Application note

Application note: Rapid identification of Polysorbates 20 and 80 directly through amber bottles

How the Vaya handheld Raman spectrometer differentiates and identifies PS 20 and PS 80 with spatially offset Raman spectroscopy (SORS) technology.

Polysorbates are common formulation ingredients to protect and stabilise active pharmaceutical ingredients (APIs). For instance, ~80 percent of monoclonal antibody drugs contain polysorbates. The two most common types in biopharmaceutical formulations are Polysorbate 20 (PS 20) and Polysorbate 80 (PS 80). Similar to other raw materials used in drug formulations, verifying the identity of PS 20 and PS 80 is required by regulations to release these ingredients to production. PS 20 and PS 80 are chemically similar, so the identification method must be selective. In addition, polysorbates are sensitive and susceptible to degradation, especially once opened, so traditional sampling to verify identity presents increased challenges to raw material identification workflows.