Inductively coupled plasma mass spectrometry (ICP-MS) is the routine technique for the four elemental impurities Pb, As, Cd, Hg in dietary supplements per USP <2232> (with USP <233> validation and <232>/ICH Q3D limits where applicable). Microwave acid digestion + ICP-MS gives sub-ppb sensitivity on a single sample; the limits in <2232> are daily-intake based and tighten further under California Prop 65's 0.5 µg/day lead Safe Harbor.

Regulatory anchors

USP <2232>
USP <233>
Prop 65

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.

Related terms

Heavy Metals Supplements

ICP-MS heavy metals (USP <2232>)

Next step

ICP-MS heavy metals (USP <2232>)

Next step