EP 6.1-泮托拉唑钠欧洲药典.pdf

Browse: British Pharmacopoeia 2009 British Pharmacopoeia Volume I II Monographs: Medicinal and Pharmaceutical Substances Pantoprazole Sodium Sesquihydrate Pantoprazole Sodium Sesquihydrate General Notices (Ph Eur monograph 2296) C16H14F2N3NaO4S,1? H2O

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164579-32-2 Action and use Proton pump inhibitor; treatment of peptic ulcer disease. Ph Eur DEFINITION Sodium 5-(difluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin-2-yl)methyl]sulphinyl] benzimidazol-1-ide sesquihydrate. Content 99.0 per cent to 101.0 per cent (anhydrous substance). PRODUCTION It is produced by methods of manufacture designed to guarantee the proper hydrate form and it complies, if tested, with a suitable test that demonstrates its sesquihydrate nature (for example near-infrared spectrophotometry (2.2.40) or X-ray powder diffraction (2.9.33)). CHARACTERS Appearance White or almost white powder. Solubility Freely soluble in water and in ethanol (96 per cent), practically insoluble in hexane. ?Crown Copyright 2006 1 IDENTIFICATION
A. Infrared absorption spectrophotometry (2.2.24). Comparison
pantoprazole sodium sesquihydrate CRS.
B. It gives reaction (a) of sodium (2.3.1). TESTS Appearance of solution The solution is clear (2.2.1) and not more intensely coloured than reference solution B6 (2.2.2, Method II). Dissolve 0.20 g in water R and dilute to 20.0 ml with the same solvent. Optical rotation (2.2.7) - 0.4° to + 0.4°. Dissolve 0.2 g in 10 ml of water R. Adjust to pH 11.5-12.0 with an 8 g/l solution of sodium hydroxide R. Dilute to 20.0 ml with water R. Related substances Liquid chromatography (2.2.29). Solvent mixture
acetonitrile for chromatography R, 40 mg/l solution of sodium hydroxide R (50:50 V/V). Test solution
Dissolve 23 mg of the substance to be examined in the solvent mixture and dilute to 50.0 ml with the solvent mixture. Reference solution (a)
Dilute 1.0 ml of the test solution