英国药典【BP】兰索拉唑【Lansoprazole】.pdf

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Lansoprazole Lansoprazole General Notices (Ph Eur monograph 2219) C H F N O S369.4103577-45-3 16 14 3 3 2 Action and use Proton pump inhibitor; treatment of peptic ulcer disease. Ph Eur DEFINITION 2-[(RS)-[[3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]sulphinyl]-1H-benzimidazole. Content 99.0 per cent to 101.0 per cent (anhydrous substance). CHARACTERS Appearance White or brownish powder. Solubility Practically insoluble in water, soluble in anhydrous ethanol, very slightly soluble in acetonitrile. It shows polymorphism (5.9). IDENTIFICATION Infrared absorption spectrophotometry (2.2.24). Comparisonlansoprazole CRS. If the spectra obtained in the solid state show differences, dissolve the substance to be examined and the reference substance separately in anhydrous ethanol R, evaporate to ©Crown Copyright 2006 1 examined and the reference substance separately in anhydrous ethanol R, evaporate to dryness and record new spectra using the residues. TESTS Appearance of solution The solution is clear (2.2.1) and not more intensely coloured than reference solution B or BY 2 2 (2.2.2, Method II). Dissolve 1.0 g in dimethylformamide R and dilute to 20 ml with the same solvent. Related substances Liquid chromatography (2.2.29). Prepare the solutions immediately before use and protect them from light. Solvent mixtureMix 1 volume of triethylamine R with 60 volumes of water R; adjust the pH to 10.5 using phosphoric acid R; mix the solution obtained with 40 volumes of acetonitrile R1. Test solutionDissolve 10 mg of the substance to be examined in the solvent