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:::Docetaxel Trihydrate:::

 
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.


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