Avantor Performance Materials has introduced a higher purity super refined grade of polysorbate products to improve solubilisation and stability in a variety of biopharmaceutical and small-molecule drug formulations. The new Super Refined grade products join Avantor’s current high-purity versions of the two most widely used types of polysorbate products: JT Baker brand Polysorbate 20 and Polysorbate 80. These products are commonly used in pharmaceutical formulations such as parenteral, otic, ophthalmic, oral and topical preparations.
Avantor’s high-purity and Super Refined grades of JT Baker polysorbates are manufactured under current Good Manufacturing Practices (cGMP) conditions in FDA-registered ISO 9000-certified facilities, and are supported by the company’s best-in-class quality systems.
While Avantor’s existing high-purity grade of polysorbates offers low levels of impurities for better performance in formulations, the new Super Refined grade takes advantage of a proprietary flash chromatographic process that removes even more polar and oxidative impurities, such as peroxides and aldehydes, which can degrade active pharmaceutical ingredients.
The surface activity of polysorbates helps to stabilise proteins by reducing the alteration or aggregation of proteins during manufacturing, distribution and storage. With poorly soluble drugs, polysorbates provide improvements in solubilisation while enhancing the stability of emulsions.
JT Baker polysorbates are vegetable-based, with a non-peanut origin, providing low endotoxin and other impurities, which is critical for formulation of biopharmaceuticals. The products meet the rigorous multi-compendial requirements of the National Formulary (NF), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) or Japanese Pharmaceutical Excipients (JPE).
The new Super Refined polysorbates are available in bottle sizes ranging from 200 mL up to 4 L, and are packaged under nitrogen to ensure premium product integrity.
Contact Details:
Allison Hosak
Vice President – Global Communications
Avantor Performance Materials, Inc
Office: 610-573-2661
Cell: 908-329-7281
Email: [email protected]
