In accordance with the Rules and Procedures of the Council of Experts, this Revision Bulletin revises General Chapter <701> Disintegration. The background information is as follows:
In the section Disks, the specification for the trapezoidal planes cut into the wall of the disks is revised to allow the depth of the notches produced at the small end to range from 1.5 to 1.8 mm. The current specification is 1.6 ± 0.1 mm (1.5 to 1.7 mm). Comment received indicates that the existing range will exclude disks currently in use in the United States. The current range represents the sign–off text agreed by the European Pharmacopoeia, the Japanese Pharmacopoeia, and USP. The revised range will embrace the dimensions allowed in the harmonized text while including the dimensions found on disks in use in the United States. The revised range also will be published in the European Pharmacopoeia and the Japanese Pharmacopoeia, in acknowledgement of discussions and agreements reached by the Pharmacopeial Discussion Group at their November 2007 meeting in Yokohama, Japan.
Please direct any comments or questions related to the revision to William Brown, Senior Scientist (301-816-8380 or web@usp.org).