ANYL 146 |
| Polyvinyl chloride, PVC, film has been widely used in medical devices for last 50 years and satisfied the demanding requirements of the healthcare industry. However, there is increasing concern on potential impurities released from some container closure systems based in PVC films, so called extractables/leachables, in the recent years due to the health consideration. This poster is intended to demonstrate a methodology on how to perform a controlled extraction from the PVC film to determine the extractables in PVC film. The experiment was carried out under a heat-induced extraction of PVC films at appropriate time and temperatures by utilizing the appropriate extraction apparatus. The volatile extractables evolved from PVC films were analyzed by Gas Chromatographic-Mass Spectroscopy (GC/MS) Headspace analyzer and quantitated against the reference standards. All experiments were performed in duplicate using GC/MS analysis in evaluating the headspace gases evolved at different incubation times and temperatures in the absence of solvent. The case study shows two organic compounds were found to be “hits” when the mass spectra were referenced against the NIST Library – 2-ethyl-1-hexanol and 2-ethylhexyl mercaptoacetate. The identity of each compound was then confirmed by the standards of 2-ethyl-1-hexanol and 2-ethylhexyl mercaptoacetate. The results showed that LOD of the method was lower than 0.1 ng. In addition, the comparison of the extractables from PVC films made from different lots and/or different manufacturers provides users a potential suggestion on a proper type of PVC films to be utilized in a container closure system. |
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General Posters
7:00 PM-9:00 PM, Sunday, August 19, 2007 BCEC -- Exhibit Hall - B2, Poster
Division of Analytical Chemistry |