Polysorbate 80 (HX2)
CAS#: 9005-65-6
Regulatory Status: JP, EP, USP/NF, ChP
JP: Japanese Pharmacopoeia
EP: European Pharmacopoeia
USP/NF: National Formulary
ChP: Chinese Pharmacopoeia
Polysorbate 80(HX2)™ is produced from 99% or higher oleic acid, developed and commercially manufactured using our proprietary technology. By employing advanced ethylene oxide addition methods and sophisticated purification processes, we achieve significant reduction of by-products and thorough removal of impurities. As a result, Polysorbate 80(HX2)™ contains exceptionally low levels of aldehydes, peroxides, and impurities such as highly unsaturated fatty acids that are easily oxidized and fatty acids with different carbon numbers. Polysorbate 80(HX2)™ is widely adopted by pharmaceutical companies around the world and is used as a stabilizer in various vaccines and antibody therapeutics.
Oxidative Stability and Formulation Benefits
Polysorbate 80(HX2)™ also exhibits remarkably high oxidative stability. Not only does it have low initial impurity levels, but it also minimizes the formation of impurities during storage and use. According to published literature on the impact of peroxides in Polysorbate 80 on protein formulations*, model protein formulations (such as IL-2 mutein) are less likely to denature when using Polysorbate 80 with low peroxide values, whereas significant denaturation occurs when using Polysorbate 80 with high peroxide values. Given that many pharmaceuticals are sensitive to peroxides, utilizing Polysorbate 80(HX2)™ ensures the necessary stability and quality of formulations, earning high praise from numerous pharmaceutical companies.
* E. Ha, W. Wang and Y. J. Wang, J. Pharmaceu. Sci., 91(10), 2252-2264 (2002)
Regulatory Status
Polysorbate 80(HX2)™ complies with major pharmacopeial standards including JP, EP, USP/NF, and is also specifically compliant with the “Polysorbate 80 (II)” monograph of the Chinese Pharmacopoeia (ChP). (DMF Registration Number: F2019000324, submitted to NMPA China)