Ultra-high purity surfactant for injectable and biopharmaceutical applications
Polysorbate 80 is a surfactant commonly used in (bio)pharmaceutical applications. While traditional Polysorbate 80 grades as defined in Ph. Eur., USP-NF and JP monographs are suitable for general use, they permit relatively high peroxide values and allow variability in composition of partial esters of fatty acids. This can lead to batch-to-batch inconsistency, oxidative degradation potential, and instability of sensitive APIs or proteins - posing risks in high-value applications.
Evonik developed MaxiPure® Polysorbate 80 to address the complex challenges faced in biopharmaceutical manufacturing and injectable formulation development - from ensuring protein stability and viral inactivation to achieving consistent solubilization of hydrophobic APIs.
MaxiPure® Polysorbate 80 is more than just a high-purity excipient, it is part of our holistic solution portfolio designed to support your innovation pipeline.
The surfactant of choice for injectable and biopharmaceutical uses
MaxiPure® Polysorbate 80 is a non-ionic surfactant of superior purity, fully compliant with Ph. Eur., USP-NF, JP, and CP monographs. Designed to meet the highest standards of pharmaceutical and biopharmaceutical manufacturing, MaxiPure® comes with ultra high oleic acid content (≥98 %), exceptional clarity and global regulatory confidence.
MaxiPure® Polysorbate 80 is particularly suited for:
Injectable formulations
- Reduces surface-induced aggregation at interfaces
- Improves the solubility of hydrophobic drugs
- Consistent, low level of impurities
- Ideal for vaccines, biologics and small molecule
Biopharmaceutical applications
- Prevents aggregation and maintains protein activity
- Efficient for viral inactivation
- Acts as a dispersant in chromatography and filtration
- Helps to reduce cell damage caused by shear stress in cell culture