Compliance & method work
Method development & validation with GC-UV.
End-to-end method development through ICH Q2(R2) validation, with documented evidence.
What this objective means
Method development designs the chromatographic and detector conditions; validation proves the method is fit for purpose. GC-UV gives an additional identity dimension that simplifies specificity and forced-degradation studies.
Why GC-UV fits
Spectral confirmation simplifies specificity and forced-degradation acceptance criteria during validation.
Reference
ICH Q2(R2) (2023).
Recommended model
INSCAN Lab
Best fit for development teams; transferable to OEM/X afterwards.
Typical turnaround
15–30 business days
Typical sample volume
Per method scope
Typical matrices
Frequently asked questions
Do you provide validation documentation?
Yes — full validation packages aligned with ICH Q2(R2) (specificity, linearity, range, accuracy, precision, LOD/LOQ, robustness, identity).
Can methods be transferred to other labs?
Yes. Vapour-phase UV spectra are instrument-agnostic, which makes inter-lab transfer simpler than with intensity-only detectors.
Related in Compliance & method work
Regulatory compliance (FDA / EMA / EPA)
Add spectral identity confirmation to FDA / EMA / EPA-aligned chromatographic methods.
Pharmacopoeia method (USP / EP / JP)
USP / EP / JP-style methods with added spectral identity confirmation.
Method transfer / cross-lab harmonization
Transfer methods between sites without losing identity confirmation.
Routine QA/QC release testing
Identity + assay + purity in a single acquisition for routine release testing.
Ready to scope it?
