Oxaliplatin

APPEARANCE                   White or almost white crystalline powder               Conforms

IDENTIFICATION:                   

A. IR               The positions and the relative sizes of the bands in the            Conforms                                          

                       spectrum of the sample are concordant with those in the

                        spectrum of the reference standard.

B. Specific optical rotation  It complies with the test for specific optical rotation     Conforms

APPEARANCE OF SOLUTION       Clear and colourless                       Conforms

ACIDITY            Not more than 0.60 ml of 0.01 M NaOH is required to        0.30ml

                        change the color of the indicator to pink.

SPECIFIC OPTICAL ROTATION        +74.5º~+78.0º                           +75.6º

IMPURITY D                             ≤0.15%                             0.0027%

RELATED SUBSTANCES

Impurity A                               ≤0.15%                             0.0044%

Impurity B                               ≤0.15%                             0.011%

Impurity C                               ≤0.10%                            Undetected

Sum of unspecified impurities              ≤0.15%                            Undetected

Sum of impurities other than D             ≤0.30%                             0.032%

SILVER                                    ≤5ppm                                       0.9ppm

LOSS ON DRYING                        ≤0.5%                               0.04%

BACTERIAL ENDOTOXINS                 ≤1.0 IU/mg                         Conforms

ASSAY(on the dried basis)           98%~102%(C₈H₁₄N₂O₄Pt)                    100.2%