Revision Bulletin

Levetiracetam

In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, the Monograph Development–Psychiatrics and Psychoactives Expert Committee has approved the Levetiracetam Monograph to move from a Pending Standard to official USP-NF status because the U.S. Food and Drug Administration (FDA) has approved the monograph sponsor's Abbreviated New Drug application. Based on the comments received the Monograph Development—Psychiatrics and Psychoactives Expert Committee (MDPP) has revised the Levetiracetam monograph in order to reflect approved manufacturers as follows:

1. Identification Test B: Changed from retention time agreement using the Assay solutions to using the Limit of Levetiracetam R-Enantiomer test
2. Limit of D-levetiracetam: This test is renamed as the Limit of Levetiracetam R-Enantiomer and the limit is increased from 0.5% to 0.8% .
3. Limit of Levetiracetam Related compound B: A note is added to reflect this is an optional test. An error in the formula has been corrected.
4. Related compounds: The table is revised to include pyrdin-2-ol, which is a process impurity in some of the approved products. Appropriate footnotes have been added to the impurities table.

The Levetiracetam Revision Bulletin supersedes the Authorized Pending Monograph that was published on the USP Pending Monographs web site. The Revision Bulletin text will be incorporated into the First Supplement to the USP 33-NF 28 Reissue.

Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301–816–8330 or ).

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