Type of Posting: Revision Bulletin
Posting Date: 22–Mar–2013
Official Date: 01–Apr–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 monograph. The purpose of the revision is to revise the monograph as follows:
- Widen the limits of tacrolimus 8-epimer and tacrolimus 8-propyl analog in Organic Impurities Procedure 2 from 0.1% to 0.15% to accommodate the sponsor’s FDA-approved limits.
- Add a footnote regarding total impurities to Table 3 in Organic Impurities Procedure 2 for consistency with a similar footnote in Table 2 in Organic Impurities Procedure 1.
- Revise the relative standard deviation criterion in Organic Impurities Procedure 2 to remove the reference to tacrolimus open ring, which is not observed in the chromatograms.
The Tacrolimus Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in USP 37–NF 32.
Should you have any questions, please contact Ahalya Wise (301-816-8161 or aww@usp.org).