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Chapter 12 PAT for pharmaceutical manufacturing process involving solid dosages forms

Research paper by Andrés D. Román-Ospino, Vanessa Cárdenas; Carlos Ortega-Zuñiga; Ravendra Singh

Indexed on: 30 Apr '18Published on: 24 Apr '18Published in: Computer Aided Chemical Engineering



Abstract

Publication date: 2018 Source:Computer Aided Chemical Engineering, Volume 41 Author(s): Andrés D. Román-Ospino, Vanessa Cárdenas, Carlos Ortega-Zuñiga, Ravendra Singh This chapter summarizes important considerations to develop multivariate methods for pharmaceuticals process monitoring and quality control in solid dosages forms based on spectroscopic techniques. The stages described in each section aimed to explain relevant knowledge of the calibration procedure, model development, and estimation of sampling error. Basic principles of near-infrared spectroscopy and the interaction between organic particles and light correspond to a critical step toward the construction of robust spectroscopic methods. The understanding of this process will allow the extraction of useful information for the calibration purpose highlighting the quality attribute of interest in the spectroscopic signal. The chapter aims to provide basic knowledge for nonexperts who want to apply NIR spectroscopy in combination with multivariate analysis as PAT tools for quality control.