Vancomycin hydrochloride
Appearance |
A white or almost white powder |
Identification |
Infrared Absorption |
PH |
2.5-4.5(50mg/ml) |
Chromatographc purity |
Vancomycin B: 88.0%min Any peak other than the main pea: 4.0% max |
Monodechlorovancomycin |
4.7% max |
Water,K.F |
5.0% max |
Bacterial endotoxins |
0.25EU/mg max |
Potency(dried substances) |
925μg/mg min |
Particulate matter |
The particle of more than 10um no more than 6000/1g The particle of more than 25um no more than 600/1g |
Heavy metals |
30ppm max |
Sterility |
Conform |
Clarity |
Conform |
Residual solvents |
Ethanol: 5000ppm max |
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