| 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. |
