Evonik launches MaxiPure Polysorbate 80 for injectable drug formulations

Ultra-high purity surfactant for biologics and parenteral drug formulations

Evonik has launched MaxiPure Polysorbate 80, a highly pure surfactant designed for injectable and biopharmaceutical applications.

Engineered to meet the stringent demands of modern drug development, this ultra-high purity excipient addresses key challenges such as protein stability, viral inactivation, and the consistent solubilization of hydrophobic active pharmaceutical ingredients (APIs).

With the launch of MaxiPure Polysorbate 80, Evonik is expanding its support for the biopharmaceutical industry by delivering high-quality, reliable excipients that meet the growing demand for new biologics and biosimilars.

“MaxiPure Polysorbate 80 is a strategic addition to our excipients portfolio. Its exceptional purity, coupled with our strong regulatory support, reflect our deep commitment to helping our customers tackle the toughest challenges in injectable formulations and bioprocesses,” said Guido Skudlarek, Head of the Health Care business line.

Polysorbate 80 is a widely used non-ionic surfactant in pharmaceutical and biopharmaceutical formulations. While conventional grades are suitable for general use, they often allow higher peroxide levels and variability in the composition of partial fatty acid esters. This can result in batch-to-batch inconsistencies, increased risk of oxidative degradation, and instability of sensitive APIs or proteins - posing challenges in high-value applications.

MaxiPure Polysorbate 80 addresses these concerns by offering ultra-high purity, with an oleic acid content exceeding 98%, exceptional clarity, and full compliance with Ph. Eur., USP, JP, and CP monographs. Designed to meet the highest standards of biopharmaceutical manufacturing, MaxiPure® ensures greater formulation reliability and global regulatory confidence.