Type of Posting: Revision Bulletin
Posting Date: 30–Dec–2009; updated 18–Mar–2010
Official Date: 01–Feb–2010
Expert Committee: Monograph Development—Gastrointestinal, Renal, and Endocrine
In accordance with the Rules and Procedures of the 2005–2010 Council of Experts, the Monograph Development—Gastrointestinal, Renal, and Endocrine Expert Committee has revised the Levothyroxine Sodium Tablets Monograph. Using a flexible monograph approach, the alternative Assay preparation under the Assay and Test solution under the Limit of liothyronine sodium are included in the monograph for the Tablets that meet the requirements of the Dissolution Test 3. The calculations under Assay and Limit of liothyronine sodium are revised to eliminate numerical coefficients which are not applicable to the alternative preparations.
The Levothyroxine Sodium Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to the USP 33–NF 28 Reissue and the monograph will be in the redesigned format at that time. USP also will retain the original, non-redesigned version with this Revision Bulletin.
Should you have any questions, please contact Elena Gonikberg (301-816-8251 or eg@usp.org).