Chlorambucil Powder 305-03-3

ITEMS                              SPECIFICATION                         RESULTS

Appearance               White or off-white crystalline powder             Off-white crystalline powder                     

HPLC Purity(In-house)      ≥99.0%                                              99.7%

Identification                 A: IR                                              Conforms

B: dissolve 50mg in 5ml of acetone and dilute with

water to 10ml. Add 1 drop of 2 N sulfuric acid, then

add 4 drops of silver nitrate TS: no opalescence is       Conforms

observed immediately (absence of chloride ion) warm

the solution on a steam bath opalescence develops

(presence of ionizable chlorine)

Solubility                   Color: colorless or faint brown;                      Clear and colorless      

Turbidity: clear

Method:100mg/ml in ethanol 

Melting point                65-69°c                                               65.6-65.3°c

Any individual Impurities    ≤0.05%                                                0.037%

(In-house)    

Total Impurities            ≤1.0%                                               0.3%

(In-house)    

Assay (on Anhydrous basis) 98.0-101%                                          100.2%

Water                      ≤0.5%                                               0.06%

Residual solvent            Ethyl acetate≤5000ppm                                1100ppm

                 Isopropanol≤5000ppm                                 1000ppm

                             Toluene≤890ppm                                      450ppm

N-hexane≤290ppm                                          160ppm

Storage : Preserve in tight, light-resistant containers

Conclusion : The product conforms to the usp42&In-house specifications

Reported by:Li Ping               Revised by:Wang Wei                Approved by:Zhang Tao