Leachables studies for ENDS & e-liquid products
ExtLe Solutions Limited designs & manages Leachables Studies that are individually tailored for client’s products.
Differences in device shape and mode of operation lead to unique challenges when conducting leachables testing of ENDS & e-liquid products. Therefore, a product by product approach is taken when designing suitable studies.
Appropriate shelf life & accelerated storage conditions, time points and analytical methodologies are utilised to ensure full alignment with current regulatory expectations, including the FDA PMTA guidance, the EU Tobacco Products Directive (TPD2) and other industry guidance documents including USP <1664> & USP <1664.1>.
Analytical leachable methods are developed and validated by our CRO partners, to ensure leachables are detectable at levels equivalent to relevant safety thresholds. These analytical methods can be either ‘specific’ and/or ‘screening’ in nature. For example, screening methods will be appropriately developed and validated for the determination of:
• Volatile Leachables
• Semi Volatile Leachables
• Non-Volatile Leachables
• Other Elemental Leachables
If in addition, the client requires support with determining what levels of the 38 named PMTA constituents are in their product, or with determining what levels of these constituents are delivered by their product, ExtLe Solutions can manage the development and validation of specific analytical methods to establish these levels.
Where any leachable is observed above a pre-agreed action threshold, which will have been defined from the Analytical Evaluation Threshold, which in turn will have been defined from a relevant daily exposure threshold (e.g. PQRI SCT), a full safety assessment will be performed by a qualified toxicologist.
An interim leachables report is produced at each time point, including trending of any observed leachable levels, with a final version generated at the end of the study.
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