An agile and robust in-line NIR potency deviation detection method for monitoring and control of a continuous direct compression process

International Journal of Pharmaceutics(2021)

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摘要
•A novel NIR method was developed for blend potency variation and deviation detection.•NIR method developed at a lab scale was directly applied to full-scale manufacturing.•The method was robust against raw material, instrument, and process variation.•It enables agile NIR development and enhanced performance in continuous manufacturing.
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关键词
Process analytical technology,Near infrared,Continuous manufacturing,Direct compression,Potency monitoring,Calibration,Robustness
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