Raman spectroscopy is highly suitable for testing and differentiating similar material due to its ability to acquire molecular finger print, specificity and instrument portability.  Although Raman spectra are not significantly impacted by the packaging materials such as liners or bottles, we have noticed some impact on spectra consistency.  This paper will present multivariate analysis (MVA) to analyze critical variability contributors for polysorbate using handheld Raman analyzers. We will demonstrate the impact of various factors in development of identification methods for Raman active materials including polysorbate. The main contributors include: lot, scan location, packaging variability and Raman settings. These contributors must be tuned to acquire optimal Raman scans suitable for Rapid Identification.

Suitability and challenges of using Raman spectroscopy for polysrobate testing– use of Multivariate analysis to quantify variability

253rd National Meeting (2017)

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