Docetaxel   (TAXOTERE®) 
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 99.0% Docetaxel

DESCRIPTION

Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butyl ester, 13-ester with 5b-20-epoxy-12a,4,7b,10b,13a-hexahydroxytax- 11-en-9-one 4-acetate 2-benzoate, anhydrous or trihydrate. 

There are two types of Docetaxel products on the market.

Docetaxel, Trihydrate is a white to almost-white crystalline powder with an empirical formula of C43H53NO14• 3H2O, and a molecular weight of 861.9. 

Docetaxel, Anhydrous is a white to almost-white microcrystalline powder with an empirical formula of C43H53NO14,    and a molecular weight of 807.9.

Specification of Docetaxel, Anhydrous:

Shelf Life - 2 years.

Specification 99.0% Docetaxel (Supplied by 21CEC) Standard
Appearance   Microcrystalline White Powder Microcrystalline White Powder
Identification Conforms Conforms           
IR Spectrum Conforms Conforms
NMR Spectrum Conforms Conforms
HPLC retention time Conforms Conforms
Specific Optical Rotation     -42.93º -35º ~ -45º     
Water    0.15% ≤1.0%     
Residue on ignition   0.1% ≤0.2% 
Heavy Metal          <20ppm                                 ≤20ppm 
Bacterial Endotoxin     <0.4EU/mg ≤0.4EU/mg        
Microbial limits             
Total aerobic microbial count    <10cfu/g  ≤100cfu/g    
Absence of Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella species and Escherichia coli Conforms Conforms
Chromatographic Impurities    
10-Deacetylbaccatin-III 0.03% ≤0.5%      
Total Impurities              0.60% ≤1.0%    
Assay (On the anhydrous, solvent- free basis ) 99.2% 

                                 

98.0 ~ 102.0%                 

 

Conclusion: This lot meets the enterprise specification.

 

Specification of Docetaxel, Trihydrate:

Shelf Life - 3 years.

Specification 99.0% Docetaxel (Supplied by 21CEC) Standard
Appearance   White crystalline powder

White or almost white     crystalline Powder

Identification Conforms Conforms           
IR Spectrum Conforms Conforms
NMR Spectrum Conforms Conforms
HPLC retention time Conforms Conforms
Solubility 

                     

Conforms

 

Soluble in ethanol, methanol, chloroform,  Hardly soluble in water
Specific Optical Rotation    -41.6º    -40º ~ -47º                   
Residue on ignition   0.1% ≤0.2% 
Water 5.22%      5 - 7%                   
Melting point    186ºC-192ºC(Trihydrate form)    191ºC 
Heavy Metal          <20ppm                                 ≤20ppm 
Bacterial Endotoxin     <0.24EU/mg ≤0.4EU/mg        
Microbial limits  ≤10cfu/g   <100cfu/g                 
Total aerobic microbial count    <10cfu/g  ≤100cfu/g    
Absence of Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella species and Escherichia coli Conforms Conforms
Chromatographic Impurities    
10-Deacetylbaccatin-III 0.06% ≤0.5%      
Total Impurities              0.64% ≤1.0%    
Assay (On the anhydrous, solvent- free basis ) 99.5% 

≥99.0% %                       

Conclusion: This lot meets the enterprise specification.

 

Background and Applications

A drug developed by Aventis Pharmaceuticals (formerly Rhône-Poulenc Rorer Pharmaceuticals Inc. and Hoechst Marion Roussel, Inc.) for the treatment of certain types of cancer, 

Taxotere is now approved in 90 countries to treat advanced breast cancer and 70 countries to treat patients with advanced non-small-cell lung cancer. 

BREAST CANCER 

Taxotere is the first anticancer agent to show a significantly higher response rate than Adriamycin® (doxorubicin), a very active agent and widely used chemotherapy in the first-line treatment of
metastatic breast cancer. Taxotere also is the first chemotherapy drug as a single agent to demonstrate increased survival among patients with advanced breast cancer compared to the combination of mitomycin C and vinblastine, a commonly used regimen in this patient population. 

Taxotere as a single agent was compared to mitomycin C in combination with vinblastine and showed a one-year survival rate of 49 percent among breast cancer patients, compared to 33 percent for those treated with the combination therapy. Fifty percent more patients treated with Taxotere were alive one year after therapy, compared to those treated with the combination. Median time to progression and time to treatment failure were significantly longer for
Taxotere. The overall response rate among patients treated with Taxotere was 28 percent vs. the combination’s 9.5 percent.  

Taxotere has been studied extensively in more than 200 clinical trials involving more than 85,000 patients worldwide. Approximately 10,000 breast cancer patients worldwide have been treated with Taxotere.  

In one randomized Phase III multi-center study, Taxotere showed a 50 percent better overall response rate compared to patients treated with Adriamycin (45 percent for Taxotere vs. 30 percent for Adriamycin). The overall response ate is the partial response rate (50 percent of greater reduction in
measurable tumor size) plus the complete response rate (complete disappearance of all clinical and radiological signs of cancer). Median time to progression, time to treatment failure, and survival were comparable for both agents.  

Patients in both Phase III trials were a poor prognostic group. In the study of Taxotere versus doxorubicin, three-quarters of all patients had disease that had spread to other internal organs, almost half had three or more organs showing evidence of disease and approximately half had received prior chemotherapy for metastatic disease. In the trial of Taxotere versus mitomycin C plus vinblastine, approximately half the patients had liver metastases, three-quarters had disease that had spread to other internal organs, and about one-third had received chemotherapy in both the adjuvant and metastatic setting. 

LUNG CANCER  - Non-Small-Cell Lung Cancer

Taxotere is the first chemotherapy agent shown to significantly improve survival for patients after failure of prior platinum-based chemotherapy. It is the first chemotherapy agent to be approved by the U.S. Food and Drug Administration for the second-line treatment of advanced NSCLC. 

In a Phase III clinical study involving NSCLC patients whose disease had progressed on prior platinum-based chemotherapy, patients treated with Taxotere 75 mg/m2 plus best supportive care had a significantly higher one-year survival rate (37 percent) compared to patients who received best supportive care alone (12 percent). 

In another study, NSCLC patients who had undergone prior platinum-based chemotherapy had a higher one-year survival rate when treated with Taxotere than with either Navelbine® (vinorelbine) or Ifex® (ifosfamide), two other chemotherapy agents. Of the patients treated with 75 mg/m2 of Taxotere, 30 percent were alive at one year, as compared to 20 percent of those treated with vinorelbine or ifosfamide. 

 


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