China (Mainland) 
quick detail:
product name: lapatinib ditosylate
synonyms: lapatinib ditosylate;benzenesulfonic acid: n-[3-chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6 -[5-[(2-methylsulfonylethylamino)methyl]-2-furyl]quinazolin-4-amine: h ydrate;n-(3-chloro-4-((3-fluorophenyl)methoxy)phenyl)-6-(5-(((2-(methylsulfonyl)ethyl)amino)methyl)-2-furanyl)-4-quinazolinamine bis(4-methylbenzenesulfonate);lapatinib ditosilate;lapatinib, tykerb, gw572016;lapatinib ditosylate (gw-572016);lapatinib(gw572016);lapatinib ditosylate hydrate
cas: 388082-78-8
mf: c41h40clfn4o11s3
mw: 925.46
product categories: anti-neoplastic;lapatinib;anti-cancer&immunity;inhibitors
mol file: 388082-78-8.mol
coa:
| test items | specification | results |
| description | light yellow or almost white crystalline powder | light yellow powder |
| identification | ir | positive |
| assay | 97.0~103.0% | 99.37% |
| melting point | 70~80°c | 70.5~76.5°c |
| specific rotation | +22~+26° | +23.09° |
| loss on drying | 0.5%max | 0.25% |
| residue on ignition | 0.1%max | 0.05% |
| heavy metals | 20ppm max | <20ppm |
| organic volatile impurities | meets the requirement. | conforms |
|
related substances |
single impurity: 1.0%max | <1.0% |
| total impurities: 2.0%max | <2.0% | |
| conclusion | the specification conforms to enterprise standard. | |
breast cancer:
in combination with letrozole for treatment of hormone receptor-positive metastatic breast cancer that overexpresses the human epidermal receptor type 2 (her2) protein in postmenopausal women who are candidates for hormonal therapy.1 5 8 combined therapy with lapatinib and an aromatase inhibitor has not been compared with trastuzumab-containing chemotherapy for treatment of metastatic breast cancer.
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