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|Type:||Auxiliaries And Other Medicinal Chemicals||MF:||C8H8O3|
|Storage:||Cool And Dry||Appearance:||White Crystalline Powder|
|Melting Point:||120-122°C||Melting Point:||120-122°C|
|CAS No.:||611-72-3||CAS No.:||611-72-3|
Pharmaceutical Intermediates 100% Natural Yew Bark Extract Paclitaxel
1. Production Description
Natural Paclitaxel is a mitotic inhibitor used in cancer chemotherapy. It was discovered in a National Cancer Institute program at the Research Triangle Institute in 1967 when Monroe E. Wall and Mansukh C. Wani isolated it from the bark of the Pacific yew tree, Taxus brevifolia and named it 'taxol'. When it was developed commercially by Bristol-Myers Squibb (BMS) the generic name was changed to 'paclitaxel' and the BMS compound is sold under the trademark 'TAXOL'. In this formulation, paclitaxel is dissolved in Cremophor EL and ethanol, as a delivery agent.
|Appearance||white powder||Wcrystalline powder.hite,|
|Water||Not more than0.5%||0.08%|
|Related substance||ImpurityJ(chloroacetanilide)not more than 10 ppm||2ppm|
|Impurity K(4-aminophenol)not more than 50 ppm||15 ppm|
|Impurity F(4-nitrophenol)not more than 0.05%||Not detected|
|any other impurity not more than 0.05%||0.01%|
|Total of other impurities not more than 0.1%||0.02%|
|Residue on ignition||Not more than 0.1%||0.05%|
|Chloride||Not more than 0.014%||Less than 0.014%|
|Sulfate||Not more than 0.02%||Less than 0.02%|
|Heavy metals||Not more than 0.001%||Less than 0.001%|
|Free p-aminophenol||Not more than 0.005%||Less than 0.005%|
|Limit of P-chloroacetanilide||Not more than 0.001%||Less than 0.001%|
|Readily carbonizable substances||Conforms||Conforms|
|Residual solvents||Residual content of acetic acid is limited||0.08%|
|by the test of loss on dryingnot more than0.5%|
|Conclusion: Complies with USP34/ BP2011|
1. Isolated the compound from the bark of the Pacific yew tree, Taxus brevifolia, and noted its antitumor activity in a broad range of rodent tumors.
2. Paclitaxel is a mitotic inhibitor drup used in the treatment of cancer.
3. Paclitaxel has since become an effective tool of doctors who treat patients with lung, ovarian, breast cancer, and advanced forms of Kaposi's sarcoma.
4. Paclitaxel is also used for the prevention of restenosis (recurrent narrowing) of coronary stents; locally delivered to the wall of the coronary artery, a paclitaxel coating limits the growth of neointima (scar tissue) within stents.
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.
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