Paclitaxel

SKU : AN017
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CAS number

33069-62-4

molecular formula

C47H51NO14

standard

USP32

Package

5kg/tin
ITEMS LIMIT
Analysis Standard
Assay (W/W) 97.0- 102.0%
Paclitaxel (HPLC) NLT99.8%
Appearance White Crystalline Powder
Identification (By IR) Complies
Identification (By HPLC) Complies
Specific Optical Rotation -49.0°~-55.0°
Water NMT4.0%
Residue of solvents Complies with ICH requirement
Residue on Ignition NMT0.2%
Bacteria Endotoxins NMT0.4USP EU/mg
Heavy Meta NMT20ppm
Microbial Limits NMT100cfu/g
Impurity
Total Impurities NMT 0.5%
Individual Impurities NMT 0.1%
Baccatin III NMT0.2%
10-Deacetylpaclitaxel NMT0.5%
7-Xylosylpaclitaxel NMT0.2%
Cephalomannine and 2,3-Dihydrocephalomannine NMT0.5%
10-deacetyl-7-epi-paclitaxel NMT0.5%
Benzyl analog and 3,4-Dehydropaclitaxel C NMT0.5%
7-Epicephalomannine NMT0.3%
7-epi-paclitaxel NMT0.5%
Other Individual Impurities NMT0.1%

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