Description

Polysorbate 80 USP

Polysorbate 80 USP is a high-purity, nonionic surfactant and solubilizing agent widely used in pharmaceutical, biologic, and vaccine formulations to enhance the solubility, dispersion, and stability of poorly water-soluble compounds. With its broad regulatory acceptance, excellent safety profile, and emulsification efficiency, it is a core excipient in parenteral, oral, ophthalmic, and topical drug delivery systems. Polysorbate 80

• Is a USP-compliant nonionic surfactant derived from sorbitan monooleate and ethylene oxide
• Improves solubility, dispersion, and stabilization of lipophilic active pharmaceutical ingredients (APIs)
• Is suitable for injectable, oral, ophthalmic, and topical formulations
• Is commonly used in biologics, vaccines, emulsions, and protein stabilization systems

Chemically also known as Polyoxyethylene (20) sorbitan monooleate, Polysorbate 80 exhibits an optimal hydrophilic-lipophilic balance (HLB ~15) for stabilizing oil-in-water emulsions. Its amphiphilic structure allows it to reduce surface tension and form micelles that enhance the solubilization of hydrophobic drug substances, improving bioavailability and formulation performance.

In pharmaceutical applications, Polysorbate 80 USP is used as:

• A solubilizer and micelle-forming agent in intravenous and intramuscular drug formulations
• A stabilizer for protein-based biologics and monoclonal antibodies, minimizing aggregation and denaturation
• A dispersant and emulsifier in oral suspensions, emulsions, and softgel delivery systems
• A surfactant in ophthalmic, nasal, and topical formulations to enhance absorption and spreading

Polysorbate 80 is also an essential excipient in vaccine manufacturing, including use in influenza, COVID-19, and recombinant protein-based vaccines, where it aids in antigen dispersion and formulation stability.

Pharmaceutical manufacturers and formulation scientists seeking to purchase Polysorbate 80 USP benefit from CarboMer’s GMP processes, rigorous quality control, and complete regulatory support. Each batch is produced under strict specifications to ensure consistency in molecular weight distribution, oleic acid content, and residual impurities.

The material is provided in sealed, tamper-evident, moisture-controlled packaging to preserve quality during storage and transport. Available in a range of standard and bulk sizes, with minimum order quantities (MOQ), lead times, and regulatory documentation tailored to both early-stage development and commercial production needs.

Each lot undergoes full USP monograph testing for acid value, hydroxyl value, saponification value, peroxide content, residual ethylene oxide, heavy metals, and microbial purity. Certificates of Analysis (CoA) and safety data sheets are provided to facilitate regulatory submissions and quality assurance.

As with all CarboMer excipients, Polysorbate 80 USP is fully supported by our technical development team, regulatory experts, and lifecycle management services empowering partners to advance safe, effective, and compliant pharmaceutical products with confidence.