MATTA, HARI BABU,KHANNA, MAHAVIR SINGH,PRASAD, MOHAN
申请号:
CA2838587
公开号:
CA2838587A1
申请日:
2014.01.06
申请国别(地区):
CA
年份:
2015
代理人:
摘要:
The present invention relates to pure crystalline Form II of an L-malic acidsalt ofsunitinib and a process forits preparation. The invention further providescrystalline Form IIof an L-malic acid salt of sunitinib having a purity of atleast 97.0%. Theinvention alsoprovides crystalline Form II of an L-malic acid salt of sunitinibsubstantially free of an anti-oxidant.The invention also provides crystalline Form II of L-malic acid salt ofsunitinibwhich remains chemically pure on storage at 25°C 2°C and40°C 2°C at a relative humidityof 60% 5% and 75% 5%, respectively, for at least 1 month.