Taxotere Docetaxel supplier Docetaxel 98%
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. |
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