Customization: | Available |
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CAS No.: | 183319-69-9 |
Formula: | C22h24cln3o4 |
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Erlotinib hydrochloride is a small molecule tyrosine kinase inhibitor that reversibly acts on the epidermal growth receptor, which is the hydrochloride salt of the molecularly targeted drug erlotinib. The U.S. Food and Drug Administration (FDA) has approved erlotinib (Tarceva) in combination with as a first-line treatment for locally advanced and metastatic pancreatic cancer. It is mainly used as the second-line or third-line treatment of locally advanced or metal silent non-small cell lung cancer (NSCLC) and the treatment of pancreatic cancer. It is used as a tyrosine inhibitor in the treatment of NSCLC. Erlotinib hydrochloride (V), a quinazoline-derived small molecule inhibitor of epidermal growth receptor (EDGFR) tyrosine kinase, was approved in November 2004 for the treatment of advanced or metastatic non-small cell lung cancer .
Appearance | White or off-white powder | Conforms |
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 |
Residue on ignition | Not more than 0.1% | 0.07% |
Loss on drying | Not more than 0.5% | 0.38% |
Heavy Metals | Not more than 20 ppm | Conforms |
Single impurity | Not more than 0.15% | 0.13% |
Total impurities | Not more than 1.0% | 0.56% |
Purity[HPLC] | Not less than 99.0% | 99.44% |
Assay(caculated on anhydrous basis) | 98.5%~101.5% | 99.3% |
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