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.

Knowledge

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.
Expertise

We deliver sound, scientific results. We have dedicated extractable and leachable groups focused on E&L work, which includes industry recognized experts.

Service

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 IonICP-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.    

    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.


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