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Description
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White or colorless acicular crystals, usually in fine needles or fluffy, white crystalline powder.
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Identification
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-
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Identification 'A' ( by IR)
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Conforms
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Identification ‘B’
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Solution gives reaction of salicylate
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Identification 'C'
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Melting range - 158°C to 161°C
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-
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Test A may be omitted if tests B and C are carried out. Test B may be omitted if tests A and C are carried out
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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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NMT 0.1
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Impurity B
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NMT 0.05%
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Impurity C
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NMT 0.02%
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Any other secondary peak
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NMT 0.05%
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Sum of all other secondary peaks
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NMT 0.2%
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Heavy metals
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NMT 20 ppm
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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 (over P2O5, in desiccator)
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NMT 0.5%
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Assay
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NLT 98.0% and NMT 100.5% of C7H6O3, calculated on the dried basis
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