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.  | |