Galantamine Hydrobromide

Type of Posting: 
Revision Bulletin
Posting Date: 
26–Nov–2008
Official Date: 
15–Dec–2008
Expert Committee: 
Monograph Development—Psychiatrics and Psychoactives Expert Committee (MDPP)
Transferred to Accelerated Revision History section: 
01–Dec–2009

In accordance with the Rules and Procedures of the 2005–2010 Council of Experts, the Monograph Development—Psychiatrics and Psychoactives Expert Committee (MDPP) has revised the Related Compounds test of Galantamine Hydrobromide Monograph Revision Bulletin to align with the specifications in several newly approved ANDAs, as follows:

  • Include three new specified impurities: N–Desmethylgalantamine with a limit of NMT 0.6%, O–Desmethylgalantamine with a limit of NMT 0.20%, and Narwedine with a limit of NMT 0.15%
  • Add a more commonly known trivial name, Galantamine N–oxide, for 6β–Hexahydrogalantamine
  • Add a more commonly known trivial name, Epigalantamine, for 6∂–Hexahydrogalantamine.

This Revision Bulletin is official as of December 15, 2008, and supersedes the currently official monograph in the forthcoming print version of USP 32–NF 27. This revision will be published in print in USP 32–NF 27 Second Supplement, which becomes available in June 2009.

Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330 or rr@usp.org).