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 toachieving 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
The benefits of MaxiPure® Polysorbate 80 at a glance:
- Highly pure surfactant with ultra high oleic acid content (>98 %)
- Various pack sizes starting from 60 g, all packed under nitrogen atmosphere to prevent oxidative degradation
- Exceptionally clear liquid (Hazen value < 20)
- Consistent cGMP quality
- Compliant with Ph. Eur., USP-NF, JP, CP
- US-DMF and C-DMF available
Want to learn more about MaxiPure® Polysorbate 80?
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"If you are looking for ways to more efficient bioprocessing and improved performance, our innovative cell culture solutions will be of great value to you. Contact us to find out how we can support and meet your needs."
Kristina Klinker
Business Development Manager