公开(公告)号：US20220023262A1

公开(公告)日：2022-01-27

申请号：US17383930

申请日：2021-07-23

申请人： CADILA HEALTHCARE LIMITED

发明人： Kumar Kamlesh SINGH ,  Sanjay Jagdish DESAI ,  Piyush Rajendra SHARMA ,  Daya Ram PAL ,  Sanjeev Kumar TRIPATHI ,  Mayur Ramnikbhai PATEL

IPC分类号： A61K31/4025 ,  A61K31/336

摘要： The present invention relates to a composition comprising high purity pyrrole derivative and method for preparation thereof. The present invention particularly relates to compositions comprising Saroglitazar magnesium having purity of 99.0% or more, and one or more of an aldehyde compound of Formula (II), diketo oxirane compound of Formula (III), hydroxy methyl compound of Formula (IV) or dimer compound of Formula (V), relative to saroglitazar magnesium, each present in an amount of about 0.15% or less, respectively, by weight, when measured by area percentage of HPLC.