Comparison of approaches for quantifying extractables in a variety of polymeric medical device materials with LC-MS/MS.

Abstract

Quantification by LC-MS using electrospray ionization (ESI) is challenging due to various factors that influence signal intensity. The gold standard involves the use of isotopically labelled standards spiked into the sample. However, for the analysis of extractable compounds from polymeric materials in medical devices, such standards are often unavailable. Nevertheless, these extractables must be monitored and quantified in accordance with regulatory requirements. In this study, we compared diff