China Made Cefepime Hydrochloride Powder Pharmaceutical Chemicals CAS 107648-80-6, Find details about China Cefepime Hydrochloride, 107648-80-6 from China Made Cefepime Hydrochloride Powder Pharmaceutical Chemicals CAS 107648-80-6
Items | Standard | Results |
APPEARANCE | Off white to white powder | White powder |
IDENTIFICATION | A: IR B: Retention time | Complies Complies |
WATER | ≤0.5% | 0.06% |
HEAVY METALS | ≤0.002% | Complies |
ISOMERS | SFBD1≤0.15% | Undetected |
SFBD2≤0.15% | Undetected | |
SFBE≤0.15% | Undetected | |
RELATED SUBSTANCES | SFBA-1≤0.15% | 0.04% |
SFBMA≤0.15% | Undetected | |
CHLORO-SFB≤0.15% | 0.05% | |
DiSFBMA-SFB≤0.15% | 0.02% | |
Methyl-SFB≤0.15% | Undetected | |
Pentafluoro-phenol≤0.15% | Undetected | |
Amino-SFB≤0.15% | Undetected | |
Any unknown impurity≤0.1% | 0.04% | |
Total impurity≤1.0% | 0.21% | |
RESIDUE SOLBENTS | Methanol≤3000ppm | Undetected |
Isopropyl alcohol≤5000ppm | 19ppm | |
Dichloromethane≤600ppm | Undetected | |
Tetrahydrofuran≤720ppm | Undetected | |
Acetic acid≤5000ppm | Undetected | |
Toluene≤890ppm | Undetected | |
Chlorobenzene≤360ppm | Undetected | |
Methyl tert-butyl ether≤5000ppm | 103ppm | |
ASSAY | ≥99.0% | 99.8% |
RESULT: It complies to prescribed enterprise standard |