Pantoprazole-Sodium-中国药典标准翻译.docVIP

PAGE / NUMPAGES Pantoprazole Sodium C16H14F2N3NaO4S·H2 Pantoprazole 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 C16H14F2N3NaO4 [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 Ⅳ A). (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 Ⅵ H). Clarity 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 Ⅸ A, method 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 Ⅴ D). The column is packed with octadecyl silane bonded silica gel, mobile phase A is 0.01 mol/L dipotassium hydrogen phosphate solution (adjust the pH to 7.0 by phosphoric acid), mobile phase B is acetonitrile, gradient elution chromatography is applied as the table below; detection wavelength is 289 nm; column temperature is 40℃. The number of the theoretical