| 摘要 |
The invention provides an improved process for preparing romidepsin. The process involves producing, purifying, or storing romidepsin under condition s that prevent the formation of undesired adducts. Purifying romidepsin at a n apparent pH lower than approximately 6.0 (e.g., between an apparent pH of 4.0 and 6.0) has been discovered to prevent the reduction of the disulfide b ond of romidepsin and the subsequent formation of dimerized, oligomerized, o r polymerized adducts. The invention also provides pharmaceutical compositio ns of monomeric romidepsin free of dimerized, oligomerized, or polymerized a dducts. |
