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Polyethylene Glycol 15-Hydroxy Stearate BP EP USP Pharma Grade: Deep Dive Into A Trusted Raw Material

What is Polyethylene Glycol 15-Hydroxy Stearate?

Polyethylene Glycol 15-Hydroxy Stearate BP EP USP Pharma Grade, often called PEG-15HS, turns up in pharmaceutical and personal care recipes—formulators like having this non-ionic surfactant around for a reason. People with years on the bench have seen how this compound, made from stearic acid and polyethylene glycol, contributes to consistent texture and reliable delivery. Clear or waxy, solid or creamy, PEG-15HS feels practical for mixing with hydrophilic and lipophilic substances. The molecular formula, C38H76O10, reveals an even balance, giving it compatibility across the board. As an ingredient, it’s been assigned the HS Code 34021300, which tags it directly as a non-ionic organic surface-active agent. The specific choices—flakes, solid chunks, even in pearls—come down to processing demands and equipment design on the floor, not just a sales pitch.

Physical Properties and Chemical Structure

Lab work always comes back to properties you can measure, and PEG-15HS stands out with a molecular weight around 700–1,000 g/mol. Its solid state at room temperature gives it some handling advantages in production, offering density steady in the range of 0.9–1.0 g/cm³. Water solubility is moderate, so formulators use it as an emulsifier or solubilizer, where it keeps hydrophobic actives in step with aqueous solutions. The structure features a polyethylene glycol chain bonded to a single hydroxy stearate group, and this configuration means the molecule bridges both water and oil systems naturally. Its melting point spans 50°C to 60°C, so heating it for compounding rarely risks overshooting. Whether working with flakes, pearls, or even a semi-solid block, consistency matters more than theoretical specs—and bulk shipments usually show less than 1% moisture for stable storage.

Common Applications, Solution Properties, and Handling

Real application stories trace to ointments, creams, and skin-friendly lotions. PEG-15HS delivers not just stability, but helps active ingredients blend without phase separation. The raw material grade for BP, EP, and USP rules demands low levels of any hazardous impurities—every consignment needs a certificate of analysis, reassuring both the regulatory teams and end-users. Down the supply chain, PEG-15HS goes into detergents and industrial lubricants, owing to its persistent non-ionic character and ability to function under both acidic and basic conditions. The compound’s appearance as a waxy solid or as small, glistening pearls comes down to the method of cooling and milling. When incorporated into solutions or dispersions, PEG-15HS helps maintain clarity and a steady viscosity, giving a finished product that can be tested and trusted batch after batch.

Safety, Hazards, and Environmental Aspects

Some substances draw red lines for safety or handling, but PEG-15HS fits among the safer options for pharmaceuticals. Fact sheets published by major chemical suppliers cite low toxicity; absorption through skin remains unlikely, and oral exposure at typical workplace concentrations does not raise concern. Still, all chemical raw materials can be mishandled: workers who spend long shifts handling flakes or dusts use gloves and masks to cut down on irritation. PEG-15HS poses minimal risk in water effluent due to its low acute aquatic toxicity, though responsible operators monitor discharges closely under Good Manufacturing Practice. Safe storage means dry, ventilated areas with sealed drums; heat extremes or water leaks can degrade the physical quality, but will not cause violent reactions or fires. Regulators and plant safety committees favor this material because it never brings along the worries found in volatile organics or highly hazardous reagents.

Molecular Details, Formula, and Specifications

Anyone reading the fine print on a material safety data sheet notices the structure’s repeating ethylene oxide units, terminated with a stearate group—this brings together polar and non-polar character in every molecule. Specifications follow international standards for pharmaceutical quality: purity above 98%, verified by HPLC, absence of phthalates, and peroxide values below 5 meq/kg. The BP/EP/USP grade reflects tight controls, including heavy metal content well beneath 10 ppm, and verified biological inertness. Testing for appearance checks for off-color, solution clarity, and freedom from foreign matter, with density and melting point documented for each batch. These details help purchasing managers and formulation chemists synchronize requirements without running into surprises or compliance headaches.

Potential for Harmful Effects—What Evidence Shows

Looking at harm, experience and published toxicology place PEG-15HS among the least problematic of surfactant types in approved drug and cosmetic use. Some users with particularly sensitive skin report mild irritation, but widespread reactions are rare. Environmental persistence is low; the compound breaks down with exposure to common wastewater bacteria, posing less risk than other surfactant raw materials. The European Chemicals Agency and US FDA have long published data on chronic exposure, showing no bioaccumulation or long-term organ harm in tested animals. Safe handling boils down to standard industrial hygiene—no need for overbuilt containment, only respect for routine spills or dust creation.

Raw Material: Real-World Perspective

Walking the shop floor or development lab, it becomes clear why PEG-15HS wins favor. Good suppliers offer this ingredient with batch tracking, certificates of analysis, and full origin traceability, offering practical risk management even before blending begins. Raw material quality impacts everything downstream—every slip in density or chemical content shows up fast in product performance. Many facilities keep careful control over bulk storage, air quality, and product rotation to preserve all material properties until the very last kilogram. Teams working in pharmaceuticals or high-end personal care see PEG-15HS less as a generic surfactant, more as a consistent, high-purity platform that helps meet standards, respond to audits, and accelerate regulatory approval. No one dies on the hill of theoretical advantages; the real test comes with every batch number, every finished lot, every third-party analysis.