Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: September 26, 2025
Targeted Official Date: October 1, 2026
Expert Committee: General Chapters–Dosage Forms
Coordinating Pharmacopoeia: European Pharmacopoeia
A revision to the harmonized standard for the currently existing chapter <701> Disintegration has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Rev. 2 sign-off cover sheet. Having reached Stage 4 (former Stage 6) of the PDG process, the revised general chapter of <701> Disintegration has been formally approved by the USP Dosage Forms Expert Committee in accordance with the Rules and Procedures of the 2020-2025 Council of Experts. General Chapter <701> Disintegration will become official from October 1, 2026.
Major changes:
- Inclusion of the Test B Basket-rack Assembly to be used with tablets and capsules that are greater than 18-mm* on their longest axis.
Additional changes:
The text of the entire chapter was edited to conform to the sign-off version of the harmonization chapter
- Download General Chapter <701> Disintegration
- Download the Disintegration PDG Sign-Off Cover Page:
- Previous Stage 6 posting in PF 31 (2), 2005 (IRA)
- Previous Stage 6 posting in PF 31 (1), 2005
Should you have any questions about this General Chapter, please contact Margareth Marques (301-816-8106 or mrm@usp.org). For any questions about the PDG and its processes, please contact Richard Lew at (240-221-2060 or rll@usp.org).
*Corrected on October 20, 2025