Product Information | |
Product Name | Docetaxel Trihydrate |
Molecular Formula | C43H53NO14.3H2O (861.9) |
Cas No. | 148408-66-6 |
Analysis | Standard |
Assay(W/W) | 98.0-102.0% |
Purity (HPLC) | ≥99.5% |
Quality standard | EP |
Physical Control | |
Appearance | White or almost white crystalline powder |
Identification | Conforms |
Specific Optical Rotation | -40°~-47° |
Water | 5.0%-7.0% |
Solubility in Polysorbate-80 | 45.0mg/ml Min |
Chemical Control | |
Residue of solvents | Complies with ICH requirement |
Residue on Ignition | ≤0.2% |
Bacteria Endotoxins | NMT0.4 EU/mg |
Heavy Metal | NMT20ppm |
Chromatographic Impurities | |
Highest Individual Impurity | NMT0.1% |
Unknown Inpurity | NMT0.1% |
Total Impurity | NMT0.5% |
Microbiological Control | |
Total Aerobic Microbial Count | NMT 100cfu/g |
S.Aureus & Aeruginosa | Negative |
Salmonella & E.Coil | Negative |
Storage | |
Store at 2-8°C, In well closed containers and protect from light and moisture. |