Product Information  | |
Product Name  | Paclitaxel (Natural) USP34  | 
Molecular Formula  | C47H51NO14(853.9)  | 
Cas No.  | 33069-62-4  | 
Quality standard  | complies with USP34  | 
Analysis  | Standard  | 
Assay (W/W)  | 97.0- 102.0%  | 
Paclitaxel (HPLC)  | NLT99.5%  | 
Physical Control  | |
Appearance  | White crystalline powder  | 
Identification (By IR)  | Complies  | 
Identification (By HPLC)  | Complies  | 
Specific Optical Rotation  | -49.0°~-55.0°  | 
Water  | NMT4.0%  | 
Chemical Control  | |
Residue of solvents  | Complies with ICH requirement  | 
Residue on Ignition  | NMT0.2%  | 
Bacteria Endotoxins  | NMT0.4USP EU/mg  | 
Heavy Metal  | 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%  | 
Storage  | |
Store in well closed containers and perfect from light and moisture.  | |