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Appearance
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White to off white crystalline powder
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Solubility
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Soluble in methanol, acetic acid. Sparingly soluble in ethyl acetate, Insoluble in water
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Melting range
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112.0 to 114.0°C
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Identification
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By IR
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IR spectrum of test sample should be concordant with the IR spectrum of standard
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By HPLC
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The retention time of test sample should match with RT of WS
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Water (by KF)
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Max 0.5% w/w
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Sulphated ash
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Max 0.2%
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Chromatographic purity (by HPLC)
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Min 99.0%
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Any individual unknown impurity
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Max 0.5%
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Total impurity
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Max 1.0%
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Assay
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Min 98.0%
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