Cefepime hydrochloride
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Contents of Testing |
Requirements |
Results of Analysis |
Description |
White to yellowish or crystalline Powder |
Meets the requirements |
Identification |
Meets the requirements |
Meets the requirements |
Water |
3.0-4.5% |
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 |
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 |
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
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