申请人:Fontana Francesco
公开号:US20120295928A1
公开(公告)日:2012-11-22
Impurities of lapatinib such as N-3-chloro-4-[(2-fluorobenzyl)oxy]phenyl}-6-[5-([2-(methylsulfonyl)ethyl]amino}methyl)furan-2-yl]quinazoline-4-amine compound of formula (I) or a salt thereof:
and analytical methods for identifying and quantifying such impurities of Lapatinib and salts thereof are provided. Also provided is Lapatinib containing less than about 0.05 percent of this and related impurities and methods for preparing such pure forms of Lapatinib.
拉帕替尼的杂质,如分子式为(I)的N-3-氯-4-[(2-氟苯基)氧基]苯基}-6-[5-([2-(甲磺酰基)乙基]氨基}甲基)呋喃-2-基]喹唑啉-4-胺化合物或其盐:提供了用于鉴定和定量拉帕替尼及其盐的这类杂质的分析方法。还提供了含有少于约0.05%的这种及相关杂质的拉帕替尼和制备这种纯度形式的方法。