Extractables and Leachables

Smithers Rapra is a leading authority for E&L assessments. Our experts have a proven track record of developing and delivering comprehensive E&L assessments tailored to your specific needs in our FDA registered laboratories.

This expertise derives from Smithers Rapra's 90 year history of working with rubber and plastic materials, our medical and pharmaceutical industry experience and our excellent understanding of analytical chemistry. 

The examination of Extractable and Leachable substances is extremely important for the protection of patients and for regulatory documentation destined for authorities such as the FDA and EMA. Find out more about Extractables and Leachables.

Smithers Rapra provides customised studies designed around your requirements

Extractables and Leachables Testing and Support

Smithers has a wealth of experience to share, to support our clients to effectively and efficiently develop, test, validate and document their products for qualification and regulatory submission. We understand that you have specific requirements that need to be addressed. Understanding E&L regulations, deciding on a suitable test strategy, and meeting timelines and resource restraints, can be a challenge for those new to E&L. Because we know that decisions made early in an E&L study will affect later stages, we can guide you through what is required, and how best to meet your needs, to support your regulatory submission and protect patients. We will:

  • Listen to your requirements
  • Understand your needs
  • Advise on strategies
  • Deliver your results
What We Provide

Each stage of an E&L study is designed with you, to develop a customised service.

  • We will provide all study plans and reports throughout the life of the project. Analysis will be performed within our FDA registered laboratories.
  • Our dedicated E&L experts will advise on the most appropriate programs of work and ensure that your regulatory requirements are fulfilled.
  • We have been performing analysis on rubbers and plastics almost from their point of invention. This expertise is unique, meaning:
    • We have generated in-house GC-MS, LC-MS and FT-IR library databases of many substances in order to aid identification of extractable and leachable substances.
    • Our scientists have developed the expertise to understand Extractable and Leachable substances, their origins and degradation products.
  • Smithers Rapra has an open door policy and sponsors are welcome to visit our site and discuss any issues with us directly.
Expert Support

As material and E&L experts, we can offer our services on a purely consultative basis. We regularly support

Contact Smithers Rapra about Extractables and Leachables

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