Product name | Cefepime |
Cas number | 88040-23-7 |
Molecular formula | C19H24N6O5S2 |
Molecular weight | 480.56 |
Appearance | colorless powder |
Melting point | 150ºC |
Contents of Testing
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Requirements
|
Results of Analysis
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Description
|
White powder
|
Meets the requirements
|
Identification
|
Meets the requirements
|
Meets the requirements
|
Water
|
3.0-4.%
|
3.2%
|
Crystallinity
|
Meets the requirements
|
Meets the requirements
|
Bacterial endotoxins
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<0.04EU/mg
|
Meets the requirements
|
Residue on Ignition
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≤0.1%
|
0.08%
|
Sterility
|
Meets the requirements
|
Meets the requirements
|
N-methylpyrrolidine
|
≤0.3%
|
Not detected
|
Heavy Metals
|
≤20ppm
|
<20ppm
|
Sterile
|
conform
|
complies
|
Related compounds
|
||
Cefepime related compound A
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≤0.3%
|
Not detected
|
Cefepime related compound B
|
≤0.2%
|
Not detected
|
Any other impurity
|
≤0.1%
|
0.04
|
Assay
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825~911ug/mg
|
856 ug/mg
|