Compliance & method work

    Method development & validation with GC-UV.

    End-to-end method development through ICH Q2(R2) validation, with documented evidence.

    What this objective means

    Method development designs the chromatographic and detector conditions; validation proves the method is fit for purpose. GC-UV gives an additional identity dimension that simplifies specificity and forced-degradation studies.

    Why GC-UV fits

    Spectral confirmation simplifies specificity and forced-degradation acceptance criteria during validation.

    Reference

    ICH Q2(R2) (2023).

    Recommended model

    INSCAN Lab

    Best fit for development teams; transferable to OEM/X afterwards.

    Typical turnaround

    15–30 business days

    Typical sample volume

    Per method scope

    Typical matrices

    All — discussed during scoping

    Frequently asked questions

    Do you provide validation documentation?

    Yes — full validation packages aligned with ICH Q2(R2) (specificity, linearity, range, accuracy, precision, LOD/LOQ, robustness, identity).

    Can methods be transferred to other labs?

    Yes. Vapour-phase UV spectra are instrument-agnostic, which makes inter-lab transfer simpler than with intensity-only detectors.

    Related in Compliance & method work

    Ready to scope it?

    Let's discuss your method development & validation project.

    Start the conversation