Moisture content determination; Freeze-dried products; Near infrared spectroscopy; Chemometrics; Pharmaceutical field
Abstract :
[en] Karl Fischer titration is the reference method for moisture content determination in the pharmaceutical industry. Near-infrared spectroscopy is considered the most suitable alternative technique. Indeed, NIRS is a safe and fast method which does not require sample preparation. Nevertheless, the development and validation phases are time-consuming. In addition, the NIRS methods presented so far were mostly product specific. The main objective of this study is to highlight that an universal calibration model can be validated for several freeze-dried products in order to speed up the validation time. This objective was led in two steps. A universal model was first evaluated. A calibration set and a validation set were built up with three freeze-dried products. An antibody drug conjugate, a large molecule and a small molecule all packed in sealed vials were used to introduce more variability. Regression methods were then compared in order to optimize the prediction values.
Research Center/Unit :
Centre Interfacultaire de Recherche du Médicament - CIRM
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