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A fast and non-destructive Fourier-transform near-infrared (NIR) spectroscopy method with corresponding chemomet- ric calibrations was developed for the identification of key intermediates of pharmaceutical active substances through the pro- tective polyethylene (PE) primary packaging in containers. The samples were measured with a laboratory spectrometer. NIR spec- tra of incoming containers samples were also recorded for calibration with a spectrometer installed in the warehouse. The spect ra of the different samples were recorded by diffuse reflectance with a 2 m long glass fiber optics probe in direct contact with th e PE-protected surface of the material. The NIR spectra of the same products were stored in files and principal component analy- sis combined with cluster analysis were used to refine the identification criteria. To achieve validation of the resulting math e- matical models, the samples were split into a calibration set and a validation set. The latter was used for external and indepe n- dent tests. The resulting NIR application can be transferred to any spectrometer of the same type.

analusis

Direct identification of key intermediates in containers using Fourier-transform near-infrared spectroscopy through the protective polyethylene primary packaging