| Product Name | Erlotinib hydrochloride |
| CAS | 183319-69-9 |
| MF | C22H24ClN3O4 |
| MW | 429.9 |
| Chemical Properties | Off-White Solid |
| Usage | Selective epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor. Antineoplastic Erlotinib HCl is an HER1/EGFR inhibitor with IC50 of 2 nM. Erlotinib HCl (OSI-744) is an EGFR inhibitor with IC50 of 2 nM, >1000-fold more sensitive for EGFR than human c-Src or v-Abl. Phase 3. |
| 1 | Appearance | White or off-white powder | Conforms |
| 2 | Identification | ||
| a) IR | IR chromatograph Conforms to the characteristic peak of R.S. | Conforms | |
| b) HPLC | The retention time of the major peak in the chromatogram Conforms to the characteristic peak of R.S. | Conforms | |
| 3 | Residue on ignition | Not more than 0.1% | 0.07% |
| 4 | Loss on drying | Not more than 0.5% | 0.38% |
| 5 | Heavy Metals | Not more than 20 ppm | Conforms |
| 6 | Related substance | ||
7 |
Single impurity | Not more than 0.15% | 0.13% |
8 |
Total impurities | Not more than 1.0% | 0.56% |
| 9 | Purity[HPLC] | Not less than 99.0% | 99.44% |
| 10 | Assay(caculated on anhydrous basis) | 98.5%~101.5% | 99.3% |
