Specifications, Uses, SDS of Polysorbate Manufacturers

	King of Chemicals Manufacturers
Specifications, Properties, Uses, SDS of Polysorbate 20 40 60 80 USP NF BP Ph Eur FCC Food Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 9005-64-5, 9005-67-8 & 9005-65-6.
King of Chemicals has several associated companies having accreditations like cGMP, GLP - FDA Approved Good Manufacturing Practice and Good Laboratory Practice of WHO standard, ISO-9001, ISO-14001, ISO/IEC 17025, ISO ISO-45000, HACCP, FSSC 220000, FSSAI, "REACH" Registered, Kosher & Halal Certified. e-CTD and DMF support can be made available if needed. We offer USP NF BP Ph Eur EP IP JP Analytical Reagent FCC Food Grade Chemicals & Nutraceuticals.

Muby Chem Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies of Polysorbate 20 40 60 80 for actual users, including retail or small pack supplies for research and development work.

We supply fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals at best prices. We and/or our associated units have all the facilities to supply as per cGMP standard observing good manufacturing practice and good laboratory practice. We can assure low microbial count and also offer a test certificate for the same. We maintain warehouses across USA, India, and UAE. Our group exports to USA, Canada, Mexico, Argentina, Brazil, Chile, Korea, Malaysia, Thailand, Indonesia, Europe, and several other parts of the world. We supply in wholesale container loads to small pack of few grams. Solid products may be specified for it size and shape as desired by the buyer.

Tween - Polysorbate 20: CAS Number: 9005-64-5, EINECS EC Number: 500-018-3, Molecular Formula: C58H114O26, Molecular Weight: 1227.54, FEMA Number 2915, HS Code ---**

Tween - Polysorbate 60: CAS Number: 9005-67-8, EINECS EC Number: 500-020-4, Molecular Formula: C64H126O26, Molecular Weight: 1,311.70, FEMA Number 2916, HS Code ---**

Tween - Polysorbate 80 CAS Number: 9005-65-6, Molecular Weight: 2917, Chemical Formula: C64H124O26, EINECS EC Number: 500-019-9, FEMA: 2917,

Polysorbates are a class of emulsifiers used in some pharmaceuticals and food preparation. They are often used in cosmetics to solubilize essential oils into water-based products. Polysorbates are oily liquids derived from ethoxylated sorbitan esterified with fatty acids.

Examples are:
Polysorbate 20& (polyoxyethylene (20) sorbitan monolaurate)
Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate)
Polysorbate 60 (polyoxyethylene (20) sorbitan monostearate)
Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate)

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.

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%
Packaging and Storage: Preserve in tight containers, protected from light and moisture. Store at room temperature.

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.

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%
Packaging and Storage: Preserve in tight containers, protected from light and moisture. Store at room temperature.

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.

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%
Packaging and Storage: Preserve in tight containers, protected from light and moisture. Store at room temperature.

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.

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.

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

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%.

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

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%.

Polysorbate 20 SDS, Safety Data Sheet
MSDS, Material Safety Data Sheet 03-Aug-21

Product Name & Other Names: Polysorbate 20.
CAS Number: 9005-64-5
EINECS EC Number: 500-018-3
Molecular Weight: 1227.54
Molecular Formula: C58H114O26
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.

Precautionary statements:
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P302+P352 - IF ON SKIN: Wash with plenty of soap and water.
P304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+313: If eye irritation persists get medical advice/attention.

Product Name & Other Names: Polysorbate 20.
CAS Number: 9005-64-5
EINECS EC Number: 500-018-3

Emergency and First Aid Procedures:
Eyes - Flush with water for at least 15 minutes, raising and lowering eyelids occasionally. Get medical attention if irritation persists.
Skin - Thoroughly wash exposed area for at least 15 minutes. Remove contaminated clothing. Launder contaminated clothing before reuse. Get medical attention if irritation persists.
Ingestion - If Polysorbate 20 is swallowed, if conscious, give plenty of water. Immediately call a physician. Never give anything by mouth to an unconscious person.
Inhalation - Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Get medical attention.

Extinguisher Media: Water spray. Carbon dioxide (CO 2). Dry chemical. alcohol-resistant foam.
Flammable Limits in Air % by Volume: N/A
Special Fire fighting Procedures: Firefighters should wear full protective equipment and NIOSH approved self-contained breathing apparatus.
Extinguishing Media Not recommended: Avoid using solid water jet as it may scatter the fire.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and the suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment Cleanup procedures and Storage: Do not inhale dust, vapors, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents and bases.

Exposure Guidelines: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

Appearance and Odor: Yellow liquid material.
Odor: Odorless.
Odor threshold: Not available.
pH: about 7
Relative density: 1.105 literature.
Melting point/freezing point: Not available.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility(ies): Soluble in water.
Viscosity: Not available.
Molecular Weight: 1227.54
Molecular Formula: C58H114O26

Stability: Stable under normal storage conditions.
Conditions to Avoid: Heat.
Incompatibility (Materials to Avoid): Strong oxidizing and bases.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide
Hazardous Polymerization: Will not occur.

LD50 Oral - Rat - 40,554 mg/kg
Carcinogenicity: No product present at levels greater than or equal to 0.1% is identified as probable, possible, or confirmed human carcinogen by IARC, NTP, ACGIH & OSHA.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity: Avoid release into the environment.
Toxicity to fish: LC50 - other fish - 350 mg/l - 24 h
Persistence and Degradability: No information available.
Mobility: No information available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

Waste Disposal Methods: Dispose Polysorbate 20 in accordance with all applicable Federal, State and Local regulations.

Land Transport DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
Sea Transport IMDG/IMO: Not regulated.
Air Transport ICAO/IATA: Not regulated.

USA:
SARA 311/312 Hazards: No SARA Hazards
California Prop. 65 Components: This product does not contain any chemicals known to State of California to cause cancer, birth defects, or any other reproductive harm.

Polysorbate 60 SDS, Safety Data Sheet
MSDS, Material Safety Data Sheet 03-Aug-21

Product Name & Other Names: Polysorbate 60.
CAS Number: 9005-67-8
EINECS EC Number: 500-020-4
Molecular Weight: 1,311.70
Molecular Formula: C64H126O26
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.

Product Name & Other Names: Polysorbate 60.
CAS Number: 9005-67-8
EINECS EC Number: 500-020-4

Emergency and First Aid Procedures:
Eyes - Flush with water for at least 15 minutes, raising and lowering eyelids occasionally. Get medical attention if irritation persists.
Skin - Thoroughly wash exposed area for at least 15 minutes. Remove contaminated clothing. Launder contaminated clothing before reuse. Get medical attention if irritation persists.
Ingestion - If Polysorbate 60 is swallowed, if conscious, give plenty of water. Immediately call a physician. Never give anything by mouth to an unconscious person.
Inhalation - Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Get medical attention.

Extinguisher Media: Water spray. Carbon dioxide (CO 2). Dry chemical. alcohol-resistant foam.
Flammable Limits in Air % by Volume: N/A
Extinguishing Media Not recommended: Avoid using solid water jet as it may scatter the fire.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and the suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

Exposure Guidelines: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies. Better keep it under 10 mg/m3
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

Appearance and Odor: Viscous yellow liquid material.
Odor: Odorless.
Odor threshold: Not available.
pH: Not available.
Relative density: about 1.044
Melting point/freezing point: Not available.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility(ies): Not available.
Viscosity: Not available.
Molecular Weight: 1,311.70
Molecular Formula: C64H126O26

Stability: Polysorbate 60 is stable
Conditions to Avoid: Heat and Strong oxidizing agents.
Incompatibility (Materials to Avoid): Strong oxidizing and bases.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide
Hazardous Polymerization: Will not occur.

LD50 Oral - Rat - > 62,640 mg/kg
LD50 Intravenous - Rat - 1,220 mg/kg
Carcinogenicity: No product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC, NTP, ACGIH & OSHA.
Teratogenic Effects: Not available.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity to fish: LC50 - Oryzias latipes - 240 mg/l - 48 h
Persistence and Degradability: No information available.
Mobility: No information available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

Waste Disposal Methods: Dispose Polysorbate 60 in accordance with all applicable Federal, State and Local regulations.

Land Transport DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
Sea Transport IMDG/IMO: Not regulated.
Air Transport ICAO/IATA: Not regulated.

USA:

SARA 311/312 Hazards: No SARA Hazards
California Prop. 65 Components: This product does not contain any chemicals known to State of California to cause cancer, birth defects, or any other reproductive harm.

Polysorbate 80 SDS, Safety Data Sheet
MSDS, Material Safety Data Sheet 03-Aug-21

Product Name & Other Names: Polysorbate 80; Polyoxymethylene 20 Sorbitan Mono-oleate.
CAS Number: 9005-65-6
EINECS EC Number: 500-019-9
Molecular Weight: 2917
Molecular Formula: C64H124O26
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.

Product Name & Other Names: Polysorbate 80; Polyoxymethylene 20 Sorbitan Mono-oleate.
CAS Number: 9005-65-6
EINECS EC Number: 500-019-9

Emergency and First Aid Procedures:
Eyes - Flush with water for at least 15 minutes, raising and lowering eyelids occasionally. Get medical attention if irritation persists.
Skin - Thoroughly wash exposed area for at least 15 minutes. Remove contaminated clothing. Launder contaminated clothing before reuse. Get medical attention if irritation persists.
Ingestion - If swallowed, if conscious, give plenty of water. Immediately call a physician. Never give anything by mouth to an unconscious person.
Inhalation - Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Get medical attention.

Personal precautions, protective equipment and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Ensure adequate ventilation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil or water sources.
Methods and materials used for containment Cleanup procedures and Storage: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). Vacuuming or wet sweeping may be used to avoid dust dispersal and then remove to an approved disposal container.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat or smoke while handling. Avoid contact with skin, eyes and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cold, dry and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing and bases.

Exposure Guidelines: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Respiratory Protection (Specify Type): None needed under normal conditions of use with adequate ventilation. NIOSH approved equipment should be worn if PELs are exceeded.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

Appearance and Odor: Dark yellow liquid material. Odorless.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: 1.06
Melting point/freezing point: Not available.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility(ies): Not available.
Viscosity: Not available.
Molecular Weight: 2917
Molecular Formula: C64H124O26

Stability: Stable under normal conditions.
Conditions to Avoid: Heat.
Incompatibility (Materials to Avoid): Strong oxidizing and bases.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide
Hazardous Polymerization: Will not occur.

LD50 Oral - Rat - > 63,840 mg/kg
Carcinogenicity: No product present at levels greater than or equal to 0.1% is identified as probable, possible, or confirmed human carcinogen by IARC, NTP, ACGIH & OSHA.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity: Avoid release into the environment.
Persistence and Degradability: No information available.
Mobility: No information available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

Waste Disposal Methods: Dispose in accordance with all applicable Federal, State and Local regulations.

Land Transport DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
Sea Transport IMO/IMDG: Not regulated.
Air Transport ICAO/IATA: Not regulated.

Polysorbate 20 40 60 80 Manufacturers, Suppliers, Exporters, Wholesalers:

Plot No. 2900/46&47 + 2900/163to167, GIDC, Ankleshwar, Dist. Bharuch, India
India, USA, UAE
TEL: (Office) 91-22-23774610, 91-22-23723564

If I give you “My Word” Nobody can undo it.
If I sign an “Agreement” my Lawyer will undo it

Our products are for industrial and laboratory use only. The user must test the material before use. We are not dispensing chemists or druggist and do not offer over the counter type (OTC) products for medical use by individuals.

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

Carbon-Chain Length	Number of Double Bonds	Percentage (%)
16	0	≥92.0

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

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

Specifications, Properties, Uses, SDS of Polysorbate 20 40 60 80 USP NF BP Ph Eur FCC Food Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 9005-64-5, 9005-67-8 & 9005-65-6.

Polysorbate 20 40 60 80 Manufacturers, Suppliers, Exporters, Wholesalers: