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Residual Solvents: General Notices and General Chapter <467>—Implementation Date Delayed

Type of Posting: Revision Bulletin: POSTPONEMENT

Posting Date: 12–Mar–2006

The Executive Committee of the Council of Experts has voted to delay the implementation date for the new requirements related to USP General Chapter <467> from January 1, 2007 to July 1, 2007. This decision affects two sections of the USP–NF: General Notices and the General Chapter. This decision, which is presented in the 4th IRA in Pharmacopeial Forum 32(4), states: "The implementation date of the section on Residual Solvents in the General Notices and the change in the title of General Chapter <467> from Organic Volatile Impurities to Residual Solvents will be delayed from January 1, 2007 to July 1, 2007." Additionally, the section in <467> titled Other Analytical Procedures, originally slated to be deleted at the time when the title changes, will be kept in the chapter until the new implementation date. Users should also recall that references to "Residual Solvents <467>: meet the requirements" were retracted from USP–NF monographs according to the Notice of Retraction issued by USP on January 1, 2006. Specifications for Organic Volatile Impurities <467> in USP–NF monographs will remain official until July 1, 2007. After July 1, 2007, the change in the title of General Chapter <467> and the General Notices statement on Residual Solvents will be effective, and references to Organic Volatile Impurities will be deleted from monographs.

Please direct any comments or questions to Horacio Pappa, Ph.D., Senior Scientist (+1-301-816-8319 or hp@usp.org).