In accordance with the Rules and Procedures of the 2005–2010 Council of Experts and the USP Pending Monographs Guideline, the Monograph Development—Pulmonary and Steroids Expert Committee (MDPS) has approved the Cetirizine Hydrochloride Oral Solution monograph to move from an Authorized Pending Monograph to official USP–NF status. At the time of approval of the official monograph, the Expert Committee incorporated changes to the Authorized text in order to accommodate information provided by another FDA approved manufacturer.
The following is a summary of the comments received:
Section: Multiple
No. of Commenters: 1
Comment Summary #1: Commenter suggested that the limit for glyceryl ester of cetirizine should be changed from 0.3% to 0.5% based on their approved ANDA.
Response: Comment incorporated.
Comment Summary #2:Commenter suggested that the limit for total impurities should be changed from 0.75% to 0.8% based on their approved ANDA.
Response: Comment incorporated.
Comment Summary #3:Commenter suggested that the acceptance criterion for the test for Chloride <191> be changed to, "Oral solution responds to the tests for Chloride <191>, except that turbidity is produced, rather than a white, curdy precipitate when the silver nitrate TS is added", to be in agreement with their results.
Response: Comment not incorporated. The Expert Committee reviewed the information and concluded that the current procedure is suitable.
Expert Committee Initiated Change: The names of the impurities listed in Impurity Table 1 were changed to make them consistent with the drug substance monograph.
USP plans to post a Revision Bulletin in December 2009 for the USP Reference Standards <11> entries. This Revision Bulletin supersedes the Authorized Cetirizine Hydrochloride Oral Solution Pending Monograph that was published on the USP Pending Monographs web site. The Revision Bulletin will be incorporated in the First Supplement to the USP 33–NF 28 Reissue, and the monograph will be in the redesign format at that time. USP also will post the redesigned monograph upon availability of the First Supplement, as well as retain the original, non-redesigned version with this Revision Bulletin.
Should you have any questions, please contact Domenick Vicchio, Ph.D. (301-998-6828 or dwv@usp.org).