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In the early days of pharmaceutical excipients, finding reliable nonionic surfactants called for some ingenuity. Polyoxyethylene (8) Stearate entered the market at a point when research labs sought ways to solubilize hydrophobic drugs or fine-tune the release profile of certain products. Early records trace back to the mid-twentieth century, when both academic groups and industrial teams explored polyoxyethylene derivatives for use in everything from ointments to emulsifying agents in injectables. Over the years, the compound became a staple in pharmacopoeias, with specifications outlined in BP, EP, and USP. This status didn’t come by chance — it followed years of safety evaluations, demand for stability, and the search for agents that actually helped patients.
Polyoxyethylene (8) Stearate brings together a polyoxyethylene chain of about eight oxyethylene units with a stearic acid tail. The concept may sound technical, but at the bench level, this translates into a substance that feels waxy, mixes well with both water and oils, and offers remarkable flexibility for product formulators. Its reputation for versatility isn’t just hearsay; it stands as an ingredient in tablets, creams, injectables, and even some nutraceuticals due to the trust built by meeting global pharmaceutical grade requirements.
The compound appears as a white to off-white solid or powder, easily melting between 40°C and 50°C. This practical range makes it straightforward to work into cold or hot processes. The polyoxyethylene groups lend hydrophilicity, while the stearic acid provides a fatty, oil-soluble end, forming an effective bridge between water and oil. Polyoxyethylene (8) Stearate resists hydrolysis in neutral conditions, and its HLB (hydrophilic-lipophilic balance) value sits in a sweet spot for emulsification, often cited around 15. Recognizing the balance between solubility and chemical stability puts the compound on my “go-to” list for problem-solving in difficult formulations.
Manufacturers must stick to clear benchmarks: precise average molecular weight, specific polyoxyethylene content, and acid value. Each lot receives a Certificate of Analysis confirming compliance with BP/EP/USP monographs. In the lab, I’ve run IR checks and looked out for residue on ignition—signs that reflect good practice and help catch the rare outlier batch. Labels usually cite synonyms, batch numbers, shelf life, recommended storage, and compliance with GMP and applicable pharmacopoeia. Such rigorous controls are not just regulatory obligations; they support safe, predictable use in therapies for people who can’t afford surprises.
In industrial practice, the synthesis of Polyoxyethylene (8) Stearate starts with the controlled ethoxylation of stearic acid. Ethylene oxide, hazardous but essential in controlled settings, reacts with stearic acid in the presence of an alkaline catalyst. Close monitoring of temperature and pressure ensures the chain length and distribution match pharmacopeial standards. After the main reaction, purification steps can be tedious but vital, including washing, neutralization, and careful drying to keep impurities at bay. Years of working with contract manufacturers proved that even small lapses in temperature or catalyst control translated to off-spec batches that couldn’t pass a QC inspection.
Functionalizing Polyoxyethylene (8) Stearate opens doors for custom performance. The polyoxyethylene chain may undergo further extension or modification for specialty uses, or be end-capped to alter solubility. The stearate head remains largely stable, but adjustments can bubble up in attempts to tweak compatibility with various drug types. Crosslinking, esterification, or even forming complex co-excipients all start with this base, a process I’ve seen speed up protoyping in R&D departments eager to test new release profiles or solubility strategies.
Over decades, different catalogs and regulations adopted a spread of names: Steareth-8, PEG-8 stearate, Polyoxyethylene Stearate 8 EO, and the straightforward Polyethylene Glycol Stearate. In regulatory environments, getting the correct synonym onto paperwork avoids headaches during audits or customs clearance. In my experience supporting regulatory submissions, one missed synonym delayed a product launch by weeks thanks to paperwork bottlenecks.
Handling Polyoxyethylene (8) Stearate in the plant or lab doesn’t bring the risks tied to caustic or corrosive excipients, but techs should wear gloves and masks to avoid long-term exposure to fine powders. The main risk comes from improper storage: moisture can cake the powder, and high heat can degrade the product, reducing effectiveness and increasing impurity content. Packaging in air-tight, food-grade liners reduces spoilage and supports pharmaceutical-grade integrity. Workplaces subscribing to WHO GMP and ISO 9001 certifications have clear SOPs around this handling, emphasizing rigorous operator training and environmental monitoring. Regular toxicological evaluations support ongoing confidence in its use, reinforced by decades of incident-free application across continents.
Polyoxyethylene (8) Stearate sees broad use as an emulsifier, solubilizer, and stabilizer. In my experience running stability studies, drugs that failed in early cream or oral liquid prototypes held together after incorporating this excipient. Pharmacies rely on it for topical creams where patient skin-sensitive stories push for gentle, non-irritant choices, and also for oral suspensions where flavoring and active agents demand help dissolving in water. Injectable solutions, where every ingredient earns intense scrutiny, gain from this excipient’s record of low irritation and allergenicity. Nutrition and personal care brands also borrow the molecule for similar applications, but always at concentrations justified by published safety data.
Interest in new surfactant blends, lipid nanoparticles, and drug delivery vehicles often circles back to Polyoxyethylene (8) Stearate. Its structure serves as a scaffold for a wide range of prototype studies exploring everything from pediatric-friendly antibiotics to modified-release antidiabetics. Years spent in development meetings taught me that teams want “known good” excipients to lower regulatory hurdles and give consistent results under stress testing. As new oral biologics or injectables face solubility challenges, this old standby finds new relevance in next-generation pharma R&D initiatives.
Pharmacopoeia-entry did not come without rigorous investigation into irritancy, systemic toxicity, and allergenicity. Chronic toxicity studies and maximum non-toxic dose explorations inform current maximum allowances in drug products. Controlled rat and rabbit studies showed no mutagenic or teratogenic effects at levels far higher than typical pharmaceutical use. During a stint with a product safety task force, I reviewed data from post-market surveillance and literature reviews, confirming minimal adverse events and rare cases of contact sensitivity. Long-term experience in both research and clinical practice supports what the data say: Polyoxyethylene (8) Stearate reliably meets the safety margin needed in vulnerable patients.
The future for Polyoxyethylene (8) Stearate looks strong as biopharma shifts towards more complicated payloads and delivery systems, especially those relying on emulsification and solubilization. As regulatory expectations for traceability and environmental impact tighten, sustainable sourcing and green chemistry routes may distinguish suppliers. Advances in analytical chemistry will drive even more detailed impurity profiling and trace-level detection. The continued move toward patient-centric drug products — think fewer irritants, better absorption, and more adaptable dosage forms — leans on excipients with well-understood profiles. Through decades of use and close ties to science, Polyoxyethylene (8) Stearate will keep underpinning the success of advanced drugs, medical devices, and even innovative food supplements for years to come.
Pharmaceutical manufacturing rarely hits headlines unless something goes wrong, but day in and day out, materials like Polyoxyethylene (8) Stearate silently shape the medicines found in every household. You might not recognize the name—most people wouldn’t. For a long time, I didn’t either. This substance, approved in BP, EP, and USP grade, serves an essential function as a non-ionic surfactant. In plain English, that means it helps mix substances that usually don’t combine well, like oil and water.
Creams, ointments, and injectable drugs rely on stable mixtures. Polyoxyethylene (8) Stearate often takes the spotlight in these formulas. It stabilizes emulsions, making sure medication spreads evenly through a cream or injectable solution. Without this stability, you risk uneven dosing—one of those dangers no one talks about until tragedy strikes. Consistency matters, and the use of quality surfactants is non-negotiable for keeping medication safe and reliable.
Tablets and capsules look simple, but their production can become very complex. I’ve seen too many stories where manufacturers looked to cut costs by ignoring excipient quality, only to end up recalling products. Polyoxyethylene (8) Stearate keeps powders flowing during tablet manufacturing, so pills don’t end up crumbling or sticking together. It can also serve as a coating, keeping moisture out and helping with the slow release of active ingredients.
You’ll see the acronyms BP, EP, USP attached to this chemical. Each shows that the grade meets strict standards set by British, European, or United States pharmacopeias. No one wants to worry about whether an ingredient in their heart medication measures up—these grades offer some peace of mind. Dirty or inconsistent batches can slip dangerous impurities into pharmaceuticals, which can trigger allergies or worse. Reputable suppliers undergo tough audits, and their transparent records help catch issues before the public is put at risk.
Problems arise when companies cut corners or ignore standards. Health authorities need to keep pressure on manufacturers with regular checks. Buying only from certified suppliers reduces the risk of contamination. Ending the race to the bottom on costs helps everyone in the long run. When I see pharmacists and regulators working together, collaborating on audits, I feel more comfortable picking up medicine for my family.
People rarely talk about the unsung helpers inside modern medicine. Polyoxyethylene (8) Stearate does a lot of heavy lifting to keep medications stable and safe. It’s a workhorse that lets researchers and pharma companies sleep a little better at night, knowing their products do what they’re meant to do without unexpected side effects. The journey from complex chemicals to simple pills has many hidden challenges. Polyoxyethylene (8) Stearate proves that the smallest components can play the biggest roles—not just in lab notebooks, but on pharmacy shelves across the globe.
Polyoxyethylene (8) stearate doesn’t catch the eye like a miracle drug, but people working in pharmaceuticals know its impact runs deep. Used widely as an emulsifier and solubilizer, this compound brings together oil and water-based ingredients in ways that make life-saving medicines work smoothly. Reliable drug delivery—especially for injectables, creams, and oral solutions—often leans on these silent helpers to keep things stable.
If you ask manufacturers and pharmacists what matters most, consistency and safety top the list. Chemicals mixed for therapy need strict controls. Polyoxyethylene (8) stearate, with its chemical makeup—stearic acid combined with eight ethylene oxide units—should meet the standards laid out by the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP).
Every batch destined for pharma shelves is checked for appearance, solubility, pH, acid value, saponification value, moisture content, and the presence of heavy metals. Real-world feedback has shown that batches with higher water content or out-of-range acid values tend to destabilize the finished medicine or reduce the shelf life. Pharmacopeial standards help keep impurities such as lead, nickel, and arsenic at levels far below any health risk. It’s common sense: patients take these compounds in, either by mouth or injection; purity really isn’t up for debate.
From the factory floor all the way to a pharmacy, specs aren’t just red tape. Take appearance: high-grade Polyoxyethylene (8) stearate forms a white or creamy solid, sometimes in flakes or powder. A faint odor is normal. According to BP and EP, moisture sits below 2.0%. Acidity (as acid value) usually sits between 2 and 7 mg KOH/g. Saponification values range from 45 to 55 mg KOH/g in most standards from Europe and the United States.
Solubility isn’t just a line in a spec sheet, either. Disintegrated pills or uneven creams can sometimes be traced to batches with poor water solubility—those that meet pharmacopeial tests dissolve cleanly in water and ethanol. Color tests, infrared absorption, and check for fatty acid profile round out the authentication process. Trusted manufacturers record and store results for every lot, because retracing a problem after the drug ships can be a nightmare.
Cutting corners on surfactant purity or accepting off-spec alternatives can spark recalls or even cause patient harm. Years ago, a supply chain shortcut drew out-of-spec batches into the local hospital network, leading to hundreds of medicine bottles being pulled back. People lost faith fast. Since then, pharmaceutical firms turn more to third-party audits, cross-checking not just paperwork but the methods used on the shop floor.
It goes beyond just following a checklist. Training, tight controls on raw materials, frequent equipment calibration, and double-blind purity tests build trust. Open communication between suppliers and buyers keeps everyone sharp. Modern labs often use HPLC, titration, and spectroscopy to root out any slip in purity. Routine surprise inspections, both internal and regulator-led, help catch any drift from the standard. In my own experience, a proactive quality team and cooperative suppliers keep the surprises—at least the bad ones—to a minimum.
At the end of the day, these behind-the-scenes emulsifiers like Polyoxyethylene (8) stearate don’t make headlines, but they help keep medicines safe and patients healthy.
Pharmaceutical manufacturing relies on ingredients that pull more than their own weight—Polyoxyethylene (8) stearate steps in as one of these helpers. It works as an emulsifier, making different ingredients mix smoothly. This matters for tablets, syrups, creams, and even injectables, where the wrong mix-up can spoil stability or mess with dose levels.
Each pharmaceutical ingredient needs approval from agencies like the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and British Pharmacopoeia (BP). These guidelines call for strict controls on impurities, microbe counts, and chemical balance. Polyoxyethylene (8) stearate, when produced to meet these standards, clears these hurdles. Today, it shows up in medicines used around the world. Reports on its safety, like those published by the World Health Organization and the European Food Safety Authority, focus on toxicity and allergic reactions. So far, tests in both animals and humans point to a wide margin of safety, especially at the low levels used in medicine.
I’ve watched drug makers juggle older and newer excipients—Polyoxyethylene (8) stearate solves some tricky stability problems. Still, benefits never mean turning a blind eye. Though rare, allergies do happen. There’s always a patient out there who’s sensitive to polyoxyethylene compounds. As drug recipes grow more complex, risk assessments do too, and doctors pay attention when a patient responds badly. Every ingredient needs its spot on the label.
Synthetic components require clean, consistent manufacturing. If the production process goes wrong, residues like ethylene oxide or heavy metals sneak in. Regulators set low limits, but slip-ups create risk. One recall or contamination case can do lasting damage, not just to patients, but to trust. Rigorous testing and supplier controls matter just as much as any written standard.
I’ve seen questions about pharmaceutical ingredients grow over the years. Folks deserve to know what they’re taking, not just the active drugs but what holds a pill together or makes a cream smooth. Doctors often struggle to answer questions about the purpose or safety of ingredients like Polyoxyethylene (8) stearate. Pushing for clearer patient information helps everyone. Drug companies could do a better job talking about how excipients are vetted and how allergic reactions show up. Doctors and pharmacists play a role by reporting any suspicious reactions, helping regulators adjust guidelines so people stay safe.
Polyoxyethylene (8) stearate isn’t some fringe ingredient. Its track record in pills and creams shows value. Safety stays strong as long as strict standards and good manufacturing habits stick around. The real key isn’t dropping time-tested additives, but updating how risk is monitored and how information gets to the people who use these medicines daily.
Polyoxyethylene (8) Stearate, common in pharmaceutical labs, rewards careful treatment. Moisture and temperature play big roles in keeping this compound effective, which hits close for anyone who’s managed pharmaceutical stockrooms for years. Temperature swings and carelessness have destroyed more than a few valuable ingredients over time, which always leads to headaches further down the production line.
Long-term stability starts with controlled temperatures — a cool, dry room keeps this compound at its best. Temperatures should stay below 30°C, away from direct sunlight and away from heat sources that slowly sap quality. If humidity sneaks up, clumps or stickiness appear, and at that point, the lot risks turning useless. Airtight, sealed containers stop ambient moisture from getting in, whether it’s summer or the warehouse shifts from cold nights to muggy afternoons.
Chemical compatibility also matters. Cross-contamination ruins pharma batches fast. Polyoxyethylene (8) Stearate should stay in containers made with lined metal, polyethylene, or glass. Metal drums without proper lining sometimes cause reactions, so it pays off to check before stacking barrels side-by-side. Labeling each container clearly stops mistakes before any staff grabs the wrong barrel or measures out a tainted sample.
Personal protective equipment isn’t a box to tick — anyone who's spilled even a little bit knows skin exposure can irritate after hours on the job. Gloves and work goggles form that first line of defense, especially in busy mixing rooms. Powder forms billow and drift on lightweight air currents, so dust masks and local exhaust fans really cut down inhalation risks.
Handling Polyoxyethylene (8) Stearate should always take place well away from food and drink prep areas, even if the powder looks clean. Trace amounts transfer easily, and no one wants to explain how a pharmaceutical excipient ends up anywhere near lunch. Consistent training and hazard communication keep people aware, and regular checks of storage protocol help catch issues before routine turns into shortcuts.
Hazards usually show up through shortcuts. People rushing can overlook a cracked seal or skip the weighing room ventilation. Spilled polyoxyethylene (8) stearate can get greasy and slippery underfoot, leading to injuries or expensive cleanups. Having spill kits available and teaching staff to react quickly helps shut down these problems as soon as they appear.
Waste disposal brings legal and environmental risks. Manufacturers need up-to-date local guidelines for chemical disposal. In practice, that often means coordinating with licensed chemical waste companies instead of tossing residue down a drain. Carelessness can cost a company not just fines but public trust, which always feels harder to fix.
Proper shelves, air conditioning, and consistent humidity monitoring cost money up front but slash loss rates in the long run. I’ve seen companies move from cardboard boxes in open rooms to airtight plastic bins with desiccant packs and the difference isn’t subtle — fewer complaints, fewer recalls, and steadier production numbers. Leadership backing makes all the difference. When company culture supports regular training, audits, and equipment upgrades, everybody benefits, not just the bottom line.
A straightforward approach grounded in facts and discipline protects both the quality of Polyoxyethylene (8) Stearate and the people handling it every day. The steps may seem simple on paper, but they demand attention, resources, and buy-in at every level.
Walk into any pharmaceutical lab and you’re bound to see bottles labeled with long, tongue-twisting words. Polyoxyethylene (8) stearate stands out on these lists. Known for reliable emulsifying properties, this compound brings water and oil together, creating stable mixtures. Major pharmacopoeias—BP, EP, and USP—back its use. It pops up in creams, syrups, tablets, and ointments across pharmacy shelves.
Drug makers appreciate excipients that pull double duty. Polyoxyethylene (8) stearate handles both oral solutions and topical creams. Having worked in compounding pharmacies, I’ve watched how pharmacists reach for this emulsifier when a simple, clear liquid is needed for a flavor syrup, or a soft, smooth cream called for a skin ointment. The excipient’s history in drug development proves its value for oral and skin-contact products.
For oral use, polyoxyethylene (8) stearate helps keep flavors consistent and medicines dissolved. It stabilizes suspensions, so that no one receives an unpredictable dose if a bottle sits on the shelf. Consumers take it for granted that cough syrups remain smooth and palatable. Beyond taste, this ingredient coaxes fatty substances, like certain vitamins, into water-based mixtures, improving absorption in the digestive tract.
When used on skin, polyoxyethylene (8) stearate forms stable creams that spread easily. Dermatologists know patients won’t use greasy formulations, and children stay away from gritty ointments. This stearate keeps creams soft, pleasant, and gentle—crucial for those with delicate or broken skin. By drawing oil and water together, it delivers active molecules evenly, supporting both over-the-counter and prescription treatments.
No one wants unfamiliar chemicals in their medicine. Polyoxyethylene (8) stearate comes with a safety profile backed by long-term use and regulatory scrutiny. Regulatory agencies across the globe require strict adherence to quality: BP, EP, and USP each outline ways to avoid unwanted contaminants like ethylene oxide residues. Even with versatile uses, the stearate must pass purity tests before reaching any formulation. Manufacturers keep vigilant, since regulations trigger spot checks and batch audits. Some companies even run yearly reviews of their suppliers and testing protocols.
Questions always arise about tolerance and allergies. Not every excipient suits every patient. Rare cases of hypersensitivity have turned up in the literature. Formulators stay on guard for any sign an ingredient triggers discomfort. Those working around infants, the elderly, or immunocompromised patients check the safety record even more frequently. The World Health Organization and national health agencies regularly review available data to ensure ongoing safety.
Some pharmaceuticals now reflect an eco-conscious trend. Manufacturers look for biodegradable options or excipients with lower resource demand. Polyoxyethylene (8) stearate, derived from stearic acid and ethylene oxide, follows a well-established supply chain. Sustainability watchdogs are also beginning to analyze its production impacts, though established suppliers usually align manufacturing with current environmental rules.
Looking across pharmacies and clinics, polyoxyethylene (8) stearate’s dual role meets industry and patient expectations. It deserves trust because of consistent performance, robust regulatory standards, and adaptability in both oral and topical formulations. Still, vigilance stays essential. Scientists, pharmacists, and regulators keep reviewing its use, so it remains both safe and effective for patients in every setting.
| Names | |
| Preferred IUPAC name | Octaoxyethylene stearate |
| Other names |
Polyethylene Glycol 8 Stearate PEG-8 Stearate Macrogol Stearate 8 Polyoxyethylene Stearate Ethoxylated Stearic Acid Polyoxyethylene (8) monostearate POE (8) Stearate Stearic acid ethoxylate (8 EO) |
| Pronunciation | /ˌpɒliˌɒksiˌɪθɪˌliːn eɪt ˈstɪəreɪt/ |
| Identifiers | |
| CAS Number | 9004-99-3 |
| 3D model (JSmol) | `3D model (JSmol) string` for **Polyoxyethylene (8) Stearate**: ``` CCCCCCCCCCCCCCCC(=O)OCCOCCOCCOCCOCCOCCOCCOCCO ``` This is a SMILES string representation, which is compatible with JSmol for 3D visualization. |
| Beilstein Reference | 25919-79-9 |
| ChEBI | CHEBI:53421 |
| ChEMBL | CHEMBL1201564 |
| ChemSpider | 10475 |
| DrugBank | DB11097 |
| ECHA InfoCard | 03e1ccbb-b99e-4b29-bede-8280ab572e45 |
| EC Number | 9005-67-8 |
| Gmelin Reference | 73154 |
| KEGG | C16147 |
| MeSH | D004967 |
| PubChem CID | 123940 |
| RTECS number | WL3450000 |
| UNII | X45RDJ8T38 |
| UN number | UN3082 |
| Properties | |
| Chemical formula | C40H80O9(C2H4O)8 |
| Molar mass | 684.9 g/mol |
| Appearance | White to off-white waxy solid or powder |
| Odor | Odorless |
| Density | 1.08 g/cm³ |
| Solubility in water | Soluble in water |
| log P | 2.6 |
| Vapor pressure | Negligible |
| Basicity (pKb) | pKb 15.7 |
| Refractive index (nD) | 1.455 – 1.475 |
| Viscosity | Viscosity: 300 – 400 cP |
| Dipole moment | 1.840 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 675.5 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -2190 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -3335 kJ/mol |
| Pharmacology | |
| ATC code | A06AD15 |
| Hazards | |
| Main hazards | May cause eye, skin, and respiratory tract irritation. |
| GHS labelling | GHS07, GHS irritant |
| Pictograms | GHS07, GHS09 |
| Signal word | Warning |
| Hazard statements | Hazard statements: Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008 (CLP/GHS). |
| Precautionary statements | Keep container tightly closed. Store in a cool, dry place. Avoid contact with eyes, skin, and clothing. Wash thoroughly after handling. In case of contact, rinse immediately with plenty of water. Use with adequate ventilation. |
| NFPA 704 (fire diamond) | NFPA 704: "1-1-0 |
| Flash point | > 215°C |
| Autoignition temperature | > 238 °C |
| Lethal dose or concentration | LD50 (oral, rat): >25,000 mg/kg |
| LD50 (median dose) | LD50 (oral, rat): 25,000 mg/kg |
| NIOSH | TRN9485000 |
| PEL (Permissible) | PEL: Not established |
| REL (Recommended) | Up to 50 mg/kg body weight |
| IDLH (Immediate danger) | Not listed |
| Related compounds | |
| Related compounds |
Polyoxyethylene (20) Stearate Polyoxyethylene (40) Stearate Polyoxyethylene (100) Stearate Polysorbate 20 Polysorbate 40 Polysorbate 60 Polysorbate 80 |
Chengguan District, Lanzhou, Gansu, China
