Certification: | ISO, FDA |
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Assay Method: | HPLC, UV |
Application Form: | Lotion, Tablet, Capsule |
Application: | Food, Health Care Products, Medicine |
State: | Powder |
Extract Source: | Yew |
Samples: |
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Customization: |
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Product Name |
Paclitaxel Extract |
Appearance |
White Powder
|
Specification |
99% paclitaxel |
Certificate |
ISO9001/Halal/Kosher/GMP |
Mesh size |
100% pass 80 mesh |
Latin name |
Taxus Chinensis extract |
Grade |
Pharmaceutical Grade |
CAS |
84238-39-1 |
COA |
Available |
Shelf Life |
2 years |
Product Keywords |
Paclitaxel Extract |
CERTIFICATE OF ANALYSIS
TEST ITEM | SPECIFICATION | RESULTS |
Appearance | White or almost white crystalline powder | White-crystalline Powder |
Identification | Conform | Conform |
Solubility | Soluble in ethanol, methanol, Chloroform, hardly soluble in water | Conform |
Solubility in Polysorbate-80 | >=45.0mg/ml | Conform |
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/g | 60cfu/g |
S. Aureus & Aeruginosa | Negative | Negative |
Salmonella & E.Coli | Negative | Negative |
Bacterial Endotoxins | <=0.4EU/mg | 0.15EU/mg |
Moisture | <=3.0% | 0.5% |
Residue of Ignition | <=0.2% | 0.05% |
Heavy Metals | <=20ppm | 12ppm |
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% |
Conclusion | The lot meets the specifications |
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