Lab

HPTLC fingerprinting (botanical identity)

TL;DR

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 engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

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/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

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