Appearance: | white crystalline powder |
---|---|
Application: | Medicine |
Model Number: | FZ010 |
Brand Name: | Fengzu |
Purity: | 99% |
Type: | Pharmaceutical Intermediates |
Place of Origin: | China (Mainland) |
EINECS No.: | 125354-16-7 |
MF: | C45H55NO15 |
Other Names: | Docetaxel/ Docetaxel Powder |
CAS No.: | 125354-16-7 |
Name: | Docetaxel |
Color: | white crystalline powder |
Quick Details
Specifications
Product name: Docetaxel/ Docetaxel Powder
CAS: .125354-16-7
MF: C45H55NO15
MW: 849.922
Appearance: white crystalline powder
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.
Test/Observation |
Specifications |
Result |
Identification |
1) By IR Sample and Standard IR spectra in mineral oil dispersion 2) By UV The light absorption spectrum of sample solution exhibits Max.282,275 and 230nm |
Complies |
Assay Content % by HPLC (on anhydrous basis) |
98.0%--102.1% |
99.78% |
Chromatographic impurities
|
≤ 0.5% ≤ 0.10% NMT1.0% |
0.2% max 0.05% 0.43% |
Appearance |
White to off-white crystal powder |
Complies |
Solubility in Polysorbate-80 |
45.0mg/ml Min |
Complies |
Specific Optical Rotation |
-49.0o - -55.0o |
Complies |
Bacterial endotoxins |
≤ 0.4EU/mg |
0.15EU/mg |
Heavy metals PPM |
≤ 5 PPM |
3PPM |
Moisture |
≤3.0% |
0.96% |
Residue on ignition |
≤0.2% |
0.05% |
Microbiology Total Plate Count Yeast & Mold E.Coli S. Aureus Salmonella |
<100cfu/g <100cfu/g Negative Negative Negative |
12cfu/g docetaxel 10 cfu/g docetaxel Complies Complies Complies |