Type of Posting: Notice of Intent to Revise
Posting Date: 16-Dec-2023
Targeted Official Date: 01-Sep-2023; Interim Revision Announcement
Expert Committee: Small Molecules 1
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 1 Expert Committee intends to revise the Acyclovir monograph.
The intent is to correct the relative retention time (RRT) for Diacetyl guanine and add the RRT for N-Acetylguanine to Table 2. Additionally, it is proposed to add Table 3 to the Organic Impurities procedure to present the current two table format style for relative retention times in Table 2 and acceptance criteria in Table 3.
It is anticipated that the proposed revision will be published as an Interim Revision Announcement in Pharmacopeial Forum 49(2) [Mar. 2023 – Apr. 2023] pursuant to the Rules and Procedures. The comment period for this revision would end on May 31, 2023. In the absence of any adverse comments, the proposed IRA would become official on September 1, 2023.
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