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Karl Fischer moisture (USP <921>)

TL;DR

Karl Fischer titration (volumetric or coulometric, USP <921>) is the reference moisture method for supplement actives, excipients and finished doses where loss-on-drying overstates water by including volatiles. Coulometric KF (10 µg–10 mg water) is the routine choice for hygro...

Karl Fischer titration (volumetric or coulometric, USP <921>) is the reference moisture method for supplement actives, excipients and finished doses where loss-on-drying overstates water by including volatiles. Coulometric KF (10 µg–10 mg water) is the routine choice for hygroscopic vitamins (B12, folate, D3 beadlets), softgel shell moisture and fish-oil water content; the result feeds the stability model and the overage calculation.

Regulatory anchors
  • USP <921>
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.
Related terms
Granulation Loss on Drying (LOD)
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