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Prospective Harmonization

Type of Posting: General Announcement

Posting Date: 09–Nov–2009

In July 2008, USP and the European Pharmacopoeia (PhEur) initiated a Prospective Harmonization pilot study for the joint development of four drug substance monographs and their associated reference materials. Two of the monographs, Montelukast Sodium and Rizatriptan Benzoate, are ready for public comment. In order to coordinate the publication of the monographs proposals with PhEur's Pharmeuropa 21.4 October 2009, USP is presenting the proposals on the USP Web site. The monographs will also appear in Pharmacopeial Forum 36(1) [Jan–Feb 2010]. Comments are due April 15, 2010.