501753 Finding a Surrogate Material to an Expensive API By Applying a Multivariate Analysis on a Material Database

M. Sebastian Escotet-Espinoza1, Gerardo Callegari2, Marianthi Ierapetritou1 and Fernando Muzzio3, (1)Department of Chemical and Biochemical Engineering, Rutgers, The State University of New Jersey, Piscataway, NJ, (2)Chemical and Biochemical Engineering, Rutgers University, Piscataway, NJ, (3)Rutgers University, Piscataway, NJ

Implementing a QbD approach in the pharmaceutical industry implies full understanding of processes effects into product performance. It also requires performing quantitative risk assessments.  Risk relies on understanding the role played not only by processing parameters, but also by raw and intermediate material properties. From this, the importance and necessity of implementing techniques to characterize material properties and to relate them with product performance through processing parameters. Within this context is that determining critical material properties is an important step towards defining the design space. Usually, the number of characterization techniques is too many. Decreasing that number without significantly losing descriptive power is the goal of this presentation, for that we use Principal Component Analysis....

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