Vrolijk, Nicholas H.,Verdine, Gregory L.,Bertel, Stephan
申请号:
AU2007342030
公开号:
AU2007342030B2
申请日:
2007.12.28
申请国别(地区):
AU
年份:
2013
代理人:
摘要:
The invention provides an improved process for preparing romidepsin. The processinvolves producing, purifying, or storing romidepsin under conditions thatprevent the formation of undesired adducts. Purifying romidepsin at an apparentpH lower than approximately 6.0 (e.g., between an apparent pH of 4.0 and 6.0) hasbeen discovered to prevent the reduction of the disulfide bond of romidepsinand the subsequent formation of dimerized, oligomerized, or polymerized adducts.The invention also provides pharmaceutical compositions of monomeric romidepsinfree of dimerized, oligomerized, or polymerized adducts.