- 3:45 PM

The Design and Scale-up of An API Crystallization: Process Understanding Supported by Modeling to Achieve Consistency

James Wertman, Sonja Sharpe, and Christopher Werner. GlaxoSmithKline, Upper Merion, PA 19406

An API crystallization was designed on bench scale with a knowledge of process thermodynamics, and scaled-up and interpreted using both empirical and semi-empirical models. This scale-up approach resulted in both process consistency and predicability.