Pharmaceutical Quality Control
Confirm structure, not just mass — for APIs, excipients, and release testing.
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.
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.
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.
- Linear range
- >4 decades
- Spectral range
- 176–330 nm
- Detection limit
- ppb (compound dependent)
What the lab actually does.
- STEP 01
Sample prep
Standard headspace or liquid injection — no derivatisation required for most impurity panels.
- STEP 02
Separation
Existing GC method retained; INSCAN attaches in line with or in place of the FID.
- STEP 03
Spectral acquisition
Full UV spectrum captured at every chromatographic point — no scan-time penalty.
- STEP 04
Library match
Automatic comparison against in-house and reference UV libraries; reviewer confirms with a single click.
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
The right INSCAN for Pharma QC.
INSCAN LAB
Drop-in benchtop detector for routine QC labs already running GC-FID or GC-MS.
Explore productGC-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.
Talk to us about Pharma QC.
Application notes, sample testing, and integration discussions for licensing, co-development, and OEM partners.
