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Polysorbate 80 (Ii) BP EP USP Pharma Grade comes from the class of nonionic surfactants. It works by binding water and oil-based substances, which is essential in mixtures used for drugs and food. This chemical is based on a sorbitol backbone with polyoxyethylene chains and fatty acid ester groups, most notably from oleic acid. Its stability and chemical makeup mean it gets chosen again and again for pharmaceutical applications. When friends in the industry talk about ingredients that keep medicines and vaccines blended and consistent, this raw material often gets named because it handles the mixing of substances that would otherwise separate. Polysorbate 80’s regulatory alignment with BP, EP, and USP standards assures chemists and manufacturers that they work with a reliable component, suitable even for injectable and oral medicines.
Under the microscope, Polysorbate 80 stands out for its branched structure, consisting of a sorbitan core with polyoxyethylene chains that end in oleate groups. The molecular formula shows as C64H124O26, with a molecular weight nearly hitting 1310 g/mol. Its arrangement delivers both hydrophilic and lipophilic properties in a single molecule. That dual nature explains why laboratories trust this compound as an emulsifier. Every pharmacist knows how useful it is to work with something that balances water and oil without effort or risk of breakdown. The interaction between the carbon-rich fatty acid and the polyoxyethylene section means it shields sensitive ingredients and maintains clarity in final products.
Polysorbate 80 usually comes as a yellowish, oily liquid, although some forms may appear semi-solid at lower temperatures. Chemists describe its viscosity as moderate—thick enough to pour without feeling syrupy, yet fluid enough for pumping and mixing. It holds a relative density around 1.07 to 1.09 g/cm³ at 25°C, which means it neither floats nor sinks among the components often mixed alongside it. While powders, flakes, and beads exist for other surfactants, this one brings its benefits as a liquid, which limits dusting and allows precise dosing by volume. As someone who’s worked hands-on with both the liquid and crystal forms of additives, I find dosing the liquid straightforward—smooth, without fear of clumping. The solution formed by Polysorbate 80 disperses rapidly in water but keeps a stable surface without forming crystals or precipitate.
To meet pharmaceutical grade, Polysorbate 80 (Ii) must align not just with purity percentages (usually greater than 98%), but also with low acidity, absence of harmful heavy metals, and clarity upon dilution. These standards are set by regulatory chapters in the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). Regular quality tests cover saponification values, hydroxyl values, and peroxide numbers. Over the years, I’ve sat alongside QA teams as they scan batch certificates and test results, and a compound failing any part of the checklist gets rejected for critical uses. This level of vigilance reflects the trust placed in products destined for human use, especially those reaching hospitals and pediatric clinics.
On the logistics floor and customs desk, every shipment of Polysorbate 80 carries the HS Code 34021300, labeling it as an organic surface-active agent. This classification ensures it passes through international borders under the correct monitoring, upholding traceability and safe distribution. Authorities worldwide recognize this code, and even smaller laboratories or formulation startups benefit from the transparency this brings. The code links the chemical to thousands of import records, showing a material that’s essential, valued, and well-tracked. Understanding this classification means manufacturers and distributors avoid compliance nightmares—with every drum and container, paperwork lines up, and supply chains keep running.
Anyone moving, storing, or working with pharmaceutical chemicals knows Polysorbate 80 ranks as low hazard when handled with routine lab safety—gloves on, spills wiped, no open flames. Acute toxicity remains low, and regulatory agencies list it as generally recognized as safe for ingestion and topical use at controlled levels. That said, eye contact or excessive inhalation of any surfactant brings risk, so chemical workers use splash goggles and proper ventilation. Over the years, as environmental concerns have grown, the biodegradability of Polysorbate 80 matters more to procurement managers. While it breaks down reasonably well compared to harder, synthetic surfactants, wastewater teams still treat effluent before release to safeguard aquatic life. The balance between function, safety, and eco-footprint shapes procurement decisions every quarter.
Anyone who’s spent time formulating medicines sees Polysorbate 80’s name pop up in countless ingredient lists. It emulsifies vitamins in syrups, solubilizes active ingredients in eye drops, and stabilizes vaccines for shipment to clinics around the world. Because it dissolves both in water and oil, it prevents separation, so the final user gets an even dose every time. For people with allergies or sensitivities, the source and grade matter—pharmaceutical grade contains fewer impurities and meets stringent standards for injection and ingestion. Over the years, drug recalls tied to ingredient instability have shown the industry the value of fully vetted surfactants. As generic drugs and advanced biologics grow, the need for surfactants meeting BP, EP, and USP standards only increases.
Manufacturers build Polysorbate 80 from raw vegetable oils—often sourced from palm or coconut—then chemically process these into the multi-chain molecule. Reliable sourcing and traceability are growing priorities, as consumer and government scrutiny on palm oil origins sharpens. Each drum or container reflects not only a chemical output but an environmental and ethical choice, with buyers in Europe and North America especially vocal about sustainable sourcing. Market trends point to steady growth, driven by vaccine production, injectable therapies, and rising consumer demand for safe, well-mixed foods and cosmetics. In my experience, buyers look for suppliers offering audit support and ISO-certification, not just the raw material itself. Cost remains a consideration, but reliability and documentation drive repeat purchases and long-term contracts.
Routine batch testing, supplier audits, and documentation trails help keep Polysorbate 80 safe and effective. Solutions for quality risks include automation in blending and filling, so every batch gets precise ingredient measurement. Laboratories continue to refine impurity testing—better chromatographs and in-depth molecular scans catch contaminants before they reach the market. For safety, employee training remains vital: clear procedures for spill response and disposal, and consistent labeling of containers. In supply chain management, digital traceability tools now track units from production to end-user, reducing errors and speeding recall responses if needed. Investment in sustainable raw material sourcing—certified palm oil, for example—reflects both environmental stewardship and a competitive edge in regulated markets striving for transparency.
Chemical name: Polysorbate 80 (Ii) BP EP USP Pharma Grade
Molecular Formula: C64H124O26
Molecular Weight: Approx. 1310 g/mol
HS Code: 34021300
Physical Form: Oily liquid (some semi-solid at low temperatures)
Density: 1.07–1.09 g/cm³ @ 25°C
Main Uses: Emulsifier, solubilizer, stabilizer in pharma, food, cosmetics
Source Material: Sorbitol and vegetable oils
Key Properties: Nonionic, surface-active, hydrophilic–lipophilic balance (HLB ≈ 15)
Regulation: Complies with BP, EP, USP pharmaceutical standards
Safety: Low toxicity, routine lab precautions, biodegradable under wastewater treatment
Chengguan District, Lanzhou, Gansu, China
