Product Information | |
Product Name | Docetaxel Anhydrous 99.5% |
Molecular Formula | C43H53NO14(807.88) |
Cas No. | 114977-28-5 |
Quality standard | EP |
Analysis | Standard |
Assay(W/W) | 98.0-102.0% |
Purity(HPLC) | ≥99.5% |
Physical Control | |
Appearance | White crystalline powder |
Identification | Conforms |
Specific Optical Rotation | -40°~-47° |
Water | ≤3.0% |
Chemical Control | |
Residue of solvents | Complies with ICH requirement |
Residue on Ignition | NMT0.2% |
Bacteria Endotoxins | 0.4EU/MG |
Heavy Metal | NMT20ppm |
Chromatographic Impurities | |
Highest Individual Impurity | NMT0.1% |
Unknown Impurity | 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. |