OmeprazoleDelayed-ReleaseCapsules（奥美拉唑缓释胶囊）USP39.pdf

Accessed from 10.6.1.1 by halifax7 on Tue Jun 14 23:22:41 EDT 2016 USP 39 Official Monographs / Omeprazole 5145 . CU = nominal concentration of omeprazole in the Omeprazole Delayed-Release Capsules Sample solution (mg/mL) Acceptance criteria: 90.0%–110.0% DEFINITION PERFORMANCE TESTS Omeprazole Delayed-Release Capsules contain NLT 90.0% • DISSOLUTION 〈711〉 and NMT 110.0% of the labeled amount of omeprazole Test 1 (C H N O S). 17 19 3 3 Acid resistance stage Medium: 0.1 N hydrochloric acid; 500 mL IDENTIFICATION Apparatus 2: 100 rpm • A. The retention time of the major peak in the Sample Time: 2 h solution corresponds to that of the Standard solution, as Buffer C, Mobile phase, Chromatographic system, obtained in the Assay. and System suitability: Proceed as directed for ASSAY Buffer stage. • PROCEDURE Standard solution: Transfer 50 mg of USP Omepra- Solution A: Dissolve 6.0 g of glycine in 1500 mL of zole RS