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Polyethylene Glycol Monopalmitate BP EP USP Pharma Grade stands out as a crucial excipient in the pharmaceutical industry and other sectors where ingredient purity and safety drive decision-making. People often see this compound under several names, sometimes called PEG Monopalmitate or PEG-16 Monopalmitate. It is derived from the reaction between polyethylene glycol (PEG) and palmitic acid, creating a versatile molecule useful in producing creams, ointments, pharmaceutical suspensions, and more. I have seen manufacturers and quality-control teams lean on it for applications where stability, dispersibility, and patient safety matter. The BP, EP, and USP tags mean it meets the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia standards, which offer peace of mind about its compliance in regulated environments.
You find Polyethylene Glycol Monopalmitate available as white to off-white flakes, powders, granules, or pearl-like beads. Some producers also sell it in solid block form or as a viscous, semi-solid mass, depending on the degree of polymerization and formulation. At room temperature, this material stays solid, but it softens at higher temperatures, somewhere around 40°C to 55°C for most grades. The substance carries a waxy consistency and melts to form a hazy liquid, which blends easily with water and many organic solvents. While it dissolves in hot water, you can also disperse it in cold water. The density often ranges between 0.9 and 1.1 g/cm³, depending on the molecular weight and PEG component.
Polyethylene Glycol Monopalmitate features an ester bond linking a PEG chain to a palmitic acid residue. The general molecular formula looks like C16H31COO(CH2CH2O)nH, where n depends on the PEG used. This structure provides both hydrophilic (PEG) and lipophilic (palmitic acid) segments, making it act as a good and stable emulsifier. It keeps oil and water from separating in creams and solutions, so texture and dosing remain consistent. The compound helps suspend ingredients, stabilize drug particles, and improve the feel of finished products.
Products labeled as Polyethylene Glycol Monopalmitate BP EP USP Pharma Grade come with strict specification sheets. The acid value usually sits between 5 and 10 mg KOH/g, and the saponification value sits in the 90–120 mg KOH/g range. The hydroxyl value, which tells you about the unreacted PEG, typically falls between 90 and 120 mg KOH/g as well. Moisture content must be below 2%, and impurities linger at low levels. Typical grades include PEG-8, PEG-12, PEG-16, and PEG-32 Monopalmitate, all indicating the average number of ethylene oxide units in the PEG chain. HS Code for customs classification falls under 3402.42, tracing to non-ionic organic surface-active agents.
Polyethylene Glycol Monopalmitate finds itself molded into different forms to cater to varying process needs. Flakes and pearls handle well in batch mixes and large-scale dissolutions, while fine powder does the trick for blending with micronized ingredients or when quick dissolution is crucial. Crystalline forms also show up, with tight melting ranges, especially in high-purity pharma grades. Liquid or pasty grades appear at higher PEG weights or in heated states, making them easier to pump or inject into closed systems. Whether handled by the liter or kilogram, this excipient stands out for its easy measuring, transfer, and mixing properties. In practice, you see technicians scooping pearls for blending, weighing out flakes for creams, or shearing powder into solutions with overhead mixers in pilot-scale labs.
On the molecular level, the length of the PEG chain largely sets the molecular weight and hydrophilicity of the finished molecule. For lower PEG grades, you see softer, wax-like solids that melt sooner. Higher PEG numbers crank up melting points and create tougher, more crystalline solids. Density tends to hover close to 1.0 g/cm³—matching the "bulk feel" of many mid-weight polymers. The product’s amphiphilic character means it works across hydrophilic and lipophilic environments, giving consistent results whether you’re stabilizing a water-rich ointment or a fat-heavy base.
Polyethylene Glycol Monopalmitate comes from combining pharmaceutical-grade polyethylene glycol with pure palmitic acid, usually derived from vegetable oils. These raw materials must pass purity checks for heavy metals, residual solvents, and microbial contamination. In my experience, sourcing high-quality PEG carries more weight than one might think, because contaminants in base ingredients can compromise a whole batch of finished product. Reactors operate at elevated temperatures in the presence of acid catalysts, followed by rigorous purification and drying. Every step, from raw material selection to the final packaging, must live up to pharmacopeial requirements if you want to label a product BP, EP, or USP.
Polyethylene Glycol Monopalmitate earns a spot on lists of generally regarded as safe (GRAS) compounds for topical and oral pharmaceutical use — provided manufacturers keep levels of process residues and free fatty acids under tight control. Inhalation or ingestion in high doses could lead to mild gastrointestinal upset, but you won’t find acute hazards here. Skin exposure rarely causes issues for workers, and those handling bulk product mainly need to worry about dust inhalation, which basic PPE can solve. The compound does not qualify as toxic, mutagenic, or hazardous under normal use or EU/US chemical regulations, though excessive heating may break it down and produce unwanted byproducts. Environmental persistence remains low, as both the PEG and fatty acid elements break down under standard waste treatment conditions. In any plant, safety data sheets lay out the measures needed for storage, transfer, disposal, and first aid, yet the real risk sits low on industry charts.
In my experience, Polyethylene Glycol Monopalmitate solves plenty of formulation problems. Drug makers and personal care brands both reach for it when other emulsifiers fall short due to skin compatibility or regulatory status. I’ve seen it smooth out gritty ointments and stabilize vitamins that tend to clump or precipitate. Choosing the right grade depends on density, PEG chain length, and melting behavior; manufacturers often run pilot batches to prove which profile brings the smoothest finish or longest shelf life. High-purity grades pass through advanced filtration and decolorization to meet injectable or ophthalmic product standards, reducing risk of allergic reactions. Some teams develop “combo systems” by pairing Polyethylene Glycol Monopalmitate with other surfactants to fine-tune viscosity, spreadability, or taste. The key lies in regular quality monitoring—whether via IR spectroscopy or titration—so impurities never sneak by.
Demand for Polyethylene Glycol Monopalmitate keeps growing, as more industries look for reliable emulsifiers and stabilizers that stay in compliance with worldwide pharmacopoeias. As more companies invest in transparent supply chains, they ask hard questions about the traceability of raw materials and the reproducibility of performance between lots. During product development meetings I've attended, the difference between a patchy cream and a market-ready formula often comes down to this excipient’s grade and batch consistency. Process engineers like it because it rarely gums up conveyors or blenders, and lab analysts appreciate the ease in validating its spec profile. By combining known safety, clean sourcing, and versatility, Polyethylene Glycol Monopalmitate BP EP USP Pharma Grade serves as a backbone in pharmaceutical and personal care development, playing a key role in reliable, patient-friendly products.
Chengguan District, Lanzhou, Gansu, China
