BRIEFING

 Bosentan Tablets for Oral Suspension. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed.

 The liquid chromatographic procedures in the Assay, Dissolution test, and in the test for Organic Impurities were validated using the J'Sphere ODS-H80 brand of column with L1 packing. The typical retention times for bosentan in the Assay, Dissolution test, and in the test for Organic Impurities are about 10, 3, and 14 min, respectively.

 (SM5: H. Ramanathan)

 Case ID—SUB-1925