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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.

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