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Weight variation USP <2091>

TL;DR

USP <2091> weight variation, the supplement-specific complement to drug-product Uniformity of Dosage Units <905>, requires that the average weight of 10 dosage units fall within ±10% (single-component supplements) or ±15% (multi-component) of the labelled weight, with no indiv...

USP <2091> weight variation, the supplement-specific complement to drug-product Uniformity of Dosage Units <905>, requires that the average weight of 10 dosage units fall within ±10% (single-component supplements) or ±15% (multi-component) of the labelled weight, with no individual unit outside double those limits. It is the routine in-process and release test for capsules, tablets and softgels in 21 CFR 111 plants.

Regulatory anchors
  • USP <2091>
  • 21 CFR 111.70
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
Capsule Content UniformityTablet Compression Supplements
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