BRIEFING

 Lisdexamfetamine Dimesylate Capsules. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

1. The liquid chromatographic procedure used in the Assay is based on analyses performed with the XBridge BEH C18 brand of column with L1 packing. The typical retention time for lisdexamfetamine is about 7 min.

2. The liquid chromatographic procedure in the Dissolution test is based on analyses performed with the XBridge BEH C18 brand of column with L1 packing. The typical retention time for lisdexamfetamine is about 2.5 min.

3. The liquid chromatographic procedure in the test for Organic Impurities is based on analyses performed with the XBridge BEH C18 brand of column with L1 packing. The typical retention time for lisdexamfetamine is about 25 min.

4. The liquid chromatographic procedure used in the test for Enantiomeric Purity is based on analyses performed with the Chiralpak IF-3 brand of column with L134 packing. The typical retention times for lisdexamfetamine and lisdexamfetamine related compound B are about 7 and 10 min, respectively.

 (SM4: G. Daddala)

 Case ID—SUB-733