Fludarabine Phosphate CAS NO.75607-67-9

description white crystalline powder conforms

identification ir conforms

specific rotation +10º~+14º +11.7º

microbial limits ≤1000cfu/g conforms

water ≤3.0% 0.88%

heavy metals ≤20ppm conforms

chloride ≤0.2% conforms

limit of free phosphate ≤0.1% conforms

limit of sodium ≤0.2% conforms

residual solvents

dmf ≤0.0020% conforms

methylene chloride ≤0.0020% conforms

ethanol ≤1.0% conforms

chromatographic impurities

individual impurity

iso-ara-guanine-monophosphate ≤0.8% conforms

isoguanine ≤0.2% conforms

3’,5’-diphosphate analog ≤0.4% conforms

2-fluoroadenine ≤0.1% conforms

2-fluoro-ara-adenine ≤0.2% conforms

2-ethoxyphosphate analog ≤0.2% conforms

any other impurity ≤0.1% conforms

sum of all other impurities ≤0.5% conforms

sum of all impurities ≤1.5% conforms

assay( on dried basis ) 98.0%~102.0% 99.20%