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Thermo Fisher Scientific

AN 50911 - Near-Infrared Analysis of Critical Parameters in Lyophilized Materials


Lyophilized materials are challenging samples for QA/QC measurement due to the inability to open the container without corrupting the product. Near-infrared analysis presents itself as the QC method of choice for lyophilized materials due to its ability to scan through containers like glass or plastic to analyze the sample inside non-destructively. The current study demonstrates the performance of the Nicolet™ Antaris™ Fourier Transform Near-Infrared (FT-NIR) spectrometer in analyzing lyophilized samples of thrombin, a topical coagulant commonly used in the medical and dental fields. Key stability parameters for lyophilized thrombin are moisture and potency which can be predicted simultaneously from a single spectrum using multivariate analysis. Other considerations for the analysis of lyophilized cakes are also discussed.


Antaris FT-NIR