1P-35 PDF
Analysis for Extractable and Leachable Compounds from Polymeric Materials
Extractable and leachable compounds, which are potentially harmful to human health, are of great concern to manufacturing industries, particularly manufacturers of food contact materials and of materials intended for use in the pharmaceutical industry or in medical devices. Recent changes in regulatory requirements have resulted in an increased need for the accurate analysis of these compounds.
This study focused on a group of 18 polymer additives (e.g. Irganox<SUP>®<SUP> 1010, Ethanox<SUP>®<SUP> 330, et.al.) that would be of interest in analyses for extractables and leachables. Samples of polymeric materials were extracted with isopropanol. Analyses were performed for extractable and leachable compounds using a new tandem quadrupole system. Due to the diverse nature of the compounds in this assay, different ionization methods were investigated to determine the method that provided the best overall sensitivity of these extractable and leachable compounds. Using positive/negative polarity switching, a MRM method has been developed to analyze for a suite of extractable/leachable compounds.