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ICP-MS heavy metals (USP <2232>)

TL;DR

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 ...

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 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.
Related terms
Heavy Metals Supplements
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