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:::Paclitaxel (Natural) USP34:::
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. |
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