Type of Posting: Revision Bulletin
Posting Date: 31–Jan–2013
Official Date: 01–Feb–2013
Archive Date: 09–Feb–2015
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 Tacrolimus Capsules monograph. The purpose of the revision is to revise the monograph as follows:
- To include Dissolution Test 4 to accommodate the sponsor’s FDA-approved parameters and tolerances.
- To revise the limit of Tacrolimus 8‐epimer in Organic Impurities Procedure 2 from 0.2% to 0.5% to accommodate the sponsor’s FDA-approved limit.
The Tacrolimus Capsules Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 36–NF 31.
Should you have any questions, please contact Ahalya Wise (301-816-8161 or aww@usp.org).