Ranitidine hydrochloride

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A white or pale yellow, crystalline powder PRODUCT NAME RANITIDINETEST STANDARDSMolecular FormulaC13H22N4O3S,HClMolecular Weight350…

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A white or pale yellow, crystalline powder PRODUCT NAME RANITIDINETEST STANDARDSMolecular FormulaC13H22N4O3S,HClMolecular Weight350.9C.A.S. NO.71130-06-8DescriptionA white or pale yellow, crystalline powderSolubilityfreely soluble in water and in methanol, sparingly soluble in ethanol, very slightly soluble in methylene chloride.IdentificationTest A,B,C,DSolution SDissolve 1.0 g in carbon dioxide-free water R and dilute to 100.0 ml with the same solvent.Appearance of solutionSolution S is clear (2.2.1) and not more intensely coloured than reference solution BY5.PHBetween 4.5 to 6.0.Related Substances By HPCImpurity A Not more than 0.5%One other Impurity Not more than 0.3%Two other impurity Not more than 0.2%Unidentified Impurity Not more than 0.01%Total Impurities Not more than 1.0%Loss on DryingNot more than 0.75%Heavy MetalsNot more than 20 PPMSulphated AshNot more than 0.1 %Assay [By Dried Basis]Between 98.50% - 101.0% wt/wt

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