Analysis of residual moisture in a lyophilized pharmaceutical product by near-infrared spectroscopy (NIRS)

Huvuddokument

This article describes how near-infrared spectroscopy in diffuse reflection can be used for the purpose of determining residual moisture in a lyophilized pharmaceutical product. Numerous sample vials containing freeze-dried pharmaceuticals were spiked with varying amounts of water for calibration purposes. The differences in the absorption wavelengths of the OH-oscillation were correlated with the water content that was determined using Karl Fischer titration using the algorithm of multiple linear regression (MLR).