High-Performance Thin-Layer Chromatography (HPTLC) fingerprinting is the chromatographic-image identity test used to confirm botanical raw materials against a validated reference (AHP, USP, HPTLC Association atlas). It satisfies 21 CFR 111.75(a)(1)(i) when the fingerprint matches the reference for the declared species under defined developing solvent, derivatisation and visualisation — and it discriminates adulteration that DNA-only methods miss in extracts where DNA has been processed away.

Regulatory anchors

21 CFR 111.75

How V5 handles it

QMS — quality records next to the work they concern.

Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.

Document control — one version in force, every change signed and explained.

Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

HPTLC fingerprinting (botanical identity)

Next step

HPTLC fingerprinting (botanical identity)

Next step