Type of Posting: Notice of Intent to Revise
Posting Date: 01–Feb–2008
The Biopharmaceutics Expert Committee will propose a revision to the Alendronate Sodium Tablets monograph. The monograph will be revised to include tolerances that will apply to all approved manufacturers (e.g., addition of another Dissolution test with a concomitant labeling requirement).
It is anticipated that the revision proposal will be published in an upcoming issue of Pharmacopeial Forum and the corresponding official date for the new Dissolution test will be indicated.
Should you have any questions, please contact Margareth Marques, Ph.D., Senior Scientist and Liaison to the Biopharmaceutics Expert Committee (301-816-8106 or firstname.lastname@example.org).