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Deferoxamine Mesylate

Type of Posting: Revision Bulletin

Posting Date: 29–Apr–2011

Official Date: 01–May–2011

Expert Committee: Monographs—Small Molecules 3

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Deferoxamine Mesylate monograph. The purpose for the revision is to accommodate the sponsor's FDA-approved acceptance criteria under Assay and Organic Impurities as follows:

  • Widen the Assay acceptance criteria from 95.0%–102.0% to 93.0%–102.0%
  • Increase the limit of Impurity A from NMT 1.5% to NMT 3.0%
  • Replace the current limit of total impurities of NMT 5.0% with two separate specifications:
    • NMT 5.0% for all impurities eluting before deferoxamine peak
    • NMT 2.0% for all impurities eluting after deferoxamine peak

The Deferoxamine Mesylate Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in USP 35–NF 30.

Should you have any questions, please contact Elena Gonikberg, Ph.D. (301-816-8251 or eg@usp.org).