BRIEFING

 Methylphenidate 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 being proposed.

1. The liquid chromatographic procedure in the Assay was validated using the Zorbax Eclipse XDB-C18 brand of column with L1 packing. The typical retention time for methylphenidate is about 7 min.

2. The liquid chromatographic procedure in the Dissolution test was validated using the Luna C18(2) HST brand of analytical column with L1 packing and the SecurityGuard C18 brand of guard column with L1 packing. The typical retention time for methylphenidate is about 2.5 min.

3. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Zorbax Eclipse XDB-C18 brand of column with L1 packing. The typical retention time for methylphenidate is about 6 min.

 (SM4: R. Radhakrishnan)

 Case ID—SUB-2198