Product name | Decitabine | MFG. Date | 20130111 |
Package | 1kg/bag | Batch number | FH20130111 |
Testing Date | 20130111 | Exp Date | 20150111 |
Standard | USP32 | Quantity | 10Kg |
Cas No. | 2353-33-5 | Odor | Characteristic |
Molecular Formula | C8H12N4O4 | Molecular Weight | 228.20 |
Function | Main functions are as follows: Antineoplastic Agents, Anti-cancer |
||
Applications | Main applications are as follows: Anticancer chemotherapy |
||
Items Tested | Specification | Result | |
Characters | White to off-white crystalline powder | Confirms | |
Melting Point | 198-203 Degree | Confirms | |
UV-Absorbance | +74°—+80°(in methanol 10mg/ml) | +67.5° | |
Assay (HPLC) | ≥99.00% | 99.51% | |
Loss on Drying | Not more than1.0% | 0.21% | |
Related substances | Not more than 1.0% | 0.11% | |
The largest impurities | ≤0.3% | 0.09% | |
Total impurities(HPLC) | ≤1.0% | 0.43% | |
Total aerobic microbial | ≤100cfu/g | 59cfu/g | |
Heavy Metal | ≤10ppm | conforms | |
Staphylococcus aureus | Absence | Absence | |
Pseudomonas aeruginosa | Absence | Absence | |
Salmonella species | Absence | Absence | |
Escherichia | Absence | Absence | |
Conclusion | Conforms USP32 |