USP <2040> is the disintegration test specific to dietary supplement tablets and capsules: 30 minutes for uncoated tablets, 45 minutes for plain coated, 60 minutes for delayed-release in buffered medium. A supplement marketed as 'enteric' or 'delayed release' must pass <2040> two-stage testing (1 h in 0.1 N HCl then buffer) or it cannot make the modified-release claim under DSHEA.

Regulatory anchors

USP <2040>

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.