BRIEFING

 Morphine Sulfate Tablets. 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, the Dissolution test, and the test for Organic Impurities are based on validations performed with the XBridge BEH Phenyl brand of column with L11 packing. The typical retention times for morphine are about 1.9, 1.9, and 6.6 min, respectively.

 (SM2: F. Gu)

 Case ID—SUB-981