Description
Polyoxyethylene (20) sorbitan monooleate, a nonionic hydrophilic emulsifier with HLB approximately 15, produced by ethoxylation of sorbitan monooleate. Used across food, pharmaceutical, cosmetic, and biotechnology applications as a water-soluble surfactant and oil-in-water emulsifier.
Amber viscous liquid with characteristic mild odor. Soluble in water, ethanol, methanol, and most polar solvents; immiscible with mineral and vegetable oils.
We supply food-grade and pharmaceutical-grade Polysorbate 80 from manufacturers in China holding ISO, Halal, Kosher and other certifications relevant to the product and production.
Common market grades include food-grade Polysorbate 80, USP/EP/JP pharmaceutical grade for injectable and oral pharmaceutical formulations, and super-refined grades with reduced peroxide and aldehyde content for biologic and vaccine applications.
Bulk and reduced-MOQ shipments. Batch-level COA covering hydroxyl value, saponification value, acid value, peroxide value, water content, and microbiology.
Introduction
Polysorbates were developed by the U.S. company Atlas Powder Company (now Croda) in the 1940s, building on the sorbitan ester technology that preceded them. Polysorbate 80 is the most widely used member of the family in both food and pharmaceutical applications.
Production begins with sorbitol-pharmaceutical-grade" class="underline" style="color: var(--sage-deep); text-decoration-color: var(--sage-deep);">sorbitol dehydration to sorbitan, esterification with oleic acid to yield sorbitan monooleate, and finally ethoxylation with approximately 20 moles of ethylene oxide per mole of sorbitan ester. The result is a hydrophilic surfactant with HLB approximately 15.
Regulated as E433 in the EU with permitted-use levels in defined categories, classified as Generally Recognized as Safe by the U.S. FDA under 21 CFR 172.840, listed in USP, EP, and JP pharmacopoeias, and approved by JECFA with an Acceptable Daily Intake of 25 mg per kg body weight (covering the polysorbate family collectively).
The molecule's combination of strong emulsification, surfactant solubilization, and pharmaceutical-grade purity has made Polysorbate 80 a near-universal excipient in biologic and vaccine formulations alongside its established food role. The COVID-19 mRNA vaccine industry significantly raised pharmaceutical-grade demand from 2020 onward.
Where it is used
- Ice cream, frozen desserts, and dairy emulsions; promotes controlled fat destabilization, dryness, and shape retention in the finished product
- Whipped toppings, aerosol cream, and non-dairy creamers
- Bakery emulsifier blends and dough conditioners
- Sauces, dressings, and condiments; oil-in-water emulsifier and stabilizer
- Beverage cloud emulsions and flavor oil solubilization
- Pharmaceutical injectable formulations including biologics and vaccines; solubilization of poorly water-soluble actives
- Pharmaceutical oral suspensions, tablets, and softgel capsules
- Cosmetics, personal-care emulsions, and shampoo formulations
- Cell-culture media and biotechnology applications as a protective surfactant
Technical data
| Item | Specification |
|---|---|
| Appearance | Amber viscous liquid |
| Hydroxyl value | 65 to 80 mg KOH/g |
| Saponification value | 45 to 55 mg KOH/g |
| Acid value | ≤ 2.0 mg KOH/g |
| Peroxide value | ≤ 10.0 meq/kg |
| Water content | ≤ 3.0% |
| Ethylene oxide and dioxane | ≤ 1 mg/kg each |
| Heavy metals (as Pb) | ≤ 5 mg/kg |
| Arsenic | ≤ 2 mg/kg |
| Total plate count | ≤ 100 CFU/g (pharmaceutical grade) |
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