Type of Posting: Revision Bulletin
Posting Date: 27–Jul–2012
Official Date: 01–Feb–2013
Archive Date: 09–Feb–2015
Expert Committee: Monographs—Small Molecules 1
Reason for Revision: Pending to Official Status
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 1 Expert Committee has approved the Famciclovir monograph to move from an Authorized Pending Monograph to official USP–NF status because the FDA has approved the sponsor’s application. The Expert Committee has also approved the following changes to accommodate specifications for other FDA approved products:
- Widened the limit of 6-chloro famciclovir from NMT 0.10% to NMT 0.15% under Organic Impurities
- Widened the limit for Heavy Metals from 10 µg/g to 20 µg/g
The liquid chromatographic procedure in the Assay is based on analyses performed with the Zorbax SB C8 brand of L7 column. The typical retention time for famciclovir is 4 min.
The liquid chromatographic procedure in the test for Organic Impurities is based on analyses performed with the Sunfire C8 brand of L7 column. The typical retention time for the famciclovir peak is 16 min.
The Revision Bulletin will be incorporated in the First Supplement to USP 36–NF 31. Should you have any questions, please contact Behnam Davani, Ph.D. (301-816-8394 or bd@usp.org).