<701> Disintegration

Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 26–April–2019
Targeted Official Date: 01–May–2020
Expert Committee: General Chapters—Dosage Forms
Coordinating Pharmacopoeia: USP

The revision to the harmonized standard for disintegration testing of pharmaceutical dosage forms has been approved by the Pharmacopeial Discussion Group (PDG) as described in the PDG sign-off cover sheet. Having reached Stage 4 of the PDG process, General Chapter <701> Disintegration has been formally approved by the General Chapters—Dosage Forms Expert Committee in accordance with the Rules and Procedures of the 2015–2020 Council of Experts.

This revised standard provides information on the dimensional description of the apparatus in standard format and corrects the description of the disks used in disintegration testing.

The revision to <701> Disintegration General Chapter will be incorporated into and become official with USP 43-NF 38.

Should you have any questions about this General Chapter, please contact Will Brown (301-816-8380 or web@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or rll@usp.org).