BRIEFING

 Bexarotene Capsules. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures in the Assay and Dissolution test were validated using the Zorbax Eclipse XDB-C18 brand of column with L1 packing. The typical retention time for bexarotene is about 4 min. The liquid chromatographic procedure in the test for Organic Impurities was validated using the Symmetry C8 brand of column with L7 packing. The typical retention time for bexarotene is about 9 min.

 (SM3: J. Li)

 Correspondence Number—C301295