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The history of polyethylene glycol monolauric acid glyceride traces back to an era when chemists began exploring new surfactants for drug formulations. Early pharmaceutical scientists faced roadblocks with poor drug solubility and erratic absorption rates. Through persistent tinkering, they discovered that by attaching fatty acid chains—like lauric acid—to a polyethylene glycol backbone, they could unlock unique amphiphilic behaviors. This blend of hydrophilic and lipophilic features led to breakthroughs in stabilizing water-insoluble drugs and enhancing delivery. In response, pharmacopeias in Europe (EP), Britain (BP), and the United States (USP) compiled standards that set precise requirements for purity, composition, and labeling, reinforcing the critical role that this molecule plays in consistent and safe drug development.
Polyethylene glycol monolauric acid glyceride acts as a multi-tool in the pharmaceutical world, serving functions from emulsifier to solubilizer to absorption enhancer. Its structure—a polyethylene glycol chain capped with monolaurin (a derivative of lauric acid linked via a glyceride)—carries a gentle but effective surfactant character. It finds a home in solid, semisolid, and liquid dosage forms. Formulators value its ability to create stable, homogenous drug dispersions, which can drive up bioavailability in poorly soluble actives. Its track record of reliable performance, evidenced through consistent results in known brands and generics, brings comfort in an industry where patient outcomes hinge on subtle differences in formulation.
This white to off-white, waxy solid often resembles a brittle resin or sometimes a pasty substance, depending on its exact polyethylene glycol chain length. It melts in the range of 40 to 55°C. Water solubility varies; lower molecular weights blend with ease, higher weights require gentle heating or extra mechanical agitation. A moderate HLB (hydrophile-lipophile balance) means formulators use it to tweak the oil-water interface—not quite as fierce as ionic surfactants, but more than enough to get moisture-loving drugs and fat-loving excipients in the same solution. Chemically, it remains stable under most pharmaceutical processes, resisting hydrolysis and oxidation as long as storage conditions stay dry and away from high heat.
Every batch must match strict pharmacopeial specifications. Typical parameters include defined polyethylene glycol chain lengths, lauric acid content, acid value, saponification value, hydroxyl number, and assay to confirm the extent of monoesterification. Color, odor, and identification tests cut out substandard or contaminated product. Labeling outlines these chemical traits, lot number, date of manufacture, and storage advice. Each grade—BP, EP, or USP—differs subtly in test limits and methodological details, but all build safety and integrity into the supply chain. From my experience reading certificates of analysis, labs leave little room for error; compliance noise triggers batch rejections at the door.
Synthesis follows a straightforward route: a transesterification reaction where polyethylene glycol meets lauric acid (or its glyceride) with a catalyst such as sodium methoxide. Conditions—temperature, time, vacuum, molar ratios—determine whether the result tilts toward mono- or diesters. Controlling side reactions limits unwanted byproducts. Several washes and sometimes distillation help purify the product. Manufacturers invest in clean reactors and tight process controls, since even slight variances ripple through the finished product’s performance. Local differences in regulatory interpretation of ‘pharma grade’ status force global companies to harmonize process documentation and traceability.
Reactive sites on both the polyethylene glycol and lauric acid components allow chemical modifications. For example, further ethoxylation may extend chain length, tilting the HLB value. Fatty acid substitutions alter the surfactant’s profile. Laboratories sometimes sulfate or phosphate the terminal groups to fine-tune compatibility with other actives or excipients. Such flexibility opens doors not only in pharma, but also in food, cosmetic, and industrial applications. Still, each tweak demands new toxicology, new stability work, and often a change in labeling and regulatory filings.
Depending on the catalog or country, this product shows up under several names: PEG Monolaurate, Polyoxyethylene Monolaurate, PEG-12 Monolaurate, and sometimes Glycol Laurate. In regulatory filings and supply chain paperwork, it’s common to see designations like “PEG 400 Monolaurate” or “PEG 600 Monolauric Acid Glyceride,” where the number reflects the average molecular weight of the PEG backbone. Trade names might further complicate identification, but each refers to a similar structure—fatty acid monoester of a defined-chain polyethylene glycol.
Safety drives usual operational measures. Industry maintains cleanroom environments to prevent microbial growth—since fatty acid esters and PEG derivatives can both serve as microbe food under the right conditions. Standard handling procedures call for protective gloves, splash-proof goggles, and dust masks during bulk transfers. High purity, confirmed by routine analyses for bioburdens, heavy metals, and residual solvents, guards patients against allergic or toxic responses. Regulatory bodies demand traceability from raw ingredient to final product. Process deviations, even those without direct evidence of harm, lead to full investigations and sometimes voluntary recalls. In over two decades of reading FDA warning letters, most problems stem from abandoned process controls or incomplete cleaning validations.
Demand flows from diverse application areas. Oral solid dose manufacturers use PEG monolaurates to solubilize BCS Class II drugs—those with low water solubility. Soft gel capsules rely on its capacity to hold oily actives without separation or crystal growth. Topical creams and ointments blend this excipient to create elegant, non-greasy textures that patients tolerate better than straight mineral oil or petrolatum bases. Injectable drugs—especially lipid emulsions—can benefit from its mild surfactant action without the harshness of ionic detergents that sometimes trigger hemolysis or allergic reactions. Nutraceutical companies and even some veterinary drugmakers draw on its flexible profile to meet stability, dosing, and absorption goals.
Researchers keep pushing boundaries. Encapsulation specialists try to wrap new vaccines and peptide drugs in PEG monolaurate-based nanoparticles for targeted oral and parenteral delivery. Modified-release tablets and pellets benefit from its potential to slow down or speed up the drug’s escape from its matrix. At scientific symposia, I have watched as poster after poster relates improvements in bioavailability for a variety of therapy areas—from antifungals to antipsychotics—when formulating with this excipient. Developers of generic drugs seek interchangeable quality, while new molecular entity projects crave the flexibility to tailor a formulation without starting over with the safety dossier.
Toxicologists probe the boundaries, seeking to understand how much PEG monolaurate can be safely ingested, injected, or applied topically. Animal studies over the years show low acute toxicity, and chronic exposure studies rarely flag organ toxicity below industry-standard threshold doses. Researchers examine metabolites—PEG, lauric acid, and traces of unchanged ester—and verify fast, reliable elimination. Allergic responses remain rare but possible; risk increases in patients with existing allergies to similar compounds. Internal toxicology teams review every literature update and signal detection case, since changes in average PEG chain length or fatty acid impurities can nudge safe dose levels. Regular collaboration with regulatory toxicologists from EMA and FDA brings confidence, but industry prepares contingency plans when safety signals emerge.
Looking ahead, PEG monolaurate stands poised to keep evolving. Innovative oral biologics, such as GLP-1 receptor agonists, demand higher-performing solubilizers, and this excipient has proven up to the challenge. Paediatric and geriatric drugs look for excipients that blend safety with ease-of-swallowing and taste-masking—the gentle nature of PEG monolaurate fits the bill. Regulatory shifts, particularly efforts to cap ethylene oxide impurities and curb environmental microplastics, will shape manufacturing techniques and quality assurance strategies. As large-scale biologics manufacturing ramps up, excipient makers anticipate renewed demand for surfactants with impeccable safety records and broad regulatory acceptance. Pharma has always thrived on molecules that do quiet, hidden work, and among those, PEG monolauric acid glyceride has earned its strong reputation.
Polyethylene glycol monolauric acid glyceride doesn’t exactly roll off the tongue, but this compound plays a crucial role in many drug formulations. This blend of fatty acid—coming from lauric acid, a substance found in coconut oil—with the water-loving features of polyethylene glycol, brings together the world of oil and water in a single substance. That’s no easy feat in chemistry, and it saves a lot of headaches for those working to turn complex pharmaceutical recipes into real, accessible products.
In tablets, creams, and even liquid medicines, this ingredient often wears the label of “excipient”—which means it isn’t there for treating a disease directly. Its job is keeping the active drug stable, helping it mix well, dissolve quickly, or reach the right spot in the body. Without helpers like polyethylene glycol monolauric acid glyceride, many pills would crumble, creams might separate, and oral mixtures could taste harsh or not work right.
Oral drugs and topical medicines face different hurdles inside and outside the body. Many active ingredients won't dissolve in water, yet the human body mostly runs on water-based systems. Polyethylene glycol monolauric acid glyceride acts as a bridge, pulling fatty molecules and water into something that holds together. That means more reliable pills and slower separation in ointments. It leads to smoother creams and more pleasant oral suspensions. Patients get a product they’re willing to take, and doctors see people stick with their prescriptions.
It’s also packed with small but key details: the fatty tail helps trap drugs that would otherwise clump together, the water-loving side helps dissolve ingredients that barely mix into liquids, and everything comes through in a way that’s not harsh or irritating. I’ve seen patients reject a medicine outright due to gritty tablets or a watery cream. Some compounding pharmacists spend hours fighting these little annoyances. This compound cuts down that battle a lot.
No ingredient is automatically risk-free, and the pharmaceutical industry takes that seriously. Polyethylene glycol monolauric acid glyceride meets strict safety checks for food and medicine use. Regulatory agencies like the US FDA evaluate additives like this, and studies publish data on its non-toxicity at the amounts found in drugs. Allergic reactions show up most often in people already sensitive to coconut or palm oils, but those cases remain rare. Pharmacists and manufacturers stay alert about new data, but compared to many synthetic substances, this one’s track record stays strong.
The rising popularity of fat-soluble drugs—like some antivirals, painkillers, and even vitamins—puts more pressure on finding ways to deliver ingredients without causing side effects or waste. As more research turns to personalized medicine, excipients like polyethylene glycol monolauric acid glyceride step out of the background. They become tools for tuning how drugs absorb, taste, or survive inside the package until someone needs them. Simple fixes like this humble compound sometimes open the door to bigger changes in how medicine reaches people. That’s something anyone can get behind: safer, more effective medications with less waste and fewer patient complaints.
Polyethylene Glycol Monolauric Acid Glyceride shows up in many pharmaceuticals as an excipient with emulsifying and solubilizing abilities. Each big pharmacopeia—British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP)—lays out its own standards to confirm you’re actually using the right material at the quality level people deserve. The real language of these pharmacopeias can throw you for a loop, but for people using or manufacturing this substance, these technical specifics aren’t just legalese. You end up relying on these specs for the patient’s safety and for the product’s reliability.
The three standards pretty much agree that the content and chemical structure of Polyethylene Glycol Monolauric Acid Glyceride matter most. They ask for a well-defined blend: mainly mono- and di-esters of lauric acid with polyethylene glycol and sometimes a bit of glycerol. The standards usually check for the range of polyethylene glycol units that form the backbone—too few, you lose solubility; too many, you get something waxy and off-spec.
Appearance means a lot, even though it seems cosmetic. Pharmacopeias ask for a white or pale yellow waxy solid or semi-solid, free from visible dirt. If the material looks odd, most seasoned formulators already start doubting purity or storage. That’s usually the first sign something went wrong during shipping or at the plant.
Identification testing gets right to the basics. These standards demand IR (infrared) spectra matching a known reference or chemical tests confirming the right ester bonds and fatty acids. Pharmacopeias use thin-layer chromatography to detect odd or rogue by-products. If you get a batch that fails this, you don’t want it near a quality medicine.
BP, EP, and USP want no less than 90% of the main esters. The range sometimes nudges up, mainly to keep inactive by-products and free polyethylene glycol below certain thresholds. If you’re mixing batches, that minimum means no room for shortcuts.
Acid value and saponification value assessments track how much free acid or ester is in there. Out-of-range results can mess with pH or the stability of finished tablets or creams. Fats and oils sometimes carry trace metals if equipment isn’t cleaned well. Tests for heavy metals, especially lead, typically hold to under 10 ppm. USP favors low peroxide and aldehyde content, since these markers show aging or risky decomposition.
Residual solvents and ethanol, if used, have strict thresholds—especially as kids and vulnerable people sometimes need medicines made with this excipient. Any sign of leftover solvent can end up as a recall or an expensive complaint from regulators.
I’ve seen suppliers offer off-spec grades when the price is right, often in emergencies, but any slip can cost much more than you save. Standards protect not only patients but anyone involved in the chain—manufacturers, pharmacists, doctors. Matching pharmacopeia specs means you get predictable performance in the real world, where temperature, humidity, and mixing equipment can introduce variables you don’t always control.
Up-to-date, validated testing methods help avoid mistakes early at the plant. Fit-for-purpose analytical tools make the difference: validated FTIR for identity, gas chromatography for solvents, strict blending protocols—these don’t just tick boxes for regulatory audits but keep people from risky substitutions or surprise product failures. Personally, I’d rather spend a bit more chasing down documentation now than answer for surprises after distribution.
Meeting BP, EP, and USP benchmarks is more than a checklist. It signals to customers and regulators that patient safety drives decisions, not just the bottom line.
Polyethylene glycol monolauric acid glyceride shows up on ingredient lists for a reason: it helps keep things smooth, mixes oily and watery stuff, and can even help certain medicines move through the stomach faster. Food companies add compounds like this to keep products stable. People in the medical field put it in creams and sometimes in capsules for its mild surfactant effects.
Over the years, research groups and food safety agencies paid attention to the safety of compounds like this one. Polyethylene glycol (PEG) by itself has been around for decades and shows up in everything from laxatives to toothpaste. Most people tolerate regular PEGs quite well, except for folks with known allergies or sensitivities. As for glycerides, our digestive system knows how to break down fatty acids. Adding lauric acid makes sense, since this medium-chain fatty acid comes from coconut oil and palm kernel oil—things people have eaten safely for a long time.
Mixing these pieces together forms the compound in question. This combo works as an emulsifier, dispersing fats in foods or pharmaceuticals. Safety research usually focuses on toxicity, allergic response, and how much actually gets absorbed. Animal studies using doses much higher than what humans ever take haven’t flagged big risks, and groups like the U.S. Food and Drug Administration (FDA) approve similar compounds for specific uses. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) assigns what’s called an "accepted daily intake" for related compounds, based on long-term studies.
My own experience in the food industry taught me that everything comes with a catch—no matter how safe a label looks. For small kids, elderly people, or anyone facing digestive issues, even commonly used chemicals can cause rare but real reactions. Some people might notice mild stomach upset from any PEG-containing product. Allergic responses sit at the far end of the risk spectrum, but they do exist.
Cross-contamination and undeclared allergens count as the biggest troublemakers in real-world use. Trace residues from production, if not managed well, might trigger reactions in sensitive people. Regulations at the manufacturing level play a big role, but consumers rarely see what happens behind the scenes. As someone who has developed new products, I learned how both the purity of an ingredient and good record-keeping help lower the odds of a mix-up.
Fact-based choices matter most when it comes to additives like polyethylene glycol monolauric acid glyceride. Labels tell part of the truth, but people still need to pay attention to any odd symptoms and talk with their doctor when adding something new. Doctors and pharmacists can help with the details, especially if someone takes regular medications or lives with conditions that increase sensitivity to additives.
For companies, transparency and ongoing testing cannot slack off. Regular third-party audits, clear documentation, and traceability of source materials let everyone sleep better at night. Companies that over-communicate about ingredient safety, sources, and testing usually earn more trust—and face fewer product recalls.
At the end of the day, compounds like polyethylene glycol monolauric acid glyceride hold up under scientific scrutiny for most healthy adults. Staying wise means balancing the proven track record with individual needs, reading labels, and keeping open lines of communication with healthcare providers.
Pharmaceutical grade products don’t leave much room for mistakes. Over the years, I’ve watched a single oversight in storage ruin an entire batch worth thousands, because someone didn’t realize how sensitive these substances are. Proper conditions aren’t just about following the rulebook—they protect patients and a company’s good name.
Even the purest product can lose its promise if left in the wrong place for too long. Most pharma grade materials should stay in a cool, dry spot—think between 2°C and 25°C. High temperatures speed up chemical reactions, and humidity can invite clumps, strange odors, or worse, a drop in quality that people might not realize until it’s too late. Direct light, especially sunlight, can also chip away at potency.
Some sensitive molecules crave tighter control. Keeping certain compounds away from light requires amber-colored containers. Others need airtight seals to keep moisture out. Failing to lock down these conditions doesn’t just hurt numbers on a test report; it opens the door for bacteria or changes that can trigger allergic reactions or altered effects in patients. The World Health Organization and FDA call for baseline rules on humidity and temperature storage, but experience teaches that you deal with a lot more than just numbers on a label. Warehouse workers have to understand that a skipped step, such as leaving a pallet in the sun, changes a product in a way that’s not always easy to spot.
Regulators ask manufacturers to publish shelf life based on real-time stability studies. These aren’t based on guesses; companies run months or years of testing, exposing samples to extreme hot and cold, wet and dry, to see how things change. Three years is a common promise for many ingredients, though certain biologics or specialty drugs can only offer one year, sometimes less. This shelf life comes with a catch: only true in unopened containers, under storage conditions spelled out on the paperwork. If someone opens a bottle too many times, or if it sits in a humid room, that three-year guarantee doesn’t mean much.
Look through a company’s internal quality control logs, and you’ll find plenty of rejected product, just because temperature tracking systems flagged a spike over a holiday weekend. This isn’t wasteful—it protects everyone down the line. Hospitals and pharmacies can’t afford to stock outdated or degraded ingredients. People’s lives often depend on getting the right dose, without surprises caused by bad storage or old material.
Modern warehouses rely on automated alarms and temperature-tracking. I’ve walked through some that look more like high-tech labs than a logistics hub. If the cooling system slips out of range, alerts go straight to on-call staff. For smaller clinics or pharmacies, the basics matter just as much. Use original containers, keep them sealed, log arrivals and expiration dates, and place the oldest stock in front. Training staff to spot unusual smells, caking, or color changes can prevent disaster.
Handling recalls and checking expiration dates carry equal weight. No one wants to see expired materials used in a rush because the right processes aren’t in place. Everyday vigilance, real training, and strong documentation make more of a difference than fancy labels or shiny marketing. Companies that take these steps seriously build trust, from manufacturing floor to patient bedside.
After years of working with new drug formulations at the bench, certain excipients turn up again and again. Polyethylene glycol monolauric acid glyceride stands out for its ability to tackle multiple jobs—standing in as a solubilizer, acting as an emulsifier, and helping control texture. In oral and topical drug work, that kind of versatility always grabs attention.
For oral formulations, a big concern is how to get poorly soluble drugs to dissolve well enough to be absorbed in the gut. Polyethylene glycol monolauric acid glyceride offers a boost here. Its amphiphilic structure allows it to form micelles, which help break up drugs that tend to clump together. There are studies showing enhanced dissolution rates for several drugs when blended with this excipient—one clinical formulation of itraconazole, for example, saw a clear increase in bioavailability using PEG-based surfactants.
The story’s similar on the topical side. The skin puts up a stubborn barrier, and creams or gels depend on excipients to help active ingredients reach deeper layers. This excipient softens the formulation, improves spreadability, and can help carry drugs past that skin barrier. Products that soothe irritated skin or deliver antifungal agents often rely on this kind of helper.
Safety has become a bigger focus over the past decade. In my own work, conducting irritation studies or checking long-term stability, it’s clear that polyethylene glycol monolauric acid glyceride has a good record. Regulatory authorities recognize its use in both food and pharmaceuticals. It’s generally tolerated in topical applications, and doesn’t trigger allergic reactions for most people. Still, the story isn’t perfect—high concentrations can lead to mild irritation, and using clean, pharmaceutical-grade material matters. I always read recent safety reports and study batch-to-batch variation.
One lesson from scaling up lab successes is this: excipients with variable quality can wreck a project. This holds especially true here, because the balance between the fatty acid and the polyethylene glycol really changes how it behaves. Pharmaceutical suppliers have improved in the past few years—indicating precise PEG chain lengths and lauric acid ratios, sharing impurity profiles, and offering good documentation. Before a new batch lands in the plant, I push for full certificates of analysis and sometimes even run verification tests. That extra up-front work pays off in the long run by preventing failures during production.
A growing number of biopharma products are demanding more from excipients. Polyethylene glycol monolauric acid glyceride is already playing a role in solid dispersions, self-emulsifying drug delivery systems, and new topical patches. The next challenge comes with patient-specific needs—finding ways to use this excipient in sensitive populations, make hypoallergenic formulations, or maybe deliver larger molecules through the skin.
In my own experience, creative formulation teams can stretch what’s possible, but every innovation must circle back to detailed safety profiles and reproducibility. Building confidence in ingredients like this means revealing all the data, sharing recent findings, and tracking every safety update.
Polyethylene glycol monolauric acid glyceride isn’t just another cog in the machine. It opens new possibilities for both tablets and ointments that help real people. Staying practical—watching raw material quality, listening to patient feedback, and learning from both published literature and our own results—keeps progress moving forward.
| Names | |
| Preferred IUPAC name | 2-hydroxyethyl (2-hydroxypropyl) dodecanoate |
| Other names |
Polyethylene Glycol Monolaurate PEG Monolaurate Macrogol Monolaurate Polyoxyethylene Laurate PEG 400 Monolaurate Polyoxyethylene Monolaurate PEG 400 ML |
| Pronunciation | /ˌpɒliˈɛθɪliːn ɡlaɪˈkəʊl ˌmɒnəˈlɔːrɪk ˈæsɪd ˈɡlɪsəˌraɪd biː-piː iː-piː juː-ɛs-piː ˈfɑːrmə ɡreɪd/ |
| Identifiers | |
| CAS Number | [9004-81-3] |
| Beilstein Reference | 1393663 |
| ChEBI | CHEBI:86321 |
| ChEMBL | CHEMBL1201471 |
| ChemSpider | 21571076 |
| DrugBank | DB11132 |
| ECHA InfoCard | 03f5a6f1-ec60-42df-aa4c-a048ad7a6ac6 |
| EC Number | 500-038-2 |
| Gmelin Reference | Gmelin Reference: 107774 |
| KEGG | C16161 |
| MeSH | Polyethylene Glycols |
| PubChem CID | 22178788 |
| RTECS number | SLBOE2015G |
| UNII | 2T06D1M41P |
| UN number | Not regulated |
| Properties | |
| Chemical formula | C15H30O5 |
| Molar mass | 344.5 g/mol |
| Appearance | White or almost white waxy solid |
| Odor | Odorless |
| Density | 1.1 g/cm³ |
| Solubility in water | Soluble in water |
| log P | -0.7 |
| Acidity (pKa) | ~4.8 |
| Basicity (pKb) | pKb: 15.2 |
| Refractive index (nD) | 1.453 |
| Viscosity | Viscosity: 35-45 mPa.s |
| Dipole moment | 3.78 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 120.6 J·mol⁻¹·K⁻¹ |
| Std enthalpy of combustion (ΔcH⦵298) | -15600 kJ/kg |
| Pharmacology | |
| ATC code | A06AD15 |
| Hazards | |
| Main hazards | May cause eye, skin, and respiratory irritation. |
| GHS labelling | GHS07, GHS08 |
| Pictograms | GHS07, GHS08 |
| Hazard statements | Hazard statements: Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008. |
| Precautionary statements | P264, P270, P273, P280, P301+P312, P305+P351+P338, P337+P313, P501 |
| NFPA 704 (fire diamond) | 1-1-0 |
| Flash point | > 220°C |
| LD50 (median dose) | LD50 (median dose): >2000 mg/kg (rat, oral) |
| NIOSH | Not established |
| PEL (Permissible) | Not established |
| REL (Recommended) | Not established |
| IDLH (Immediate danger) | Not established |
| Related compounds | |
| Related compounds |
Polyethylene Glycol Monolaurin Lauric Acid Polyethylene Glycol 400 Polyethylene Glycol 3350 Polyethylene Glycol Monostearate Glycerol Monolaurate PEG-12 Laurate PEG-6 Caprylic/Capric Glycerides Glyceryl Monostearate |
Chengguan District, Lanzhou, Gansu, China
