Type of Posting: Revision Bulletin
Posting Date: 29–Dec–2011; updated 24–Feb–2012*
Official Date: 01–Jan–2012
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 new FDA-approved specifications by widening the acceptance criteria in:
- Definition and Assay from “98.0%–102.0%” to “97.0%–102.0%”
- Organic Impurities for Specified unidentified impurity (at RRT of 1.8) from “0.30%” to “0.50%”
The Primaquine Phosphate Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 35–NF 30.
Should you have any questions, please contact Leonel Santos, Ph.D. (301-816-8168 or lxs@usp.org).
* Table 1 now appears below the Acceptance criteria section. In the previous version it was above this section.