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Extractables studies for ENDS & e-liquid products

Working with client subject matter experts, ExtLe Solutions Limited designs & manages Extractables Studies tailored to the clients requirements. 

These studies are designed to utilize solvent systems, extraction conditions, and analytical methodologies fully aligned to current industry guidance documents and directives including

  • PMTA 

  • TPD2

  • USP <1663>

  • ISO 10993-18:2020

  • 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 in addition the client requires support with determining extractable levels of any of the 38 HPHCs named in the PMTA guidance, ExtLe Solutions can manage the development and validation of specific analytical methods to establish these levels.

 

The world class Extractables data generated by our CRO partners will be compiled into an extensive Extractables Report containing all results, conclusions and expert recommendations on next steps. 

Click on the button below to arrange an initial no obligation discussion of your requirements.

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