| Function: | Antibiotic and Antimicrobial Agents |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
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Tests
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Specifications
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Results
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Appearance
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Off-white to white powder
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White powder
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Identification
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Chemical identification
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Conforms
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Infrared spectrometry
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Conforms
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Solubility
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Freely soluble in methylene chloride Soluble in methanol,Sparingly soluble in ehtanol,Practiaclly insoluble in water.
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Conforms |
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Melting Point(ºC)
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148~152
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148~150
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Specific rotation(°)
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-1~+1
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-0.01
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Loss ondrying(% w/w)
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≤0.5
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0.29
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Residue on ignition(% w/w)
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≤0.1
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0.05
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Heavy Metals(%)
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≤0.002
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Conforms
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Chromatographic purity by
TLC
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The principal spot obtained from the Test solution has about the same size and RF value as that obtained from the standard solution,and the sum of the intensities of any secondary spots obtained from the Test solution does not exceed the intensity of the principal spot obtained from the
Diluted standard solution.
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Conforms
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Assay(%)
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It content not less than 98.0 and not more than 102.0 on dried basis.
98.0~102.0
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100.50
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Residual solvents
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Methanol ≤3000ppm
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Conforms
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Acetone ≤5000ppm
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Conforms
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Methyl Chloride ≤600ppm
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Conforms
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Ethyl Acetate ≤5000ppm
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Conforms
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Toluene ≤900ppm
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Conforms
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