Type of Posting: Revision Bulletin
Posting Date: 29–Apr–2011
Official Date: 01–May–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 4 Expert Committee has revised the Lamotrigine Tablets monograph. The purpose for the revision is to:
- Add Dissolution Test 3 for a new generic product.
- Clarify sample solution preparation for Assay and Organic impurities tests.
The Lamotrigine Tablets Revision Bulletin supersedes the currently official monograph and replaces the monograph in USP 34–NF 29, which was scheduled to become official on May 1, 2011. The Revision Bulletin will be incorporated in USP 35–NF 30.