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Enhanced capability in leachables and extractables

By January 20, 2025No Comments

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

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.

Comprehensive Testing Capabilities
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.

Meeting Regulatory Expectations
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.

This expanded service complements our newly launched LCMS testing for nitrosamine impurities, offering you a broader range of solutions for product safety and compliance.

If you have questions or would like to discuss your testing needs, please feel free to reach out to us by phone or email.