Compliance & method work
Regulatory compliance (FDA / EMA / EPA) with GC-UV.
Add spectral identity confirmation to FDA / EMA / EPA-aligned chromatographic methods.
What this objective means
Regulatory compliance work follows agency-issued methods (FDA, EMA, EPA) and underlying guidelines (ICH Q2/Q3, USP, EPA TO/Method series). GC-UV adds the orthogonal identity check that ICH Q2(R2) explicitly recognises.
Why GC-UV fits
UV peak-purity confirmation supports FDA/EMA identity criteria for chromatographic methods.
Reference
ICH Q2(R2) (2023); USP <621>.
Recommended model
INSCAN Lab
Validated platform with full method-validation documentation support.
Typical turnaround
10–20 business days
Typical sample volume
Per regulated method
Typical matrices
Frequently asked questions
Is GC-UV listed in any official method?
GC-UV is currently used as a complementary identity detector. Several pharmacopoeial residual-solvent and L&E workflows include UV confirmation as best practice.
Can GC-UV qualify for 21 CFR Part 11?
Yes — INSCAN data acquisition runs under audit-trailed software designed to support 21 CFR Part 11 in regulated environments.
Related in Compliance & method work
Pharmacopoeia method (USP / EP / JP)
USP / EP / JP-style methods with added spectral identity confirmation.
Method development & validation
End-to-end method development through ICH Q2(R2) validation, with documented evidence.
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?
