Polysorbate analysis | Quality Assistance

Polysorbates (PS), mainly PS20 and PS80, are non‑ionic surfactants widely used in biopharmaceutical formulations where they play a key role in protein stabilisation by preventing aggregation, adsorption to container surfaces and degradation during manufacturing, storage and transport. Their performance can be impacted by oxidation and/or hydrolysis, making close monitoring of both PS content and integrity an important requirement for regulatory compliance.

The study sheet presents the analytical methods available (GC-FID, LC-FMA, LC-CAD and LC-MS) to quantify polysorbates, profile ester species, and assess degradation pathways.

The full study sheet is available for download.

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