公开(公告)号：US20240262864A1

公开(公告)日：2024-08-08

申请号：US18006110

申请日：2022-06-17

申请人： Shanghai Techwell Biopharmaceutical Co., Ltd

发明人： Rongguo SHI ,  Min CHEN ,  Yushan GUO ,  Yan LI ,  Xiaoming JI

IPC分类号： C07K7/56 ,  C07K1/16

CPC分类号： C07K7/56 ,  C07K1/16

摘要： The present disclosure provides an echinocandin drug impurity and preparation and purification methods and use thereof. The echinocandin drug impurity has a structure shown in Formula I:




In the present disclosure, micafungin sodium is reacted with a protonic acid aqueous solution to obtain an echinocandin drug impurity, and a high-purity echinocandin drug impurity is obtained after chromatographic purification. The present disclosure overcomes problems that an echinocandin drug impurity is prone to being degraded during the purification, and purification difficulty is high, and an HPLC purity of the obtained echinocandin drug impurity may reach 90% or more. The echinocandin drug impurity may be used as a reference substance for establishing an analysis method for use in echinocandin drug quality control.