BRIEFING

 Nicardipine Hydrochloride in Sodium Chloride Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed. Based on comments received, the proposal in PF 44(6) has been canceled and is being replaced with a new proposal. The liquid chromatographic procedure in the Assay and the test for Organic Impurities was validated using the Atlantis dC18 brand of column with L1 packing. The typical retention time for nicardipine is about 14 min.

 (SM2: F. Gu)

 Case ID—SUB-2158