Polysorbate 80 USP/NF

Applications

Polysorbate 80 USP/NF is a hydrophilic nonionic surfactant used as an emulsifier or surfactant in foods, medicines, skincare products, vaccines etc. It also acts as a surfactant in soaps and cosmetics.USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF).

Sales Specifications

Appearance: Oily, colorless or brownish yellow, clear or slightly opalescent liquid
Solubility: Dispersible in water, in anhydrous ethanol, in ethyl acetate and in methanol, practically insoluble in fatty oils and in liquid paraffin
Relative Density (g/ml): About 1.10
Viscosity @ 25oC: ~ 400
Identification
A) By infrared absorption: The absorption maxima in the spectrum obtained with the sample shall correspond to the reference spectrum of polysorbate 80/reference standard
B) Test for hydroxyl value: Should comply with the test for hydroxyl value
C) Test for saponification value: Should comply with the test for saponification value
D) Test for composition of fatty acids: Should comply with the test for composition of fatty acids
E) Chemical test: The solution should become blue
Acid Value (mgKOH/g):2.0 Max
Hydroxyl Value (mgKOH/g):Between 65 and 80
Peroxide Value:10 Max
Saponification Value (mgKOH/g):Between 45 and 55

Composition of fatty acids by GC
a) Myristic Acid:5.00 % Max
b) Palmitic Acid:16.00 % Max
c) Palmitoleic Acid:8.00 % Max
d) Stearic Acid:6.00 % Max
e) Oleic Acid:Not less than 58.00 %
f) Linoleic Acid:18.00 % Max
g) Linolenic Acid:4.00 % Max

Ethylene Oxide & Dioxane
a) Ethylene Oxide:1 ppm Max
b) Dioxane: 10 ppm Max
Water: 3.00 % Max
Total ash: Not more than 0.25 %