spectrometry, Time-of-Flight Mass Spectrometry, Stir Bar Sorptive Extraction (SBSE), Thermal Desorption, Thermal Extraction, Gas Chromatography

ABSTRACT

IV bag components were analyzed for extractables using direct thermal desorption/thermal extraction combined with a unit mass resolution GC/MSD system. The results were compared to those obtained for leachables by stir bar sorptive extraction of an aqueous simulant stored in the exact same type of IV bag, again combined with GC/MS determination of the leached compounds. In addition, the high resolution GC/Time of Flight (TOF) mass spectrometer was used to verify or disprove some of the MSD findings.

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