Paclitaxel (Taxol)
The No. 1 Anti-Cancer Drug - A "Billiob Dollar Molecule"
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Business Opportunity The "Billion Dollar Molecule", Paclitaxel Injection  To be the  Exclusive Agent for EU generic Paclitaxel Injection in your country.

Exciting News: Paclitaxel and Paclitaxel Injection entered USP26. We are the first supplier of the high quality USP26 Standard Paclitaxel and Paclitaxel Injection in the world.

Today, Paclitaxel is the No. 1 Anti-cancer Drug in the battle of we humans against  cancer. It constitutes about 22% of all major cancer chemotherapy drugs on the world market.

In 2000.  BMS reported its annual sales of Taxol (Paclitaxel Injection) was $1.592 billion - equal to excess $4.3 million per day.

 

In January 2001.  Ivax announced that $30 million of its generic Paclitaxel Injection (Onxol)  has been sold in a 10-week period - in USA alone. And in the second quarter of 2001,  Paclitaxel sales accounted for in excess of 25% of Ivax's total revenue.

These figures reflect the urgent needs of effective anti-cancer drugs. Particular the generic Paclitaxel Injection brought the price down and made it more affordable for global cancer patients.

This web site will tell you all about Paclitaxel. No matter you are the patient or your family member  / friend need help; or you are the professionals, the merchant, the scientist, you can find some information useful or interesting here.

Yew trees. These precious yew trees growing only in certain regions on the earth. It grows very slow. Many countries list it as protected plants. Even large planting fields have been developed in some countries. However the yew trees resources are limited. From 1998, FDA/USP not to limit any source of Paclitaxel. 
Taxus baccata (Europe)
Taxus brevifolia (North America)
Taxus yunnanensis (China)

Now these 3 yew tree species are the most commonly used source  of  Paclitaxel.
Yew tree contains very small amount of Paclitaxel. It need 10 tons of yew tree leaves to extract and purify 1kg 99.5% Paclitaxel.

Paclitaxel structural formula is shown here.
Molecular formula C47H51NO14 
Molecular weight of 853.93

Pure Paclitaxel is a white to off-white crystalline powder and is highly lipophilic, insoluble in water, and melts at around 216-217C. 

Paclitaxel success is largely due to its unique mechanism of action - tubulin polymerization - and its excellent ability to work in combination with other anticancer agents.

This 3D picture shows the Paclitaxel (yellow) integrated into a tubulin molecule - the skeletal structures that assemble and divide throughout the life of a cell.
But Paclitaxel can make the microtubules so clogged, then the cancer cell cannot divide and grow.

Paclitaxel products available here:
99.5% Paclitaxel  (USP-PF, DMF, Injectable grade) -  for manufacturers to make injections

Paclitaxel Injection 30mg/5mL vials
Paclitaxel Injection 100mg/16.7mL vials
(EU origin) - for global distributors and wholesalers.

We are selecting potential Exclusive Agent for EU generic Paclitaxel Injection in each country.

 Paclitaxel (USP26)

(>99.5% Injectable Grade, DMF, )

SPECIFICATION

Shelf life - 3 years. 

Specification 99.5% Paclitaxel (Supplied by 21CEC) Standard (USP26)
Appearance White crystalline powder White crystalline powder     
Identification :           
1. IR Spectrum Conforms Absorption (197K)
2. MASS Spectrum : Conforms   (not required)
3. NMR Spectrum Conforms (not required)
4. UV Spectrum 227 (+/_2) nm. (not required)
5. HPLC retention time      Conforms     Conforms
Specific Optical Rotation         -52.84  -49 ~ -55                       
Melting Point   219.0C               213~ 220C                       
Water                                        0.38% ≤4.0%             
Residue on Ignition                               0.10% ≤0.2%        
Heavy Metal                                      <20ppm ≤20ppm       
Related Compounds:    
1. Baccatin III 0.00% <0.2%
2. 10-Deacetylpaclitaxel 0.00% <0.5%
3. 7-Xylosylpaclitaxel  0.00% <0.2%
4. Cephalomanine (Paclitaxel related compound A) 0.02% <0.5% (a1+a2)*
5. 2",3"-Dihydrocephalomannine
6. 10-Deacetyl-7-epipaclitaxel (Paclitaxel related compound B) 0.05% <0.5%
7. Benzyl analog 0.00% <0.5%(b1+b2)*
8. 3", 4"-Dehydropaclitaxel C
9, 7-Epicephalomannine 0.00% <0.3%
10. 7-Epipaclitaxel  0.03% <0.5%
Any other single impurity Conforms <0.1%
Total Impurities      

 0.38%

≤2.0%  
Organic volatile impurities:    
1.Methanol          11ppm  ≤3000ppm     
2.Acetone        < 10ppm ≤5000ppm      
3.Isopropyl alcohol                               < 10ppm ≤5000ppm     
4.Methylene chloride                                90ppm ≤600ppm     
5.Hexane                                       < 10ppm ≤290ppm         
6.Ethyl acetate         < 10ppm ≤5000ppm    
Bacterial Endotoxins  0.16EU/mg ≤0.4EU/mg    
Microbial Limits      <20cfu/g          ≤100cfu/g 
Total aerobic Microbial <10cfu/g    
Total fungal count <10cfu/g ≤100cfu/g 
Absence of Staphylococcus aureus, Pseudomonas aeruginosa,
Salmonella
 
species, and  Escherichia coli.
Conforms Conforms
Assay (On the anhydrous, solvent- free basis ) 99.87%  97.0 ~ 102.0% 
Conclusion: This product meets the specification of USP26 .

* USP26 requires the sum of a1+a2 is no more than 0.5% .
** USP26 requires the sum of b1+b2 is no more than 0.5%.


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