China (Mainland) 
quick detail:
| 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. |
applications:
erlotinib hydrochloride is a kind of small molecule egfr tyrosine kinase reversible inhibitor, is mainly used for the treatment of locally advanced or metastatic non small cell lung cancer second-line or three line treatment and pancreatic cancer.
erlotinib hydrochloride specification:
| 1 | appearance | white or off-white powder | conforms |
| 2 | identification | ||
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a) ir | ir chromatograph conforms to the characteristic peak of r.s. | conforms |
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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 |
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7 |
single impurity | not more than 0.15% | 0.13% |
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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% |
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