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Modafinil Tablets

Type of Posting: Revision Bulletin

Posting Date: 30–Nov–2012

Official Date: 01–Dec–2012

Archive Date: 09–Feb–2015

Expert Committee: Monographs—Small Molecules 4

Reason for Revision: Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Modafinil Tablets monograph. The purpose for the revision is to:

  • Add Dissolution Test 2 for a new generic product approved by the FDA.
  • Widen the acceptance criteria for any individual unspecified impurity from NMT 0.1% to NMT 0.2% to be consistent with FDA-approved specifications. The limit for total impurities remains unchanged.

The Modafinil Tablets Revision Bulletin supersedes the currently official Modafinil Tablets monograph. The Revision Bulletin will be incorporated in Second Supplement to USP 36–NF 31.

Should you have any questions, please contact Mary Waddell (301-816-8124 or msw@usp.org.)