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Acetaminophen

Type of Posting: Notice of Intent to Revise

Posting Date: 26–Jul–2013

Targeted Official Date: Interim Revision Announcement 01–May–2014

Expert Committee: Monographs—Small Molecules 2

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Small Molecules 2 Expert Committee intends to revise the Acetaminophen monograph to correct the Relative Response Factors for Acetaminophen related compound B and Acetaminophen related compound C and clarify the Relative Response Factor for individual unspecified impurity. It is proposed to revise the Relative Response Factor for Acetaminophen related compound B to 1.2 and 0.38 for Acetaminophen related compound C. The Relative Response Factor for individual impurity is going to be specified as 1.0. It is anticipated that the revision will be published as a Proposed Interim Revision Announcement in PF 39(6) [Nov.–Dec. 2013] pursuant to section 7.02 of the Rules and Procedures.

Should you have any questions, please contact Hui-Zhi (Hillary) Cai, Ph.D. (301-230-3379, hzc@usp.org).