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Leachables and Extractables Testing

We have been conducting extractable studies since the early 2000s, adapting to increasingly complex requirements driven by evolving regulations and a deeper understanding of the risks posed by compounds leaching from plastic packaging materials and manufacturing apparatus.

Chemika has expanded its leachables and extractables testing services with the recent commissioning of a triple quadrupole LCMS system.

Our new LCMS system enhances our existing capabilities, which include:

  • Headspace GCMS and direct injection GCMS: Together, these techniques cover a broad range of compounds, from volatiles to semi-volatiles and non-volatiles.
  • ICP-OES and ICP-MS: These systems allow for full screening and quantification of potential elemental extractables.

We are fully prepared to help you meet your obligations for leachables testing. Our team is well-versed in the latest guidelines, including:

  • USP chapters <1663>, <1664>, and <1665>
  • Upcoming ICH Q3E guidance on leachables