Type of Posting: Revision Bulletin
Posting Date: 30–Oct–2009; updated 26–Feb–2010
Official Date: 01–May–2010
Expert Committee: Monograph Development—Pulmonary and Steroids
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 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: Related Compounds
No. of Commenters: 1
Comment Summary: Commenter suggested adding Test 2 for Related compounds since the current method does not resolve all the impurities present in cetirizine hydrochloride manufactured using their process.
Response: An alternative test for impurities was added to be used if either cetirizine ethanol or cetirizine acetic acid are present in the article being analyzed.
An entry for Description and Solubility is also approved and will become official as of the same date as the 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 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).