Formula:C47H51NO14
Molecular weight:853.9
Description :White crystalline powder
Identification (By IR):The Infra-red absorption spectrum in potassium bromide dispersion of sample exhibits maximal at the same wave length as per that of similar preparation of paclitaxel working standard.
Identification (By HPLC):The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation as obtained in the assay.
Specific Optical Rotation:-49.0o ~ -55.0o
Water(K.F.):NMT 4.0%
Residue on ignition :NMT 0.20%
Bacteria Endotoxins:NMT 0.4USP EU/mg
Heavy metal:NMT 20ppm
Microbial Limits:NMT 100cfu/g
Paclitaxel (W/W):97.0% ~ 102.0%
Total Impurities(HPLC): NMT 2.0%
Baccatin III:NMT 0.2%
10-Deacetylpaclitaxel:NMT 0.5%
7-Xylosylpaclitaxel:NMT 0.2%
7-Epicephalomannine:NMT 0.3%
7-Epipaclitaxel:NMT 0.5%
Other Individual Impurities:NMT 0.1%
Methane Dichloride:NMT 600ppm
Chloroform:NMT 60ppm
Tricholroethylene:NMT 80ppm
1,4-Dioxane:NMT 380ppm
Paccking:1g/foilbag or as customer’s requitment