Evaluation of stir-bar sorptive extraction coupled with thermal desorption GC–MS for the detection of leachables from polymer single use systems to drugs
Abstract(#br)Stir-bar Sorptive Extraction (SBSE) in combination with thermal desorption and gas chromatography-mass spectrometry (TD-GC–MS) is widely accepted as the gold–standard analysis method for trace amounts of organic substances, including leachables in aqueous matrices. Meanwhile, as far as pharmaceutical quality control in protein-based parenteral drugs is concerned, the use of SBSE analysis remains unexplored. Previous studies reported a strong influence of the matrix on the method’s recovery.