A structured approach to cope with impurities during industrial crystallization development
Urwin, Stephanie J. and Levilain, Guillaume and Marziano, Ivan and Merritt, Jeremy M. and Houson, Ian and Ter Horst, Joop H. (2020) A structured approach to cope with impurities during industrial crystallization development. Organic Process Research and Development, 24 (8). pp. 1443-1456. ISSN 1083-6160
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Abstract
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. Here, we present 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.
Creators(s): |
Urwin, Stephanie J., Levilain, Guillaume, Marziano, Ivan, Merritt, Jeremy M., Houson, Ian and Ter Horst, Joop H. ![]() | Item type: | Article |
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ID code: | 73374 |
Keywords: | impurity rejection, crystallisation, product purity, phase diagrams, workflows, Pharmacy and materia medica, Organic Chemistry, Physical and Theoretical Chemistry |
Subjects: | Medicine > Pharmacy and materia medica |
Department: | Faculty of Science > Strathclyde Institute of Pharmacy and Biomedical Sciences |
Depositing user: | Pure Administrator |
Date deposited: | 29 Jul 2020 13:53 |
Last modified: | 21 Jan 2021 12:08 |
URI: | https://strathprints.strath.ac.uk/id/eprint/73374 |
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