Items
|
Standard
|
Appearance
|
A white to off white powder
|
Identification
|
IR
HPLC
PXRD
|
Appearance of solution
|
Clear and NMT B5 or BY5 or Y5
|
PH
|
6.0-8.5
|
Optical rotation
|
+37.0° to +41.0°
|
Heavy metals
|
20ppm max
|
Sulfate ash
|
0.1%max
|
Related substances
|
Monoacetyl-AZA: 0.15%max
|
Impurity UK1(RRT1.07): 0.10%max
|
Impurity UK2(RRT1.09): 0.10%max
|
Single unknown impurity: 0.10%max
|
Total impurities: 1.0%max
|
Residual solvents
|
Methanol: 0.15%max
|
DMSO: 0.15%max
|
2-propanol: 0.05%max
|
Dichloromethane: 0.01%max
|
Methyl formate: 0.02%max
|
Methyl acetate: 0.02%max
|
Purity
|
99.0%min
|
Assay by HPLC
|
98.0-102.0%
|
Bacterial Endotoxin
|
1.25EU/mg max
|