BRIEFING

 Pitavastatin Tablets. 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 YMC-PAK ODS-AM brand of column with L1 packing. The typical retention time for pitavastatin is about 11 min.

2. The liquid chromatographic procedure in the test for Dissolution is based on validation performed with the Inertsil C8-3 brand of column with L7 packing. The typical retention time for pitavastatin is about 7.3 min.

3. The liquid chromatographic procedure in the test for Organic Impurities is based on validation performed with the Zorbax Eclipse XDB-C8 brand of column with L7 packing. The typical retention time for pitavastatin is about 19 min.

 (SM2: W. Yang)

 Case ID—SUB-808, SUB-858