Type of Posting: Revision Bulletin
Posting Date: 24–Nov–2010; updated 06–Dec–2010*
Official Date: 01–Dec–2010
Expert Committee: Monographs—Small Molecules 1
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 Valacyclovir Hydrochloride monograph. The purpose of this revision is to accommodate the sponsor’s FDA-approved specifications for the following:
- Widen the limit of Heavy Metals from NMT 10 ppm to NMT 20 ppm
- Widen the limit of Water (for the hydrous form) from 5.0%–9.0% to 5.0%–11.0%
- Delete the limit of Total unspecified impurities (NMT 0.2%)
This Valacyclovir Hydrochloride Revision Bulletin supersedes the currently official monograph and will be incorporated in the Second Supplement to USP 34–NF 29.
Should you have any questions, please contact Leonel Santos (301-816-8168 or lxs@usp.org).
* The third item in the list above ("Delete the limit of Total unspecified impurities (NMT 0.2%)") was added to document a comprehensive list of revisions contained in the Revision Bulletin. The PDF Revision Bulletin has not changed from the original posting.