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Levetiracetam Extended-Release Tablets

Type of Posting: Revision Bulletin

Posting Date: 31–Jan–2014

Official Date: 01–Feb–2014

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 Levetiracetam Extended-Release Tablets monograph. The purpose for the revision is to add Dissolution Test 5 and Test 6 to reflect products approved by the FDA.

The liquid chromatographic procedure used in the Dissolution Test 5 is based on analyses performed with an Eclipse XDB Phenyl brand of L11 column manufactured by Agilent Technologies. The typical retention time for levetiracetam is about 4 minutes.

The liquid chromatographic procedure used in the Dissolution Test 6 is based on analyses performed with a Discovery C18 brand of L1 column manufactured by Supelco. The typical retention time for levetiracetam is about 2 minutes.

In addition, alternative sample preparation procedures have been included in the Assay and Organic impurities tests to achieve complete extraction of the drug substance due to variation in the formulation components.

This Levetiracetam Extended-Release Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 37–NF 32.

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