JT Baker® 4600-06 Polysorbate 20, Vegetable NF Grade, Multi-Compendial, 1L Amber Glass Bottle (Case
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JT Baker® Polysorbates: High Purity for Demanding Drug Formulations
Avantor™ Performance Materials offers the two most widely used types of polysorbates—polysorbate 20 and polysorbate 80—under its J.T.Baker® brand. Each type is now available in both high-purity and Super Refined®* grades, manufactured under cGMP conditions.
While high-purity grade polysorbates offer low levels of impurities to ensure high performance in formulations, the proprietary flash chromatographic Super Refined® process has been shown to remove even more polar and oxidative impurities, such as peroxides and aldehydes, that can degrade active pharmaceutical ingredients (APIs).
Polysorbates are used in a variety of biotechnology and small molecule drug formulations to improve solubilization and stability. The surface activity of polysorbates serves to stabilize proteins, by reducing the alteration or aggregation of proteins during manufacturing, distribution and storage. When formulated with poorly soluble drugs, polysorbates provide improvements in solubilization. In addition, the enhanced stability of emulsions with polysorbates is widely known.
Higher Purity Provides Improved Drug Stability and Shelf-Life
Composed of fatty acid esters of polyoxyethylene sorbitan, polysorbates are surfactants which are amphiphilic and non-ionic. The largest fatty acid component dictates the general type of polysorbate—polysorbate 20 is based on lauric acid, while polysorbate 80 is based on oleic acid. These structures provide high hydrophilic-lipophilic balance (HLB) numbers and low critical micelle concentration values, the factors responsible for their common use in drug formulations. The choice between polysorbate types depends on their specific interaction with APIs or other excipients.
JT Baker ® brand polysorbates are vegetable-based, with a non-peanut origin, providing low endotoxin and other impurities. These high-purity materials can provide robust formulation by improving oxidative stability and shelf life. The low endotoxin and peroxide level is critical for formulation of biopharmaceuticals.
With state-of-the-art cGMP subdivision processes in FDA-registered ISO 9000-certified facilities, Avantor offers polysorbates in a variety of container sizes, packaged under nitrogen to ensure premium product integrity. These products meet the rigorous multicompendial requirements of the National Formulary (NF), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) or Japanese Pharmaceutical Excipients (JPE).