Polysorbate 20 40 60 80 Specifications of Commercial Pure & BP Ph Eur USP NF FCC Food Grade Manufacturers & Exporters
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Polysorbate 20 CAS Number 9005-64-5
Polysorbate 60 CAS Number 9005-67-8
Polysorbate 80 CAS Number 9005-65-6
Specifications of Polysorbate 20 BP Ph Eur 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 mPas at 25C.
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: 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 Specifications:
The ratio of the OH group to the (C11H23COO) group is mainly 3:1.
Polyethylene glycol 20 sorbitan ether monolaurate;
Polyoxyethylene 20 sorbitan monododecanoate;
Polyoxyethylene 20 sorbitan monolaurate CAS 9005-64-5
DEFINITION
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. The fatty acids may be of vegetable, animal, or synthetic origin.
IDENTIFICATION
A. Infrared Absorption
B. It meets the requirements in the Assay for Composition of Fatty Acids.
ASSAY
Composition of Fatty Acids: Polysorbate 20 exhibits the composition profiles of fatty acids shown in Table 1, as determined in Fats and Fixed Oils, Fatty Acid Composition.
Table 1
| Carbon-Chain Length |
Number of Double Bonds |
Percentage (%) |
| 6 |
0 |
≤1.0 |
| 8 |
0 |
≤10.0 |
| 10 |
0 |
≤10.0 |
| 12 |
0 |
40.0-60.0 |
| 14 |
0 |
14.0-25.0 |
| 16 |
0 |
7.0-15.0 |
| 18 |
0 |
≤11.0 |
| 18 |
1 |
≤11.0 |
| 18 |
2 |
≤3.0 |
Residue on Ignition: NMT 0.25%
Limit of Ethylene Oxide and Dioxane:
Acceptance criteria
Ethylene oxide: NMT 1 ppm
Dioxane: NMT 10 ppm
Bacterial Endotoxins Test:
For Polysorbate 20 intended for use in the manufacture of injectable dosage forms: The level of bacterial endotoxins is such that the requirement in the relevant dosage form monograph(s) in which Polysorbate 20 is used can be met. Where the label states that Polysorbate 20 must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is such that the requirement in the relevant dosage form monograph(s) in which Polysorbate 20 is used can be met.
Fats and Fixed Oils, Acid Value:
Sample: 10.0 g
Analysis: Transfer the Sample to a wide-mouth, 250-mL conical flask, and add 50 mL of neutralized alcohol. Heat on a steam bath nearly to boiling, occasionally shaking thoroughly while heating. Invert a beaker over the mouth of the flask, cool under running water, and add 5 drops of phenolphthalein. Titrate with 0.1 N sodium hydroxide. Calculate the acid value as directed in the chapter.
Acceptance criteria: NMT 2.0
Fats and Fixed Oils, Hydroxyl Value: 96 to 108
Fats and Fixed Oils, Peroxide Value:
Sample: 10.0 g
Saturated potassium iodide solution: Prepare a saturated solution of potassium iodide in carbon dioxide-free water. Make sure the solution remains saturated as indicated by the presence of undissolved crystals.
Analysis: Introduce the Sample into a 100-mL beaker, and dissolve with 20 mL of glacial acetic acid. Add 1 mL of Saturated potassium iodide solution, mix, and allow to stand for 1 min. Add 50 mL of carbon dioxide-free water and a magnetic stirring bar. Titrate with 0.01 M sodium thiosulfate, determining the endpoint potentiometrically. Perform a blank titration. Calculate the peroxide value as directed in the chapter.
Acceptance criteria: NMT 10.0
For Polysorbate 20 intended for use in the manufacture of injectable dosage forms: NMT 5.0
Fats and Fixed Oils, Saponification Value: 40 to50
Water Determination: NMT 3.0%
Polysorbate 40 USP Grade Specifications:
The ratio of OH group to C15H31COO group is mainly 3:1.
Polyethylene glycol 20 sorbitan ether monopalmitate;
Polyoxyethylene 20 sorbitan monohexadecanoate;
Polyoxyethylene 20 sorbitan monopalmitate CAS 9005-66-7
DEFINITION
Polysorbate 40 is a palmitate ester of sorbitol and its anhydrides copolymerized with about 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides. The fatty acids may be of vegetable, animal, or synthetic origin.
IDENTIFICATION
A. Infrared Absorption
B. It meets the requirements in the Assay for Composition of Fatty Acids.
ASSAY
Composition of Fatty Acids:
Polysorbate 40 exhibits the composition profiles of fatty acids shown in Table 1, as determined in Fats and Fixed Oils, Fatty Acid Composition.
Table 1
| Carbon-Chain Length |
Number of Double Bonds |
Percentage (%) |
| 16 |
0 |
≥92.0 |
Residue on Ignition: NMT 0.25%
Ethylene Oxide and Dioxane:
Acceptance criteria
Ethylene oxide: NMT 1 ppm
Dioxane: NMT 10 ppm
Bacterial Endotoxins Test:
For Polysorbate 40 intended for use in the manufacture of injectable dosage forms: The level of bacterial endotoxins is such that the requirement in the relevant dosage form monograph(s) in which Polysorbate 40 is used can be met. Where the label states that Polysorbate 40 must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is such that the requirement in the relevant dosage form monograph(s) in which Polysorbate 40 is used can be met.
Fats and Fixed Oils, Acid Value:
Sample: 10.0 g
Analysis: Transfer the Sample to a wide-mouth, 250-mL conical flask, and add 50 mL of neutralized alcohol. Heat on a steam bath nearly to boiling, shaking thoroughly occasionally while heating. Invert a beaker over the mouth of the flask, cool under running water, and add 5 drops of phenolphthalein TS. Titrate with 0.1 N sodium hydroxide VS. Calculate the acid value as directed in the chapter.
Acceptance criteria: NMT 2.0
Fats and Fixed Oils, Hydroxyl Value: 89 to 105
Fats and Fixed Oils, Peroxide Value:
Sample: 10.0 g
Saturated potassium iodide solution: Prepare a saturated solution of potassium iodide in carbon dioxide-free water. Make sure the solution remains saturated as indicated by the presence of undissolved crystals.
Analysis: Introduce the Sample into a 100-mL beaker, and dissolve with 20 mL of glacial acetic acid. Add 1 mL of Saturated potassium iodide solution, mix, and allow to stand for 1 min. Add 50 mL of carbon dioxide-free water and a magnetic stirring bar. Titrate with 0.01 M sodium thiosulfate, determining the endpoint potentiometrically. Perform a blank titration.
Calculate the peroxide value as directed in the chapter.
Acceptance criteria: NMT 10.0
For Polysorbate 40 intended for use in the manufacture of injectable dosage forms: NMT 5.0
Fats and Fixed Oils, Saponification Value: 41 to 52
Water Determination: NMT 3.0%
Polysorbate 60 USP NF Grade Specifications:
The ratio of OH group to the sum of C15H31COO and C17H35COO groups is mainly 3:1.
Polyethylene glycol 20 sorbitan ether monostearate;
Polyoxyethylene 20 sorbitan monooctadecanoate;
Polyoxyethylene 20 sorbitan monostearate CAS 9005-67-8
IDEFINITION
Polysorbate 60 is a mixture of stearate and palmitate esters of sorbitol and its anhydrides copolymerized with about 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides. The fatty acids may be of vegetable, animal, or synthetic origin.
IDENTIFICATION
A. Infrared Absorption
B. It meets the requirements in the Assay for Composition of Fatty Acids.
ASSAY
Composition of Fatty Acids:
Polysorbate 60 exhibits the composition profiles of fatty acids shown in Table 1, as determined in Fats and Fixed Oils, Fatty Acid Composition.
Table 1
| Carbon-Chain Length |
Number of Double Bonds |
Percentage (%) |
| 18 |
0 |
40.0 to 60.0 |
| Sum of stearic acid (C18:0) and palmitic acid (C16:0) |
≥90.0 |
Residue on Ignition: NMT 0.25%
Ethylene Oxide and Dioxane:
Acceptance criteria
Ethylene oxide: NMT 1 ppm
Dioxane: NMT 10 ppm
Fats and Fixed Oils, Acid Value:
Sample: 10.0 g of Polysorbate 60
Analysis: Transfer the Sample to a wide-mouth, 250-mL conical flask, and add 50 mL of neutralized alcohol. Heat on a steam bath nearly to boiling, shaking thoroughly occasionally while heating. Invert a beaker over the mouth of the flask, cool under running water, and add 5 drops of phenolphthalein. Titrate with 0.1 N sodium hydroxide. Calculate the acid value as directed in the chapter.
Acceptance criteria: NMT 2.0
Fats and Fixed Oils, Hydroxyl Value: 81 to 96
Fats and Fixed Oils, Peroxide Value:
Sample: 10.0 g
Saturated potassium iodide solution: Prepare a saturated solution of potassium iodide in carbon dioxide-free water. Make sure the solution remains saturated as indicated by the presence of undissolved crystals.
Analysis: Introduce the Sample into a 100-mL beaker, and dissolve with 20 mL of glacial acetic acid. Add 1 mL of Saturated potassium iodide solution, mix, and allow to stand for 1 min. Add 50 mL of carbon dioxide-free water and a magnetic stirring bar. Titrate with 0.01 M sodium thiosulfate, determining the endpoint potentiometrically. Perform a blank titration.
Calculate the peroxide value as directed in the chapter.
Acceptance criteria: NMT 10.0
Fats and Fixed Oils, Saponification Value: 45 to 55
Water Determination: NMT 3.0%
Specifications of Polysorbate 20 FCC Food Grade
Polyoxyethylene (20) Sorbitan Monolaurate; Sorbitan
Monododecanoate; Poly(oxy-1,2-ethanediyl) Derivative
INS: 432 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%.
Specifications of Polysorbate 60 BP Ph Eur Grade
Polyoxyethylene 20 Sorbitan Monostearate
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 mPas 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 Specifications:
The ratio of OH group to the sum of C15H31COO and C17H35COO groups is mainly 3:1.
Polyethylene glycol 20 sorbitan ether monostearate;
Polyoxyethylene 20 sorbitan monooctadecanoate;
Polyoxyethylene 20 sorbitan monostearate CAS 9005-67-8
DEFINITION
Polysorbate 60 is a mixture of stearate and palmitate esters of sorbitol and its anhydrides copolymerized with about 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides. The fatty acids may be of vegetable, animal, or synthetic origin.
IDENTIFICATION
A. Infrared Absorption
B. It meets the requirements in the Assay for Composition of Fatty Acids.
ASSAY
Composition of Fatty Acids:
Polysorbate 60 exhibits the composition profiles of fatty acids shown in Table 1, as determined in Fats and Fixed Oils, Fatty Acid Composition.
Table 1
| Carbon-Chain Length |
Number of Double Bonds |
Percentage (%) |
| 18 |
0 |
40.0 to 60.0 |
| Sum of stearic acid (C18:0) and palmitic acid (C16:0) |
≥90.0 |
Residue on Ignition: NMT 0.25%
Ethylene Oxide and Dioxane:
Acceptance criteria
Ethylene oxide: NMT 1 ppm
Dioxane: NMT 10 ppm
Fats and Fixed Oils, Acid Value:
Sample: 10.0 g of Polysorbate 60
Analysis: Transfer the Sample to a wide-mouth, 250-mL conical flask, and add 50 mL of neutralized alcohol. Heat on a steam bath nearly to boiling, shaking thoroughly occasionally while heating. Invert a beaker over the mouth of the flask, cool under running water, and add 5 drops of phenolphthalein. Titrate with 0.1 N sodium hydroxide. Calculate the acid value as directed in the chapter.
Acceptance criteria: NMT 2.0
Fats and Fixed Oils, Hydroxyl Value: 81 to 96
Fats and Fixed Oils, Peroxide Value:
Sample: 10.0 g
Saturated potassium iodide solution: Prepare a saturated solution of potassium iodide in carbon dioxide-free water. Make sure the solution remains saturated as indicated by the presence of undissolved crystals.
Analysis: Introduce the Sample into a 100-mL beaker, and dissolve with 20 mL of glacial acetic acid. Add 1 mL of Saturated potassium iodide solution, mix, and allow to stand for 1 min. Add 50 mL of carbon dioxide-free water and a magnetic stirring bar. Titrate with 0.01 M sodium thiosulfate, determining the endpoint potentiometrically. Perform a blank titration.
Calculate the peroxide value as directed in the chapter.
Acceptance criteria: NMT 10.0
Fats and Fixed Oils, Saponification Value: 45 to 55
Water Determination: NMT 3.0%
Polysorbate 60 FCC Food Grade Specifications
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%.
Polysorbate 80 USP NF Grade Specifications:
Sorbitan, mono-9-octadecenoate, poly(oxy-1,2-ethanediyl)derivs., (Z)-;
Polyoxyethylene 20 sorbitan monooleate CAS 9005-65-6
DEFINITION
Polysorbate 80 is a mixture of partial esters of fatty acids, mainly oleic acid, with sorbitol and its anhydrides ethoxylated with approximately 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydrides.
IDENTIFICATION
A. It meets the requirements of the test for Composition of Fatty Acids.
B. Infrared Absorption
ASSAY
Composition of Fatty Acids: To pass the test by chromatography.
Residue on Ignition:
Sample: 2.00 g
Analysis: Heat a silica or platinum crucible to redness for 30 min, allow to cool in a desiccator, and weigh. Evenly distribute the Sample in the crucible. Dry at 100C to 105C for 1 h and ignite to constant mass in a muffle furnace at 600±25C, allowing the crucible to cool in a desiccator after each ignition. Flames should not be produced at any time during the procedure. If after prolonged ignition the ash still contains black particles, take up with hot water, pass through an ashless filter paper, and ignite the residue and the filter paper. Combine the filtrate with the ash, carefully evaporate to dryness, and ignite to constant mass.
Acceptance criteria: NMT 0.25%
Ethylene Oxide and Dioxane: To pass the test by chromatography.
Acceptance criteria: NMT 1 ppm for ethylene oxide; NMT 10 ppm for dioxane
Specific Gravity: 1.06 to 1.09
Viscosity-Capillary Methods or Viscosity-Rotational Methods: 300 to 500 centistokes at 25C
Fats and Fixed Oils, Acid Value: To pass the test.
Acceptance criteria: NMT 2.0
Fats and Fixed Oils, Hydroxyl Value: To pass the test.
Acceptance criteria: 65 to 80
Fats and Fixed Oils, Peroxide Value: To pass the test.
Acceptance criteria: NMT 10
Fats and Fixed Oils, Saponification Value: To pass the test.
Acceptance criteria: 45 to 55
Water Determination: NMT 3.0%, determined on 1.0 g
Packaging and Storage: Store in an airtight container, protected from light.
Specifications of Polysorbate 80 BP Ph Eur Grade
Polyoxyethylene 20 Sorbitan Mono-oleate
Action and use: Non-ionic surfactants.
DEFINITION
Mixture of partial esters of fatty acids, mainly Oleic 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, yellowish 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: About 1.10.
Viscosity: About 400 mPas at 25C.
IDENTIFICATION
First identification A, D.
Second identification B, C, D, E.
A. Infrared absorption spectrophotometry.
B. Hydroxyl value (see Tests).
C. Saponification value (see Tests).
D. Composition of fatty acids.
E. Dissolve 0.1 g in 5 ml of methylene chloride. Add 0.1 g of potassium thiocyanate R and 0.1 g of ;cobalt nitrate. Stir with a glass rod. The solution becomes blue.
TESTS
Acid value: Maximum 2.0.
Hydroxyl value: 65 to 80.
Peroxide value: Maximum 10.0.
Saponification value: 45 to 55, determined on 4.0 g.
Composition of fatty acids: To pass the test.
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.
Specifications of Polysorbate 80 FCC Food Grade
Polyoxyethylene (20) Sorbitan Monooleate; Sorbitan Mono-
9-octadecenoate; Poly(oxy-1,2-ethanediyl) Derivative
INS: 433 CAS 9005-65-6
DESCRIPTION
Polysorbate 80 occurs as a yellow to orange colored, oily liquid. It is a mixture of oleate 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 very soluble in water, producing a nearly colorless solution, and it is soluble in alcohol, in fixed oils, in ethyl acetate, and in toluene. It is insoluble in mineral oil.
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. Add bromine dropwise, to a 1:20 aqueous solution. The bromine is decolorized.
C. A 60:40 (v/v) mixture of Polysorbate 80:water at 25C or below 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 96.5% and 103.5% of Polysorbate 80, calculated on the anhydrous basis.
Acid Value: Not more than 2.
1,4-Dioxane: Not more than 10 mg/kg.
Hydroxyl Value: Between 65 and 80.
Lead: Not more than 2 mg/kg.
Oleic Acid: Between 22 and 24 g per 100 g of sample.
Residue on Ignition: Not more than 0.25%.
Saponification Value: Between 45 and 55.
Water: Not more than 3.0%.
SDS MSDS of Polysorbate 20 40 60 80 BP Ph Eur EP JP USP NF IP ACS Analytical Reagent FCC Food grade Manufacturers |
