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Specification
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According to European Pharmacopoeia 7.8
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Items
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Specification
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Results
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Appearance
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White or slightly yellowish crystalline powder
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White crystalline powder
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Solubility
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Should meet the requirement
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Conforms
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IR Identification
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Should correspond to the RS Infrared Absorption
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Correspond to the reference substance
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Appearance of solution
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Should meet the requirement
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Conforms
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Related substance
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Impurity A
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≤0.15%
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0.05%
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Impurity B
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≤0.15%
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0.02%
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Impurity C
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≤0.2%
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0.03%
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Impurity D
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≤0.2%
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0.05%
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Unspecified Ims.
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≤0.1%
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0.06%
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Total
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≤1.0%
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0.30%
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Residual solvents
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Methanol
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≤0.3%
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Not detected
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Ethanol
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≤0.5%
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0.031%
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Methylene dichloride
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≤0.06%
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Not detected
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n-hexane
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≤0.029%
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Not detected
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Acetic acid ethyl ester
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≤0.5%
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Not detected
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Toluene
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≤0.089%
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0.025%
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Acetic acid
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≤0.5%
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0.036%
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Loss on drying
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≤0.5%
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0.20%
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Sulphated ash
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≤0.1%
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Conforms
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Melting point
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261 ºC -263 ºC
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261.1 ºC -262.2 ºC
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Particle size
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90% Less than 200um
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Conforms
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Assay
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99.0％～101.0％
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99.9%
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Conclusion
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It conforms to European Pharmacopoeia 7.0
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