Extractables and Leachables
Providing Support - Insights from the Experts
Capabilities and Expertise
We perform customized, cGMP studies that follow the most current regulatory requirements and guidances.
- Unique insights as a manufacturer of components and devices - nearly 100 years of elastomer experience.
We deliver sound, scientific results. We have dedicated extractable and leachable groups focused on E&L work, which includes industry recognized experts.
We partner with our clients on E&L study design, determination of leachable compounds using our E2L™ assessment, toxicology support, and method development and validation including stability storage and testing.
We offer the following off-the-shelf extractable packages for selected rubber formulations:
- VeriSure™ Report
- Extractables Data Report
- Materials Characterization
- Theoretical Material Extractables
Contact our Technical Customer Support group for additional information regarding the above packages.
New and Novel Techniques
ICP tandem MS offers unparalleled performance for the removal of polyatomic interferences, allowing for ultra trace analysis in the most demanding matrices.
LC/MS Q-ToF and Ion Mobility Q-ToF Instrumentation
- Accurate mass for detected compounds
- Complex matrices are not a problem with the added ion mobility capability. The instrumentation allows for better separation which can lead to more information for unknown compounds.
E2L is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.