BRIEFING

 Nimodipine Capsules. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures in the tests for Assay, Dissolution, and Organic Impurities are based on validation performed with the Spherisorb ODS2 brand of column with L1 packing. The typical retention time for nimodipine is about 15 min for Assay, Dissolution, and Organic Impurities tests.

 (SM2: F. Gu)

 Case ID—SUB-798