BRIEFING

 Febuxostat 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 procedures in the Assay and the Dissolution test are based on validations performed with the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for febuxostat is about 3 min for both the Assay and the Dissolution test.

2. The liquid chromatographic procedure in the Organic Impurities test is based on validations performed with the YMC-Pack Phenyl brand of column with L11 packing. The typical retention time for febuxostat is about 25 min.

 (SM2: W. Yang)

 Case ID—SUB-644, SUB-664