Faster Development of the Crystallization Process Thanks to Process Analytical Technologies
DOI:
https://doi.org/10.54779/chl20240342Keywords:
active pharmaceutical ingredient, process analytical technology, crystallization, FBRM technique, EasyViewer systemAbstract
The development of process analytical technologies is continuously advancing and today allows us to combine several techniques into a single measurement probe. In this work, we compared in-line data from the Focused Beam Reflectance Measurement probe and the EasyViewer probe with off-line analyses. The recrystallization of the intermediate appeared to be sensitive to the length of mixing. With time, the crystalline material was breaking down, which prolonged the subsequent filtration. For the crystallization of the final active pharmaceutical substance, we confirmed the correct setting of the crystallization parameters, which enabled us to isolate a material with a monomodal distribution of particles.