Patent ID: 8471012

Claim:
A process for preparation of crystalline erlotinib hydrate having a water content in the range of about 1-10% by weight and characterized by peaks in the powder X-ray diffraction pattern having 2θangle positions at about 6.4, 7.4, 11.2, 12.8, 14.5, 16.3, 18.2, 20.0, 20.5, 21.9, 22.3, 23.3, 23.5, 24.6, 27.6, 30.0+/−0.2 degrees comprising: a) dissolving erlotinib free base in an organic solvent or a mixture of organic solvents at a temperature between 40° C. and a reflux temperature of the solvent used to form a solution; b) adding water as an anti-solvent to the solution obtained in step (a); and c) collecting precipitated crystalline erlotinib hydrate having water content in the range of about 1-10% by weight.