Polysorbate 80 is a non-ionic surfactant with a molecular formula C64H124O26. It is part of the series of polyoxyethylene sorbitan fatty acid esters.
Polysorbate 80 is a light yellow to orange yellow viscous liquid, which tastes slightly bitter and astringent. It's soluble in warm water, methanol, ethyl acetate and very slightly dissolved in mineral oil. And it’s an oil-in-water(O/W) type emulsifier that can be used as stabilizer, diffusion agent, antistatic agent, fiber lubricant, etc. Polysorbate 80 is produced by the reaction between sorbitan monooleate and ethylene oxide.
By comparing the quality standards of polysorbate 80 in the United States pharmacopoeia (USP-29), British pharmacopoeia (BP2005), European pharmacopoeia (EP5.4), Japanese pharmacopoeia (JP14) and Chinese pharmacopoeia (CP2010), it's know that the standards of polysorbate 80 varies among most pharmacopoeias, while CP and USP are basically the same.
Different countries' pharmacopoeias have no significant differences in terms of hydroxyl value, saponification value, acid value, heavy metal, burning residue, moisture, viscosity, density and other indexes. In general, the control standards of EP and BP are stricter than those of CP, USP and JP, mainly reflected in the control levels of the impurities and contents contained.
EP and BP has same indexes on peroxide value (≤10.0), nutmeg acid (≤5.0%), palmitic acid (≤16.0%), palm oleic acid (≤8.0%), stearic acid (≤6.0%), linoleic acid (≤18.0%), linolenic acid (≤4.0%), ethylene oxide (1, 4-dioxane content ≤ 10ppm) and oxacyclopropane content (≤1ppm). The control indexes of oleic acid content of BP (58.0%-85.0%) and EP (≥58.0%) were slightly different. BP also controlls 2-chloroethanol content (≤10ppm), glycol content (≤ 0.25%) and diethylene glycol content (≤ 0.25%), while EP does not control these three indexes.