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Extractables Studies

Working with client subject matter experts, ExtLe Solutions Limited designs, manages, and executes Extractables Studies, that are tailored for the clients manufacturing process and/or product.

 

These 'Controlled' Extractables Studies are designed to utilise solvent systems, extraction conditions, and analytical methodologies, that are fully aligned to current regulatory expectations, including

  • USP <1663>

  • Relevant FDA & EMA guidance on container closure systems

  • PQRI guidance

  • BPOG guidance

The world class Extractables data generated by our CRO partners include, but are not limited to

  • Volatile Extractables  

  • Semi Volatile Extractables

  • Non Volatile Extractables

  • Elemental Extractables aligned to the guidance provided by ICH Q3D

  • Extractable Silicone Oil (if relevant)

Data are fully 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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