Impurity & trace work

    Genotoxic / nitrosamine impurities with GC-UV.

    Nitrosamine and genotoxic impurity screening with selective deep-UV sensitivity.

    What this objective means

    Genotoxic impurity testing screens for trace electrophilic contaminants — most notably nitrosamines (NDMA, NDEA) — at the AI/TTC limit. GC-UV exploits the strong N–N=O absorption around 230 nm for selective detection.

    Why GC-UV fits

    The N-nitroso chromophore has a strong, characteristic UV absorption that gives selective response far above an FID baseline.

    Reference

    EMA/369136/2020 Guidance on nitrosamine impurities; ICH M7(R2).

    Recommended model

    INSCAN Lab

    Highest sensitivity and validated for regulated impurity workflows.

    Typical turnaround

    7–14 business days

    Typical sample volume

    100–500 mg API

    Typical matrices

    Pharma formulations & APIsStatic headspaceDynamic headspace / purge & trap

    Frequently asked questions

    Can GC-UV reach the 0.03 ppm AI for nitrosamines?

    Yes — concentration via headspace or solvent extraction plus the strong N–N=O absorption brings nitrosamines into the detectable range without GC-MS/MS.

    How is identity confirmed?

    By spectral match against a reference nitrosamine spectrum at the peak apex — orthogonal to retention time.

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