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Smithers Extractables & Leachables Asia conference

December 5, 2023
December 6, 2023

Shanghai, China

Katrien Salens
+32 16 40 04 84
[email protected]

We’re excited to announce that we will be exhibiting at Smithers Extractables & Leachables Asia conference in Shanghai, China.

Shanghai, China

For more information, please visit: https://www.eandl-conference.com/extractables-leachables-china.

Our scientific Advisor Jan Baeten PhD will present “Selecting the right surrogate standards for semi-quantitative concentration determinations of extractables in GC/MS: what the Nelson Labs Database can learn us.”

This presentation is scheduled Tuesday 5 December at 3:10 pm CET.

In recent years, the utilization of Analytical Chemistry techniques for characterizing extracts from Medical Devices, in alignment with the latest ISO 10993-18:2020 Standard, has experienced significant growth. Biocompatibility assessment, relying on (experimental) Chemical Characterization of Medical Devices, has now become a standard approach for several toxicological endpoints. Nonetheless, an ongoing point of debate revolves around the challenge of rendering a non-targeted analysis, one capable of detecting and identifying a wide array of compounds, adequately reliable and quantifiable to facilitate subsequent toxicological risk analyses.

While authorities recommend using a set of surrogate standards (e.g., three for GC/MS and five for LC/MS) with varying retention times or functional groups to aid in quantifying detected extractables, they provide little to no guidance on the criteria for selecting an appropriate surrogate to quantify a detected compound.

In a first step to address this issue, Nelson Labs has evaluated over 3200 compounds of which the analysis of authentic standards provided relative response values in GC/MS. GC/MS was selected as a first action as it is often a more standardized chromatographic and MS- method and it is considered as the “work horse” in E/L testing. The findings in GC/MS could also lead to guidance on how to optimize the orthogonal and complementary non-targeted analysis methodology (combining different techniques and detectors) it low responding GC/MS compounds could be well defined.

The database of over 3200 compounds was evaluated against a number of physico-chemical properties such as boiling point, molecular weight, retention time, LogKow… While a lot of these parameters show to have some impact on the response of a compound, there is one parameter that stands out and would allow either a differentiated approach in the use of responses for compounds detected in GC/MS or it would allow selecting surrogate standards in a more scientific way.