Polysorbate 80 (USP/NF) – Pharmaceautical Grade

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Technical Specifications

  • Chemical Name: Polysorbate 80 (Polyoxyethylene (20) sorbitan monooleate)
  • CAS Number: 9005-65-6
  • Molecular Formula: C64H124O26
  • Molecular Weight: ~1310 g/mol
  • Appearance: Amber to yellow viscous liquid
  • Grade: Pharmaceutical Grade (USP/NF compliant)
  • Solubility: Soluble in water, ethanol, methanol, and ethyl acetate; insoluble in mineral oil and vegetable oils.
  • Density: ~1.06 g/cm³ at 25°C
  • Viscosity: 300-500 cP at 25°C
  • Hydrophilic-Lipophilic Balance (HLB): ~15
  • pH: 5.0-7.0 (10% aqueous solution at 25°C)
  • Peroxide Value: ≤10.0 meq/kg
  • Saponification Value: 45-55 mg KOH/g
  • Acid Value: ≤2.0 mg KOH/g
  • Hydroxyl Value: 65-80 mg KOH/g
  • Residue on Ignition: ≤0.25%
  • Storage Conditions: Store in a tightly sealed container, protected from light, at a temperature of 15-30°C.
  • Shelf Life: Typically 24 months when stored properly.
  • Applications:
    • Emulsifying agent for pharmaceuticals, cosmetics, and food products.
    • Stabilizer in drug formulations and injectable solutions.
    • Solubilizer for vitamins and essential oils.
    • Surfactant for cream and lotion formulations.
    • Excipient in vaccine production.
  • Regulatory Compliance:
    • Conforms to USP/NF standards.
    • Approved for use in pharmaceuticals and food by major regulatory agencies (FDA, EMA).
  • GHS Hazard Classification:
    • Hazard Statements: Generally recognized as safe; not classified as hazardous under GHS.
    • Precautionary Statements: Avoid prolonged contact with skin and eyes; use in well-ventilated areas.

Documents:

Safety Data Sheet

Description

Polysorbate 80 is a nonionic surfactant and emulsifier commonly used in medications, foods, and cosmetics. This synthetic chemical produces a thick, water-soluble yellow liquid.

Polysorbate 80 is used as a food emulsifier, but research suggests it may “profoundly impact intestinal microbiota in a manner that promotes gut inflammation and associated disease states. It can also be used as a surfactant in soaps and cosmetics (including eyedrops) or as a solubilizer in mouthwash. The cosmetic grade of polysorbate 80 may have more contaminants than the food grade. It is also used as a surfactant and solubilizer in a wide range of oral and topical medicinal preparations.

Applications for Polysorbate 80 (USP/NF):

Pharmaceutical Applications:

  • Injectable Solutions:
    • Used as a solubilizer and stabilizer in drug formulations.
    • Enhances the delivery of hydrophobic active ingredients.
    • Commonly found in vaccines and biologics.
  • Topical Formulations:
    • Emulsifies and stabilizes creams, ointments, and gels.
    • Improves the consistency and spreadability of topical medications.
  • Oral Solutions & Suspensions:
    • Acts as an emulsifying agent in syrups and elixirs.
    • Ensures uniform distribution of active ingredients.
  • Tablets & Capsules:
    • Aids in the solubilization of poorly water-soluble drugs.

Cosmetic Applications:

  • Lotions and Creams:
    • Provides smooth, stable emulsions for moisturizers and anti-aging products.
    • Ensures consistency in oil-and-water-based formulations.
  • Hair Care Products:
    • Used in shampoos, conditioners, and styling products to mix water and oil phases.
  • Serums & Facial Sprays:
    • Enhances solubility and stability of active ingredients in lightweight products.
  • Bath Products:
    • Stabilizes and emulsifies bath oils and bubble baths.

Food Industry Applications:

  • Baked Goods:
    • Acts as a dough conditioner to improve texture and elasticity.
  • Ice Cream and Desserts:
    • Ensures smoothness and prevents the separation of fats and water.
  • Sauces and Dressings:
    • Stabilizes emulsions in salad dressings, mayonnaise, and gravies.
  • Beverages:
    • Keeps flavors and colors evenly dispersed in drinks.

Industrial Applications:

  • Paints and Coatings:
    • Ensures smooth dispersion of pigments and reduces surface tension.
  • Textile and Leather Processing:
    • Acts as a wetting and dispersing agent.
  • Cleaning Products:
    • Helps stabilize formulations in detergents and household cleaners.

 

Additional information

Size

500mL (16 Fl Oz), 1000ml (32 Fl Oz)