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Mometasone Furoate Topical Solution

Type of Posting: Revision Bulletin

Posting Date: 30–Sept–2010

Official Date: 01–Oct–2010

Expert Committee: Monographs—Small Molecules 2

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monograph—Small Molecules 2 (SM2) Expert Committee has revised the Mometasone Furoate Topical Solution monograph. The purpose for the revision is to accommodate the sponsor's FDA-approved specifications for Organic impurities as follows:

  • Increase the limit of 21-Chloro-9β,11β-epoxy-17-hydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) from NMT 0.9% to NMT 1.0%
  • Increase the limit of Unspecified individual impurity from NMT 0.2% to NMT 0.5%
  • Increase the limit of Total impurities from NMT 1.3% to NMT 2.0%

The Mometasone Furoate Topical Solution Revision Bulletin supersedes the currently official monograph and will be incorporated in the First Supplement to USP 34–NF 29.

Should you have any questions, please contact Clydewyn Anthony (301-816-8139 or cma@usp.org).