The Next Evolution in Extractables & Leachables Testing
Medical products ranging from oral medication to biomedical devices undergo rigorous testing to ensure the safety and quality of the products.One of the most important tests is extractables and leachables (E&L) testing. During E&L testing, products are tested for compounds of concern that can leach into the human body and cause safety concerns. One standard way to test for these compounds is gas chromatography-mass spectrometry (GC-MS). The standard approach with GC-MS is to screen for compounds of concern are present, followed by targeted quantification using extensive calibration. The calibration is required for quantification when using GC-MS because response factors can differ significantly from compound to compound. Recently, ARC has completed testing demonstrating the effectiveness of a different approach for E&L: pairing MS with Polyarc-FID. With this ARC split configuration (Figure 1), the effluent of the GC column splits between the MS and Polyarc-FID. The Polyarc system allows for single point accurate quantification, while the MS can provide identification. This new technique has two major benefits over the existing method. No iterative screening is required to identify compounds above the threshold of concern and quantitative analysis for each compound is performed without extensive calibrations. Consistent, linear response factors must be observed for different molecule classes to enable single point surrogate calibration (independent of molecular identity). To show this, nine compounds of five different concentrations each were run on the split system, and relative response factors were recorded for both MS and Polyarc-FID. The results, shown in Figure 2, demonstrate in black that the Polyarc-FID is much more predictable and consistent than MS alone. This enables accurate quantification with a single surrogate standard. Table 1 shows the quantification results on both MS and Polyarc-FID when using a surrogate standard. With this configuration E&L analysis can be simplified for our customers, but more importantly it can result in safer, higher quality medical products for the end users. This approach saves time for analysts, allowing them to increase throughput, as well as consistently screen for all GC-amenable compounds of concern without the worry for low responses in the MS during screening. Figure 1: Polyarc-FID paired with a MS using ARC’s Precision Split™ technology. Figure 2: Comparison of Polyarc/FID (blue circle) and MS (red diamond) Relative Response Factors. Eight common extractable or leachable compounds are shown on the graph Table 1: Quantification using MS and Polyarc-FID Want more information? Automated and Simultaneous Identification and Quantification in E&L, Poster Contact ARC today for all your methanizer related questions.