BRIEFING

 Cinacalcet Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed. On the basis of comments received, the proposal in PF 42(4) has been canceled and is being replaced with a new proposal.

1. The liquid chromatographic procedure in the Assay and the Organic Impurities test was validated using the Symmetry Shield RP-18 brand of column with L1 packing. The typical retention time for cinacalcet is about 6 min.

2. The liquid chromatographic procedure in the Dissolution test was validated using the Luna Phenyl-Hexyl brand of column with L11 packing. The typical retention time for cinacalcet is about 2.5 min.

 (SM3: S. Singireddy)

 Case ID—SUB-620, SUB-1373, SUB-1381, SUB-2674, SUB-2675