Docetaxel

APPEARANCE                   white to almost white crystalline powder                 Conforms

IDENTIFICATION:

IR                     According with reference standard spectrumof Docetaxel   Conforms

HPLC                 The retention time of the major peak of the sample solution  Conforms

                       corresponds to that of the standard solution, as obtained

                       in the assay.

SPECIFIC ROTATION                -39.0º~-41.0º                              -40.2º

WATER                               ≤3.0%                                     0.52%

RELATED SUBSTANCES:

2-Debenzoxyl 2-pentenoyl docetaxel(Impurity A) ≤0.5%                            0.01%

6-Oxodocetaxel(Impurity B)                   ≤0.3%                              0.04%

4-Epidocetaxel(Impurity C)                    ≤0.3%                            0.02%

4-Epi-6-oxodocetaxel(Impurity D)               ≤0.2%                                   0.01%

Other maximum single impurity                 ≤0.1%                               0.03%

Total impurities                               ≤1.0%                                   0.13%

RESIDUE SOLVENT:

Hexane                              ≤100ppm                                    2ppm

Acetone                             ≤5000ppm                                 193ppm

Tetrahydrofuran                      ≤300ppm                                   ＜3ppm

Ethyl acetate                         ≤500ppm                                    43ppm

Methanol                            ≤500ppm                                   ＜7ppm

Dichloromethane                      ≤300ppm                               118ppm

Toluene                              ≤400ppm                                 ＜11ppm

Pyridine                              ≤100ppm                                 ＜6ppm

RESIDUE ON IGNITION                        ≤0.10%                                  0.06%

HEAVY METALS                                  ≤20ppm                                     ＜20ppm

BACTERIAL ENDOTOXINS TEST      ≤0.3EU/mg                                 ＜0.3EU/mg

MICROBIAL ENUMERATION TESTS AND TESTS FOR SPECIFIED MICROORGANISMS:

The Total Aerobic Microbial Limit        ≤100cfu/g                                       ＜10cfu/g

The Total Yeast and Mold Count        ≤10cfu/g                                   ＜10cfu/g

ASSAY(on the anhydrous and solvent-free basis) 97.5 – 102.0%                       99.7%