148408-66-6 Docetaxel Trihydrate Docetaxel
Docetaxel Trihydrate
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 |
complies with In-house Standard |
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. |
Docetaxel Trihydrate
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 |
complies with In-house Standard |
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. |
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