Posting Date: 28–Jan–2011
Official Date: 01–Feb–2011
Expert Committee: Monographs—Small Molecules 3
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Mycophenolate Mofetil Tablets monograph. The purpose for the revision is to accommodate the sponsors' FDA-approved specifications:
- Revise the specifications under Organic impurities as follows:
- Increase the limit of mycophenolic acid from NMT 0.7% to NMT 1.0%
- Increase the limit of total degradation products from NMT 1.0% to NMT 1.5%
- Add Dissolution Test 2 and Dissolution Test 3 for two recently FDA-approved products
- Include a correction factor for calculation of the dissolved amount at the second time point to Dissolution Test 1.
The Mycophenolate Mofetil Tablets Revision Bulletin supersedes the Mycophenolate Mofetil Tablets monograph in Supplement 2 to the USP 33–NF 28 Reissue, which was scheduled to become official on February 1, 2011. The Revision Bulletin will be incorporated into the Second Supplement to USP 34–NF 29.