Determination of Response Uncertainty Factor for Liquid Chromatography-Mass Spectrometry with Diode Array Detection (LC-DAD-MS) Using 34 Polymer Extractable Compounds

This technical note describes the determination of an uncertainty factor in LC-DAD-MS based on various compounds which are extractables from polymers/medical devices. Standards are injected at known concentrations, responses measured and a database is created which allows estimation of uncertainty based on the standard deviation of the dataset. An uncertainty factor of 2.4 was found for the dataset analyzed (using diode array detection). This uncertainty factor (rounded to 2) can be applied when screening for unknown material extractables compounds in order to estimate semi-quantitative amounts that are present without the analysis of an authentic reference standard for each species.