Extractables studies for ENDS & e-liquid products
Working with client subject matter experts, ExtLe Solutions Limited designs and manages Extractables Studies tailored to the client’s requirements.
These studies are designed to utilize solvent systems, extraction conditions, and analytical methodologies fully aligned to current industry guidance documents & directives including
• FDA PMTA
• EU TPD2
• ISO 10993-18:2020
• USP <1663>
• PQRI guidance
Studies are designed to screen for the following groups of extractables, at levels equivalent to appropriate safety thresholds:
• Volatile Extractables
• Semi Volatile Extractables
• Non-Volatile Extractables
• Elemental Extractables
If required, the methodologies employed to screen for the above groups of extractables can be designed to include the capability of quantifying levels of any of the 38 named PMTA constituents.
The world class Extractables data generated by our CRO partners will be fully compiled into an extensive Extractables Report containing all results, conclusions and expert recommendations on next steps.
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