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Half Oleic Acid Ester Sorbitan BP EP USP Pharma Grade refers to a refined non-ionic surfactant produced by the partial esterification of sorbitan with oleic acid. This raw material serves pharmaceutical, cosmetic, and food industries as an emulsifier, solubilizer, and stabilizer. Though it goes by different trade names, its role stays consistent: facilitating the mixing of ingredients that would normally resist blending, which matters in creams, ointments, and certain liquid drugs. Throughout my professional life, I saw this compound smooth out stubborn mixtures and help deliver actives more efficiently across diverse formulations. Its pharmaceutical grade indicates purity according to norms set out in the BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia), offering manufacturers confidence in its safety and performance standards.
Chemically, Half Oleic Acid Ester Sorbitan carries the formula C18H34O6, reflecting the sorbitan backbone and fatty acid chain. The finished raw material takes shape as flakes, powder, solid chunks, or dense pearls, depending on manufacturing method and storage conditions. It appears pale yellow or off-white, sometimes translucent, with a waxy texture, which dissolves slowly in warm liquids. Density falls in the range of roughly 1.02 – 1.08 g/cm³. As a non-crystalline substance, it tends to remain amorphous rather than forming sharp edges. The melting point usually sits around 40–50°C, which makes it easy to handle above room temperature. In personal use, I found its handling straightforward, melting easily for pre-mixes without fouling or clumping. Whether it comes in flakes, solid blocks, or a fine granular powder, the way it softens and incorporates under gentle heat simplifies industrial scale-up.
Half Oleic Acid Ester Sorbitan carries a balance between hydrophilic sorbitan units and lipophilic oleic acid chains. This amphiphilic character gives it a moderate Hydrophilic-Lipophilic Balance (HLB), making it suitable for oil-in-water emulsions but also helpful for water-in-oil stabilization. The Pharma Grade version meets strict thresholds for purity, water content, and acid/hydroxyl numbers. Residue testing ensures low amounts of free fatty acids, with peroxide and saponification values controlled so sensitive pharmaceutical formulations bear minimal risk of degradation. In practical experience, this high level of quality helps downstream developers minimize product variability and ensures final medicines meet shelf-life targets.
The molecular weight of this ester sits close to 346–370 g/mol, depending on how much of the sorbitan is converted and what minor by-products arise. The HS Code for import and export tracking, often required on customs entries and safety documents, is generally 34021300 for non-ionic organic surfactants. In terms of international commerce, knowing and correctly labeling this code keeps shipments moving and reduces compliance issues. Many times I have seen batches held up at customs for missing or incorrect chemical classification; getting this right builds in efficiency.
Sorbitan esters appear in several forms, so handling procedures depend on batch size and temperature. Flakes melt down and disperse into heated oil phases with minimal fuss. Powders, when used, must stay dry during storage since clumping reduces dosing accuracy. Solid bricks or blocks break down for industrial kettle use but suit bulk operations less practical for lab-scale or bench-top activities. Pearl forms find favor in controlled-feed applications, often paired with automated process lines. True liquid versions are uncommon for this ester except where specific blends or solutions are prepared for direct dosing. I've always found the flaked and granulated forms most flexible—they store well, pour easily, and allow precise measurement for both small trials and full-scale runs.
Water solubility remains limited; this ester disperses more readily in oils and non-polar solvents. Agitation and mild heat support its uniform distribution, a necessary step when building emulsions or combining with actives dissolved in other carriers. At room temperature, the density aids in predicting settling or stratification risk within a mixture. For liquid dose forms, pre-dissolving the ester into oils or bases before final compounding usually reduces lot-to-lot variation and supports stable finished products. On the rare occasion, I’ve seen it used as a suspension aid, especially when paired with wetting agents, expanding its flexibility.
Half Oleic Acid Ester Sorbitan maintains a strong profile for safety, earning places in topical, oral, and even parenteral formulations. On ingredient lists, it rarely triggers hypersensitivity responses compared to other surfactants or emulsifiers. Still, handling guidelines in manufacturing environments require gloves, masks, and splash guards, as the raw powder may cause eye or respiratory irritation. Storage should keep the product dry and away from strong oxidizers. From years of plant tours and blending room routines, I always found dust control and spill management necessary but not difficult, as standard chemical hygiene managed most risks. No major fire hazards emerge under normal use, but facilities typically keep basic firefighting agents nearby for oils and esters.
Global supply of this raw material comes from both plant-based and synthetic fatty acid sources, so sustainable choices exist for buyers concerned about palm oil or other ecological issues. As quality standards march higher, especially for injectable medicines, manufacturers source from partners displaying full traceability, audit-ready records, and compliance with major pharmacopoeias. During my collaborations with procurement teams, performance could hinge on robust quality agreements and a clear understanding of ingredient origin, mitigating risks tied to supply chain or regional regulatory variations.
Demand for high-purity, well-characterized batches of Sorbitan esters continues to rise, especially as novel drug delivery systems expand. More companies seek out sustainable, traceable supply chains with clear documentation both for environmental and regulatory reasons. Process optimization can cut down on by-products and improve lot consistency, which keeps final pharmaceutical and personal care formulations running smoothly. Open communication across manufacturing, regulatory affairs, and supply teams leads to better product outcomes and fewer failed batches. Through my time in both development and large-scale facilities, regular feedback from operators translated into smart investments in equipment and protocols, setting the groundwork for lasting process safety and enhanced quality profiles.
Chengguan District, Lanzhou, Gansu, China
