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)