Contact Us
Chengguan District, Lanzhou, Gansu, China
© 2025 Jeifer Pharmaceutical, All Right
Reserved.
Polyethylene Glycol Monostearate Sorbitol Ester began making appearances in pharmaceutical preparations several decades back, during a period when the industry started shifting towards more sophisticated surfactants and emulsifiers. Researchers looking for compounds that could do more than just mix oil and water found themselves working with various esters. By the seventies, advances in polymer chemistry helped manufacturers turn out highly specific grades of PEG derivatives, opening doors for improvements in both drug solubility and stability. Older records from pharmacopeia updates show how the standards changed, reflecting both progress in synthesis and a better understanding of these materials in real-world applications.
This compound brings together several components. At its core, polyethylene glycol (PEG) combines with monostearate and a sorbitol backbone, resulting in something that handles water-loving and fat-loving environments at the same time. Having worked in labs where these products come off the shelf, it’s clear that their popularity has roots in their adaptability. In pharmaceutical grade, the quality standards rise high, requiring clean, consistent results and certification by BP, EP, and USP.
Polyethylene Glycol Monostearate Sorbitol Ester takes the form of a white to off-white waxy solid at room temperature, with a faint, fatty odor common among stearate compounds. As it warms, it melts easily past 50 degrees Celsius, forming a viscous liquid. The material dissolves in water to some extent, much more readily in alcohol or chloroform, giving operators flexibility depending on their process. The hydrophilic-lipophilic balance (HLB) of the compound can shift depending on the polyethylene glycol chain length and the degree of esterification, which matters a great deal in formulation development. Chemists I have worked with focus on these properties when they look for ways to improve solubility and compatibility with active pharmaceutical ingredients.
Pharma-grade material demands attention to precise figures. Typical specs put the acid value below 5, saponification value in the 45-65 range, with a moisture content under 2% for long shelf-life and stability. Particle size may also get reported for granulated forms. Ingredient lists on labels reveal synonyms and trade names, but the specifications section grabs the formulator’s attention. Quality control relies heavily on methods listed in international pharmacopeia, running spectroscopic or chromatographic validation for each lot. Consistency in labeling and traceability holds up during audits, a point companies take seriously to build trust with regulators and customers alike.
Manufacture of this ester calls for esterification of sorbitol with stearic acid, often using catalysts or acid chlorides, followed by reaction with polyethylene glycol under heat. The process looks simple on paper, but controlling the reaction conditions — like temperature and timing — decides whether the product meets pharma standards. Industrial reactors set up with vacuum and inert atmospheres keep unwanted side reactions at bay. Purification removes any unreacted starting materials, and the final product gets tested for heavy metals, microbial counts, and purity.
Chemists appreciate how small tweaks to the synthesis route can change performance. Swapping out the type or chain length of PEG alters the emulsifying and solubilizing properties, letting formulators match the needs of the drug or supplement in question. Additional chemical modifications can graft functional groups, introducing new performance features. Some research explored how partial hydrogenation of the stearate portion could reduce oxidation over shelf life, although every modification brings new questions about compatibility and safety.
Walk through any raw material catalog and you’ll see a list of alternate labels: PEG Stearate Sorbitan Ester, Polyoxyethylene Stearate, and various brand names unique to leading suppliers. The BP stands for British Pharmacopoeia, EP for European Pharmacopoeia, and USP for United States Pharmacopeia, meaning the grade meets corresponding international standards. Navigating synonyms brings challenges when searching literature or sourcing globally, as the naming conventions don’t always line up, leading to confusion or miscommunication unless cross-checking happens thoroughly.
Safety remains a core principle during manufacturing and use in pharmaceuticals. The relevant pharmacopeial monographs spell out testing for contaminants like ethylene oxide, diethylene glycol, or heavy metals, along with bioburden control. In GMP-compliant plants, operators follow strict personal protective equipment rules and handle all materials with documented batch protocols. The safety record for pharmaceutical use looks clean, supported by years of toxicological data and post-market surveillance, but new uses or modifications still require thorough evaluation.
Pharmaceutical industry professionals often turn to Polyethylene Glycol Monostearate Sorbitol Ester in oral, topical, and sometimes parenteral products. Thanks to its unique chemistry, it makes it possible to form stable emulsions for creams and ointments, or create improved suspension in liquid medications. Solid oral dosage forms rely on it for its ability to enhance wetting or solubility of active drugs, ultimately shaping bioavailability in ways that impact therapeutic outcomes. Over-the-counter creams and prescription medications alike benefit from these properties, making the product a staple for a wide range of manufacturers.
In today’s market, there is always pressure to deliver better drug formulations, which means researchers keep pushing the boundaries of excipient performance. Recent R&D efforts have looked for ways to combine this ester with other surfactants or polymers, building smarter delivery systems with controlled release or targeted uptake in the body. Laboratory studies often focus on nanoparticle formation or micelle creation, believing these approaches could allow otherwise poorly-soluble drugs to reach patients who need them. Collaboration between academic groups and industry labs keeps the pipeline full of fresh ideas and incremental improvements, many of which stem from a solid understanding of long-established agents like PEG Monostearate Sorbitol Ester.
Any compound playing this big a role in pharmaceuticals must stand up to detailed safety review. Toxicity studies typically involve acute and chronic exposure profiles in animal models, checking for organ effects, allergenicity, and metabolic pathways. It’s a relief to see that the data, so far, point to minimal toxicity at expected exposure levels, with regulatory agencies comfortable allowing use in drugs, foods, and cosmetics alike. Still, rare cases of sensitivity or irritation prompt ongoing review, which means vigilance in pharmacovigilance systems and continued research into possible byproducts or breakdown products over the product’s lifecycle.
Looking down the road, demand for versatile, proven excipients like Polyethylene Glycol Monostearate Sorbitol Ester will likely keep rising. New types of drug molecules, such as biologics or gene therapies, ask for improved delivery systems with precise control over solubility and release profiles. Engineers and chemists in the field already explore advanced modifications, taking lessons from what works now and translating them into even better performance for tomorrow’s medicines. Thanks to decades of safe use and adaptability, this molecule’s story is far from finished, with its potential applications spreading into new therapeutic and technological territories faster than ever.
Polyethylene Glycol Monostearate Sorbitol Ester, usually tucked under the lab shorthand PEG Monostearate or just PEGMS, plays a pretty quiet but important role in pharmaceuticals. Find it on the back of a bottle, and there’s a good chance most people won’t give it a second thought. Years working in pharmaceutical writing taught me to trace the domino effect of so-called “inactive” ingredients—how something that looks boring on a label can make or break the way a medicine performs.
Most folks experience PEG Monostearate through tablets and capsules. It acts as an emulsifier, a stabilizer, and a lubricant—all jobs that sound technical but mean your medication actually gets where it’s supposed to go and works as promised. Take a coated tablet: the slick surface helps the pill go down easier, but it also helps keep the active medicine inside from reacting with moisture or air before you swallow it. That stability means less waste, fewer spoilage worries, and safer dosage.
I've watched the stress that comes when a pharmacy receives a batch of medicines with varying shelf lives. The worry isn’t just paperwork—it’s about patients, especially those needing life-saving medications. PEG Monostearate matters because it prevents clumping and keeps the other ingredients from separating over time or during shipping, keeping the medicine just as effective as the day it was made.
Beyond tablets, PEG Monostearate helps blend ingredients in creams and ointments. Anyone who’s opened an old tube just to find the contents separated knows the frustration. Affected consistency leads to uneven dosing—especially in treatments for skin conditions or topical pain relief where too little or too much affects health. Reliable consistency lowers risks and avoids patient confusion. Fact remains that the right blend of excipients can keep costs down, too, because there's less risk of returns for poor quality or recalls for contamination.
Some people worry about what “extra” ingredients end up in their prescriptions. PEG Monostearate, used in regulated amounts, stays on the safer side according to the leading pharmacopoeias like BP, EP, and USP. These agencies lay out strict standards for what’s acceptable, requiring evidence and testing to protect patients. Allergic reactions remain rare, but pharmaceutical companies and the FDA keep an eye on reports and adapt if new evidence surfaces. For those with chemical sensitivities, pharmacists can often suggest alternatives or medication forms where feasible.
Better transparency about excipients would help patients feel more in control of their health. I’ve met many who want understandable explanations on their prescription leaflets—not just technical names but real language. Initiatives nudging companies toward clearer communication and clearer labelling make a real difference, especially for parents, seniors, and those with allergies or complicated medical backgrounds. Direct patient education, through pharmacists and digital apps, arms individuals with the knowledge to ask questions and spot problems early.
Staying aware of how PEG Monostearate works and why it’s chosen can help keep trust in medicine high, encourage ongoing research into even safer formulations, and give people a little more peace of mind at the pharmacy counter.
Pharmaceuticals rely on more than just active drugs to do their job. Excipients and additives like polyethylene glycol monostearate sorbitol ester pop up often in ingredient lists, especially in pills, creams, and even eye drops. PEG monostearate sorbitol ester acts as an emulsifier and solubilizer, keeping things mixed and stable during manufacturing and storage. It’s not a flashy ingredient, but it does some heavy lifting in the background.
A lot of safety information on PEG monostearate sorbitol ester comes from toxicology studies, clinical trials, and regulatory filings. The U.S. Food and Drug Administration considers some forms of PEG-based compounds, including specific sorbitan esters, as "generally recognized as safe" when used under specific limits. It’s important that not every derivative gets a blanket green light, but the ester version here has received attention for its low toxicity profiles in established doses.
According to published studies and the World Health Organization, PEG monostearate sorbitol esters don’t tend to accumulate in body tissues. Instead, they break down into smaller, more manageable pieces and exit the body through urine or feces. Allergic reactions are rare, usually popping up in people with unusual sensitivities or after high doses far past what any medicine or supplement carries.
People have raised questions about PEG compounds in general, especially when it comes to injections. Large doses or repeated exposure to polyethylene glycol-based additives can lead to problems in folks with kidney issues or certain allergic conditions. There have even been case reports of allergic reactions to PEGs in certain vaccines. That said, allergic reactions remain rare given the millions of prescriptions filled worldwide.
No pharmaceutical ingredient should get a free pass. Doctors and pharmacists watch for rare reactions, and companies still need to put every batch through purity checks. Careful manufacturing reduces the risk of contamination, especially from tiny bits left over from production. The ester form isn’t the same as pure PEG, but it still asks for tight controls.
Patients want assurance they’re taking something safe, and trust comes from open information and good science. I’ve seen firsthand how an unlabeled additive can spark confusion or worry among people on sensitive medications. It helps to know that regulators continue to monitor additives like polyethylene glycol monostearate sorbitol ester for both short-term side effects and longer-term risks. A clear explanation and honest answers give patients a solid footing for decision-making.
Continued research matters as new applications for PEG-based esters show up in drug delivery systems or new formulations. Companies can collaborate with researchers to pinpoint potential risks early, exploring alternative compounds or safer versions for people with extra sensitivities. Regulators rely on up-to-date science, so reporting even isolated reactions helps everyone move forward.
Pharmacies and healthcare providers can also flag allergies in patient records and check labels on compounded medications. Patients, too, should feel encouraged to ask about ingredients and report any unusual symptoms. Everything adds up to safer, smarter care.
Pharmaceutical products get tested and released only after meeting some of the strictest standards out there. These standards come from pharmacopeias like the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). Each has its own way of making sure a product is pure, consistent, and safe. Anyone who works in this field, whether they’re in the lab or out talking with regulators, feels the weight of these requirements every day.
The BP lays out clear specifications for pharmaceutical substances, ranging from chemical identity to the allowable amounts of impurities. For basic chemicals like paracetamol or sodium chloride, BP sets identity tests using chemical methods and ensures infrared spectra match authentic samples. Clarity matters—solutions must not look cloudy, colored, or off in any way. Limits on impurities carry real importance. BP wants to see results from high-performance liquid chromatography (HPLC) or titration, with impurity thresholds often sitting around 0.1% for unknowns and 0.5% for totals.
The EP builds on similar methods, but the breadth extends across all European countries. The spectroscopic fingerprint, whether using IR or UV-Vis, has to match exactly. EP goes a step further with heavy metal limits, often keeping them at ten parts per million or even lower, because exposure can build up over many years and cause real harm. Water content must be measured using techniques like Karl Fischer titration, and results outside the stated range quickly lead to rejected batches. The EP also demands regular microbial testing, especially for products that get used in injections or eye drops, where a contaminated vial can have serious consequences.
USP standards reflect the way testing actually happens in most American labs. Tests for identification use precise, validated analytical methods. USP often sets stricter acceptance criteria for active ingredient content—usually 98.0% to 102.0% of the labeled amount for tablets, for example. This pushes labs to tighten up calibration and documentation, creating a culture where mistakes rarely slide by. Residual solvents, organic volatile impurities, and heavy metals get tested with sensitive tools like gas chromatography and atomic absorption, with limits often matching or improving on global norms. USP monographs also spell out reference materials, which give labs the right “yardstick” for measuring quality.
Pharmacists and lab technicians see firsthand the difference that strict standards make. I’ve come across products, even from established companies, suddenly failing on a retest because storage conditions changed or a batch picked up trace contamination. If the standards weren’t there, or the tests didn’t have enough rigor, patients could face problems ranging from mild allergic reactions to life-threatening side effects. Each pharmacopeia adapts with new science, reacting to recalls and supporting traceability—an ecosystem of checks that isn’t just red tape, but literal protection for people who rely on medicines every day.
Keeping up with changing pharmacopeial chapters takes effort, especially for small manufacturers or overloaded labs. Auditors expect detailed documentation, frequent validation, and complete traceability. Training staff on why every test matters keeps lapses rare. Investing in systems like LIMS (Laboratory Information Management Systems) and regular proficiency testing keeps results reliable, even as regulations tighten. Cross-pharmacopeial harmonization projects make the job easier, but nothing replaces discipline and a well-resourced lab.
Companies can benefit from choosing reference standards approved by all three major pharmacopeias, cutting down extra testing and paperwork. Collaboration with regulators smooths the process for new products. Continuous education for scientists on the latest updates keeps skills sharp and prevents costly errors. A culture built around responsibility, from top management through to the newest technician, means fewer recalls, safer products, and long-term trust from those who rely on every tablet, solution, or treatment.
Polyethylene Glycol Monostearate Sorbitol Ester, often known by its mouthful of a chemical name, crops up in products many of us use every day. Bakers find it in everything from whipped toppings to sponge cakes. Pharma workers use it to blend tablets. Even some creams and lotions bring it into play, thanks to its clever ability to bring oily and watery stuff together.
Over the years, I’ve seen warehouse spaces packed to the rafters with ingredients. Some managers treat all powders alike. That can lead to ruined shipments and lost money. Polyethylene Glycol Monostearate Sorbitol Ester isn’t a diva, but it needs the right setup. Direct sunlight makes this stuff clump, yellow, or even melt. So, cool, dry shelf space works best. I once saw a shipment sitting at the end of an oven line—within two days it had fused into a sticky chunk. Keep factory heat and sunlight away, it pays off.
This material absorbs moisture like a sponge, making sealed packaging important. Humid air softens and degrades the powder. I’ve found that plastic drums or metal tins with tight lids cut down on losses. Closing the lid right after scooping—every time—keeps bugs and humidity out.
Food and pharma rules don’t leave room for sloppy work. I’ve visited sites where staff handled scoop after scoop using open hands and old containers. Sometimes this led to cross-contamination. Using clean, dry scoops and gloves isn’t fancy, it’s just common sense. Dedicated tools and containers keep batches free from dust and other ingredients. Staff training matters too. New hires often think any old scoop will do, but reminders and clear signage help build the right habits.
Polyethylene Glycol Monostearate Sorbitol Ester is stable—within reason. Overheating can break it down. Storage below 30°C preserves its texture and keeps chemical changes at bay. Stack packages away from radiators and don’t pile too high, since the material can get compacted under heavy weight.
It may not carry the same risk as corrosive chemicals, but a bit of powder in the eye can sting and irritate. Breathing in fine dust never did lungs any good, either. A simple dust mask and safety glasses make a big difference, especially during transfers or large batch pours. Slips and spills can turn a floor slippery. Regular cleaning is more than just company policy; it helps keep the day running smoothly and avoids accidents.
Modern ingredient storage uses climate-controlled rooms—these work wonders by setting humidity and temperature limits year-round. In smaller outfits, even a basic dehumidifier and thermometer near the shelving help. Some teams put package labels with “open date” and “best by” so rotating stock stays simple.
Disposal deserves a mention too. Avoid pouring excess down the sink. Local rules often ask for solid waste to go to proper disposal. Connecting with suppliers and local regulators helps keep compliance easy.
Polyethylene Glycol Monostearate Sorbitol Ester has helped drive advances in food, pharma, and cosmetics. Handling it right matters just as much as recipe development or marketing. The focus stays on clean space, sealed storage, clear training, and honest respect for the rules. That’s what gives consumers confidence and businesses peace of mind.
A question that echoes across pharmaceutical circles revolves around whether a single product can bridge the gap between oral and topical uses. It's not just some technical debate tucked away in a lab—this issue shapes how people experience medicine, how companies build therapies, and how health workers treat patients.
For a product to work in an oral tablet or syrup, safety takes the front seat. The digestive system twists and churns, enzymes chew through compounds, and the whole body can absorb what’s inside that pill or liquid. Some substances get broken down by stomach acids; others can trigger allergic reactions or disrupt the gut. Anything destined for oral use must clear high bars set by organizations like the FDA or EMA.
I’ve seen headaches when trying to get a substance suitable for mouth, gut, and absorption. You must dig into every published study, look out for clinical trials, hunt down reports about toxicity or bioavailability. If there’s any risk of the product breaking down into something harmful, it’s game over.
Topical products face different hurdles. Instead of the stomach, the battleground is our skin—a living barrier that keeps bad stuff out and let’s sweat, oil, and heat go free. For medicine applied to the skin, you need to know if the product causes redness, blisters, or long-term irritation. There's no shortcut here; some compounds soak in just fine without trouble, others set off a storm of reactions.
I remember watching a clinical trial where a well-known oral medicine got reformulated as a cream. It led to rashes in most patients—turns out, fine for inside the body, bad news for the skin’s defenses. These stories remind everyone: what works inside doesn’t always play nice on the outside.
Some products, like certain antibiotics, pull off double duty and pass safety checks for both oral and topical use. Hydrocortisone, for example, sits on pharmacy shelves as a cream and inside some oral medications. Still, this isn’t true for every ingredient. Methylparaben can work as a preservative in oral syrups and topical lotions, but not all antimicrobials or actives share that track record.
Every time regulators approve a product for both worlds—by mouth and through the skin—they rely on piles of data and real-world experience. Toxicology, risk of allergies, absorption rates, and every possible side effect need solid answers.
Anyone serious about pursuing a product for both oral and topical drug use can’t skip early research. Check long-term safety records, pull out recent scientific reviews, test the product on human tissues in the lab, and run patch tests. Keep an eye out when something doesn’t add up. Get advice from pharmacists and toxicology experts. Talk to patients about any reactions they notice with either form—tablets or creams.
New drug development, especially one aiming for both oral and topical routes, demands scientific rigor and open collaboration. Every patient deserves therapy chosen not just for convenience, but for safety and proven results. By leaning on the latest evidence and staying close to the ground with patients and health professionals, the industry keeps progress moving the right way.
| Names | |
| Preferred IUPAC name | Sorbitan mono(oxyethylene) stearate |
| Other names |
PEG 400 Monostearate Polyoxyl 40 Stearate Macrogol Stearate Steareth-20 Polyethylene Glycol 400 Monostearate PEG Stearate Polyoxyethylene Stearate |
| Pronunciation | /ˌpɒliˈɛθɪliːn ɡlaɪˈkɒl ˌmɒnəˈstiːəreɪt ˈsɔːbɪtɒl ˈiːstər/ |
| Identifiers | |
| CAS Number | 9005-67-8 |
| Beilstein Reference | 1721404 |
| ChEBI | CHEBI:53274 |
| ChEMBL | CHEMBL1201472 |
| ChemSpider | 27483 |
| DrugBank | DB14153 |
| ECHA InfoCard | 03c7dc37-4ec8-41e6-9235-cf2b0b26d6b2 |
| EC Number | 500-018-3 |
| Gmelin Reference | Gmelin Reference: 199881 |
| KEGG | C02737 |
| MeSH | D009056 |
| PubChem CID | 24889988 |
| RTECS number | TR2530000 |
| UNII | C1Y4OED876 |
| UN number | UN 3082 |
| Properties | |
| Chemical formula | C64H126O24 |
| Molar mass | 604.85 g/mol |
| Appearance | White or almost white waxy solid |
| Odor | Odorless |
| Density | 1.03 g/cm³ |
| Solubility in water | Soluble in water |
| log P | -1.3 |
| Vapor pressure | Negligible |
| Acidity (pKa) | pKa ≈ 15-16 |
| Magnetic susceptibility (χ) | -7.0e-6 |
| Refractive index (nD) | 1.452 |
| Viscosity | Viscosity: 30-40 cP |
| Dipole moment | 2.89 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 560 J·mol⁻¹·K⁻¹ |
| Pharmacology | |
| ATC code | A06AD15 |
| Hazards | |
| Main hazards | May cause eye, skin, and respiratory irritation. |
| GHS labelling | GHS labelling: "Not classified as hazardous according to GHS; no pictogram, signal word, hazard statement, or precautionary statement required. |
| Pictograms | GHS07, GHS08 |
| Signal word | No signal word |
| Hazard statements | May cause eye irritation. |
| Precautionary statements | P264, P280, P270, P301+P312, P305+P351+P338, P337+P313, P501 |
| Flash point | > 220 °C |
| LD50 (median dose) | LD50 (median dose): > 25,000 mg/kg (rat, oral) |
| NIOSH | TRN8661000 |
| PEL (Permissible) | 50 mg/m³ |
| REL (Recommended) | Not established |
| IDLH (Immediate danger) | Not Established |
| Related compounds | |
| Related compounds |
Polyethylene Glycol Monostearate Sorbitan Monostearate Polysorbate Sorbitol Stearic Acid Polyoxyethylene Stearate Polyethylene Glycol Stearate |
Chengguan District, Lanzhou, Gansu, China
