BRIEFING

 Omeprazole Delayed-Release 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 for the Assay and Dissolution test were validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention time for omeprazole is about 4 min. The liquid chromatographic procedure for the test for Organic Impurities was validated using the ACQUITY UPLC BEH Shield RP18 brand of column with L1 packing. The typical retention time for omeprazole is about 25 min.

 (SM3: J. Li)

 Case ID—SUB-1172