Superiority:
Appearance White or almost white crystalline powder
Identification (1),(2),(3)
Appearance of solution 2# max
Clear 1# max
PH 9.5-11.6
Specific optical rotation +97? ~+105?
Residual Solvents Methanol: 0.2% max
Ethanol: 0.5% max
Acetone:0.5% max
Acetonitrile: 0.041% max
Related substance A impurities: 1.0% max
Single impurities: 1.0% max
Other impurities: 3.0%max
Loss on drying 7.0% max
Residue on ignition 0.5% max
Bacterial endotoxins 0.33BU/mg max
Assay(on dry base) 95-102%
Biological potency 910u/mg min
Details:
Appearance White or almost white crystalline powder
Identification (1),(2),(3)
Appearance of solution 2# max
Clear 1# max
PH 9.5-11.6
Specific optical rotation +97? ~+105?
Residual Solvents Methanol: 0.2% max
Ethanol: 0.5% max
Acetone:0.5% max
Acetonitrile: 0.041% max
Related substance A impurities: 1.0% max
Single impurities: 1.0% max
Other impurities: 3.0%max
Loss on drying 7.0% max
Residue on ignition 0.5% max
Bacterial endotoxins 0.33BU/mg max
Assay(on dry base) 95-102%
Biological potency 910u/mg min