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Appearance
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White or almost white, hygroscopic, crystalline powder
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Solubility
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Freely soluble in water, soluble in anhydrous ethanol, practically insoluble in Methylene chloride
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Identification 'A', 'B', 'C' and 'D'
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-
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Melting point
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115-118°C
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Infrared spectrum
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To comply
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TLC test
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To comply
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Identification 'D'
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The solution gives reaction of sodium
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Appearance of solution
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Solution S, examined immediately after preparation, is clear and not more intensely coloured than reference solution BY6
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Assay (by HPLC; on dried basis)
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95.0- 102.0%
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pH (1% solution in CO2 free water)
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9.5 to10.5
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Related Substances
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-
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Impurity A
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NMT 3.0%
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Unspecified impurities
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NMT 0.5%
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Sum of impurities other than A
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NMT1.0%
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Chloride (Cl)
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Max 0.035%
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Sulphate (SO4)
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Max 0.03%
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Water (by KF)
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Max 5.0%
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