Appearance A white to off white powder
Identification A. IR: Sample IR spectrum corresponds with that of the standard
B. HPLC: The RT of the major peak of the Test solution corresponds to that of the Standard solution
C: PXRD: Positive
Loss on drying NMT 1.0%
Heavy metals NMT 20ppm
Sulphated ash NMT 0.1%
Related substances α-Decitabine:≤0.15%
Single unknown impuritie:≤0.1%
Total impurities:≤1.0%
Residual solvents DMSO:NMT 0.5%
Methanol: NMT 0.3%
Methyl formate: NMT 0.05%
Acetonitrile: NMT 0.041%
Methyl toluate: NMT 0.05%
Assay(HPLC) 98.0-102.0%(On the dried basis)