| 摘要 |
<p>The present invention relates to a process for preparation of amorphous (R)-3-[1-(2,6- Dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1H-pyrazol-4-yl]pyridin-2-amine (I) or its premix. (I) The present invention also relates to the amorphous (R)-3-[1-(2,6-Dichloro-3- fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1H-pyrazol-4-yl]pyridin-2-amine (I) having mass spectrum peak at about [M+] = 450.1, at least three IR peaks selected from 3470 cm -1, 3388 cm -1, 1117 cm -1, 1252 cm -1, or 740 cm -1 ± 2.0 cm -1 and less than 2% w/w of volatiles measured up to 170 °C by TGA. The invention further relates to pharmaceutical compositions comprising amorphous (R)-3-[1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1H-pyrazol-4-yl]pyridin- 2-amine or its premix, having anti-cancer activity.</p> |
