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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