BRIEFING

 Nicardipine Hydrochloride 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 is based on validation performed with the Lichrospher 100 RP-8 brand of column with L7 packing. The typical retention time for nicardipine is about 12 min.

2. The liquid chromatographic procedure in the Organic Impurities test is based on validation performed with the Luna C-8 brand of column with L7 packing. The typical retention time for nicardipine is about 15 min.

 (SM2: F. Gu)

 Case ID—SUB-548