Fludarabine Phosphate

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%