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Product:Docetaxel Anhydrous
CAS No.:114977-28-5
Mol.Formula:C43H53NO14
Appearance: White crystalline powder
Purity(HPLC) : 99%
Docetaxel is a clinically well established anti-mitotic chemotherapy medication used mainly for the treatment of breast, ovarian, and non-small cell lung cancer. Docetaxel has an approved claim for treatment of patients who have locally advanced, or metastatic breast or non small-cell lung cancer who have undergone anthracycline-based chemotherapy and failed to stop cancer progression or relapsed.Administered as a one-hour infusion every three weeks generally over a ten cycle course, docetaxel is considered better than doxorubicin, paclitaxel and fluorouracil as a cytotoxic antimicrotubule agent.
1.It is a clinically well established anti-mitotic chemotherapy medication (that is, it interferes with cell division).
2.It is used mainly for the treatment of breast, ovarian, and non-small cell lung cancer.
3.Ithas an FDA approved claim for treatment of patients who have locally advanced, or metastatic breast or non small-cell lung cancer who have undergone anthracycline
based chemotherapy and failed to stop cancer progression or relapsed. An European
approval docetaxel for use in hormone-refractory prostate cancer.
4.It is considered better than doxorubicin, paclitaxel and fluorouracil as a cytotoxic antimicrotubule.
Docetaxel intermediate is a crucial intermediate for Docitaxel, two of the best anti-cancer drugs ever invented. By extracting the precursor, docetaxel intermediate in large quantites from the Taxus baccata leaf, many subsequent semisyntheses can be carried out.
The esterification of docetaxel intermediate also causes an enhancement in the kinetics, and therefore the pharmacological profile of these important chemo-therapeutic agents.
Analysis |
Standard |
Assay(W/W) |
98.0-102.0% |
Purity(HPLC) |
≥99.5% |
Physical Control |
|
Appearance |
White crystalline powder |
Identification |
Conforms |
Specific Optical Rotation |
-40°~-47° |
Water |
≤3.0% |
Chemical Control |
|
Residue of solvents |
Complies with ICH requirement |
Residue on Ignition |
NMT0.2% |
Bacteria Endotoxins |
0.4EU/MG |
Heavy Metal |
NMT20ppm |
Chromatographic Impurities |
|
Highest Individual Impurity |
NMT0.1% |
Unknown Impurity |
NMT0.1% |
Total Impurity |
NMT0.5% |
Microbiological Control |
|
Total Aerobic Microbial Count |
NMT 100cfu/g |
S.Aureus & Aeruginosa |
Negative |
Salmonella & E.Coil |
Negative |
Storage |
|
Store at 2-8°C, In well closed containers and protect from light and moisture. |