CERTIFICATE OF ANALYSIS

PRODUCT NAME DOCETAXEL

QUANTITY 10 grams

DATE OF MANUFACTURE 13,12,2000

DATE OF REPORT MAY,2001

Test items Specifications Results

Description White Powder Complies

Specific Optical Rotation Between -40° to -47° -43.53°

Chromatographic Not more than 1.0% 0.65%

impurities

Total impurities

Identification By UV The light absorption spectrum Complies

of sample solution exhibits

maxima at 283.275 and 230 nm

Water content 6----8% 6.6%

Assay (By HPLC) ≥98.0 99.22%

REMARKS: Complies with inhouse standards

Docetaxel Injection Concentrate

Formula:C43H53NO14·3H2O

M.W. : 861.9