Abstract
A shift in particle size distribution toward smaller particle sizes has been observed in batches of Compound A Triethanolate, an isolated intermediate of a commercially available active pharmaceutical ingredient, leading to poor deliquoring of the filter cake and longer filtration times, which compromised the overall process cycle time. In the most extreme case, product breakthrough during filtration was observed, leading to significant yield loss. Compound A Triethanolate is crystallized through antisolvent addition/distillation/cooling crystallization in ethyl acetate/water/ethanol. Laboratory experiments were carried out using representative product streams in order to identify the cause for the shift in particle size distribution, which could be attributed to excessive secondary nucleation at an early stage of the process caused by the use of seed particles that have been previously dried under agitation. While statically dried particles exhibit a smooth surface, the surface of particles dried under a...
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