Rapid Identification of Polysorbates 20 and 80 Directly Through Amber Bottles

Polysorbate 20 (PS 20) (Tween 20) and Polysorbate 80 (PS 80) are inactive ingredients that are often used in the formulation of biopharmaceuticals to help protect the active ingredient. Around 80% of commercial monoclonal antibody formulations contain polysorbates. Polysorbates are susceptible to degradation through hydrolysis or auto-oxidation, so they require specific packaging and packaging conditions. To preserve product composition and shelf-life, PS 20 and PS 80 are packaged under an inert atmosphere and are typically stored in small to medium-sized amber glass bottles. In accordance with ICH requirements on raw materials (1), bio-pharmaceutical and pharmaceutical manufacturers must identify polysorbates before use. Identification testing by FTIR or wet chemistry involves sampling from each bottle, which can impact the sterility of the sample, causing it to degrade. Raman spectroscopy provides an alternative means of verifying the identification of raw materials, directly, without opening the sample bottle. However, many commercially available Raman spectrometers cannot collect reasonable quality spectra of polysorbate through amber glass bottles. In this study, an Agilent Vaya Raman spectrometer with Spatially Offset Raman Spectroscopy (SORS) technology was used for the identification and differentiation of PS 20 and PS 80 through amber glass.

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