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Appearance
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A white or greyish-white, crystalline powder; odourless. It darkens on exposure to air and light, decomposition being faster in the presence of moisture and athigher temperatures.
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Assay (on anhydrous basis)
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98.0-101.0%
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Solubility
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Freely soluble in water, slightly soluble in ethanol(95%), practically insoluble in chloroform and in
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Appearance of solution
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To comply IP test
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Identification A (IR spectrum)
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To confirm the structure
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Identification ‘B’
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Absorption maxima at 279 nm, about 0.4 absorbance
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Identification 'C'
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It gives reaction of tartrate
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Related substance (by HPLC)
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Impurity A
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Max 0.3%
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Impurity B, C
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Max 0.2% each
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Total unspecified impurities
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Max 0.1% each
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Total impurities
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Max 0.6%
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Phenones (by UV)
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Max 0.1 absorbance at 310 nm
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Loss on drying
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Max 0.5%
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Sulphated ash
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Max 0.1%
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pH (1% w/v solution)
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2.8 - 4.0
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Specific optical rotation ([α]20/D)
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-50.0° to -54.0°
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