Docetaxel Anhydrous is the anhydrous form of docetaxel, a semisynthetic side-chain analogue of paclitaxel with antineoplastic property. Docetaxel binds specifically to the beta-tubulin subunit of microtubules and thereby antagonizes the disassembly of the microtubule proteins. This results in the persistence of aberrant microtubule structures and results in cell-cycle arrest and subsequent cell death.
Docetaxel was patented in 1986 and approved for medical use in 1995. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.
Specifications |
Results |
||
Characters |
Appearance |
White or almost white powder |
White powder |
Solubility |
Freely soluble in water and in methanol , practically insoluble in hexane |
Conform |
|
Identification |
A. Infrared Absorption |
ir spectrum of the sample corresponds to that of the ref standard |
Conform |
B.HPLC |
The retention time of the major peak in the chromatograms corresponds to that in the reference standard |
Conform |
|
c. Tartrate Reaction |
Positive for tartrate |
Conform |
|
Test |
Clarity of solution |
Clear solution(140mg/10ml water) |
Clear solution |
Color of solution |
Absorbance at 420nm NMT0.03 (1.4%W/V solution in water) |
0.003 |
|
PH |
3.3~3.8 |
3.5 |
|
Water |
Not more than 4.0% |
2.3% |
|
Residue on ignition |
Not more than 0.1 |
Conform |
|
Heavy metals |
Not more than 20ppm |
NMT 10ppm |
|
Boron |
Not more than 50ppm |
Conform |
|
Fluorides |
Not more than 50ppm |
Conform |
|
Silver |
Not more than 5ppm |
Conform |
|
Related Compounds |
Impurity A |
Not more than 0.3% |
0.04% |
Any other impurity |
Not more than 0.2% |
0.10% |
|
Sum of impurities other than A |
Not more than 0.7% |
0.23% |
|
Residual Organic solvent |
|
Not more than 0.005% |
0.003% |
|
Not more than 0.01% |
0.004% |
|
|
Not more than 0.5% |
It is antineoplastic agent, half synthesis derivative of vincamedine for the equilibrium of microtubule protein or capillary's dynamical, suppressing polymerization of microtubule protein through G2 and the M which suitable to the noncellule lung cancer, transferring breast cancer, difficult lymphoma, ovarian cancer and pate tumor patient .
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