USP Adopts Revised Harmonized Chapter <701> Disintegration

On 26 September 2025, the United States Pharmacopeia (USP) announced the adoption of the revised harmonized Chapter <701> Disintegration, describing procedures to assess whether tablets and capsules disintegrate within a specified time in a liquid medium under defined conditions.

The revision was coordinated through the Pharmacopeial Discussion Group (PDG), with the European Pharmacopoeia acting as the lead, and endorsed by the USP Dosage Forms Expert Committee, bringing the PDG process to Stage 4.

Key updates include the inclusion of the Test B basket-rack assembly for tablets and capsules greater than 18 mm in their longest dimension (not 188 mm, which appears to be a typographical error in the draft). The entire chapter text was also edited to conform with the harmonized sign-off version.

The revised chapter is slated to replace the current <701> version starting 1 October 2026, providing standardized guidance for disintegration testing of dosage forms across pharmacopeias.

06-10-2025