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Product name
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Perindopril erbumine/Perindopril tert-butylamine EP
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CAS NO.
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107133-36-8
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Appearance
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White crystalline powder
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Identification
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IR
Specific optical rotation
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Specific optical rotation
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-66.0 ~ -69.0°
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Water
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1.0%max
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Sulfated ash
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0.1%max
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Heavy metals
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0.001%max
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Assay
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99.0-101.0%
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Impurity A(TLC)
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0.25%max
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Stereochemical purity (HPLC)
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Impurity I: 0.1%max
Unspecified impurities: 0.1%max
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Substances (HPLC)
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Impurity B: 0.3%max
Impurity E: 0.4%max
Impurity F: 0.2%max
Impurity H: 0.2%max
Any other unknown impurity: 0.1%max
Total impurities: 1.0%max
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Residual reagents(GC)
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T.E.A: 0.002%max
Pd: 0.0005%max
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Residual solvents
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Acetone: 5000ppm max
Ethanol : 5000ppm max
Dichloromethane :600ppm max
Acetonitrile: 410ppm max
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>>Alphabetical order
