Pantoprazole-Sodium-中国药典标准翻译

Pantoprazole SodiumC16H14F2N3NaO4S·H2O 423.378Pantoprazole Sodium is 5-difluoromethoxy-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sodium, monohydrate. It contains not less than 98.0% and not more than 102.0% of C16H14F2N3NaO4S, calculated on anhydrous basis.[Description] A white or almost white crystalline powder.Freely soluble in water or methanol; practically insoluble in chloroform or diethyl ether. [Identification] (1) Dissolve 10 mg in 20 ml of water to 2 ml of the resulting solution add 5 drops of dilute hydrochloric acid, then add 1 ml of silicotungstic acid TS dropwise, a white curdy precipitate is produced.(2) The light absorption of a solution of 15 μg per ml in ethanol exhibits a maximum at 292 nm, and minimum at 250 nm (Appendix A).Ⅳ(3) The infrared absorption spectrum is concordant with the reference spectrum of pantoprazole sodium (Appendix ).ⅩⅥ(4) Yields the reaction characteristic of sodium salts (Appendix ). Ⅲ[Inspection] Alkalinity An aqueous solution of 20 mg per ml, pH 9.5-11.0 (Appendix H). ⅥClarity and colour of solution Dissolve 0.20 g in 10 ml of water, the solution is clear and colourless; any colour produced is not more intense than that of reference solution Y2 (Appendix A, Ⅸmethod 1). Related substances Dissolve a quantity of the product in solvent [0.001 mol/L sodium hydroxide-acetonitrile (1:1)] to obtain a solution of 0.4 mg per ml as test solution. Pipet accurately 1 ml of the test solution, to a 100 ml volumetric flask, dilute to volume with above solvent, mix well as reference solution. Carry out the method for high performance liquid chromatogrphy (Appendix D). The column is packed with Ⅴoctadecyl silane bonded silica gel, mobile phase A is ...