POLYSORBATE 60
POLYSORBATE 60
EC / List no.: 500-020-4
CAS no.: 9005-67-8
CAS number: 9005-67-8
Polysorbic acid 60
e435
PEG-60 sorbitan stearate
POE(20) sorbitan monostearate
Polyoxyethylene (60) sorbitan monostearate
Polyoxyethylene sorbitan monostearate
Polyoxyethylene (20) Sorbitan Monostearate
Sorbomacrogol stearate 300
Tween 60
Polysorbate 60 – is used as co-emulsifier, solubilizer, dispersing agent.
Polysorbate 60 is a surface-active substance that is used as an emulsifier and wetting agent in foods and pharmaceuticals, for example.
Polysorbate 60 is used in food, medicine, plastic, cosmetics and other industries.
Polysorbate 60 is an excellent emulgator and one of elements to constitute polyacrylonitrile fiber spinning oil.
Polysorbate 60 also used as softening agent after processing fiber and eliminate fiber static and improve its softness.
Polysorbate 60 is a non-ionic surfactant. Its stability and relative non toxicity enable its use as a detergent and emulsifier.
CAS number: 9005-67-8
Polysorbate 60
Potential Uses:
emulsifying agents
essential oils solublizer
fragrance solublizer
surfactants
Tween™ 60
Produces stable O/W emulsions, especially when combined with Span 60 and cetostearyl alcohol or other fatty alcohols. Excellent for the emulsification of esters, minerals and silicone oils. Vegetable-derived.
Polysorbate 60 is an oil-in-water co-emulsifier for use in skin care, hair care and decorative cosmetics.
Polysorbate 60 has an HLB value of 14.9, and it is useful as an oil-in-water emulsifier.
This grade produces stable emulsions, especially when used with cetyl or stearyl alcohols.
Polysorbate 60 is used in creams, gels and cleansing products.
Polysorbate 60 is a yellow colour liquid chemical compound which has a oily texture. It is obtained from sorbitan and esterified with fatty acids. It is considered as an emulsifier and a food additive.
Polysorbate 60 is used as a oil-in-water (O/W) emulsions, and also as a dispersants/solubilizers of oils, used in various products like skin fresheners, skin care products, skin cleansing products, makeup bases and foundations, shampoos, and fragrance powders.
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. Polysorbate 60 is a sorbitol-based emulsifier and surfactant.
Applications:
Polysorbate 60 is used in moisturizer, shampoos, styling gels, lotions, hair sprays, hair color and bleaching products, conditioners, sunscreens, toners, astringents, sunless tanning products, scalp treatment products, exfoliants, scrubs, bar soaps, and detanglers.
Polysorbate 60 is a mixture of stearate esters of sorbitol and sorbitol anhydrides, consisting predominantly of the monoester, condensed with approximately 20 moles of ethylene oxide.
CAS Numbers: 9005-67-8 (Generic)
EC/List Numbers: 500-020-4
Trade Names:
Technical Names:
Polyoxyethylene (20) Sorbitan Monostearate
Polyoxyethylene Sorbitan Monostearate (20E.O.)
Polysorbate 60 (IFRA)
Polysorbate 60 (INCI)
Sorbimacrogol Stearate 300
Sorbitan, Monooctadecanoate, Poly(Oxy-1,2-Ethanediyl) Derivs.
Product Categories:
Cleaning Products
Industrial and Automotive Chemicals
polyethyleneglycol sorbitan monostearate
Polysorbate 60
Sorbitan monostearate, ethoxylated
Sorbitan monostearate, ethoxylated
Sorbitan, monooctadecanoate, poly(oxy-1,2-ethanediyl) derivs.
IUPAC names
Sorbitan monostearate, ethoxylated
Sorbitan monostearate, ethoxylated
Polysorbate 60
* A thickening agent
Polysorbate 60 is a thickening agent and oily liquid used in cosmetics and skin care formulas to dissolve in a solvent in which they would not normally dissolve.
Polysorbate 60 also helps to form emulsions by reducing the surface tension of the substances to be emulsified.
Polysorbate 60 is a surfactant created by reacting sorbitol with ethylene oxide and fatty acids obtained from vegetable fats and oils. It is used to disperse oil in water in formulas, and seen in a wide variety of products, including skin fresheners, skin care products, skin cleansing products, makeup bases and foundations, shampoos, and fragrance powders.
Polyoxyethylene (60) sorbitan monolaurate
CAS: 9005-67-8
An oily liquid derived from PEG-ylated sorbitan (a derivative of sorbitol) esterified with fatty acids.
Other Known Names: PEG(60)sorbitan monolaurate, Alkest TW 60, Tween 60
Molecular Formula: C58H114O26
Applications: pharmaceutical, food additive, detergent, emulsifier, wetting agent
Product advantages:
effective emulsifying properties,
99% of the active substance in the product,
high solubility in water and other solvents,
safe for the water environment,
biodegradable.
Product applications:
cosmetics,
agrochemicals,
textile,
metalworking,
drilling fluids.
Categories
Alternative names
Polyoxyethylene sorbitan monostearate, Polysorbate 60, E435, PS 60, Polyethylene sorbitan monostearate, Ethoxylated sorbitan monostearate, Polyoxyethylene sorbitan monooctadecanoate, Polysorban, PEG (20) sorbitan monostearate, Polyethylene glycol, sorbitan monostearate
Synonyms: POLYSORBATE 60
Chemical Names: MIXTURE OF THE PARTIAL ESTERS OF SORBITOL AND ITS MONO- AND DIANHYDRIDES WITH EDIBLE COMMERCIAL STEARIC ACID AND CONDENSED WITH APPROXIMATELY 20 MOLES OF ETHYLENE OXIDE PER MOLE OF SORBITOL AND ITS ANHYDRIDES
CAS number: 9005-67-8
INS: 435
Functional Class:
Food Additives
EMULSIFIER
Evaluations
Polysorbate 60 is part of a class of emulsifiers that is commonly used in food preparation and certain pharmaceuticals. It is used in cosmetics to turn essential oils into water based products.
Tween 60, (=Polyoxyethylene Sorbitan Monostearate), also known as polysorbates, is used in some food preparation or cosmetics to solubilize essential oils.
They are oily liquids that come from a derivative of sorbitol with fatty acids.
Polysorbate 60 is a nonionic surfactant based on natural raw material.
Polysorbate 60 is an ethoxylated sorbitan monostearate derivative called INCI Polysorbate 60.
Polysorbate 60 can be in liquid form or semi-liquid yellow to brown paste.
Solidification in the temperature range 25-31°C.
Polysorbate 60 dissolves well in water, ethanol, benzene and its homologues.
Polysorbate 60 has the ability to create an O/W emulsion (oil in water).
Polysorbate 60 or Tween 60, the full name polyoxyethylene (20) sorbitan monostearate, is an ingredient made from sorbitol, stearic acid (C18) and ethylene oxide.
Polysorbate 60 is primarily used as an emulsifier in food (the European food additive number E435) and a solubilizer & surfactant in cosmetics.
Polysorbate 60 is emulsifier for pharmaceuticals and cosmetics, Stabilizer for color materials, Stabilizer for emulsion polymerizations, Emulsifier for adjuvant of agrochemicals, Emulsifier for water based metal process cutting oils, Surface coating type antistatic agents.
Polysorbate 60 is an oil-in-water emulsifier. Polysorbate 60 also acts as a spreading aid for bath oils, adds water-dispersibility to anhydrous systems and is a solubilizer for oils and fragrances.
Polysorbate 60 is used as a emulsifier for cosmetics and pharmaceuticals, dispersant for insecticides, herbicides, cattle dyes, penetrant, levelling agent, lubricant, antistat.
Polysorbate 60 is a common little helper ingredient that helps water and oil to mix together, aka emulsifier.
Polysorbate 60 is a synthetic ingredient that is used in cosmetics and skincare to improve the texture and sensory feel of formulations. It is used in products as a surfactant, emulsifier, and solubilizer.
Polysorbate 60 is produced by the ethoxylation of sorbitan. Sorbitan is the dehydrated form of sorbitol, a sugar alcohol that can naturally be found in some fruits. Ethoxylation is a chemical reaction in which ethylene oxide is added to a substrate, in this case, sorbitan. Sorbitan is reacted with 60 units of ethylene oxide, hence the 60 in the ingredient name. The final step is the reaction with fatty acids obtained from vegetable fats and oils, such as lauric acid, palmitic acid, stearic acid, or oleic acid. In addition to its function in cosmetics, polysorbate 60 can be used to prepare a wide variety of products in the food and pharmaceutical industries.
Polysorbate 60 is used to improve the texture and feel of products.
Solubilizer
Polysorbate 60 is a solubilizer that helps other ingredients to dissolve in a solvent in which they would not normally dissolve.
Specifically, polysorbate 60 helps to disperse oil in water as opposed to water in oil. Polysorbate 60 is an excellent solubilizer for essential oils.
Polysorbate 60 is an orangish colored oily viscous liquid at room temperature. It will be a semisolid at lower temperatures.
Polysorbate has an HLB (hydrophilic/lipophilic balance) of 14.9. It is slightly more lipophilic than polysorbate 20 and 40 due to the longer length of stearic acid.
Polysorbate 60 is soluble in water due to its high HLB ratio and not soluble in oils. Polysorbate 60 easily blends into water.
Polysorbate 60 is commonly used in flavors and other food products as well as cosmetics and personal care items.
Polysorbate 60 is an excellent choice to blend fat-based flavor components into a water-based emulsion type flavor.
Due to its very high HLB ratio, Polysorbate 60 helps water and oil-based ingredients blend and to prevent their separation.
Polysorbate 60 can also be used with low HLB ratio emulsifiers to assist with both oil in water and water in oil emulsions.
Applications that require foaming, aeration, and blending of oils into water-based products are where polysorbate 60 excels.
Polysorbate 60 works great in cake batters to assist in aeration and also breads to create a silky smooth crumb.
Polysorbate 60 is also commonly used in cake or buttercream type icings to assist with aeration and to help prevent water separation.
Chemical Properties
Polysorbate 60 has a faint, characteristic odor and a warm, somewhat bitter taste. It is a mixture of stearate and palmitate partial esters of sorbitol and sorbitol anhydrides condensed with approximately 20 mole of ethylene oxide (C2H4O) for each mole of sorbitol and its mono- and dianhydrides.
Uses
Tween 60 is an emulsifier manufactured by reacting stearic acid with sorbitol to yield a product which is reacted with ethylene oxide. It is a nonionic, waterdispersible surface-active agent which is very hydrophilic. It is also termed polysorbate 60. It is used in whipped vegetable toppings for overrun and lightness; in cakes for increased volume and fine grain; in icings and confectionery for lightness and syneresis control; and in salad dressing for emulsion stability. It is frequently used with sorbitan monostearate or monoand diglycerides. The typical usage range is 0.10–0.40%.
Uses
Lonzest SMS-20 is used as an emulsifier for plastic & polymers, personal care and industrial applications.
Uses
Glycosperse S-20 KFG is used as an emulsifier. Suggested applications: cakes, shortenings, milk substitute, chocolate flavored syrup. Product Data Sheet
Uses
azalide antibiotic
Definition
ChEBI: A polymer composed of PEG-ylated sorbitan, where the total number of poly(ethylene glycol) units is 20 (w + x + y + z = 20) and a single terminal is capped by a stearate group.
brand name
Tween 60 (ICI Americas).
Safety Profile
Moderately toxic by intravenous route. Experimental reproductive effects. Questionable carcinogen with experimental tumorigenic data. When heated to decomposition it emits acrid smoke and irritating fumes.
Tween 60 Preparation Products And Raw materials
Raw materials
Epoxy Nitrogen ETHYLENE OXIDE Span 60 Hydrogen peroxide Stearic acid Sodium ethoxide Sorbitol
Preparation Products
Spining lubricant agent
Polysorbate 60 is hydrophilic secondary surfactant for O/W emusification, dispersion and solubilization of lipophilic substances.
CAS No. 9005-67-8
Polysorbate 60 is used as a high HLB emulsifier in combination with low HLB emulsifiers to create stable oil-in-water emulsions. Suggested pairings are with cetyl or stearyl alcohols, or sorbitan stearate.
INCI: Polysorbate 60
Polysorbate 60 is an emulsifier. Emulsifiers enable water and oil to stay mixed together.
What does Polysorbate 60 do for the hair?
Polysorbate 60 keeps oil and water together in the hair allowing the hair to stay moisturized for longer periods of time; thus, helping to retain length.
Polysorbate 60 adds releif to dehydrated hair. Effects increase when combined with Cetyl alcohol
FDA approved Maximum usage levels in Foods
Whipped toppings 0.4% – assists in aeration
Yeast leavened bakery products 0.5% – improves texture
Ice cream 0.1% – improves aeration and texture
Dressings 0.3% – keeps fats from separating
Cakes, icings, and fillings 0.46% – assists in aeration
Sugar confection coatings 0.2% – improves texture
Polysorbate 60 is an additive used in processed food products for its emulsifying properties (ability to keep fats from separating out).
Commercially produced frozen desserts, baked goods, and imitation dairy products are just some of the foods that may contain polysorbate 60.
Additionally, it used as an additive in some cosmetic and personal care products.
If it is included in a product, it should be noted on the list of ingredients found on the label.
Polysorbate 60 may compromise proper gastrointestinal function. Research studies have shown that it can increase intestinal membrane permeability (how much the intestinal membrane allows to pass through into the bloodstream). This may be caused by a variety of mechanisms including polysorbate 60\’s potential ability to release enzymes that damage the structure of intestinal cells.
Sources
Commercially produced frozen desserts, baked goods, and imitation dairy products are just some of the foods that may contain polysorbate 60.
Additionally, it used as an additive in some cosmetic and personal care products.
If it is included in a product, it should be noted on the list of ingredients found on the label.
Physical Effects
Polysorbate 60 may compromise proper gastrointestinal function. Research studies have shown that it can increase intestinal membrane permeability.
This may be caused by a variety of mechanisms including its potential ability to release enzymes that damage the structure of intestinal cells.
What is Polysorbate 60 (E435) in Food ?
Polysorbate 60 or Tween 60, the full name polyoxyethylene (20) sorbitan monostearate, is an ingredient made from sorbitol, stearic acid (C18) and ethylene oxide.
Polysorbate 60 is primarily used as an emulsifier in food (the European food additive number E435) and a solubilizer & surfactant in cosmetics.
Like other polysorbates, the number 60 after polysorbate means the type of fatty acid, here is monostearate; the number 20 following polyoxyethylene indicates the total number of oxyethylene groups in the molecule structure.
How is it made?
According to the FDA, polysorbate 60 is manufactured by reacting stearic acid with sorbitol to obtain sorbitan monostearate first and then condensed with ethylene oxide. (1)
What is it made of?
As the commercial food grade stearic acid usually contains palmitic acid, so polysorbate 60 is a mixture of ethoxylated ethers of stearic and palmitic acid esters of sorbitol and its mono- and dianhydrides and other related compounds.
Polysorbate 60 is the common name for polyoxyethylene sorbitan monostearate, it is a hydrophilic (water-loving) surfactant.
Polysorbate 60 is made by reacting stearic acid with sorbitol and then ethylene oxide.
Polysorbate 60 is a common food grade emulsifier used as a solubilizer and surfactant.
Use: Hydrophilic emulsifier; solubilizer; dispersant; water soluble; plant-derived
Polysorbate 60 is a highly hydrophilic surfactant and approved as a food additives. Polysorbate 60 is a usuful emulsifier, dispersant and solubilizer for aroma chemicals and oils.
Tween 60
Polyoxyethylene (20) sorbitan monostearate (IUPAC)
E 435
Molecular formula: C 64 H 126 O 26
Brief description: dark yellow, viscous liquid
Tween 60 is oil/water type emulsifier. It is soluble in 40℃ water, organic solvents, and insoluble in oil. HLB value: 14.9.
Tween 60 is used as emulsifier in food, medicine, plastic and cosmetics. Tween 60 is also used as softener for fiber processing.
Properties
The derivative of sorbitol as a complex compound with fatty acids (mainly stearic acid 50) and ethylene oxide is produced in a multi-stage process from usually vegetable fats.
Polysorbate 60 has an HLB value of 14.9 and is therefore suitable for the production of oil-in-water emulsions.
The emulsifying effect is strong and independent of acidity and temperature.
Usage
Polysorbate 60 is approved in the EU as a food additive with the number E 435 for certain foods in quantities of up to five, in shortening also up to ten grams per kilogram and in food supplements without maximum quantity restrictions ( quantum satis ).
The permitted daily dose is 10 milligrams per kilogram of body weight for all polysorbates combined.
It acts as an emulsifier, foaming agent and complexing agent.
Why Is Polysorbate Used In Skincare?
In cosmetics and skincare products, polysorbate 60 functions as a surfactant, emulsifier, and solubilizer.
Surfactant
As a surfactant, polysorbate 60 works by lowering the surface tension between two substances, such as two liquids or a liquid and a solid. A surfactant molecule contains one end that is hydrophilic or attracted to water and one end that is lipophilic or attracted to oil. This allows surfactants to attract and suspends oils, dirt, and other impurities that have accumulated on the skin and wash them away. Due to these properties, polysorbate 60 can be found in many different cleansers, shampoos, and body washes.
Emulsifier
As an emulsifier, polysorbate 60 is often used in formulations that contain both water and oil components. Mixing water and oil-based ingredients can be difficult as they will often separate and split. To address this problem, an emulsifier like polysorbate 60 can be added to improve the consistency of a product, which enables an even distribution of topical skincare benefits.
Solubilizer
A solubilizer helps other ingredients to dissolve in a solvent in which they would not normally dissolve. Specifically, polysorbate 60 helps to disperse oil in water as opposed to water in oil. Polysorbate 60 is an excellent solubilizer for essential oils.
Is Polysorbate 60 Safe?
The United States Food and Drug Administration (FDA) allows polysorbate 60 to be directly added to food as a flavoring agent or as a multipurpose additive. The safety of polysorbate 60 has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel, a group responsible for evaluating the safety of skincare and cosmetic ingredients. The Expert Panel evaluated the scientific data and concluded that polysorbate 60 was safe as used in cosmetics and personal care products.
Despite the approval of polysorbate 60 by the CIR Expert Panel, there are concerns about the presence of ethylene oxide in this ingredient. This is because the process of ethoxylation may lead to contamination with 1,4-dioxane, a potentially dangerous by-product. 1,4-dioxane is a known animal carcinogen that penetrates readily into the skin. According to the National Toxicology Program, ‘1,4-dioxane is reasonably anticipated to be a human carcinogen.’ It has also been linked with skin allergies. However, the potential presence of 1,4-dioxane can be controlled through purification steps to remove it before blending polysorbate 60 into cosmetic formulations.
Polysorbates are metabolized like fatty acids in the human organism and are biodegraded in nature like natural fat.
See also
Other representatives from the group of polysorbates include:
Polysorbate 20
Polysorbate 40
Polysorbate 65
Polysorbate 80
What Is It?
Polysorbate 20 and the other Polysorbate ingredients (Polysorbate 21, Polysorbate 40, Polysorbate 60, Polysorbate 61, Polysorbate 65, Polysorbate 65, Polysorbate 80, Polysorbate 81, Polysorbate 85) are a series of general purpose hydrophilic, nonionic surfactants. The Polysorbates are used in a variety of products including skin fresheners, skin care products, skin cleansing products, makeup bases and foundations, shampoos, permanent waves and fragrance powders.
Why is it used in cosmetics and personal care products?
The Polysorbate ingredients help other ingredients to dissolve in a solvent in which they would not normally dissolve. They also help to form emulsions by reducing the surface tension of the substances to be emulsified.
Scientific Facts:
Polysorbates are surfactants that are produced by reacting the polyol, sorbitol, with ethylene oxide. The number in the name of the Polysorbate indicates the average number of moles of ethylene oxide that has been reacted per mole of sorbitol. The polyoxyethylenated sorbitan is then reacted with fatty acids obtained from vegetable fats and oils such as lauric acid, palmitic acid, stearic acid and oleic acid. Polysorbates function to disperse oil in water as opposed to water in oil
Hydrophile-Lipophile Balance (HLB)
14.9, gives oil-in-water emulsions, O/W.
It is more lipophilic than polysorbate 20 and 40 due to the long length of the fatty acids – stearic acid, compared with other fatty acids, lauric acid (C14) and palmitic acid (C16) that linked to the polyoxyethylene sorbitan part of the molecule, respectively.
Solubility
Soluble in water, insoluble in mineral oil and vegetable oils.
Soluble in ethyl acetate and toluene.
What’re the Uses of Polysorbate 60?
Polysorbate 60 is a synthetic multi-ingredient that can be used as a surfactant, emulsifier, solubilizer, stabilizer in food, cosmetics and personal care products.
Food
Polysorbate 60 helps water-based and oil-based ingredients blend easily and prevent their separation in food. Polysorbate 60 and 80 are mostly used in food among the category of polysorbates, but the latter is used more than 60 in food.
As a high HLB emulsifier, its food grade can be blended with a low HLB emulsifier (e.g. sorbitan stearate, mono and diglycerides) to provide a suitable HLB value for the various food uses, either oil in water, or water in oil emulsion.
Cosmetics
Its general purpose in cosmetics is to mix water and oil together. Polysorbate 60 functions as a surfactant, emulsifier, solubilizer and dispersing agent.
Some of its applications as follows:
Help wash away body dirties by lowering the surface tension on the skin when used in shampoos and body washes.
Distribute essential oils, fragrances and colorants evenly in water.
Following cosmetic products may with it:
Lotions
Creams
Hair products
Skin care products
Makeup products
Is Polysorbate 60 Safe to Eat?
Yes, it has been approved as a safe ingredient by the U.S. Food and Drug Administration (FDA) and European Food Safety Authority (EFSA), as well as the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
FDA
Polysorbate 60 may be safely used in food with multifunctions, such as an emulsifier, foaming agent, dough conditioner, dispersing agent, and surfactant & wetting agent.
The following food may contain it and the maximum usage (3):
Whipped edible oil topping 0.4%
Shortenings and edible oils 1%
Ice cream 0.1%
Dressings 0.3%
Cakes and cake mixes, icings and fillings 0.46%
Sugar confection coatings 0.2%
Vegetable fat-water emulsions 0.4%
Yeast-leavened bakery products 0.5%
EFSA
Polyoxyethylene (20) sorbitan monostearate (E435) is listed in Commission Regulation (EU) No 231/2012 as an authorised food additive and categorized in “Additives other than colours and sweeteners” (4).
Safety re-evaluation in 2018
Its safety was re-evaluated in 2018, together with other polysorbates (20, 40, 65, 80). (5)
UK Food Standards Agency
Categorized in “Emulsifiers, stabilisers, thickeners and gelling agents” (6)
Food Standards Australia New Zealand
It is approved ingredient in Australia and New Zealand with the code number 435. (7)
JECFA
Function Class: food additives, emulsifier. (8)
Acceptable daily intake: ADI “0-25mg/kg bw” set in 1973. (9)
What are the possible Side Effects of Polysorbate 60?
When we talk about the side effects of polysorbates, mostly focus on two carcinogens, one is ethylene oxide (Group 1), the raw material for the production; another one is 1,4-dioxane (Group 2B), a by-product of polysorbate ethoxylation.
However, the safety of these two substances in polysorbates have been approved due to the very few assay.
See also:
Details of the safety of two carcinogens
Frequently asked questions
What is the difference with polysorbate 65?
Polysorbate 65, the full name polyoxyethylene (20) sorbitan tristearate. There are three stearic acids in its molecule structure while polysorbate 60 only has one.
Is it Natural?
It is not natural as it is made from chemical synthesis between sorbitan fatty acid with ethylene oxide.
Is it Halal?
Yes, polysorbate 60 would be halal if the fatty acid stearic acid is sourced from vegetable oils.
Is it Vegan?
Yes, it is vegan if the fatty acid stearic acid derived from vegetable oils which are suitable for vegetarians. Stearic acid used to synthesize polysorbate 60 may also come from animal sources.
ynonyms:
emasol S-120V
glycosperse S-20
glycosperse S-20 KFG
hetsorb S-20
kaopan TW-S-120
liposorb S-20
lonzest SMS-20
monebat – 60
nikkol TS-10MV
norfox sorbo T-60
poe-20 sorbitan monostearate
polyethyleneglycol sorbitan monostearate
polyoxyethylene (20) sorbitan monostearate
polysorbate 60 FCC
polysorbate 60 USP/NF
rheodol TW-S120V
tween 60
Polysorbate 60
Chemical Description
Polysorbate 60
Product Description
Super Refined Polysorbates solubilise and stabilise the most sensitive active ingredients across dosage forms including injectable and oral.
Super Refining removes impurities (including primary and secondary oxidation products) from an excipient without altering its chemical composition, helping to reduce API interaction and degradation.
The benefits of Super Refined Polysorbates over standard pharmaceutical polysorbates include: Better API stability and finished formulation integrity.
Reduced potential for cellular irritation Improved taste profile when used in oral liquid dosage forms.
Pharmacopoeia Compliance
FDA-IID Listed
JP
PhEur
USP/NF
Polysorbates are an emulsifier and food additive that comes from a reaction of sorbitan fatty acid with ethylene oxide. The name includes a range of polysorbates, such as 20, 60, 65 and 80. However, Polysorbates 60 and 80 are the most commonly used in food production. They are used in baked goods and frozen desserts to help with:
Extended shelf life
Improved crumb color and strength
Increased volume1
How do Polysorbates Work?
Polysorbates are very surface active, with a HLB value ranging from 14 to 16. They cause similar reactions as monoglycerides and diglycerides, but smaller quantities are used to produce the same results. Polysorbates are created by reacting stearic acid, sorbitol and ethylene oxide. They create a nonionic surfactant, with hydrophilic and hydrophobic ends. So it allows water and oil to mix, and gives oil-in-water emulsions. It can be combined with other HLB emulsifiers to create stable products, and works best with fatty alcohols.
Types of Polysorbates
The most common types of polysorbates are 20, 40, 60, 65, and 80, with the number representing the fatty acid associated with the polyoxyethylene sorbitan component of the molecule. The fatty acids are lauric (C14), palmitic (C16), stearic (C18:0), and oleic (C18:1). The lower numbers are more hydrophilic, while higher ones have higher lipophilic properties.
Application
Polysorbates are sold as a waxy, yellow paste that mixes easily. They are found in shortening, margarine, peanut butter, dry mixes, ice cream, dairy products, and baked goods.
Polysorbate 60 can be an effective dough conditioning agent at a level as low as 0.2 percent based on flour weight.2 Even better results can be reached if mono and diglycerides are used along with Polysorbate 60.
To be soluble in water, it must be at 25 oC or 77oF.2
FDA Regulations
Polysorbates 60, 80, and 85 are allowed as a direct food additive in the United States, under clearly restricted levels and applications.
While they are used around the world, some countries in the Middle East and Japan have not approved polysorbates.
As a food additive, Polysorbates 60 and 80 must have an acid number between 0 to 2.
There are different regulations on the amounts to be used as an emulsifier and coating agent or combined with other emulsifiers for polysorbate 60 and limitations on polysorbate 80 as a solubilizing, dispersing, and emulsifying agent, so be sure to check the full FDA stipulations.
Kolliphor PS 60
Kolliphor PS 60 is used as an emulsifier or co-emulsifier in topical pharmaceutical applications like creams and lotions and as non-ionic solubilizer in solid, semi-solid and liquid dosage forms or as foam stabilizer
Polysorbates are a class of emulsifiers used in some pharmaceuticals and food preparation.
They are non-ionic surfactants and emulsifiers derived from polyethoxylated sorbitan and stearic or oleic acid.
Polysorbates are mainly used as a solubilizer, emulsifier or suspension stabilizer for pharmaceutical application.
The choice of emulsifiers for specific applications depends on the desired properties of the formulation (i.e. stability, viscosity, skin feel and API), or on the desired processing technology (i.e. PIT, hot or cold processing).
Why choose Kolliphor PS 60?
Suitable for cold processing of semi-solid dosage forms
Suitable for solid, semi solid and liquid dosage forms
Good skin tolerance and broad pH range
Fully approved – quality you can trust
Processing at room temperature to save time and energy
Besides the well known emulsifying process with two hot phases there is also the possibility to formulate an emulsion with a processing temperature at room temperature.
The processing of O/W emulsions at room temperature has several significant benefits.
For example, it is no longer necessary to heat the water and oil phase to 70-80 °C.
This saves considerable amounts of energy and reduces the production time as the cooling step is eliminated.
Another very important advantage is that head-sensitive APIs can be added to the emulsion at any point.
Kolliphor PS 60 is very suitable for this kind of application.
Application fields of Kolliphor PS 60
O/W emulsifier
Oral solid dosage forms
Semi-solid dosage forms
Cold processing of semi-solid dosage forms
Liquid dosage forms
Foam stabilizer
Product Details
Previous name: Polysorbate 60 PH
CAS-No.:9005-67-8
Regulatory Status:Ph. Eur, USP/NF, JPE: Polysorbate 60
General characterization: Kolliphor PS 60 is a yellowish-brown gelatinous mass which becomes a clear liquid at temperatures above 25 °C.
Skin Tolerance: Kolliphor PS types have a good skin tolerance.
Raw material origin: All Kolliphor PS grades are based on vegetable and synthetic raw materials.
Polysorbate 60.
The food additive polysorbate 60 (polyoxyethylene (20) sorbitan monostearate) which is a mixture of polyoxyethylene ethers of mixed partial stearic and palmitic acid esters of sorbitol anhydrides and related compounds, may be safely used in food in accordance with the following prescribed conditions:
(a) The food additive is manufactured by reacting stearic acid (usually containing associated fatty acids, chiefly palmitic) with sorbitol to yield a product with a maximum acid number of 10 and a maximum water content of 0.2 percent, which is then reacted with ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 45-55.
Acid number 0-2.
Hydroxyl number 81-96.
Oxyethylene content 65 percent-69.5 percent.
(c) It is used or intended for use as follows:
(1) As an emulsifier in whipped edible oil topping with or without one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 65;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not exceed 0.4 percent of the weight of the finished whipped edible oil topping; except that a combination of the additive with sorbitan monostearate may be used in excess of 0.4 percent, provided that the amount of the additive does not exceed 0.77 percent and the amount of sorbitan monostearate does not exceed 0.27 percent of the weight of the finished whipped edible oil topping.
(2) As an emulsifier in cakes and cake mixes, with or without one or a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
When used alone, the maximum amount of polysorbate 60 shall not exceed 0.46 percent of the cake or cake mix, on a dry-weight basis. When used with polysorbate 65 and/or sorbitan monostearate, it shall not exceed 0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or the sorbitan monostearate exceed 0.61 percent, and no combination of these emulsifiers shall exceed 0.66 percent of the cake or cake mix, all calculated on a dry-weight basis.
(3) As an emulsifier, alone or in combination with sorbitan monostearate, in nonstandardized confectionery coatings and standardized cacao products specified in §§ 163.123, 163.130, 163.135, 163.140, 163.145, and 163.150 of this chapter, as follows:
(i) It is used alone in an amount not to exceed 0.5 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.
(ii) It is used with sorbitan monostearate in any combination of up to 0.5 percent of polysorbate 60 and up to 1 percent of sorbitan monostearate: Provided, That the total combination does not exceed 1 percent of the weight of the finished nonstandardized confectionery coating or standardized cacao product.
(4) [Reserved]
(5) As an emulsifier in cake icings and cake fillings, with or without one or a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
When used alone, the maximum amount of polysorbate 60 shall not exceed 0.46 percent of the weight of the cake icings and cake fillings. When used with polysorbate 65 and/or sorbitan monostearate, it shall not exceed 0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or the sorbitan monostearate exceed 0.7 percent, and no combination of these emulsifiers shall exceed 1 percent of the weight of the cake icing or cake filling.
(6) To impart greater opacity to sugar-type confection coatings whereby the maximum amount of the additive does not exceed 0.2 percent of the weight of the finished sugar coating.
(7) As an emulsifier in nonstandardized dressings whereby the maximum amount of the additive does not exceed 0.3 percent of the weight of the finished dressings.
(8) As an emulsifier, alone or in combination with polysorbate 80, in shortenings and edible oils intended for use in foods as follows, when standards of identity established under section 401 of the act do not preclude such use:
(i) It is used alone in an amount not to exceed 1 percent of the weight of the finished shortening or oil.
(ii) It is used with polysorbate 80 in any combination providing no more than 1 percent of polysorbate 60 and no more than 1 percent of polysorbate 80, provided that the total combination does not exceed 1 percent of the finished shortening or oil.
(iii) The 1-percent limitation specified in paragraph (c)(8) (i) and (ii) of this section may be exceeded in premix concentrates of shortening or edible oil if the labeling complies with the requirements of paragraph (d) of this section.
(9) As an emulsifier in solid-state, edible vegetable fat-water emulsions intended for use as substitutes for milk or cream in beverage coffee, with or without one or a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
The maximum amount of the additive or additives shall not exceed 0.4 percent by weight of the finished edible vegetable fat-water emulsion.
(10) As a foaming agent in nonalcoholic mixes, to be added to alcoholic beverages in the preparation of mixed alcoholic drinks, at a level not to exceed 4.5 percent by weight of the nonalcoholic mix.
(11) As a dough conditioner in yeast-leavened bakery products in an amount not to exceed 0.5 percent by weight of the flour used.
(12) As an emulsifier, alone or in combination with sorbitan monostearate, in the minimum quantity required to accomplish the intended effect, in formulations of white mineral oil conforming with § 172.878 and/or petroleum wax conforming with § 172.886 for use as protective coatings on raw fruits and vegetables.
(13) As a dispersing agent in artificially sweetened gelatin desserts and in artificially sweetened gelatin dessert mixes, whereby the amount of the additive does not exceed 0.5 percent on a dry-weight basis.
(14) As an emulsifier in chocolate flavored syrups, whereby the maximum amount of the additive does not exceed 0.05 percent in the finished product.
(15) As a surfactant and wetting agent for natural and artificial colors in food as follows:
(i) In powdered soft drink mixes in an amount not to exceed 4.5 percent by weight of the mix.
(ii) In sugar-based gelatin dessert mixes in an amount not to exceed 0.5 percent by weight of the mix.
(iii) In artificially sweetened gelatin dessert mixes in an amount not to exceed 3.6 percent by weight of the mix.
(iv) In sugar-based pudding mixes in an amount not to exceed 0.5 percent by weight of the mix.
(v) In artificially sweetened pudding mixes in an amount not to exceed 0.5 percent by weight of the mix.
(16) As an emulsifier in ice cream, frozen custard, fruit sherbet, and nonstandardized frozen desserts when used alone or in combination with polysorbate 65 and/or polysorbate 80, whereby the maximum amount of the additives, alone or in combination, does not exceed 0.1 percent of the finished frozen dessert.
(d) To assure safe use of the additive, in addition to the other information required by the Act:
(1) The label of the additive and any intermediate premixes shall bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide a final product that complies with the limitations prescribed in paragraph (c) of this section.
The MONTANOX range is composed of different grades of polysorbates that can be used to solubilize active pharmaceutical and/or biological ingredients and to formulate oil-in-water emulsions for oral, topical and injectable products.
The triple action of polysorbates
MONTANOX products are polyethoxylated sorbitan esters.
These hydrophilic surfactants play a triple role: They are used as emulsifiers to formulate oil in water emulsions but also as solubilizers for active ingredients with low solubility and also as antiaggregants for biological active ingredients.
MONTANOX products are stable in acidic or basic media and in the presence of electrolytes and are compatible with other surfactants.
They can be combined with MONTANE to produce highly stable emulsions.
A suitable grade for every application
The MONTANOX range is composed of monoesters of lauric, stearate or oleic fatty acids.
They each have a degree of ethoxylation of 20 and are characterized by their HLB (Hydrophilic-Lipophilic Balance).
There are two pharmaceutical grades: PPI and PHA PREMIUM.
The PPI grade is designed for injectable administration and products are manufactured according to the Good Manufacturing Practices “GMP part II” and comply with the EP, USP and JP or JPE pharmacopoeia.
The PHA PREMIUM grade is designed for oral and topical administration and products are manufactured according to IPEC’s GMPs and comply with the EP and USP pharmacopoeia.
Nom Commercial Nom Chimique HLB EO Voie d’Administration
MONTANOX20 PPI Polysorbate 20 17 20 Injectable/Orale/Topique
MONTANOX80 PPI Polysorbate 80 15 20 Injectable/Orale/Topique
MONTANOX80 API* Polysorbate 80 15 20 Injectable/Orale/Topique
MONTANOX80 LPI** Polysorbate 80 15 20 Injectable/Orale/Topique
MONTANOX20 PHA PREMIUM Polysorbate 20 17 20 Orale/Topique
MONTANOX60 PHA PREMIUM Polysorbate 60 15 20 Orale/Topique
MONTANOX80 PHA PREMIUM Polysorbate 80 15 20 Orale/Topique
*API: very low water quantity
** LPI: grade with low pH
Tween 60 is an oil-in-water co-emulsifier for use in skin care, hair care and decorative cosmetics.
It has an HLB value of 14.9, and it is useful as an oil-in-water emulsifier.
This grade produces stable emulsions, especially when used with cetyl or stearyl alcohols.
Tween 60 is used in creams, gels and cleansing products.
The Tween Series of surfactants are polyoxyethylene derivatives of the Span Series products.
Tween surfactants are hydrophilic, generally soluble or dispersible in water, and soluble in varying degrees inorganic liquids.
They are widely used in personal care applications.
Polysorbates are a group of emulsifiers used in food preparation and pharmaceuticals.
In cosmetics, polysorbates are used to solubilize essential oils into products with a water base.
Derived from sorbitan and esterified with fatty acids, polysorbates are oily liquids.
The number 60 following polysorbate refers to the fatty acid chemically associated with the polyoxyethylene sorbitan component of the molecule, in this case monostearate.
Functions
Dispersing Agents
Emulsifiers
Surfactants / Detergents
Regional Availability
Asia
Europe
Latin America
N America
Applications
Bath, Shower & Soaps
After Sun
Eye Contour Care
Face / Neck Skin Care
Facial Cleansers
Hair Conditioners – Rinse off
Shaving / Hair Removal
Styling
Sun Protection
Tanning
APPEARANCE
Pale yellow waxy paste
DESCRIPTION
It removes polar impurities, preventing adverse interactions with APIs and enhancing the stability of pharmaceutical formulations. Offer the complete solution when formulating parenteral, oral, ophthalmic and topical pharmaceutical products.
FUNCTION
It is used in whipped vegetable toppings for overrun nd lightness; in cakes for increased volume and fine grain; in icings and confectionary for lightness and syneresis control; and in salad dressing for emulsion stability.
SYNONYMS
Polysorbate 60 NF FCC Kosher; Unisperse 60; Lumisorb PSMS-20 K; Polyoxyethylene 20 Sorbitan Monostearate; Glycosperse S-20 FG K
STORAGE
Store in a dry, cool, clean area in unopened containers.