We offer a complete suite of extractables and leachables (E&L) testing services to assist in the evaluation of the manufacturing process, including single use systems (SUS), final container/closure, drug delivery devices and overall packaging configuration of your product.

Adhering to ICH guidelines and in full compliance with cGMP requirements, we perform method development and validation for necessary analytical techniques. In addition, you can access our support and expertise through our toxicological risk assessments on your E&L data to meet FDA and global regulatory submission requirements.

Products We Test

  • Medical devices
  • Containers
  • Container closure systems
  • Raw materials
  • Single use systems (SUS)
  • Manufacturing components, including rubber closures for parenteral products
  • Primary and secondary packaging

Extractables and Leachables Services

We offer comprehensive E&L testing services to evaluate final fill, intermediate storage and manufacturing systems:

  • Development of tailored E&L study designs
  • Development of optimized protocols based on FDA guidelines
  • Controlled extraction studies
  • Extractables profiling and identification
  • Simulation studies
  • Leachables studies on drug product over shelf life and/or accelerated stability programs
  • E&L method development, validation and routine testing

Extractables and Leachables Instrumentation

Our experts leverage state-of-the-art instrumentation to produce high-quality data and submission-ready results. Our technology includes:

  • HPLC-MS, UPLC-MS, HPLC-MS/MS, HPLC high-resolution MS
  • HPLC-UV/CAD/ELSD, UPLC-UV/CAD/ELSD
  • HS-GC-MS, GC-MS, GC-FID, GC-ECD
  • ICP-OES, ICP-MS, IC
  • FTIR, NMR
  • TGA, DSC

Contact our analytical testing team by clicking below

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