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.
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