Extractables & Leachables
Expertise in E&L to support you from early stages of development through the full lifecycle of your product.
Resolian’s dedicated Extractables and Leachables (E&L) team will provide the data to allow assessment of the safety and compatibility of your product with its selected storage and delivery devices, as required by regulators. This analytical data will enable you to profile extractables from the primary packaging or device materials, and target leachables in the final product.
Resolian is committed to providing you the analytical solutions you need to ensure the safety and compliance of your products.
Reach out to us directly to learn more about Resolian’s Extractables & Leachables services.
Services in Detail
Resolian offers extensive expertise in assessing extractables and leachables testing, including:
- Pharmaceuticals
- Biopharmaceuticals
- Animal healthcare
- Consumer healthcare
- Medical devices
- Single-use systems
- Nicotine delivery products
Tailored Study Designs: Tailored to your unique needs, and in line with the latest regulatory guidelines, Resolian delivers data to support a regulatory submission or change of manufacturing process, device component or supplier.
E&L Screening Studies: Extractables and Leachables studies utilize organic and inorganic screening methods (HS-GCMS, GCMS, HR-LCMS, ICP-MS) with a range of sample preparation techniques for your specific sample matrix to enable identification and quantification of compounds of concern.
Accelerated Leachables Studies: Can be utilized to provide you with timely results and insights into potential leachables and aid in defining the testing requirements for related stability trials.
Characterization of Unknowns: Resolian specializes in characterizing unknown components, providing you with a complete understanding of potential extractables and leachables.
Validation of Leachable Assay Methods: The E&L team can develop and validate assay methods for leachables of concern, allowing targeted monitoring throughout stability trials or shelf life of the product.
