| Product Information |
| Product Name |
Paclitaxel (Semi-synthetic) USP31 |
Molecular Formula |
C47H51NO14 (853.9) |
Cas No. |
33069-62-4 |
Quality standard |
complies with USP31 |
| 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 |
NMT0.5% |
10-DAB Ⅲ |
NMT0.1% |
Baccatin Ⅲ |
NMT0.2% |
Photodegradant |
NMT0.1% |
10-Deacetylpaclitaxel |
NMT0.5% |
2-Debenzoylpaclitaxel-2-pentenoate |
NMT0.7% |
10-deacetyl-7-epi-paclitaxel |
NMT0.4% |
7-epi-paclitaxel |
NMT0.4% |
10,13-bissidechainpaclitaxel |
NMT0.5% |
7-Acetylpaclitaxel |
NMT0.6% |
13-tes-baccatin Ⅲ |
NMT0.1% |
7-tes-paclitaxel |
NMT0.3% |
Other Individual Impurities |
NMT0.1% |
Storage |
Store in well closed containers and perfect from light and moisture. |
