Who can run an extractables and leachables study?
Extractables studies use solvents and conditions to find what could migrate; leachables studies measure what actually migrates into product. Devices typically follow ISO 10993-18 with a toxicological assessment (ISO 10993-17); pharmaceutical packaging commonly references USP <1663>/<1664>.
What the method covers
Device materials, drug containers, closures and process components; analytics include GC-MS, LC-MS and ICP-MS.
Applicability caveats
- Study design depends on contact type, duration and patient population — design before sending samples.
- Unidentified peaks and analytical evaluation thresholds drive cost and conclusions.
- E&L data needs qualified toxicological interpretation.