Product Information | |
Product Name | Paclitaxel (Natural) USP34 |
Molecular Formula | C47H51NO14(853.9) |
Cas No. | 33069-62-4 |
Quality standard | complies with USP34 |
Analysis | Standard |
Assay (W/W) | 97.0- 102.0% |
Paclitaxel (HPLC) | NLT99.5% |
Physical Control | |
Appearance | White crystalline powder |
Identification (By IR) | Complies |
Identification (By HPLC) | Complies |
Specific Optical Rotation | -49.0°~-55.0° |
Water | NMT4.0% |
Chemical Control | |
Residue of solvents | Complies with ICH requirement |
Residue on Ignition | NMT0.2% |
Bacteria Endotoxins | NMT0.4USP EU/mg |
Heavy Metal | NMT20ppm |
Microbial Limits | NMT100cfu/g |
Impurity | |
Total Impurities | NMT 0.5% |
Individual Impurities | NMT 0.1% |
Baccatin Ⅲ | NMT0.2% |
10-Deacetylpaclitaxel | NMT0.5% |
7-Xylosylpaclitaxel | NMT0.2% |
Cephalomannine and 2,3-Dihydrocephalomannine | NMT0.5% |
10-deacetyl-7-epi-paclitaxel | NMT0.5% |
Benzyl analog and 3,4-Dehydropaclitaxel C | NMT0.5% |
7-Epicephalomannine | NMT0.3% |
7-epi-paclitaxel | NMT0.5% |
Other Individual Impurities | NMT0.1% |
Storage | |
Store in well closed containers and perfect from light and moisture. |