Extractables and Leachables Analysis
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.
LC/MS Q-ToF and Ion ICP-QQQ
ICPtandem MS offers unparalleled performance for the removal of polyatomic interferences, allowing for ultra trace analysis in the most demanding matrices.
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.