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TEST ITEMS
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SPECIFICATION
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RESULTS
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Description
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: White Or Almost White Crystalline Powder
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White Powder
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Identification
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: Infrared Absorption
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Positive
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Assay
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: 97.0~103.0%
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99.15%
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Melting Point
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: 33~37°C
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34.5~36.5°C
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Loss On Drying
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: 0.5%max
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0.30%
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Specific Rotation
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: +32°~ +36°(C=1 in dioxane)
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+33.5°
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Organic Volatile Impurities
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: 2500PPm max
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<1000PPm
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Residual Solvents
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: Meet the requirements.(USP29)
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Confirms
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Chromatographic purity
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: sum of impurities:3.0%max
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<3.0%
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Conclusion
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The specification conform with USP32 standard
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