A Structured Approach to Cope with Impurities during Industrial Crystallization Development

The perfect separation with optimal productivity, yield, and purity is very difficult to achieve. Despite its high selectivity, in crystallization unwanted impurities routinely contaminate a crystallization product. Awareness of the mechanism by which the impurity incorporates is key to understanding how to achieve crystals of higher purity. Prof Joop ter Horst presented a general workflow which can rapidly identify the mechanism of impurity incorporation responsible for poor impurity rejection during a crystallization. A series of four general experiments using standard laboratory instrumentation is required for successful discrimination between incorporation mechanisms.

The workflow is demonstrated using four examples of active pharmaceutical ingredients contaminated with structurally related organic impurities. Application of this workflow allows a targeted problem-solving approach to the management of impurities during industrial crystallization development, while also decreasing resources expended on process development. This webinar could be downloaded for  researchers interested in crystallization, looking to solve day to day crystallization challenges and optimize their best practices.

This year Prof. Joop H. ter Horst started a new position at the University of Rouen within the laboratory of separation science and methods, continuing his work on Industrial Crystallization Fundamentals. His research group identifies and applies fundamental knowledge relating particulate product properties, crystal structure and product molecule for the optimization of innovative crystallization processes. Previously, his research group is part of the Centre on Continuous Manufacturing and Crystallisation, a large Strathclyde based centre on Advanced Pharmaceutical Manufacturing. He was coordinator of the Horizon2020 Innovative Training Network CORE consisting of 15 PhD students, 8 academic and 7 industrial partners. 

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