NOF CORPORATION

Polysorbate and Solubilizer

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Quality

Structure of Polysorbate 80
Structure of Polysorbate 80
 Low Impurity

One of the essential components of Polysorbate 80(HX)TM is highly-pure oleic acid, EXTRA OLEIN 99TM, which purity is < 99% and is manufactured by NOF proprietary technology. The Extra Olein 99TM is fully eliminated unsaturated fatty acids, that is susceptible to oxidation. NOF is the only manufacturer who can supply such highly-pure oleic acid in the world.
Gas chromatogram for NOF Oieic acid comparared to conventional product
Gas chromatogram for NOF oleic acid, EXTRA OLEIN 99TM comparared to conventional product
 Low Peroxide

Polysorbate 80(HX)TM contains low peroxide products. The peroxide products in Polysorbate 80 cause some problem of drug stablity in their formulation.
Following is stability comparison data of protein drugs (IL-2), formulated by different types of Polysorbate 80. This data shows that low peroxide value (POV) of Polysorbate 80 maintains good stability of the drug.
Formuation of oxidized IL-2 mutein in solution during incubation at 40ºC. EMILY HA et.al. (Bayer) J. Pharma. Sci. 91,(10) 2252-, 2002
Formuation of oxidized IL-2 mutein in solution during incubation at 40oC. EMILY HA et.al. (Bayer) J. Pharma. Sci. 91,(10) 2252-, 2002

 Colorless

Polysorbate 80(HX)TM is colorless and odorless product. By contrast, conventianal Polysorbate 80 is yellowish and interferes UV analysis for certain drug due to its color. The outstanding features of Polysorbate80(HX)TM give huge advantage for drug formulation. Left: NOF Polysorbate 80, Right: Competitors Polysorbate 80
Left: NOF Polysorbate 80(HX)TM, Right: Conventional Polysorbate 80
 Multi Compendial

NOF Polysorbate80(HX)TM meets multi Compendital NF, EP, and JP.