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基本信息
化學名稱：(±)-1H-苯并咪唑-7-羧酸-2-乙氧基-1-[[2-(1H-四氮-5-基)[1,1-二苯]-4-基]甲基]-1-[[（環己基氧基）羰基]氧基]乙酯
結構式：.jpg)
分子式：C33H34N6O6
分子量：610.67
CAS號：145040-37-5
質量標準：USP/ EP/ 國家標準， 可提供DMF/ CEP/ GMP。
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Specificatin
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EP 7.8
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ITEM
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CRITERIA
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RESULTES
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Appearance
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A white or almost white powder.
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White powder
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Identification-IR
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Conform to the reference spectrum
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Conforms
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Identification- UV
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Maximal absorptions at 254nm, minimum absorption at 242nm
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Conforms
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Water
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≤ 0.3%
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0.19%
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Residual solvents
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Methanol
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Less than 3000ppm
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N. D.
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Ethanol
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Less than 5000ppm
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N. D.
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Ethyl ether
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Less than 5000ppm
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62ppm
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Acetone
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Less than 5000ppm
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505ppm
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Ethyl acetate
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Less than 5000ppm
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N. D.
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Dichloromethane
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Less than 600ppm
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N. D.
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Dimethylformamide
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Less than 880ppm
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N. D.
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Related substances
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Impurity A
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≤ 0.15%
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0.04%
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Impurity B
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≤ 0.3%
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0.03%
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Impurity F
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≤ 0.2%
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0.02%
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Impurity G
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≤ 0.2%
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0.04%
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Impurity H
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≤ 0.15%
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N. D.
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Other individual impurity
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≤ 0.10%
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0.04%
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Total impurities
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≤ 0.6%
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0.23%
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Sulfated ash
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≤ 0.1%
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0.07%
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Heavy metals
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≤ 10ppm
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<10ppm
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Assay (Dried substance)
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99.0~101.0%
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99.9%
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Conclusion
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Conforms to EP
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