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
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.
Related in Impurity & trace work
Trace impurity identification
Pull trace impurities out of noisy baselines and confirm them spectrally — in one run.
Unknown peak identification
Use the UV spectrum at the peak apex to identify what your other detectors cannot.
Residual solvents (USP <467> / ICH Q3C)
Compendial residual-solvent testing with spectral identity confirmation built in.
Degradation & stability products
Spot, identify and quantify degradation products as they appear over a stability study.
Ready to scope it?
