BRIEFING

 Dexmethylphenidate Hydrochloride Extended-Release 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 in the Assay was validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for dexmethylphenidate is about 3 min.

2. The liquid chromatographic procedure in Dissolution Test 1 was validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for dexmethylphenidate is about 3 min.

3. The liquid chromatographic procedure in Dissolution Test 2 was validated using the Eclipse XDB C18 brand of column with L1 packing. The typical retention time for dexmethylphenidate is about 9 min.

4. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Acquity UPLC BEH C18 brand of column with L1 packing. The typical retention time for dexmethylphenidate is about 4 min.

5. The liquid chromatographic procedure in the test for Enantiomeric Purity was validated using the Astec Chirobiotic V2 brand of column with L88 packing. The typical retention time for dexmethylphenidate is about 7 min.

 (SM4: Y. Yang)

 Case ID—SUB-307, SUB-1302