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Description
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White, or colourless acicular crystals or white, crystalline powder
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Solubility
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Solubility Freely soluble in ethanol (95 per cent) and in ether, sparingly soluble in chloroform, slightly soluble in water
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Identification
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-
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Identification 'A'
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The spectrum of sample should be concordant with spectrum of standard
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Identification 'B'
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Solution should give the reaction (A) of salicylates
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Identification 'C'
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Melting range: 158°C-161°C
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Appearance of solution
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The solution is clear and colourless
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Related substance (by HPLC)
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-
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Impurity A
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Max 0.1%
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Impurity B
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Max 0.05%
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Impurity C
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Max 0.02%
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Unknown impurities
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Max 0.05%
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Total impurities
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Max 0.2%
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Iron
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NMT 2 ppm
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Chlorides
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NMT 125 ppm
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Sulphates
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NMT 200 ppm
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Sulphated ash
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NMT 0.1%
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Loss on drying
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NMT 0.5%
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Assay (on dried basis)
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99.0 – 100.5%
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