Levofloxacin

Type of Posting: 
Revision Bulletin
Posting Date: 
29–Jul–2011
Official Date: 
01–Aug–2011
Expert Committee: 
Monographs—Small Molecules 4
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 Levofloxacin monograph. The purpose of the revision is to accommodate the sponsor’s FDA approved specifications as follows:

  • Using a flexible monograph approach, Organic Impurities Procedure 2 and Procedure 3 are added to the monograph to capture potential impurities and the corresponding limits from a different synthetic route. A note is added to specify that the currently official Organic Impurity procedure is now designated as Procedure 1 and Organic impurities, Procedures 2 and Procedure 3 are recommended if levofloxacin related compound B is a potential organic impurity.

    • These newly added liquid chromatographic procedures were previously published on the USP Pending Monographs Web site as a part of the Authorized Pending Monograph. The HPLC procedures used in the Organic impurities, Procedure 2 is based on analysis performed with the YMC-OD-A brand of L1 column. The typical retention time of Levofloxacin peak is about 7.7 min. The HPLC procedure used in for Enantiomeric purity, Procedure 3 is based on analysis performed with the Symmetry Shield RP18 brand of L1 column. The typical retention time of Levofloxacin peak is about 6.9 min.

  • Widen the acceptance criteria for Assay from 98.5%–102.0% to 98.0%–102.0%.

  • Widen the limit for water content from 2.1%–2.7% to 2.0%–3.0%.

This Levofloxacin Revision Bulletin supersedes the currently official Levofloxacin monograph. The Revision Bulletin will be incorporated in USP 35–NF30, First Supplement.

Should you have any questions, please contact Behnam Davani, Ph.D. (301-816-8394 or bd@usp.org).