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Appearance
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A white or colourless crystalline powder
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Solubility
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Freely soluble in water, sparingly soluble in ethanol (95 per cent)
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Identification 'A', 'B' & 'C'
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Passes IP test
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Appearance of solution
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Solution is clear not more intensly coloured than refrence solution BYS7 and odourless
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Specific optical rotation
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+52.5° to +53.3°
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Related substance (by HPLC)
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-
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Maltose and isomaltose
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NMT 0.4%
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Maltotriose
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NMT 0.2%
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Fructose
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NMT 0.5%
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Other impurities
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NMT 0.1%
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Total impurities
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NMT 0.5%
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Soluble starch, sulfites
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NMT 15 ppm
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Dextrin
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The sample should dissolves completely
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Arsenic (As)
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Max 0.0001%
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Conductivity
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NMT 20 uScm-1
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Water
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NMT 1.0%
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Assay (by HPLC)
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NLT 97.5% and NMT 102.0% (on anhydrous basis)
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