title: Impurity rejection in the crystallization of ABT-510 as a method to establish starting material specifications.
abstract: 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.
authors.affiliation: Abbott Global Pharmaceutical Process R&D, Dept. R450, Bldg R13, 1401 Sheridan Road, North Chicago, IL 60064-6290, USA.
authors.forename: John C
authors.initials: JC
authors.lastname: Tolle
authors.forename: Calvin L
authors.initials: CL
authors.lastname: Becker
authors.forename: Jean C
authors.initials: JC
authors.lastname: Califano
authors.forename: Jane L
authors.initials: JL
authors.lastname: Chang
authors.forename: Kevin
authors.initials: K
authors.lastname: Gernhardt
authors.forename: James J
authors.initials: JJ
authors.lastname: Napier
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Wittenberger
authors.forename: Judy
authors.initials: J
authors.lastname: Yuan
mesh_terms: D020533:Angiogenesis Inhibitors / Q000737:chemistry*; D003460:Crystallization; D009842:Oligopeptides / Q000737:chemistry*
chemical_list: D020533:Angiogenesis Inhibitors; C500617:NAc-Sar-Gly-Val-(d-allo-Ile)-Thr-Nva-Ile-Arg-ProNEt; D009842:Oligopeptides