This application note demonstrates the potential of Process Raman spectroscopy for in-line monitoring of low-dose active pharmaceutical ingredients (APIs) in powder blends. Using the HORIBA Process Raman PI-200, caffeine was quantified as a model API within a mixture of lactose and microcrystalline cellulose, using a feed frame simulator representative of continuous tablet manufacturing. Raman spectra were combined with Partial Least Squares Regression (PLSR) to develop a predictive model, achieving a cross-validation error (RMSECV) of approximately 0.07% for API quantification. These results highlight the potential of Raman spectroscopy as a rapid, non-destructive Process Analytical Technology (PAT) solution for monitoring API concentration and supporting content uniformity assessment during pharmaceutical manufacturing.
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