In recent years process analytical technologies have developed as important tools to understand and optimize ideal process conditions and ensure consistent crystallization scale-up. Supersaturation, the driving force for crystallization, often varies with changes in seed load, agitation, and crystallizer operating conditions. Qualitative supersaturation control facilitates development of a process map where optimal cooling profiles are determined in the minimum number of experiments.
A new calibration free method of supersaturation control using in situ FTIR measurements and synchronized software provides rapid solubility and supersaturation determination without lengthy calibration. By tracking solute peak-height versus temperature, inline FTIR enables users to control the cooling rates to achieve an ideal supersaturation level. This ideal cooling rate can then be applied during scale up to ensure optimum batch repeatability.
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