Polysorbate 20

General Specifications of Polysorbate 20
Appearance: Faint Yellow to Yellow Viscous Liquid
Refractive index at 20C: 1.467 - 1.473
Water (by Karl Fischer): Not more than <_ 3.0 %
Residue on ignition (Ash): Not more than 0.25 %
Acid Value: ): Not more than 2.0 ml
Heavy Metal: ): Not more than 10 ppm
Hydroxyl Value: ): Not more than 96.0 - 108.0
Saponification Value: 40.0 - 50.0
Arsenic (As): 3 ppm
Cadmium (Cd): 1 ppm
Mercury (Hg): 1 ppm
Lead (Pb): 2 ppm.

Polysorbate 20 BP Grade
Polyoxyethylene 20 Sorbitan Monolaurate
Ph Eur
Action and use: Non-ionic surfactants.

DEFINITION
Mixture of partial esters of fatty acids, mainly lauric (dodecanoic) acid, with sorbitol and its anhydrides ethoxylated with approximately 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides.

CHARACTERS
Appearance: Oily, yellow to brownish-yellow, clear or slightly opalescent liquid.
Solubility: Soluble in water, in ethanol, in ethyl acetate and in methanol, practically insoluble in fatty oils and in liquid paraffin.
Relative density: About 1.10.
Viscosity: About 400 mPa·s at 25 °C.

IDENTIFICATION
First identicationıA, D.
Second identificationıB, C, D, E.
A. Infrared absorption spectrophotometry.
B. It complies with the test for hydroxyl value.
C. It complies with the test for saponification value.
D. It complies with the test for composition of fatty acids.
E. Dissolve 0.1 g in 5 ml of methylene chloride. Add 0.1 g of potassium thiocyanate and 0.1 g of cobalt nitrate. Stir with a glass rod. The solution becomes blue.

TESTS
Acid value: Maximum 2.0.
Hydroxyl value: 96 to 108.
Peroxide value: Maximum 10.0.
Saponification value: 40 to 50, determined on 4.0 g.
Composition of fatty acids:
Composition of the fatty acid fraction of the substance:
caproic acid : maximum 1.0 per cent;
caprylic acid : maximum 10.0 per cent;
capric acid: maximum 10.0 per cent;
lauric acid : 40.0 per cent to 60.0 per cent;
myristic acid : 14.0 per cent to 25.0 per cent;
palmitic acid : 7.0 per cent to 15.0 per cent;
stearic acid : maximum 7.0 per cent;
oleic acid : maximum 11.0 per cent;
linoleic acid : maximum 3.0 per cent.
Ethylene oxide and dioxan: Maximum 1 ppm of ethylene oxide and 10 ppm of dioxan.
Heavy metals: Maximum 10 ppm.
Water: Maximum 3.0 per cent, determined on 1.00 g.
Total ash: Maximum 0.25 per cent, determined on 2.0 g.

Polysorbate 20 USP NF Grade
Sorbitan, monododecanoate, poly(oxy-1,2-ethanediyl) derivs.
Polyoxyethylene 20 sorbitan monolaurate [CAS 9005-64-5].
Polysorbate 20 is a laurate ester of sorbitol and its anhydrides copolymerized with approximately 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides.

Identification:
A: It meets the requirements of Identification test A under Polysorbate 80.
B: To 2 mL of a solution (1 in 20) add 0.5 mL of bromine dropwise: the bromine is not decolorized (distinction from Polysorbate 80).
Hydroxyl value: between 96 and 108.
Saponification value: between 40 and 50.
Organic volatile impurities: meets the requirements. (Official until July 1, 2007)
Other requirements: It meets the requirements for Water, Residue on ignition, Heavy metals, and Acid value under Polysorbate 80.

Polysorbate 20 FCC Food Grade
Polyoxyethylene (20) Sorbitan Monolaurate; Sorbitan
Monododecanoate; Poly(oxy-1,2-ethanediyl) Derivative
INS: 432 CAS: [CAS 9005-64-5]

DESCRIPTION
Polysorbate 20 occurs as a yellow- to amber-colored liquid. It is a mixture of laurate partial esters of sorbitol and sorbitol anhydrides condensed with approximately 20 moles of ethylene oxide (C2H4O) for each mole of sorbitol and its monoand dianhydrides. It is soluble in water, in alcohol, in ethyl acetate, in methanol, and in dioxane, but it is insoluble in mineral oil and in mineral spirits.
Function: Emulsifier; stabilizer.

REQUIREMENTS
Identification: Add 5 mL of 1 N sodium hydroxide to 5 mL of a 1:20 aqueous solution, boil for a few minutes, cool, and acidify with 2.7 N hydrochloric acid. The solution is strongly opalescent.
Assay for Oxyethylene Content: Not less than 70.0% and not more than 74.0% of oxyethylene groups (—C2H4O—), equivalent to between 97.3% and 103.0% of Polysorbate 20 calculated on the anhydrous basis.
Acid Value: Not more than 2.
1,4-Dioxane: Not more than 10 mg/kg.
Hydroxyl Value: Between 96 and 108.
Lauric Acid: Between 15 and 17 g per 100 g of sample.
Lead: Not more than 2 mg/kg.
Residue on Ignition: Not more than 0.25%.
Saponification Value: Between 40 and 50.
Water: Not more than 3.0%.

Certifications :
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