Type of Posting: Revision Bulletin
Posting Date: 28–Sep–2012
Official Date: 01–Oct–2012
Archive Date: 09–Feb–2015
Expert Committee: Monographs—Small Molecules 1
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 1 Expert Committee has revised the Primaquine Phosphate monograph. The purpose of this revision is to accommodate the sponsor’s updated FDA-approved specifications under Organic Impurities. The organic impurity with relative retention time of 1.8, previously listed as “specified unidentified impurity” is now identified as secaquine (N3-(6-methoxyquinolin-8-yl)pentane-1.3-diamine), and its limit is widened from NMT 0.50% to NMT 0.80%.
The Primaquine Phosphate Revision Bulletin supersedes the currently official monograph and replaces the monograph in the Revision Bulletin posted on December 29, 2011 which became official January 1, 2012 and is being incorporated in the Second Supplement to USP 35–NF 30. This Revision Bulletin will be incorporated in First Supplement to USP 36–NF 31.
Should you have any questions, please contact Leonel Santos (301-816-8168 or lxs@usp.org).