- MaxiPure® Polysorbate 80 is designed for injectable and biopharmaceutical applications.
- It addresses protein stability, viral inactivation, and solubilization of hydrophobic APIs.
- The product offers ultra-high purity with over 98% oleic acid content.
- MaxiPure® complies with Ph. Eur., USP, JP, and CP monographs.
Introduction
Evonik has launched MaxiPure® Polysorbate 80, a highly pure surfactant tailored for injectable and biopharmaceutical applications. This excipient is engineered to meet the rigorous demands of modern drug development.
Key Features
MaxiPure® Polysorbate 80 addresses critical challenges such as protein stability, viral inactivation, and the consistent solubilization of hydrophobic active pharmaceutical ingredients (APIs). It offers ultra-high purity with an oleic acid content exceeding 98%, ensuring greater formulation reliability.
Regulatory Compliance
The product complies with Ph. Eur., USP, JP, and CP monographs, providing global regulatory confidence. This compliance is crucial for maintaining consistency and stability in high-value applications.
Industry Impact
Polysorbate 80 is a widely used non-ionic surfactant in pharmaceutical formulations. Conventional grades often allow higher peroxide levels and variability, leading to batch inconsistencies and oxidative degradation. MaxiPure® Polysorbate 80 mitigates these risks, enhancing the stability of sensitive APIs or proteins.
