Docetaxel CAS NO.114977-28-5

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%