|
Items
|
Specification
|
|
Appearance
|
A white to off white powder
|
|
Identification
|
Meet the requirement
|
|
Appearance of solution
|
Clear and NMT B5 or BY5 or Y5
|
|
Water
|
0.3%max
|
|
Optical rotation
|
+65° to +72°
|
|
Heavy metals
|
20ppm max
|
|
Sulfate ash
|
0.1%max
|
|
Related substances
|
|
Method A
|
Alfa-Decitabine: 0.15%max
|
|
Single unknown impurities:0.10%max
|
|
Total impurities: 0.85%max
|
|
Method B
|
Mono toluoyl decitabine: 0.15%max
|
|
Method A+B
|
Total imp.(M.A)+Mono-T-Deci(M.B): 1.0%max
|
|
Residual solvents
|
DMSO: 0.5%max
|
|
Methanol: 0.3%max
|
|
Methyl formate: 0.05%max
|
|
Acetonitrile: 0.041%
|
|
Methyl toluate: 0.05%max
|
|
Assay by HPLC
|
98.0-102.0%
|
>>Alphabetical order
