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Mirtazapine Tablets

Type of Posting: Notice of Intent to Revise

Posting Date: 29–Jul–2011

Targeted Official Date: Interim Revision Announcement, 01–May–2012

Expert Committee: Monographs—Small Molecules 4

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 4 Expert Committee intends to revise the Mirtazapine Tablets monograph. The purpose of the revision is to revise the Organic Impurities test by including a Table identifying process impurities and degradants along with their relative retention times and appropriate relative response factors. In addition, the Dissolution section is revised to include a formula to calculate the percentage of mirtazapine dissolved.

It is anticipated that the revision will be published as a Proposed Interim Revision Announcement in PF 37(6) [Nov.–Dec. 2011] pursuant to section 7.02 of the Rules and Procedures.

Should you have questions, please contact Ravi Ravichandran, Ph.D., Principal Scientific Liaison to the Monographs—Small Molecules 4 Expert Committee (301-816-8330 or