GORE VINAYAK GOVIND,TRIPATHI ANILKUMAR,JADHAV MADHAV
申请号:
NZ62879611
公开号:
NZ628796A
申请日:
2011.07.22
申请国别(地区):
NZ
年份:
2016
代理人:
摘要:
Disclosed is a process for the preparation of erlotinib hydrochloride form A, comprising crystallisation of erlotinib hydrochloride from a solvent, wherein the solvent is a straight chain, branched or cyclic C5 to C20 alcohol (such as amyl alcohol, 1-pentanol, cyclopentanol, 1-hexanol, cyclohexanol, 1-heptanol, 1-octanol, or a mixture thereof), and wherein the erlotinib hydrochloride form A exhibits an X-ray powder diffraction (XRPD) pattern comprising at least the characteristic peaks 5.6, 9.8, 18.9, 22.7 and 23.5 ± 0.2 degrees 2&thetas. Also disclosed is a pharmaceutical composition comprising erlotinib hydrochloride form A when prepared by a process as defined above.