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Phase Transitions: Oiling Out, Polymorphs and Solvates
Detection and Understanding of Phase Transitions Reduces Batch Failure
Crystallization of organic compounds via anti-solvent addition often results in complex multi-phase systems. Solid-liquid equilibrium (SLE) data are essential for understanding the conditions that can lead to the occurrence of undesirable polymorph, solvated or liquid forms of the product. Even with complete SLE data, what can be lacking is information on the possibility of oiling out or generating undesirable metastable forms throughout the course of a dynamic process where the metastable zone widths can vary due to scale-up effects.
It is therefore not uncommon to experience oiling out or have undesirable polymorphs form after scaling-up the crystallization of organic molecules. The use of process analytical tools for scale-up, such as FBRM and PVM, has routinely shown value in the rapid detection of unexpected phase transitions, and the ability to characterize the operating conditions that lead to them. Identifying the root cause of the undesirable phase can rapidly lead to a modified crystallization process that produces the desired crystal form that consistently meets the necessary product specifications.
It is therefore not uncommon to experience oiling out or have undesirable polymorphs form after scaling-up the crystallization of organic molecules. The use of process analytical tools for scale-up, such as FBRM and PVM, has routinely shown value in the rapid detection of unexpected phase transitions, and the ability to characterize the operating conditions that lead to them. Identifying the root cause of the undesirable phase can rapidly lead to a modified crystallization process that produces the desired crystal form that consistently meets the necessary product specifications.
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