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Taxol/Abraxane/Docetaxel Manufacturer

China Taxol/Abraxane/Docetaxel Manufacturer, Find details about China Paclitaxel, Docetaxe from Taxol/Abraxane/Docetaxel Manufacturer

Model NO.
QY-0025
China
Organic Extract
Trademark
EYECHEM
Transport Package
1kg 25kg
Specification
99.5%
Origin
China
HS Code
2932999099
Model NO.
QY-0025
China
Organic Extract
Trademark
EYECHEM
Transport Package
1kg 25kg
Specification
99.5%
Origin
China
HS Code
2932999099

Product Name: Paclitaxel Powder

Active Ingredient: Paclitaxel

Purity: 99.5%

Part Used:Bark

Appearance: white crystalline powder

CAS Number: 33069-62-4

Molecular Formula: C15H24N202

Molecular Weight: 264.36

Extract Method:Water/Enthanol

 

 

Function

 

Paclitaxel is now used to treat patients with lung, ovarian, breast cancer, head and neck cancer, and advanced forms of Kaposi's sarcoma. Paclitaxel is also used for the prevention of restenosis.

 

Paclitaxel stabilizes microtubules and as a result, interferes with the normal breakdown of microtubules during cell division. Together with docetaxel, it forms the drug category of the taxanes.

 

 COA:

 

 

ITEMS

SPECIFICATION

RESULTS

BP2010 /EP6

Appearance

crystalline powder

Conforms

Melting point

About 205°C

206.4°C~206.7°C

Identification

Meet the requirements

Conforms

Appearance of

solution

Clear, not more intense than Y7

Conforms

PH

2.4~3.0

2.60

Loss on drying

≤0.5%

0.04%

Sulphated ash

≤0.1%

0.01%

Heavy metals

≤20 ppm

<20 ppm

Related substances

≤0.25%

Conforms

Assay

99.0%~101.0%

99.8%

USP32

Identification

Meet the requirements

Conforms

Loss on drying

≤0.5%

0.04%

Residue on ignition

≤0.1%

0.01%

Heavy metals

≤0.003%

<0.003%

Residue solvent - Ethanol

≤0.5%

<0.04%

Chloride

16.9%~17.6%

17.1%

Assay

98.0%~102.0%

100.0%

Conclusion: The product complies with BP2010/USP32/EP6 standard

 



CERTIFICATE OF ANALYSIS

Product name:Docetaxel
Storage Condition:Preserve in tight, light-resistant containers, and store at -2°C--8°C.
 
TEST ITEMSPECIFICATIONRESULTS
AppearanceWhite or almost white crystalline powderWhite-crystalline Powder
IdentificationConformConform
SolubilitySoluble in ethanol, methanol, Chloroform, hardly soluble in waterConform
Solubility in Polysorbate-80>=45.0mg/mlConform
Reconstitution Stability of 2ml of 45mg/ml solution of Docetaxel.trihydrate in polysorbate-80, with 6.0ml of 15.25% v/v absolute alcohol in water solution. The solution should be physically stable. No precipitation should be observed for at least 12 hours of storage of reconstituted solution at room temperature.
Specific Optical Rotation-40°--47°-41ºC
Microbial Limits
Total Aerobic Microbial Count<=10000cfu/g60cfu/g
S. Aureus & AeruginosaNegativeNegative
Salmonella & E.ColiNegativeNegative
Bacterial Endotoxins<=0.4EU/mg0.15EU/mg
Moisture<=3.0%0.5%
Residue of Ignition<=0.2%0.05%
Heavy Metals<=20ppm12ppm
Chromatographic Impurities
Highest individual Impurity<=0.5%0.12%
Unknown Impurity<=0.10%Conform
Total Impurity<=1.0%Conform
Purity (HPLC)>=99.5%99.52%
ConclusionThe lot meets the specifications

What's the product?

English Name: Docetaxel intermediate

Test Method: HPLC

Purity: HPLC≥98%

[Synonyms]: Docetaxel intermediate

[CAS No.] 114915-14-9 

[Mol. Formula]  C49H55Cl6NO18

[Mol. Weight]  807.885

[Loss on drying]  ≤2.0%

[Catalogue No.]  S-140

[Purity] >98% 99% by HPLC 

[Packaging]  20mg, 50mg,100mg,1g,10g,100g,kgs and so on

Package and quantity according to customer's detail requirement. 

How does it work?

 

· 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.It has 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. 

 

What field apply to?

Docetaxel intermediate  is a crucial intermediate for Docitaxel, two of the best anti-cancer drugs ever 

invented. By extracting the pre-cursor, docetaxel intermediate  in large quantites from the Taxus

baccata leaf, many subsequent semi-syntheses 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.

Product Name:  Taxol
Botanical Name: Taxus Chinensis Rehd
Plant Part Used: Stem & Leaf
Quantity:      20kg
 
ITEM                              SPECIFICATIONRESULTS
Physical&Chemical Control  
AppearanceFine powderComplies
ColorWhite Complies
Odor&TasteCharacteristicComplies
Loss On Drying<1.0%0.35%
Ash<0.2%0.18%
Assay (Paclitaxel, by HPLC)≥99.5%99.558%
Sieve Analysis98% pass 100 meshComplies
As<2ppmComplies
Heavy Metals                         <10ppmComplies
Bulk density45-65g/100ml  Complies
SolubilitySoluble in hydro-alcoholic solutionComplies
Microbiological Control  
Total plate count<1000 CFU/gComplies
Yeast & mold<100 CFU /gComplies
E.coli   NegativeNegative
SalmonellaNegativeNegative

 

What's the product?

English Name: Docetaxel intermediate

Test Method: HPLC

Purity: HPLC≥98%

[Synonyms]: Docetaxel intermediate

[CAS No.] 114915-14-9 

[Mol. Formula]  C49H55Cl6NO18

[Mol. Weight]  807.885

[Loss on drying]  ≤2.0%

[Catalogue No.]  S-140

[Purity] >98% 99% by HPLC 

[Packaging]  20mg, 50mg,100mg,1g,10g,100g,kgs and so on

Package and quantity according to customer's detail requirement. 

How does it work?

 

· 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.It has 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. 

 

What field apply to?

Docetaxel intermediate  is a crucial intermediate for Docitaxel, two of the best anti-cancer drugs ever 

invented. By extracting the pre-cursor, docetaxel intermediate  in large quantites from the Taxus

baccata leaf, many subsequent semi-syntheses 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.

Taxol/Abraxane/Docetaxel Manufacturer
 

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