Tab. 4.
Batch analysis of Impurities for different samples.
| Name of the Product | Docetere™ 80 mg | Docetere™ 20 mg | Taxotere® 80 mg | ||||
|---|---|---|---|---|---|---|---|
| Batch No. | A7469 | A8252 | A7486 | A8331 | D6D400 | ||
| Months before Expiry | 9 | 14 | 10 | 16 | 9 | ||
| RRT | K1 | Name | % Impurity | ||||
| 0.119 | 4.5 | 10-Deacetylbaccatin III | ND | ND | ND | ND | ND |
| 0.200 | 8.3 | 7-Epi-10-deacetylbaccatin III | ND | ND | ND | ND | ND |
| 0.233 | 9.8 | 7-Epi-10-oxo-10-deacetylbaccatin III | ND | ND | ND | ND | ND |
| 0.425 | 18.6 | Placebo | NA | NA | NA | NA | NA |
| 0.447 | 19.8 | Placebo | NA | NA | NA | NA | NA |
| 0.827 | 37.4 | Placebo | NA | NA | NA | NA | NA |
| 0.872 | 39.5 | Unknown | 0.01 | 0.09 | 0.04 | 0.06 | 0.04 |
| 0.893 | 40.5 | 2′,3′-Eepidocetaxel | ND | ND | ND | ND | ND |
| 0.902 | 40.9 | Unknown | 0.09 | 0.11 | 0.02 | 0.04 | 0.00 |
| 0.945 | 42.9 | 2′-Epidocetaxel | ND | ND | ND | ND | ND |
| 0.967 | 43.9 | Unknown | 0.03 | 0.05 | 0.03 | 0.01 | 0.12 |
| 0.972 | 44.2 | Oxetane ring opened impurity of Docetaxel | ND | ND | ND | ND | ND |
| 0.98 | 44.5 | Unknown | 0.01 | 0.01 | 0.01 | 0.05 | 0.01 |
| 1.00 | 45.5 | Docetaxel | NA | NA | NA | NA | NA |
| 1.05 | 47.8 | 10-Oxodocetaxel | 0.19 | 0.20 | 0.22 | 0.12 | 0.20 |
| 1.11 | 50.6 | 7′-Epidocetaxel | 0.11 | 0.09 | 0.11 | 0.13 | 0.04 |
| 1.14 | 52.0 | 10-Oxo-7′-epidocetaxel | 0.02 | 0.03 | 0.01 | 0.04 | 0.00 |
| Total Impurities | 0.45 | 0.45 | 0.32 | 0.45 | 0.41 | ||
NA = Not Applicable; ND = Not Detected