J.T.Baker® brand cGMP-manufactured Polysorbate 20 and Polysorbate 80 now available in both high-purity and new Super Refined® grades
Center Valley, PA (USA) – September 10, 2013 – Avantor™ Performance Materials has introduced a higher purity Super Refined® grade of polysorbate products to improve solubilization and stability in a variety of biopharmaceutical and small-molecule drug formulations.
Avantor’s Super Refined® J.T.Baker® Polysorbate 20 and 80The new Super Refined® grade products join Avantor’s current high-purity versions of the two most widely used types of polysorbate products: J.T.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 J.T.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. “Pharmaceutical manufacturers are increasingly facing challenges to ensure the stability of their formulations and improve the shelf life of their products,” said Paul Smaltz, Avantor Executive Vice President for Pharmaceuticals. “We’re pleased to now offer these additional options in our polysorbate products so customers can match the right level of purity to their formulation needs.”
The surface activity of polysorbates helps to stabilize proteins by reducing the alteration or aggregation of proteins during manufacturing, distribution and storage. With poorly soluble drugs, polysorbates provide improvements in solubilization while enhancing the stability of emulsions.
J.T.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.
Information on Avantor’s J.T.Baker® polysorbates is available on the “Surfactants and Detergents” product page and in the Technical Literature Library product profiles section for pharmaceuticals at www.avantormaterials.com.
Visit www.avantormaterials.com or www.twitter.com/avantor_news for more information about Avantor Performance Materials.
About Avantor™ Performance Materials
Based in Center Valley, PA (USA), Avantor Performance Materials manufactures and markets high-performance chemistries and materials around the world under several respected brand names, including the J.T.Baker®, Macron Fine Chemicals™, Rankem™, BeneSphera™, and POCH™ brands.
Avantor products are used in a wide range of industries. Our biomedical and life science solutions are used in pharmaceutical production, laboratory research for academic, industry and quality control, and in medical lab testing. Our electronics materials products are used in the manufacturing of semiconductors. For additional information please visit www.avantormaterials.com or follow www.twitter.com/avantor_news.
Media Contacts:
Allison Hosak
Vice President, Global Communications
Avantor Performance Materials, Inc. Office: 610-573-2661
Cell: 908-329-7281
[email protected]
Bob Martin
Marketing Communications Manager
Avantor Performance Materials, Inc.
Office: 610-573-2683
Cell: 908-329-4869
[email protected]