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USP Statement: USP ISSUES IMMEDIATE INTERIM REVISION ANNOUNCEMENT FOR GENERAL CHAPTER <467> RESIDUAL

Type of Posting: Interim Revision Announcement

Posting Date: 30–Mar–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 USP 30–NF 25. 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 website under Announcements—Explanatory note regarding USP–NF General Chapter <467> Organic Volatile Impurities.

Please direct any comments or questions to Horacio Pappa, Ph.D., Senior Scientist (301-816-8319 or hp@usp.org).