Impurity & trace work

    Residual solvents (USP <467> / ICH Q3C) with GC-UV.

    Compendial residual-solvent testing with spectral identity confirmation built in.

    What this objective means

    Residual solvent testing under USP <467> / ICH Q3C requires identification and quantification of Class 1, 2 and 3 solvents in APIs and excipients. GC-UV adds a spectral identity check to every peak alongside the headspace-GC quantitation.

    Why GC-UV fits

    USP <467> Class 1–3 solvents have characteristic UV absorption that confirms peak identity beyond retention time.

    Reference

    USP <467>; Walsh, P. et al., J. Pharm. Biomed. Anal. 158, 384–391 (2018).

    Recommended model

    INSCAN Lab

    Validated benchtop platform aligned with compendial GC requirements.

    Typical turnaround

    3–5 business days

    Typical sample volume

    50–500 mg API / 1–5 mL formulation

    Typical matrices

    Pharma formulations & APIsStatic headspaceDynamic headspace / purge & trap

    Frequently asked questions

    Is GC-UV compendially acceptable for USP <467>?

    USP <467> specifies a GC procedure with FID. GC-UV runs as a complementary identity-confirmation detector; the FID quantitation can be retained if needed.

    Does GC-UV cover all three solvent classes?

    Yes — most Class 1, 2 and 3 solvents (benzene, chlorinated solvents, alcohols, ethers) are UV-active in the deep UV.

    Related in Impurity & trace work

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