2353-33-5 Decitabine 99%
TEST |
SPECIFICATION |
RESULTS |
Appearance |
Off-white to white crystal powde No smell,Tasteless |
Off-white powder |
Appearance of solution |
Clear and colorless |
Conforms |
Identification |
A. IR B. HPLC C. PXRD |
Conforms Conforms Conforms |
Appearance of solution |
Clear and NMT B5 or BY5 or Y5 |
Conforms |
specific rotation |
+67° ~ +75° |
+72.1° |
Residual organic solvents |
DMSO: ≤0.30% Methanol:≤0.25% Methyl formate:≤0.02% Acetonitrile:≤0.02% Methyl toluate: ≤0.02% |
0.028% 0.097% ND ND ND |
Related Substances |
а-Decitabine: ≤ 0.15% Mono toluoyl decitabine:≤ 0.15% Single unknown impurity: ≤ 0.10% Total imp.(M.A)+Mono-T-Deci(M.B): ≤1.0% |
0.02% 0.02% 0.02% 0.06% |
Sulphated ash |
≤0.1% |
0.01% |
Water (K.F.) |
≤1.0% |
0.28% |
Heavy metals |
≤20ppm |
Conforms |
Assay (HPLC) |
98.0% ~ 102.0% (on dried basis) |
99.70% |
TEST |
SPECIFICATION |
RESULTS |
Appearance |
Off-white to white crystal powde No smell,Tasteless |
Off-white powder |
Appearance of solution |
Clear and colorless |
Conforms |
Identification |
A. IR B. HPLC C. PXRD |
Conforms Conforms Conforms |
Appearance of solution |
Clear and NMT B5 or BY5 or Y5 |
Conforms |
specific rotation |
+67° ~ +75° |
+72.1° |
Residual organic solvents |
DMSO: ≤0.30% Methanol:≤0.25% Methyl formate:≤0.02% Acetonitrile:≤0.02% Methyl toluate: ≤0.02% |
0.028% 0.097% ND ND ND |
Related Substances |
а-Decitabine: ≤ 0.15% Mono toluoyl decitabine:≤ 0.15% Single unknown impurity: ≤ 0.10% Total imp.(M.A)+Mono-T-Deci(M.B): ≤1.0% |
0.02% 0.02% 0.02% 0.06% |
Sulphated ash |
≤0.1% |
0.01% |
Water (K.F.) |
≤1.0% |
0.28% |
Heavy metals |
≤20ppm |
Conforms |
Assay (HPLC) |
98.0% ~ 102.0% (on dried basis) |
99.70% |
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