Response Factor Variation for Extractables and Leachables

Video Credit: Jordi Labs

Chemical analysis for leachables is one of the principal methods used to evaluate the substances that leach from pharmaceutical packaging, medical devices, and food packaging, and pose a risk to patients and consumers. Numerous high-profile incidents have shown that leachables can have severe effects on product safety and can also lead to product recalls. One notable example of this is the widely publicized transfer of bisphenol A from baby bottles, but other examples associated with children’s medication and food contact applications (cereal packaging) have also been reported.[1],[2],[3]

Fundamental to precise chemical analysis and risk assessment processes where Extractables and Leachables (E&L) are concerned is being able to determine and quantify relevant species in relevant solutions, and conducting a suitable toxicological analysis.

Identification and quantification are both complicated areas of analytical science due to the broad range of potential leachables and extractables. Furthermore, these methods can be challenging due to the complexity of many leachables solutions as well as the absence of appropriate reference standards.

Therefore, the industry has addressed the latter problem by combining relative quantitation with surrogate standards. However, this can lead to errors and miscalculation in quantitation due to response factor variation, i.e. divergent detector responses for compounds present at an equal concentration. This video presentation reports the results of a methodical study examining the response factors for E&L compounds. Response factor variation was investigated using three different detector systems (LCMS, UV, CAD) and the variation or divergence in response factors by each detector was cross-examined to identify which detectors are more universal and for which various compound classes.

Furthermore, comparative studies of the stability of the response factors on multiple LCMS-UV-CAD systems were conducted. These comparisons were performed to determine if response factor databases produced on one instrument could be transferred to alternative platforms without causing any additional errors. Conclusively, the overall effect of response factor variation on quantitative accuracy will be emphasized, and the appropriate guidance will be offered for the prime detector configurations to limit quantitative error.

References and Further Reading

[1] Update on Bisphenol A for Use in Food Contact Applications: January 2010. https://www.fda.gov/food/food-additives-petitions/bisphenol-bpa-use-food-contact-application

[2] Kellogg Company Voluntarily Recalls Select Packages of Kellogg’s® Corn Pops®, Kellogg’s® Honey Smacks®, Kellogg’s® Froot Loops® and Kellogg’s® Apple Jacks®. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kellogg-company-voluntarily-recalls-honey-smacks-cereal-due-possible-health-risk

[3] McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica. https://www.in.gov/isdh/files/McNeil_Consumer_Healthcare_Recall.pdf

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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