Description
White Or Almost White Crystalline Powder
White Powder
Melting Point
93~104℃
94.5~103.5℃
Specific Rotation
+35°~ +40°
+38.49
Assay
≥97%
98.56%
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%
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
Appearance White or almost white crystalline powder
Identification A: IR absorption
B: UV absorption
C: TLC
Melting point 168~172℃
Water 0.5% max
Related substances Impurity J(chloroacetanilide) 10ppm max
Impurity K(4-aminophenol) 50ppm max
Impurity F(4-nitrophenol) 0.05% max
Any other impurities 0.05% max
Total of impurities 0.1% max
Residue on ignition 0.1% max
Chloride 0.014% max
Sulfate 0.02% max
Sulfide Conforms
metals 0.001% max
Free p-aminophenol 0.005% max
Limit of P-chloroacetanilide 0.001% max
Readily carbonizable substances Conforms
Residual solvents Residue content of acetic acid is limited by the test of loss on drying not more than 0.5%
Assay(anhydrous basis) 99.0~101.0%
Appearance A white or light yellow powder, odorless, hygroscpic
Identification A,B,C The positive reaction
Soluility Very soluble in water, insoluble in acetone,chloroform,ether
PH 5.5-7.5
Loss on drying 8.0% max
Assay 600 I.U/mg min(dry)