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Karl Fischer moisture (USP <921>)

In short

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 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.
Related terms
Granulation Loss on Drying (LOD)
Software that covers Karl Fischer moisture (USP <921>)
V5 Ultimate Dietary Supplements
Written for supplement contract manufacturers and brand owners tired of surviving FDA 483s on paper.
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