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Paclitaxel
| 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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