Type of Posting: Revision Bulletin
Posting Date: 26–Mar–2010
Official Date: 01–May–2010
Expert Committee: Monograph Development—Ophthalmology, Oncology, and Dermatology Expert Committee
In accordance with the Rules and Procedures of the 2005–2010 Council of Experts, the Monograph Development—Ophthalmology, Oncology, and Dermatology Expert Committee has revised the Methotrexate monograph. The purpose for the revision is to accommodate the sponsor’s FDA-approved specifications for the limits of MTX–1–monomethylester and MTX–5–monomethylester in the Organic impurities.
The Methotrexate Revision Bulletin supersedes the currently official monograph and will be incorporated in the USP 34–NF 29.
Should you have any questions, please contact Feiwen Mao (301-816-8320 or fm@usp.org).