How to Overcome Uncertainty Factors in E&L Testing

Extractables and leachables (E&L) testing is a crucial factor where product quality in a broad range of application areas is concerned, especially in applications where poor control of certain products can significantly impact human health. This includes medical devices, pharmaceutical products, and food contact materials which are among the most strictly controlled goods from an E&L perspective. Nevertheless, it is still common practice to carry out E&L testing with relative quantitation and surrogate standards. This is due to the great variety of observable species and the lack of consistent reference standards.

One typical issue that arises from the shortcomings of traditional E&L testing is the fluctuations and changeability relative to response factors (RF). Separate compounds at equal concentrations may provide signal intensities that differ completely, therefore, demonstrating differential RF values. This may affect quantitative accuracy, as well as any equivalent toxicological risk assessments.

Jordi Labs has explored a broad spectrum of techniques for limiting RF variation and, consequently, the requirement for uncertainty factors in E&L testing. The latest publication presents how Jordi Labs reduced RF variation utilizing a multidetector approach to E&L testing, producing better accuracy and reducing the need for uncertainty factors.

E&L Testing with Jordi Labs

Jordi Labs is the foremost authority on E&L testing. Download the publication using the following link and contact a member of the team if you would like further information regarding the multidetector approach.

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This information has been sourced, reviewed and adapted from materials provided by Jordi Labs.

For more information on this source, please visit Jordi Labs.

 

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