USP: Harmonized Chapter <701> Disintegration Adopted

On 26 September 2025, the United States Pharmacopeia (USP) announced the adoption of the revised harmonized chapter <701> Disintegration.

General Chapter <701> Disintegration describes the procedure to determine whether tablets or capsules disintegrate within a prescribed time when placed in a liquid medium under defined conditions.

The revision was approved by the Pharmacopeial Discussion Group (PDG), with the European Pharmacopoeia acting as the coordinating pharmacopoeia, and endorsed by the USP Dosage Forms Expert Committee. With this, the PDG process has reached Stage 4 (formerly Stage 6). 

A Notice of Adoption of Harmonized Standard lists the following major changes:

• "Inclusion of the Test B Basket-rack Assembly to be used with tablets and capsules that are greater than 188-mm[*] on their longest axis."
  * Note: According to the draft published in PF 49(5), this appears to be a typographical error; it should likely read 18 mm: :"Use the Test A basket-rack assembly for tablets and capsules that are not greater than 18 mm at the longest dimension."

In addition,

• "the text of the entire chapter was edited to conform to the sign-off version of the harmonization chapter."

The revised chapter will replace the current version of <701> from its targeted official date of 1 October 2026.