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.

Agglomerative crystallization of ABT-510 in a partially miscible solvent system.

A modification of wet agglomeration technique is developed and demonstrated by agglomerative crystallization process for a nonapeptide (ABT-510) to improve processing of needle like crystals. Our procedure involves exploiting partial miscibility of the crystallization solvent system for in situ generation of a wetting agent with suitable agglomerative properties. Experiences with ABT-510 show that a relatively small fraction of phase separation (1-5%) is needed to create enough wetting agent for effective agglomeration.