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Polyethylene Glycol Monostearate BP EP USP Pharma Grade finds frequent use in pharmaceutical, cosmetic, and food industries because it works well as a non-ionic surfactant and emulsifying agent. It consists of polyethylene glycol and stearic acid, creating a molecular structure that handles both water-soluble and oil-soluble substances smoothly. This gives the compound a unique nature—bringing water and oil together, a property valued by formulators across industries.
Built from a PEG backbone and stearate tail, the typical formula for Polyethylene Glycol Monostearate reads as C18H35COO(CH2CH2O)nH. That “n” stands for the number of repeating ethylene glycol units, with pharmaceutical grades often specifying a certain range to ensure quality and performance. Molecular weight can vary, usually falling between 600 and 1800, depending on the application. The structure delivers both hydrophilic and lipophilic qualities, a reason why it serves as an all-rounder in emulsifying and stabilizing tasks.
From my hands-on experience in lab settings, Polyethylene Glycol Monostearate usually shows up as solid white flakes, powder, or even pearl-like granules, showing very low odor and staying stable in normal storage. Some formulations may involve it as a creamy-white paste or crystalline solid. Density ranges close to 0.97 to 1.05 g/cm³. This product melts gently between 50°C and 60°C, which has made it easier for those in manufacturing to blend it with other ingredients and control process steps without risking temperature-sensitive actives. Water dispersibility remains moderate—meaning, it won’t dissolve instantly but breaks up into fine particles over time, especially when warmed. In liquid form, its mild viscosity helps bind and modify texture, important in both oral and topical pharma products.
Under international trade, Polyethylene Glycol Monostearate commonly falls under HS Code 3402.13.00. This covers non-ionic organic surface-active agents. The BP, EP, and USP tags mean the product meets British, European, and United States Pharmacopoeia standards for purity, quality, and performance. Documentation and supply chains often need to show traceability to those standards, so end users feel confident about safety and regulatory compliance.
Labs require strict attention to specs—acid value typically below 3.5 mg KOH/g, saponification value around 80 to 100 mg KOH/g, and an iodine value less than 1. Water content stays under control, no more than 1%. For pharmaceutical grades, heavy metals like lead or arsenic drop below tight thresholds, no more than 10 ppm. Understanding these metrics means knowing what goes into the blend, as they can directly affect the stability and safety of finished products. Clarity of solution, residue on ignition, and absence of harmful solvents or unreacted stearic acid top the checklist for qualifying a batch.
Manufacturers offer Polyethylene Glycol Monostearate as raw material in various physical forms—flakes, solid chunks, fine powders, and pearl-shaped granules. Choosing the right form often depends on whether it needs rapid dissolution or gradual melting. Shelf stability sits high, with dry storage at room temperature giving products two years or beyond. The material resists caking, resists moisture pickup in normal conditions, and won’t break down under light if packaged properly. Polyethylene Glycol Monostearate works well with other excipients like glycerin, fatty alcohols, and preservatives, supporting both water-based and oil-based solutions without clumping or separating.
Over the years, I’ve seen how safety awareness helps prevent problems during handling. Polyethylene Glycol Monostearate typically comes labeled as non-toxic and non-irritant when used according to specifications. Minor skin or eye irritation might occur if undiluted product gets into sensitive areas, but there are no acute hazards under ordinary use. Most safety datasheets back this up: classified as non-hazardous under normal circumstances, without risk of chronic toxicity, carcinogenicity, or reproductive harm. Raw materials sourced for pharma-grade batches demand strict screening, so each lot has consistent quality and no contamination. Disposal follows local guidelines for non-hazardous chemicals, with low worry about environmental persistence or aquatic toxicity. Still, lab workers wear gloves, goggles, and dust masks when handling large volumes to avoid irritation.
In pharma, Polyethylene Glycol Monostearate plays roles in tablets, capsules, creams, ointments, and lotions. It gives smoothness, consistency, and the kind of spreadability that makes medicated creams pleasant to use. The same property carries over to food, where it helps chocolates stay glossy or keeps sauces uniform. Cosmetic formulators rely on it for texture, shine, and the ability to hold fragrance. As a solution in water or in alcohol, it dissolves active ingredients or acts as a carrier for flavors, colors, or vitamins. All these come from those dual chemical properties: part petroleum, part fatty acid, joining what usually doesn’t mix.
It’s easy to ignore an ingredient in a long list, but understanding what Polyethylene Glycol Monostearate does can make a difference, both for consumers and manufacturers. As supply chains tighten and customers demand traceability, the pharma-grade batch comes with full documentation—meeting BP, EP, and USP. Each shipment provides confidence for product development, regulatory inspection, and end use. Using proven, well-characterized raw materials like Polyethylene Glycol Monostearate means fewer recalls and safety incidents. That said, choosing suppliers who monitor quality, test for heavy metals, and avoid cross-contamination protects both worker safety and consumer trust. Broader adoption of sustainable sourcing and greener chemistry methods could further reduce the carbon footprint of this material.
Chengguan District, Lanzhou, Gansu, China
