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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

Specifications

High quality Docetaxel 99%powder with good price,medical grade Docetaxel

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

  1. A. Highest individual impurity
  2. B. Unknow impurity
  3. C. Total imputities

 

 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