USP Statement
USP ISSUES IMMEDIATE INTERIM REVISION ANNOUNCEMENT FOR GENERAL CHAPTER <467> RESIDUAL SOLVENTS EFFECTIVE JUNE 1, 2007.
March 30, 2007
The General Chapter <467> method for water-insoluble articles located
in the section "Identification, Control, and Quantification of Residual Solvents" is
being revised to replace the existing procedure for these products with a new
procedure. Changes proposed in PF 32(5) related to the analytical procedures
are also included in this Immediate Interim Revision Announcement, while the
remaining changes will appear in the 2nd Supplement to USP30–NF25. In
addition, the chapter now indicates that users may skip Procedures A and B
and test articles according to Procedure C, based on information available
from the manufacturing process. Additional information regarding General Chapter <467> can
be found on USP's Web site under Announcements – Explanatory note regarding
USP–NF General Chapter <467> Organic Volatile Impurities at http://www.usp.org/USPNF/notices/generalChapter467.html.
Please direct any comments or questions to Horacio Pappa, Ph.D., Senior Scientist (301-816-8319 or ).
