Impurity rejection in the crystallization of ABT-510 as a method to establish starting material specifications.
Understanding impurity rejection in a drug substance crystallization process is valuable for establishing purity specifications for the starting materials used in the process. Impurity rejection has been determined for all known ABT-510 impurities and for many of the reasonable & conceivable impurities. Based on this study, a very high purity specification (e.g., > 99.7%) can be set for ABT-510 with a high level of confidence.
Tolle
John C
JC
Abbott Global Pharmaceutical Process R&D, Dept. R450, Bldg R13, 1401 Sheridan Road, North Chicago, IL 60064-6290, USA.
Becker
Calvin L
CL
Califano
Jean C
JC
Chang
Jane L
JL
Gernhardt
Kevin
K
Napier
James J
JJ
Wittenberger
Steven J
SJ
Yuan
Judy
J
D020533:Angiogenesis Inhibitors / Q000737:chemistry*; D003460:Crystallization; D009842:Oligopeptides / Q000737:chemistry*
D020533:Angiogenesis Inhibitors; C500617:NAc-Sar-Gly-Val-(d-allo-Ile)-Thr-Nva-Ile-Arg-ProNEt; D009842:Oligopeptides