In this experiment, the analysis of lyophilized materials using FT-NIR spectroscopy was shown to be an effective, rapid, and
non-destructive method for analyzing lyophilized materials. In this case, both moisture and potency were examined, with the
primary methods used being Karl Fischer titration and colloidal light scattering, respectively. The moisture analysis calibration
showed a correlation coefficient of 0.998 and an RMSEC of 0.005, with a residual of approximately ±1.5%. These data suggest
that FT-NIR analysis of lyophilized materials for moisture is limited only by the error implicit in the reference method.
The analysis for potency indicated a correlation coefficient of 0.999 with an RMSEC of 21.9 and an average residual of ±0.15%.
Figure 8. The Predicted Errror Sum of Squares (PRESS) Plot for Potency.
Jeffrey Hirsch is a near-infrared pharmaceutical applications scientist, Thermo Electron Corporation,
5225 Verona Rd., Madison, WI 53711, 608.276.5634; Fax: 608.273.5046; Jeffrey.Hirsch@thermo.com