Type of Posting: Notice of Intent to Revise
Posting Date: 28-Jan-2022; updated 11–Feb–2022
Targeted Official Date: 01-Jan-2023; Interim Revision Announcement
Expert Committee: Small Molecules 2
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 2 Expert Committee intends to revise the Acetaminophen monograph.
Comments were received that indicate manufacturers cannot consistently meet the requirement of the Relative standard deviation, NMT 1.0%, in the Assay in the Acetaminophen monograph. Based on supporting data, the Expert Committee proposes to revise the concentration of Standard solution and Sample solution and the injection volume so that the requirement of the Relative standard deviation can be met.
It is anticipated that the proposed revision will be published as a proposed Interim Revision Announcement in Pharmacopeial Forum 48(4) [Jul.–Aug. 2022] pursuant to the Rules and Procedures of the Council of Experts. If published as anticipated, the comment period for this revision would end on September 30, 2022. In the absence of certain comments necessitating revisions, the proposed IRA would become official on January 1, 2023.
Should you have any questions, please contact Mark Tiedje, Senior Scientist II (mark.tieje@usp.org).
CN-22-033-01
This Notice was updated on February 11, 2022 to provide updated contact information for the responsible Documentary Standards Scientist.