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Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description
09 Jun 2023 | Contributor(s):: Popkin, ME, Omer, BASeibert, KD, Luciani, CV, Srivastava, S, Hobson, L, Lepore, JV
A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by Design (QbD) development of the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API...
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Nucleation kinetics of paracetamolethanol solutions from induction time experiments using Lasentec FBRM®
09 Jun 2023 | Contributor(s):: Mitchell, Niall A., Ó'Ciardhá, Clifford T., Frawley, Patrick J.
A study of the nucleation kinetics for cooling crystallisation of paracetamolethanol solutions in a batch reactor is described in this paper. Induction time experiments were conducted in order to estimate the nucleation kinetics of the system. Measured induction times can be affected by numerous...
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Nucleation kinetics of paracetamolethanol solutions from metastable zone widths
09 Jun 2023 | Contributor(s):: Mitchell, Niall A., Frawley, Patrick J.
A study of the nucleation kinetics for a cooling crystallisation of paracetamolethanol solutions in a batch reactor is described in this paper. Metastable zone width (MSZW) experiments were conducted in order to estimate the nucleation kinetics of the system. Measured MSZWs can be affected by...
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Monitoring of Batch Industrial Crystallization with Growth, Nucleation, and Agglomeration. Part 1: Modeling with Method of Characteristics
09 Jun 2023 | Contributor(s):: Porru, Marcella, Özkan, Leyla
This paper develops a new simulation model for crystal size distribution dynamics in industrial batch crystallization. The work is motivated by the necessity of accurate prediction models for online monitoring purposes. The proposed numerical scheme is able to handle growth, nucleation, and...
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Incorporating Solvent-Dependent Kinetics To Design a Multistage, Continuous, Combined Cooling/Antisolvent Crystallization Process
09 Jun 2023 | Contributor(s):: Schall, JM, Capellades, GMandur, JS, Braatz, RD, Myerson, AS
Combined cooling and antisolvent crystallization enables crystallization of many pharmaceutical products, but its process design typically neglects solvent composition influences on crystallization kinetics. This paper evaluates the influence of solvent-dependent nucleation and growth kinetics on...