Extractables and Leachables Analysis

Providing Support - Insights from the Experts

West has been performing E&L studies for almost 20 years and has the scientific knowledge to design and execute E&L studies and to interpret the results. West partners with our clients to help navigate through the challenging regulatory landscape to provide them with meaningful E&L information.


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.


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.    

    LC/MC Q-ToF and Ion Mobility Q-To-F Instrumentation

    Extractables and Leachables Video







    E2L is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.