| Product Information |
| Product Name |
Fludarabine Phosphate USP31 |
Molecular Formula |
C10H13FN5O7P(365.21) |
Cas No. |
75607-67-9 |
| Quality standard |
complies with USP31 |
Analysis |
Standard |
Assay (W/W) |
98.0~102.0% |
Purity (HPLC) |
≥98.5% |
Physical Control |
Appearance |
White or almost white powder |
Identification(by IR and HPLC) |
Conforms |
Specific optical rotation |
+10º~+14º |
Water(K.F.) |
NMT3.0% |
Chemical Control |
Chloride |
NMT 0.2% |
Free phosphate |
NMT 0.1% |
Ethanol |
Not more than 0.5% |
Limit of Sodium |
Not more than 0.2% |
Heavy metals |
Less than 20ppm |
Microbial limits |
The total aerobic microbial count shall not exceed 1000cfu/g |
Chromatographic Impurities |
Relative Impurities |
NMT1.5% |
Iso-ara-guanine-monophosphate |
≤0.8% |
Isoguanine |
≤0.2% |
3’,5’-Diphosphate |
≤0.4% |
2-Fluoroadenine |
≤0.1% |
2-Fluoro-ara-adenine |
≤0.2% |
2-Ethoxyphosphate analog |
≤0.2% |
Other individual impurity |
≤0.1% |
Storage |
| Cold storage in well closed containers and protect from light and moisture. |
