申请人:Vanda Pharmaceuticals Inc.
公开号:EP3470405A1
公开(公告)日:2019-04-17
A process for preparing a batch of highly purified, pharmaceutical grade tasimelteon comprises analyzing a batch of tasimelteon synthesized under GMP conditions for the presence of one or more identified impurities.
制备一批高纯度医药级他西美替胺的工艺包括分析一批在 GMP 条件下合成的他西美替胺中是否存在一种或多种确定的杂质。