Type of Posting: Revision Bulletin
Posting Date: 28–Sep–2012
Official Date: 01–Oct–2012
Archive Date: 09–Feb–2015
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 Oxaliplatin Injection monograph. The purpose for the revision is to revise the limit for any individual unspecified impurity from NMT 0.20% to NMT 0.2% in the Organic impurities to accommodate the sponsor's FDA-approved specification.
The Oxaliplatin Injection Revision Bulletin supersedes the currently official Oxaliplatin Injection monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 36–NF 31.
Should you have any questions, please contact Feiwen Mao (301-816-8320 or fm@usp.org).