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Test Items
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Specifications
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Result
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Appearance
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White or almost white powder
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Conforms
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Solubility
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Practically insoluble in water, soluble in ethanol(96 per cent).
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Conforms
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Identification
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A. Ultraviolet and visible absorption spectrophotometry
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Conforms
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B. Infrared absorption spectrophotometry
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Conforms
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C. Thin-layer chromatography
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Conforms
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Optical rotation
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-0.02°~ +0.02°
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0°
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Water (EP 2.5.12)
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≤3.0%
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2.2%
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Sulphated ash (EP 2.4.14)
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≤0.1%
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0.03%
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Heavy metals (EP 2.4.8)
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≤10ppm
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<10ppm
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Related compounds
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Impurity B≤0.3%
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0.1%
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Unspecified impurity≤0.10%
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Conforms
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Total impurities≤0.5%
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0.1%
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Impurity A
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≤5ppm
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Conforms
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Assay
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98.0 per cent to 102.0 per cent (anhydrous substance).
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99.8%
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Storage:
Keep in well-closed container, protected from light.
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