MOISTURE CONTENT DETERMINATION OF FREEZE-DRIED PRODUCTS BY NEAR-INFRARED SPECTROSCOPY: A CASE STUDY FOR UNIVERSAL REGRESSION MODEL

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.