Validation of an in-line Raman spectroscopic method for continuous active pharmaceutical ingredient quantification during pharmaceutical hot-melt extrusion |
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| Authors: | L. Saerens N. Segher C. Vervaet J.P. Remon T. De Beer |
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| Affiliation: | 1. Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Harelbekestraat 72, 9000 Ghent, Belgium;2. Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, 9000 Ghent, Belgium |
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| Abstract: | A calibration model for in-line API determination was developed based on Raman spectra collected during hot-melt extrusion. This predictive model was validated by calculating the accuracy profile based on the analysis results of validation experiments. Furthermore, based on the data of the accuracy profile, the measurement uncertainty was determined. Finally, the robustness of the model was evaluated. |
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| Keywords: | Hot-melt extrusion In-line Raman spectroscopy Validation Accuracy profile Total error Robustness testing |
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