Lab
Disintegration USP <2040>
TL;DR
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> ...
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.
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