Near-Infrared Analysis of Critical Parameters in Lyophilized Materials - Near-infrared spectroscopy is an effective and non-destructive way to analyze lyophilized materials. - BioPharm International

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Near-Infrared Analysis of Critical Parameters in Lyophilized Materials
Near-infrared spectroscopy is an effective and non-destructive way to analyze lyophilized materials.


BioPharm International
Volume 19, Issue 2

CONCLUSION


Figure 8. The Predicted Errror Sum of Squares (PRESS) Plot for Potency.
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%.

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;


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