Compliance & method work

    Regulatory compliance (FDA / EMA / EPA) with GC-UV.

    Add spectral identity confirmation to FDA / EMA / EPA-aligned chromatographic methods.

    What this objective means

    Regulatory compliance work follows agency-issued methods (FDA, EMA, EPA) and underlying guidelines (ICH Q2/Q3, USP, EPA TO/Method series). GC-UV adds the orthogonal identity check that ICH Q2(R2) explicitly recognises.

    Why GC-UV fits

    UV peak-purity confirmation supports FDA/EMA identity criteria for chromatographic methods.

    Reference

    ICH Q2(R2) (2023); USP <621>.

    Recommended model

    INSCAN Lab

    Validated platform with full method-validation documentation support.

    Typical turnaround

    10–20 business days

    Typical sample volume

    Per regulated method

    Typical matrices

    Pharma formulations & APIsDrinking & wastewaterVOCs in ambient air

    Frequently asked questions

    Is GC-UV listed in any official method?

    GC-UV is currently used as a complementary identity detector. Several pharmacopoeial residual-solvent and L&E workflows include UV confirmation as best practice.

    Can GC-UV qualify for 21 CFR Part 11?

    Yes — INSCAN data acquisition runs under audit-trailed software designed to support 21 CFR Part 11 in regulated environments.

    Related in Compliance & method work

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