| Product name | Cefepime |
| Cas number | 88040-23-7 |
| Molecular formula | C19H24N6O5S2 |
| Molecular weight | 480.56 |
| Appearance | colorless powder |
| Melting point | 150ºC |
|
Contents of Testing
|
Requirements
|
Results of Analysis
|
|
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
|
<0.04EU/mg
|
Meets the requirements
|
|
Residue on Ignition
|
≤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
|
≤0.3%
|
Not detected
|
|
Cefepime related compound B
|
≤0.2%
|
Not detected
|
|
Any other impurity
|
≤0.1%
|
0.04
|
|
Assay
|
825~911ug/mg
|
856 ug/mg
|