Application of the Quality
by Design Principles for the Development of the Crystallization Process
for a Piperazinyl-Quinoline and Definition of the Control Strategy
for Form 1
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Abstract
The studies carried out to develop a robust crystallization
method for the substituted piperazinyl-quinoline (<b>1</b>)
a compound potentially active in the treatment of depression, are
described in this contribution. These studies include the control
of a solvate that could have potentially formed in the crystallization
process. The principles of quality by design (QbD) were applied to
generate the process understanding and to define the control strategy
for the control of the formation of the solvate during the crystallization.
The application of process analytical technology (PAT) tools was key
in achieving the desired process control
