期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 25, 期 3-4, 页码 379-386出版社
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/S0731-7085(00)00517-3
关键词
solid phase microextraction; SPME; gas chromatography; mass spectrometry; GC/MS; off-odor; pharmaceutical packaging
The use of a solid phase microextraction (SPME) sampling technique, in conjunction with gas chromatography/ mass spectrometry (GC/MS) analysis, to identify an off-odor in a heat-stressed pharmaceutical packaging material is described. The ability of the commercially available polydimethylsiloxane (PDMS) coated microfiber to concentrate a trace volatile compound of interest enabled identification of the odor compound of interest. Despite being present at levels that defied detection using conventional headspace sampling techniques, ethyl-2-mercaptoacetate was determined to be the compound responsible for the offending odor. Formation of the thioester resulted from an unanticipated reaction (either esterification or transesterification) between a common residual solvent (ethanol), present in a commonly used pharmaceutical tablet dispersant, and low-level amounts of reactants or synthetic intermediates of an FDA-approved polyvinyl chloride (PVC)-resin thermal stabilizing agent. (C) 2001 Elsevier Science B.V. All rights reserved.
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