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Disintegration USP <2040>

In short

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 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
f2 similarity factor (dissolution)Tablet friability USP <1216>
Software that covers Disintegration USP <2040>
V5 Ultimate (Dietary Supplements)
V5 Ultimate runs Master Manufacturing Records and executed Batch Production Records under 21 CFR Part 111, with mandatory…
V5 Ultimate Dietary Supplements
Written for supplement contract manufacturers and brand owners tired of surviving FDA 483s on paper.
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