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CAS 9005-65-6 Non-Ionic Surfactant / Emulsifier Non-Ionic Surfactant / Emulsifier

Polysorbate 80 (for injection)

IUPAC: Polyoxyethylene (20) sorbitan monooleate View on PubChem
CAS NUMBER
9005-65-6
MOL. FORMULA
C64H124O26
MOL. WEIGHT
~1,310 g/mol
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Scientific Overview

Polysorbate 80's amphiphilic PEO-sorbitan-oleate structure lowers surface tension and prevents protein aggregation and adsorption to container surfaces, making it a critical stabilizing excipient in monoclonal antibody and vaccine formulations. It is present in numerous licensed injectable biologics and vaccines, including mRNA and viral-vector COVID-19 vaccines, where it aids antigen dispersion.

Polysorbate 80 is a non-ionic surfactant derived from ethoxylated sorbitan esterified with oleic acid, widely used as a solubilizer, emulsifier, and stabilizer in injectable drugs, vaccines, and biologic formulations.

Full Technical Data
Chemical Name Polysorbate 80 (Tween 80; Polyoxyethylene (20) Sorbitan Monooleate)
CAS Number 9005-65-6
IUPAC Name Polyoxyethylene (20) sorbitan monooleate
Molecular Formula C64H124O26
Molecular Weight ~1,310 g/mol g/mol
Density 1.10 g/mL at 25°C
Flash Point 113°C
Reaction Scheme
Sorbitol + Oleic Acid
Ethylene Oxide
NA
Polysorbate 80
NA
Commercial Applications

Biologics & Vaccine Stabilization

Prevents protein aggregation and surface adsorption in monoclonal antibody and vaccine formulations.

Parenteral Emulsifier

Stabilizes oil-in-water emulsions in IV lipid formulations and injectable drug delivery systems.

Oral & Topical Solubilizer

Enhances dissolution and bioavailability of poorly water-soluble APIs in oral liquids and topical products.

Nanoparticle Formulation

Used as a surface-stabilizing agent in polymeric and lipid nanoparticle drug delivery systems.

Market Therapeutic Focus
NON-IONIC SURFACTANT / EMULSIFIER PHARMACEUTICAL MANUFACTURING BIOLOGICS & VACCINE FORMULATION INJECTABLE DRUG DELIVERY SPECIALTY EXCIPIENTS CRO/CDMO
Scientific Literature

Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways

Authors: Kerwin, B.A.

J. Pharm. Sci.

DOI: 10.1002/jps.21190

Macromolecules in polysorbate 80 for injection: an important cause of anaphylactoid reactions

Authors: Li, Y. et al.

BMC Pharmacol. Toxicol.

DOI: 10.1186/s40360-022-00591-y

Safety of Polysorbate 80 in the Oncology Setting

Authors: Schwartzberg, L.S. et al.

Adv. Ther.

DOI: 10.1007/s12325-020-01498-8
Peer Queries & FAQs
Why is Polysorbate 80 used in vaccines?
It stabilizes protein and lipid nanoparticle antigens against aggregation and interfacial stress during manufacturing, storage, and administration.
Is injection-grade Polysorbate 80 different from standard grade?
Yes, injection grade undergoes tighter control of peroxide content and trace impurities to minimize oxidative degradation and hypersensitivity risk in parenteral use.
Can Polysorbate 80 cause allergic reactions?
Rare hypersensitivity/anaphylactoid reactions have been reported, generally linked to trace macromolecular impurities rather than the surfactant itself.
What is the recommended storage condition?
Store in a tightly sealed, light-protected container at room temperature; protect from oxidation, which generates peroxides and formaldehyde over time.

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