Polysorbate 60

General Specifications of Polysorbate 60:
Appearance: Semi-solid to Solid Pale Yellow.
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
Hydroxyl Value: 81.0 - 96.0
Saponification Value: 45.0 - 55.0
Arsenic (As): Not more than 3 ppm
Cadmium (Cd): Not more than 1 ppm
Mercury (Hg): Not more than 1 ppm
Lead (Pb): Not more than 10 ppm.

Polysorbate 60 BP Grade
Polyoxyethylene 20 Sorbitan Monostearate
Ph Eur
Action and use: Non-ionic surfactants.

DEFINITION
Mixture of partial esters of fatty acids, mainly Stearic acid 50 (1474), with sorbitol and its anhydrides ethoxylated with approximately 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides.

CHARACTERS
Appearance: Yellowish-brown gelatinous mass which becomes a clear liquid at temperatures above 25C.
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 30C.

IDENTIFICATION
First identication A, D.
Second identification B, 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: 81 to 96.
Peroxide value: Maximum 10.0.
Saponification value: 45 to 55, determined on 4.0 g.
Composition of fatty acids:
Composition of the fatty acid fraction of the substance:
stearic acid : 40.0 per cent to 60.0 per cent;
sum of the contents of palmitic and stearic acids: minimum 90.0 per cent.
Ethylene oxide and dioxan: Maximum 1 ppm of ethylene oxide and maximum 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 60 USP NF Grade
Sorbitan, monooctadecanoate, poly(oxy-1,2-ethanediyl) derivs.
Polyoxyethylene 20 sorbitan monostearate [Compound usually contains also associated fatty acids.]
[CAS 9005-67-8].

Polysorbate 60 is a mixture of stearate and palmitate esters 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 for Identification tests A and C 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 81 and 96.
Saponification value: between 45 and 55.
Organic volatile impurities: meets the requirements. [NOTE—A G16 column has been shown to be an appropriate secondary column.] (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 60 FCC Food Grade
Polyoxyethylene (20) Sorbitan Monostearate; Sorbitan
Monooctadecanoate; Poly(oxy-1,2-ethanediyl) Derivative
INS: 435 CAS: [9005-67-8]

DESCRIPTION
Polysorbate 60 occurs as a yellow to orange colored, oily liquid or semigel. It is a mixture of stearate and palmitate partial esters of sorbitol and sorbitol anhydrides condensed with approximately 20 moles of ethylene oxide (C2H4O) for each mole of sorbitol and its mono- and dianhydrides. It is soluble in water, in aniline, in ethyl acetate, and in toluene, but it is insoluble in mineral oil and in vegetable oils.
Function: Emulsifier; stabilizer.

REQUIREMENTS
Identification:
A. 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.
B. A 60:40 (v/v) mixture of Polysorbate 60:water at 25C or cooler yields a gelatinous mass.
Assay for Oxyethylene Content: Not less than 65.0% and not more than 69.5% of oxyethylene groups (—C2H4O—), equivalent to between 97.0% and 103.0% of Polysorbate 60, calculated on the anhydrous basis.
Acid Value: Not more than 2.
1,4-Dioxane: Not more than 10 mg/kg.
Hydroxyl Value: Between 81 and 96.
Lead: Not more than 2 mg/kg.
Residue on Ignition: Not more than 0.25%.
Saponification Value: Between 45 and 55.
Stearic and Palmitic Acids: Between 21.5 and 26.0 g per 100 g of sample.
Water: Not more than 3.0%.

Certifications :
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