Yanan Pharmaceutical Co., Ltd
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Product Name: Natrual Paclitax extract
Standard: USP 32
Appearance: white crysaline powder
Mole formular: C47H51NO14
CAS:33069-62-5 / 33069-62-5
Melting point: 213-216 degree
Certificate of Analysis:
Appearance | White or almost white crystalline powder |
Identification | FT-IR |
HPLC | |
NMR | |
Mass | |
Solubility | Soluble in ethanol, methanol, Chloroform, hardly soluble in water |
Specific Optical Rotation | -49.0º ~ -55.0º at 20°C |
Melting Point | 213°C­—216°C |
Water | ≤1.0% |
Residual Solvent | Meets the requirements of ICH |
Ethyl Acetate | ≤5000ppm |
Acetone | ≤5000ppm |
Methanol | ≤3000ppm |
Acetic acid | ≤5000ppm |
Residual of volatile Solvents | Meets the requirements of ICH |
Chloroform | ≤60ppm |
Dichloromethane | ≤600ppm |
Hexane | ≤290ppm |
Toluene | ≤890ppm |
Residue on Ignition | ≤0.2% |
Bacteria endotoxins | ≤0.4 USP EU/mg |
Total aerobic microbial count | ≤100 cfu/g |
Staphylococcus aureus | Absence |
Pseudomonas aeruginosa | Absence |
Salmonella species | Absence |
Escherichia Coli | Absence |
Heavy Metals | ≤20 ppm |
IMPURITIES: | |
10-Deacetyl Baccatin III | ≤0.1% |
Baccatin III | ≤0.2% |
Photodegradant | ≤0.1% |
10-Deacetyl Paclitaxel | ≤0.5% |
2-Debenzoylpaclitaxel-2-pentenoate | ≤0.7% |
Oxetane ring opened, Acetyl and benzoyl | ≤0.1% |
10-Acetoacetyl paclitaxel | ≤0.1% |
10-Deacetyl-7-epi-paclitaxel | ≤0.3% |
| ≤0.4% |
7-epi-paclitaxel | ≤0.4% |
10,13-Bissidechainpaclitaxel | ≤0.5% |
7-Acetyl Paclitaxel | ≤0.6% |
Function:
1. Paclitaxel is a mitotic inhibitor drup used in the treatment of cancer.
2. 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.
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.
Evaluate
- Favourable(100%)
- Medium(0%)
- Negative(0%)
