All impact areas
    Pharma QC

    Pharmaceutical Quality Control

    Confirm structure, not just mass — for APIs, excipients, and release testing.

    The Context

    Pharmaceutical QC laboratories live and die by the certainty of their identifications. Regulatory frameworks — ICH Q3A/B, USP <467>, EP 2.4.24 — demand confirmation of impurities and residual solvents at increasingly low levels. The hardest cases are positional and stereo-isomers of an active ingredient: they share a molecular formula and a mass spectrum, yet differ in toxicology, potency, and stability. GC-UV resolves these structural ambiguities directly from the electronic spectrum, providing a second, orthogonal dimension of identity that mass spectrometry cannot deliver alone.

    The Challenges

    What conventional detection misses.

    Genotoxic impurities at ppm levels

    Nitrosamines, alkyl halides and aromatic amines must be quantified far below the API's specification — and unambiguously distinguished from benign isomers.

    Residual solvent class confirmation

    ICH Q3C class 1 and 2 solvents include positional isomers (e.g. xylenes, dichloroethanes) that elute close to one another on standard columns.

    Cross-contamination in shared facilities

    Multi-product lines need rapid, unambiguous detection of trace carryover between API campaigns.

    The GC-UV Answer

    How INSCAN resolves it.

    • Electronic absorption spectra in 176–330 nm provide a structural fingerprint independent of fragmentation behaviour.
    • Lambert-Beer quantification removes ionisation variability — calibration curves are linear over four orders of magnitude.
    • Non-destructive detection allows a downstream MS or FID confirmation on the same chromatographic run.
    At a glance
    Linear range
    >4 decades
    Spectral range
    176–330 nm
    Detection limit
    ppb (compound dependent)
    The Workflow

    What the lab actually does.

    1. STEP 01

      Sample prep

      Standard headspace or liquid injection — no derivatisation required for most impurity panels.

    2. STEP 02

      Separation

      Existing GC method retained; INSCAN attaches in line with or in place of the FID.

    3. STEP 03

      Spectral acquisition

      Full UV spectrum captured at every chromatographic point — no scan-time penalty.

    4. STEP 04

      Library match

      Automatic comparison against in-house and reference UV libraries; reviewer confirms with a single click.

    Where it's used

    Typical applications.

    • Genotoxic impurity screening (NDMA, NDEA, NMBA)
    • Residual solvent analysis per ICH Q3C / USP <467>
    • API isomer purity (ortho/meta/para; cis/trans)
    • Cleaning validation in shared manufacturing suites
    • Excipient identity and supplier qualification
    Recommended platforms

    The right INSCAN for Pharma QC.

    Recommended

    INSCAN LAB

    Drop-in benchtop detector for routine QC labs already running GC-FID or GC-MS.

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    Recommended

    INSCAN

    Integrated GC-UV platform for high-throughput release testing.

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    Questions answered

    GC-UV for Pharma QC — FAQ.

    Specifics that matter to lab managers, method developers and process owners evaluating GC-UV against existing GC-MS or GC-FID workflows.

    How does GC-UV improve genotoxic impurity (NDMA / NDEA) testing in pharma?
    GC-UV records the full electronic absorption spectrum of every eluting compound, giving an identity that is orthogonal to mass spectrometry. For nitrosamines such as NDMA and NDEA, this provides a second, structure-based confirmation that defends against false positives from isobaric interferences common in API matrices.
    Can INSCAN replace GC-MS for ICH Q3C residual solvent analysis?
    INSCAN can serve as the primary detector or as an orthogonal confirmation alongside MS. For most ICH Q3C class 1 and 2 solvents — including positional isomers like xylenes and dichloroethanes — UV spectra deliver baseline-resolved identification with Lambert-Beer-traceable quantitation across more than four decades.
    Is GC-UV accepted under USP <467> and EP 2.4.24?
    USP <467> and EP 2.4.24 are detector-agnostic: they specify performance criteria (linearity, LOQ, specificity) rather than mandating a detector. GC-UV satisfies all of these criteria and is increasingly used as either the primary or confirmatory detector in compendial workflows.
    Does INSCAN integrate with existing GC-FID or GC-MS instruments in QC labs?
    Yes. INSCAN LAB is engineered as a drop-in detector that attaches in line with or in place of an FID, leaving the existing GC method, autosampler and data system untouched. Most pharma QC labs validate the addition with a comparative bridging study.
    What detection limits can GC-UV reach for pharma impurities?
    Compound-dependent detection limits are typically in the low- to sub-ppb range for aromatic and conjugated impurities, with linear quantitation extending across more than four orders of magnitude — sufficient for ICH Q3A/B threshold work and most genotoxic impurity panels.

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