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Appearance
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White to almost white crystalline powder
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Identification
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To comply IP, BP, USP tests
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Solubility
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Freely soluble in water, sparingly soluble in ethanol (96 per cent)
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Specific optical rotation (20°C, 589 nm) (C=10, H2O/dilute NH3) (Anhydrous substance)
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+52.5° to +53.3°
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Specific optical rotation (20°C, 589 nm) (C=10, 0.012N NH4OH)
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+52.6° to +53.2°
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Appearance of solution
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To comply BP test
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Colour of solution
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To comply USP test
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Acidity or alkalinity
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To comply IP,BP, USP test
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Sulphite
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Max 0.0015% (passes IP test)
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Heavy metal (as Pb)
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Max 0.0005%
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Barium (Ba)
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Passes IP, BP test
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Calcium (Ca)
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Passes BP test
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Lead (Pb)
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Max 0.00005%
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Loss on drying (1 g, 105°C, 16h)
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Max 0.5 %
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Foreign sugars, soluble starch, dextrins
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Max 1.0%
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Bacterial endotoxin
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Not more than 0.5 Endotoxin unit/ ml of a 5 % w/v solution
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