Squalene BP EP USP Pharma Grade: Substance Profile and Analysis

What is Squalene BP EP USP Pharma Grade

Squalene BP EP USP Pharma Grade shows up on ingredient lists for a reason: it plays an active role in pharmaceutical manufacturing and high-end cosmetic formulations. Sourced mainly from plant oils—like olive or amaranth—or refined from shark liver oil, squalene finds heavy use in the pharma sector. The BP, EP, and USP tags tell us Squalene meets the British, European, and United States pharmacopoeia standards. These pharmacopoeias serve as regulatory benchmarks for purity, identity, and safety. The substance is translucid or faintly yellow, displaying an oily appearance in pure liquid form, with no visible crystal structure until significant cooling or processing.

Products and Applications

People use Squalene in vaccines, topical medicines, and high-stability skin products. Its global reach spans vaccine adjuvant systems and as an emollient and skin barrier restore in topical medications and premium creams. Because it's non-comedogenic, it works for sensitive skin and allergy-prone cases. Beyond that, industries count on its antioxidative strength, helping pharmaceuticals hold up against oxidative degradation. Derived strictly from plant sources for pharma work, Squalene keeps away from marine contaminants and animal-based disease vectors.

Properties and Chemical Structure

With a molecular formula C30H50, Squalene is a triterpene compound. The molecule itself shows six isoprene units connected in a long chain, bringing flexibility and fluidness to its chemical behavior. Its appearance—clear, colorless to pale yellow liquid—matches the expectations for high-purity triterpenes. Squalene shows a density of roughly 0.857 to 0.865 g/cm³ at 20°C. It does not solidify easily, retaining liquid state down to low temperatures, making it practical for both room-temperature and refrigerated storage. Squalene’s insolubility in water and easy solubility in organic solvents keeps it compatible with oils, esters, and soft-gel bases.

Specifications and Material Form

Typical specifications for pharmaceutical Squalene include assay of ≥ 99.0%, refractive index of 1.492-1.508, and a peroxide value kept below 10 meq/kg. The substance comes available in drums or food-grade containers, strictly controlled to prevent exposure to light or oxygen—oxidation being a major issue with all triterpenes. Packaging uses nitrogen flush or inert atmospheres for long-term storage. Its non-crystalline character means squalene sits as a liquid almost exclusively in commercial supply; you won’t encounter it as powder, flakes, solid pearls, or crystals unless the temperature drops to freezing. In the market, pharma grade Squalene takes shape only in its liquid, unadulterated form.

HS Code, Molecular Details, and Safety Considerations

International shipping uses HS Code 1516.20 for animal or plant-derived Squalene. In electronic customs, the compound falls under raw materials for pharmaceutical industries, with clear labeling for regulatory inspection. At a molecular level, the formula never changes: C30H50, boiling near 285°C at 1 mmHg, extremely low melting point—about -75°C—allowing use under various manufacturing conditions. Squalene is considered non-reactive under normal conditions, but suppliers must protect it from heat, light, and oxidizing agents. Exposure to high heat or air may generate harmful peroxides. Toxicological assessment scores squalene as biologically inert and non-hazardous at doses typically used in pharma or cosmetic applications; though excessive inhalation or high vapor concentrations could irritate the respiratory tract, such conditions very rarely occur outside specific industrial accidents.

Raw Materials and Purity

Quality starts at the source. Plant oils—specifically olive and amaranth—form the foundation for pharma-grade Squalene production. Refining removes impurities and contaminants common to food-grade or cosmetic squalene. Strict adherence to pharmacopeial protocols guarantees only the highest purity, with heavy metal content, solvent residues, and by-products like fatty acids kept below detection thresholds. Pharmaceutical processes operate batch-controlled, digitized, and under full traceability to guard product integrity.

Use, Risk, and Future Direction

From my experience managing pharmaceutical ingredient inventories, quality control around squalene is non-negotiable: batch certificates, chromatographic purity profiles, and regulatory documents need to move together from warehouse to production floor. Any deviation in peroxide value, oxidation products, or origin creates traceability headaches, slows vaccine or drug batch release, and draws regulatory scrutiny. Modern pharma manufacturing addresses these risks by leveraging vacuum distillation, continuous nitrogen blanketing, and in-line chromatography testing. Alternative plant sourcing becomes more common—part eco-ethics, part supply chain robustness. Eco-awareness drives manufacturers away from shark-derived Squalene, narrowing the field to olives, amaranth, and sugarcane processes, and helping end-users deliver products both safe and sustainable.