Type of Posting: Revision Bulletin
Posting Date: 23–Nov–2011
Official Date: 01–Dec–2011
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 Lamivudine monograph. The purpose for the revision is to widen the limit for water determination test from 0.2% to 2.0% to accommodate the sponsor's FDA-approved specification. This revised limit for water determination test was previously published on the USP Pending Monographs website as a part of the Authorized Pending Monograph.
The Lamivudine Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 35–NF 30.
Should you have any questions, please contact Behnam Davani, Ph.D. (301-816-8394 or bd@usp.org).