CONTACT US
+44 (0) 1223 756577 , +44 (0) 7841 647537 contact@extlesolutions.com

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.

Ready To Talk?

If you're ready to discuss your requirements and would like to arrange a call with us click the button below, otherwise if you have general questions or comments please don't hesitate to get in touch

Registered in England No. 10155666 | VAT No. 246 7451 88
© 2021 ExtLe Solutions Limited. All Rights Reserved
View our Privacy Policy