Appearance White to off-white,crystalline,nonhygroscopic solid
Identification Infrared absorption spectrophotometry should correspond to that of cefepime hydrochloride CRS
Clarity of solution Should be clear
(the solution is less clear than an equal volume of water contained in a similar vessel and examined similarly)
Particulate contamination No visible foreign matter
Crystallinity Should complies
Water 3.0~~4.5%
Residue on ignition ≤0.1%
Heavy metals ≤0.002%
Residual solvents Methanol ≤ 0.3%
Acetone ≤0.5%
N-methypyrrolidine ≤ 0.3%
Related compounds Cefepime related compound A≤0.3%
Cefepime related compound B≤0.2%
Any other impurity ≤0.1%
Particulate matter ≥10 um ≤6000 Grain/g
≥25 um ≤600 Grain/g
Bacterial endotoxins Not more than 0.04EU per mg of cefepime HCl
Sterility Should be sterile
Assay not less than 82.5%and not more than 99.1%(w/w) of Cefepime on the anhydrous basis
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