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Glycerol monooleate stands as a prime example of how chemistry, over time, can change the face of the pharmaceuticals and personal care industries. In the early 20th century, researchers started taking esters of glycerin and fatty acids beyond food and soap, entering the medicine cabinet. Over decades, scientists refined glycerol monooleate and set standards for quality and purity, eventually aligning it with the growing demands of regulated markets. Standards like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) came about due to an urgent need for reliability, especially in the pharma world where inconsistencies can cost more than money. It is not a surprise that by the second half of the 20th century, this compound found its place in emulsions and delivery systems crucial to drug formulation and release. Its journey through the European and American regulatory systems shaped its modern image as a well-characterized, high-purity substance.
In pharma-grade form, glycerol monooleate 40 often features about 40% monoester content. This profile helps meet strict regulatory requirements and underpins its function as a stabilizer, solubilizer, and emulsifier. Its physical form, a white to pale yellow waxy solid or liquid depending on temperature, makes it easy to handle and incorporate into both solid and liquid drugs. A manufacturer choosing this grade for tablet coatings or ointment bases knows what they’re getting. Glycerol monooleate holds onto a reputation for being non-toxic in sensible quantities and is valued for being both biodegradable and compatible with a wide range of excipients.
Chemically, this compound is a monoester of glycerol and oleic acid, giving a C21H40O4 signature. Its melting point hovers in the 34-38°C range, so it remains pliable over a broad process window. It has moderate solubility in ethanol, strong miscibility with oils, and low solubility in water. The hydrophilic-lipophilic balance (HLB) lies around 3.4, leaning strongly toward oil solubility, perfect for water-in-oil emulsions. Specific gravity checks in at about 0.95, and its iodine value, which nods to the unsaturated tail, reflects the underlying chemical reactivity. The fatty acid profile likely matches high-purity oleic acid, and the monoester content guarantees most of the molecules do exactly the job they’re chosen for: acting as selective surfactants and carrying active ingredients.
Quality-minded suppliers test for acid value, saponification value, color index, monoesters percentage, free glycerol, and moisture content. The best lots show acid values below 5 mg KOH/g and monoester percentages at or above 40%, hence the “40” in the trade name. Color often falls below 4 on the Gardner scale, offering visual assurance of purity. Proper labeling on pharma grade stock means full traceability: batch number, manufacturer details, production and expiry date, and storage instructions. This isn’t just to comply with regulations but to keep patients and researchers out of harm’s way.
Industrially, the preparation draws on direct esterification or interesterification of glycerin and high-grade oleic acid (often from vegetable oils). Process engineers drive the reaction under reduced pressure and moderate heat, pulling off water to promote the ester bond. Catalysts, sometimes mineral acids or even enzyme systems, push the yield higher and cut down reaction time. Post-synthesis, purification tackles leftover reactants, diglycerides, and color bodies through distillation, filtration, and sometimes molecular sieving. This keeps batch-to-batch performance tight, which sets pharma-grade glycerol monooleate apart from more variable industrial material.
In the lab, this monoester behaves as chemists predict. The ester group readily undergoes hydrolysis under acidic or alkaline conditions, breaking down to its parent alcohol and acid. Under oxidative stress, the unsaturated tail reacts, which means careful storage and deliberate formulation choices in pharmaceuticals. Chemists sometimes tweak the molecule for specialized applications, acetylating the remaining hydroxyls or saturating the double bond to shift solubility and oxidative stability. But in pharma, pure, unmodified monooleate is usually preferred for its predictable behavior and biocompatibility.
Suppliers and pharmacopeia listings may call this product glyceryl monooleate, monoolein, 1-(cis-9-octadecenoyl)-rac-glycerol, or even Glycomul-O. International shipments sometimes carry local trading names, but quality regulators recognize it by CAS number 25496-72-4. This tangle of synonyms sometimes slows down literature searches, but in the end, careful researchers always confirm chemical structure and grade.
Working with glycerol monooleate means following good manufacturing practice and keeping to recommended temperature ranges, ideally cool, well-ventilated, and away from light or oxidizers. Standard handling, transfer, and blending equipment constructed of stainless steel holds up well. Accidental ingestion at high levels could cause minor digestive upset, though at pharmaceutical dosages, long histories of safe use back up regulatory approval. Operators use gloves, goggles, and lab coats. Fire risk remains low, and its easy clean-up boosts operational safety in busy plants.
Formulators rely on this excipient most in sustained-release tablets, topical creams, ointments, and some specialty injectables. Its strong emulsifying action lets it stabilize water-in-oil mixtures, an asset in transdermal, oral lipid-based, and eye drop drug systems. In soft gel capsules, it enhances bioavailability of poorly soluble drugs. Glycerol monooleate steps up in nutritional supplements, vaccines, veterinary medicines, and cosmetic shipments. Its non-toxic profile and broad European and US pharmacopoeia approval spur research into even more innovative uses.
Researchers continue finding new delivery routes for complex drugs, and glycerol monooleate is often picked as a carrier when they need reliable, biocompatible fats. Its self-emulsifying properties power micro- and nanoscale drug vehicles, opening up more ways to boost absorption. One example came out of a recent industry project aiming to deliver oral peptides with better systemic uptake. That group got promising results using monooleate-based emulsions, which resisted breakdown in gastric fluids. In advanced wound care, new gels use monooleate to ease drug incorporation in therapeutic dressings. Its structure attracts biotechnologists wanting to anchor enzymes, proteins, and even nanoparticles in controlled-release setups.
Long-term studies in rodents and human volunteers show short exposures at or below pharmaceutical levels cause no measurable toxic effects, allergic reactions, or carcinogenicity. Regulatory bodies read and review these dossiers across multiple drug submissions. That said, researchers do watch for unusual immune responses, especially with chronic use, and regulators require full trace contamination profiling in every pharma batch. Manufacturers test for residual solvents and potential cross-contamination with related fatty acid esters at parts-per-million sensitivity, proving they take public health seriously.
Rising interest in targeted therapeutics, personalized medicine, and low-toxicity excipients points toward more use of glycerol monooleate in the future. As drug makers push for new oral, dermal, and injectable systems that challenge old excipients, compounds with simple, well-characterized structures gain favor. Cost pressures drive every sector, so larger suppliers are scaling up production without losing the tight analytical controls demanded in pharma. Sustainability demands are also shaping sourcing decisions—buyers increasingly check for documented, renewable-input supply chains. In the next decade, new patents and clinical trials could establish monooleate as a preferred excipient for hard-to-deliver drugs and next-generation medical formulations.
People hear “Glycerol Monooleate 40 BP EP USP Pharma Grade” and their eyes glaze over. I get it—it sounds like something you would only need inside a lab, hidden away behind a wall of paperwork and safety glasses. In truth, this ingredient plays a much bigger part in modern medicine than most expect. For anyone who has ever swallowed a gel capsule or used a topical cream, Glycerol Monooleate has touched their lives.
Here’s where things get real. Picture a time you popped a pill and wondered how the stuff inside gets to work. Glycerol Monooleate acts as an emulsifier, supporting medications to carry active ingredients to where they matter. In simpler terms, it helps ingredients mix, dissolve, and get delivered to the right parts of your body. That solves a fundamental problem in pharma: oil and water don’t mix, but drugs often need to blend both. This ingredient supports that bond.
Any parent knows the feeling of reading every word on a medicine box for their kids. The terms BP, EP, and USP attached to Glycerol Monooleate aren't just fancy extras. These are accepted quality standards, making sure what goes into medicine is both safe and reliable. Personally, I care about this any time I see someone reach for a lifesaving medication. Poor quality ingredients can put people at risk, especially those with chronic conditions who depend on daily doses. Strict standards change the game here.
It’s hard to overstate how important this compound is for the feel and performance of all sorts of products. In creams, it helps create texture that absorbs evenly. For soft-gel capsules, it gives stability and keeps them from breaking apart too soon. Glycerol Monooleate helps active drugs break apart and get absorbed more predictably. That can mean less stomach upset, faster relief—or a child who manages to take their medicine without a fight. In our house, anything that makes medicine taste less terrible earns a gold star.
Of course, nothing’s perfect. Some worry about synthetic ingredients and potential side effects. The truth is, pharma relies on transparent research, steady regulation, and honesty about risks. The solution? Support more independent research and better education, so patients and healthcare workers understand what’s in the products they use. Personally, I think there’s another step: encourage manufacturers to keep looking for new sources—plant-based or otherwise—to build trust and address allergy concerns.
Glycerol Monooleate might sound like just another line in an ingredient list, but behind it sits real progress in making medications safer and more effective. With chronic disease on the rise and older populations needing more targeted drugs, the role of reliable emulsifiers keeps getting bigger. This isn’t just chemistry—it’s a question of health, access, and trust every time someone opens a bottle or peels the seal off a new tube.
Pharmaceutical companies often turn to Glycerol Monooleate 40 (GMO 40) because of the unique things it offers during tablet and capsule production. Manufacturers lean on it as an emulsifier and stabilizer. This compound holds up well during rough mixing and can help active ingredients mix better with liquids and powders.
As someone with a background in pharmacy, I’ve seen how crucial excipients like GMO 40 are in getting medicines to work the right way. Without the right “helper” ingredients, you may end up with clumping, poor absorption, or unstable finished products. GMO 40 can help solve some of these headaches. By keeping fats, oils, and water-loving ingredients together, it opens the door for smoother manufacturing — but beyond the process side, safety stays top of mind.
The big question always circles back to safety. The Food and Drug Administration (FDA) lists GMO and similar mono- and diglycerides as “Generally Recognized as Safe” (GRAS) additives for food, which sets a strong starting point. Researchers have looked at toxicology, absorption, and metabolic breakdown, with studies showing that GMO 40 breaks down into glycerol and oleic acid, both of which the body already handles via normal digestion. Long-term feeding studies in animals rarely turn up toxicity, even at much higher doses than those seen in drug formulations.
Still, being used in food doesn’t automatically green-light a chemical for medicine. Pharmaceutical use often involves more scrutiny. There’s always the off-chance someone is sensitive or allergic, though the records available reveal little to no reports of genuine allergic reactions. Any real risk tends to stem from poorly controlled manufacturing, where impurities might sneak in or where the ingredient isn’t held to tight quality standards. That’s not a science fiction scenario—years ago, some excipients imported from facilities cutting corners stirred up concerns about impurities, especially in less regulated markets.
Pharmacopeias such as the United States Pharmacopeia (USP) and European Pharmacopeia set clear rules on purity, residue, and labeling. Pharmaceutical companies are expected to source GMO 40 only from suppliers who can trace each batch and who test against strict specs. I’ve seen manufacturers pull lots or change suppliers just to keep up with these standards. Testing ensures the ingredient is free from harmful levels of heavy metals, pesticides, or other byproducts that could pose problems down the line.
Regulatory agencies keep a sharp eye out for excipient safety, often requiring fresh safety data if companies want to use these ingredients in new or different ways. In countries with strong oversight, pharmaceutical-grade GMO 40 gets tested for impurities and stability. Batch consistency also matters, and this gets checked every time it is used. That means safer medicine for people who count on it.
Staying informed about what goes into medication makes sense. Anyone with sensitivities will want to check ingredient lists, especially in compounded drugs or imported products. Doctors and pharmacists play a role in educating patients about excipients and helping them report any unusual side effects. On the company side, focusing on trusted suppliers and full transparency throughout the supply chain keeps risks low.
Glycerol Monooleate 40 has proven itself through years of use and testing. Monitoring, transparency, and smart sourcing protect safety so patients and caregivers have less to worry about as new ingredients get added to medicines we rely on daily.
Few people outside the pharmaceutical and food sectors spend much time thinking about Glycerol Monooleate 40, but for product safety and reliable results, the details of its specification and purity levels matter. In my years handling excipients and additives for pharmaceutical formulations, I’ve seen just how big a difference it makes when sourcing only top-grade ingredients. Regulators set the bar high for substances used in medicine and food, so staying informed about these requirements isn’t just paperwork — it’s public health.
Glycerol Monooleate 40 has to meet the demands of three pharmacopeial standards: British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). These standards focus on clear benchmarks:
Dealing with Glycerol Monooleate in a development lab taught me that impurities aren’t just numbers on a specification sheet. Mixing lower-purity glycerides in complex formulations can lead to cloudiness in solutions, unpredictable shelf life, and even allergic responses in vulnerable populations. More than once, I’ve watched colleagues scramble to trace stability issues back to hidden impurities that only appeared with closer chemical analysis.
High purity also plays into regulatory compliance. The FDA, MHRA, and EMA all review supplier data. A recall or warning letter over dirty inputs can derail entire projects. Some colleagues still talk about an episode where an excipient provider lost certification over trace pesticide contamination — a situation entirely avoidable with better sourcing and tighter testing.
There’s plenty of room for smarter systems in the world of Glycerol Monooleate quality. Companies embracing regular third-party audits and cross-lab checkups catch problems before they land on the production line. Transparent supplier agreements and direct-from-manufacturer purchases help avoid brokers whose sample quality doesn’t match their shipments.
Switching to high-sensitivity analytical testing offers another safety net. Techniques like gas chromatography and mass spectrometry can pick up subtle solvents or environmental contamination that pass routine tests. On-site teams also benefit from ongoing training, since knowing what’s at stake raises everyone’s standards.
Trust in product safety starts with raw materials. Manufacturers find peace of mind when they keep Glycerol Monooleate quality at the front of their minds, not just as a checkbox but as a commitment to patients and consumers. In my experience, this attention often makes the difference between hitting the market smoothly and running into costly regulatory delays.
Pharmaceutical companies look for both safety and performance in excipients. Glycerol Monooleate 40 stands out for its ability to stabilize and emulsify drug formulations. This ingredient supports the delivery of active compounds, especially in oral and topical products, adding value to both manufacturers and healthcare professionals. Choosing a high-quality, stable batch can mean the difference between a medicine that delivers its intended effect and one that fails patients or sits unused on a shelf.
Product shelf life always comes down to stability data and practical experience. Glycerol Monooleate 40 Pharma Grade, stored under recommended conditions, generally holds its properties for about two years. This isn’t just a detail. Medicine makers rely on that window, since any breakdown in the excipient can compromise finished product safety or lead to costly recalls. I’ve spoken with pharmacists who double-check storage dates on such ingredients, especially if they supply both large batches and small, customized blends.
Quality doesn’t just slip suddenly; changes creep in as the material sits exposed to air, heat, or moisture. Hydrolysis and oxidation, for example, can alter both purity and functional performance. These changes risk patient outcomes, particularly when a formulation calls for precise ingredient profiles.
Reliable storage makes all the difference. Glycerol Monooleate 40 keeps best in a sealed container, away from sunlight and moisture. Cool, dry storage slows chemical changes. Even a few degrees difference in room temperature influences the material’s stability over time. Humidity, an old enemy in most pharmaceutical warehouses, can trigger hydrolysis and spoil the texture or reactivity of the product.
Pharma professionals frequently set up double seals or nitrogen-blanketed storage to cut down on oxidation. I remember a compounding pharmacy that lost an entire drum due to a cracked lid and high summer heat—they switched to climate-controlled storage afterward, which protected not just Glycerol Monooleate 40 but other sensitive excipients as well. Small steps like labeling with both the arrival and expiration dates help keep inventory fresh, avoiding waste and saving costs.
One overlooked risk comes from improper repackaging. Moving Glycerol Monooleate 40 to smaller bottles for sampling or batching exposes it to oxygen and humidity, especially when rushed or handled during humid seasons. This raises the chance of product degradation or cross-contamination. Staff training in clean, quick transfer methods prevents most losses.
Pharmaceutical firms invest in regular quality checks. Running simple tests for acidity or visual clarity can flag a problem before it escalates. Suppliers sometimes offer a “Certificate of Analysis” with each lot, but trust ultimately comes from the end-user double-checking each batch remains in spec throughout its shelf life.
Investing in reliable storage equipment pays off. Close monitoring of temperature and humidity with electronic loggers adds reassurance. Regular inventory turns, clear storage guidelines for warehouse staff, and rapid isolation of expired lots build a culture of safety. These habits reduce waste, protect reputations, and ensure patients get stable, effective medicines. Glycerol Monooleate 40 may quietly underpin many formulations, but giving it the right care behind the scenes does more for drug safety and quality than any marketing campaign ever will.
Glycerol Monooleate 40 shows up in quite a few pharmaceutical and food applications. This emulsifier blends oils and water, and it also helps pills hold together. You will spot it listed in countless ingredient decks because it supports many processes, not just in the lab but in actual products on shelves. With demand so high, every pharmacist and manufacturer asks a similar question: is it up to the standards set by the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP)?
Pharmacopoeia standards act as a gatekeeper for quality and safety. These published requirements get updated from years of work by scientists and regulatory bodies. They don't just describe what a substance looks like or how pure it is; they lay out everything from allowable contaminants to exact assay results. Anyone creating something people will ingest, inject, or absorb needs to pay attention here.
For Glycerol Monooleate 40, BP, EP, and USP all specify purity levels, identification tests, and allowable impurity limits. Genuine compliance means passing tests for acidity, residual solvents, and heavy metals, and hitting target values for contents of mono- and diglycerides and fatty acid composition. Manufacturers who fall short don’t just break rules on paper—there’s a real risk to patient safety or drug stability.
Plenty of suppliers claim to deliver Glycerol Monooleate 40 that reaches the bar for BP, EP, and USP standards. Problems begin with documentation—someone might call a product “pharmaceutical grade,” but labels and certificates don’t guarantee compliance without detailed, batch-specific testing. Speaking from experience working in a contract lab, it’s not unusual to get raw materials that appear fine on the surface, only to find copper or other heavy metals at unacceptable levels.After all, global supply chains toss in wild cards. Some factories operate under stricter controls than others. A product coming from Europe or Japan often brings solid traceability and data, but the same compound from an unknown factory overseas may cut corners and skip crucial tests. Sooner or later, someone’s product fails release, and everyone scrambles to find out where the breakdown happened.
People trust medicines because they trust the systems behind them. If Glycerol Monooleate 40 fails to match BP, EP or USP criteria, it puts patients at risk and can disrupt supply for critical medicines. Drug recalls and regulatory actions burn through budgets and reputations. Companies that treat compliance as an afterthought get caught sooner or later.
Full alignment with BP, EP, and USP isn’t automatic. Manufacturers who want to meet these standards should build quality at every step—from sourcing fats and oils to running every batch through documented tests. As a buyer, leaning on trusted suppliers and demanding full specification reports isn’t an extra step; it’s the minimum for patient and product safety.
Third-party labs can run verification and catch issues before product launches or regulatory inspections. The chemistry isn’t the roadblock. Many times, investment in better controls and stricter documentation saves time and money in the long run, compared to dealing with a failed batch.
| Names | |
| Preferred IUPAC name | 2,3-dihydroxypropyl (Z)-octadec-9-enoate |
| Other names |
Glyceryl Monooleate GMO Monoglyceride Oleic Acid Monoolein Glycerol Monoolein 1-Monoolein |
| Pronunciation | /ˈɡlɪs.ə.rɒl ˌmɒn.oʊˈoʊ.leɪ.ət ˈfɔːrti ˌbiː ˈpiː ˌiːˈpiː ˌjuːˈɛsˈpiː ˈfɑː.mə ɡreɪd/ |
| Identifiers | |
| CAS Number | 25496-72-4 |
| Beilstein Reference | 2634095 |
| ChEBI | CHEBI:53615 |
| ChEMBL | CHEMBL1233312 |
| ChemSpider | 8178806 |
| DrugBank | DB04077 |
| ECHA InfoCard | ECHA InfoCard: 100.029.646 |
| EC Number | 267-008-6 |
| Gmelin Reference | 8266 |
| KEGG | C02595 |
| MeSH | D005957 |
| PubChem CID | 24699 |
| RTECS number | MJQ1F9V6EK |
| UNII | 4H5P6VH59D |
| UN number | 'UN number: Not regulated' |
| CompTox Dashboard (EPA) | DTXSID8057507 |
| Properties | |
| Chemical formula | C21H40O4 |
| Molar mass | 356.54 g/mol |
| Appearance | Pale yellow oily liquid |
| Odor | Odorless |
| Density | 0.94 g/cm³ |
| Solubility in water | Insoluble in water |
| log P | -1.1 |
| Vapor pressure | <0.01 mmHg (20°C) |
| Basicity (pKb) | 8.9 |
| Magnetic susceptibility (χ) | -8.5×10⁻⁶ |
| Refractive index (nD) | 1.463 – 1.467 |
| Viscosity | Viscosity: 85-98 cP |
| Dipole moment | 2.65 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 665.8 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | –1486 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -4040 kJ/mol |
| Pharmacology | |
| ATC code | A06AG04 |
| Hazards | |
| Main hazards | Not regarded as a health or environmental hazard under current legislation. |
| GHS labelling | GHS labelling: Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008 (CLP). |
| Pictograms | GHS07 |
| Signal word | No Signal Word |
| Hazard statements | No hazard statements. |
| Precautionary statements | Precautionary statements: P261, P264, P270, P272, P273, P280, P302+P352, P305+P351+P338, P333+P313, P337+P313, P362+P364 |
| NFPA 704 (fire diamond) | 1-1-0 |
| Flash point | > 210°C |
| Autoignition temperature | 430°C |
| Lethal dose or concentration | LD50 (Oral, Rat): > 50,000 mg/kg |
| LD50 (median dose) | LD50 (median dose): 50 g/kg (oral, rat) |
| NIOSH | Not listed |
| PEL (Permissible) | 10 mg/m3 (mist, total) |
| REL (Recommended) | 100 gm |
| Related compounds | |
| Related compounds |
Mono- and diglycerides of fatty acids Glycerol monostearate Glycerol monopalmitate Glycerol monolaurate Glyceryl triacetate Propylene glycol monooleate |
Chengguan District, Lanzhou, Gansu, China
