Biochemical
Paclitaxel
Description
Paclitaxel
Test Standard Results
Appearance White to off-whitecrystalline powder White crystalline powder
Identification Infrared Absorption Conform
HPLC Conform
Solubility Insoluble in water, soluble I alcohol. Conform
Assay Not less than 97.0 bercen1. and not more than102.0 percent of calculated on the anhydrous, solvent free badis. 99.5%
Water NMT 4.0% 0.96%
Specific Rotation -49.0~ -55.0(at 20) -49.4
Residue on Ignition NMT 0.2% 0.12%
Heavy Metals NMT 0.002% NMT 0.002%
Microbial limits Total aerobic microbialNMT 100cfu/g.
Absence of Staphaureusn aureus,
Pseudomonas aeruginos, Salmonella species,
and Escherichia coli. Conform
Bacterial endotoxins 0.4EU/mg 0.2EU/mg
Related Compounds
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