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Long before monolinoleic acid glyceride became a staple in pharmaceutical and food processing labs, researchers struggled to find molecules that could help deliver sensitive bioactive compounds safely into the body. By the time the 1950s rolled around, fatty acid esters began attracting attention for their role in transportation and uptake of nutrients and drugs. Laboratories in Europe and North America started examining the functions of monoacylglycerols, particularly those derived from linoleic acid. These compounds showed promise due to their amphiphilic properties, meaning they blended the characteristics of oily and watery substances. The pharma sector latched on to these advantages, and over a few decades, purity benchmarks like BP, EP, and USP standards developed to regulate quality and boost confidence in their use. Today, ingredients like monolinoleic acid glyceride still owe much of their mainstream appeal to decades-old discoveries about emulsification, compatibility, and patient safety.
Monolinoleic acid glyceride, at its core, stands as a product of careful synthesis — a monoester of glycerol and linoleic acid. You’re looking at a clear or slightly yellowish oily liquid that carries faint, fatty undertones. It doesn’t have a sharp smell. It typically meets strict pharma specifications, confirming its purity and quality. Manufacturers tune it for pharmaceutical work, maintaining consistency across batch after batch so dosing remains reliable. Over the years, industries expanded its application space, including topical preparations, oral capsules, and even emulsified injectables, all thanks to its combination of tolerability and low reactivity.
This glyceride comes with a molecular formula C21H40O4, packing a molecular weight of 356.54 g/mol. It dissolves fairly well in oils, fats, and most organic solvents, yet resists dissolving in water. Its flash point climbs above 210°C, so it handles moderate heat without breaking down. Viscosity falls in the light liquid category, making it easy to dispense and blend. Color readings, according to pharma specs, rarely exceed a faint yellow, suggesting minimal impurities. Without lingering reactivity, especially in buffered pharmaceutical environments, this glyceride rarely throws off other excipients or actives.
Sourcing a pharma-grade monolinoleic acid glyceride involves tracing every step, right from crude extraction all the way to final packaging. Drug master files typically spell out limits for free fatty acids, peroxide values, moisture content, heavy metals, and microbial count. BP, EP, and USP monographs instruct on limits for appearance, odor, saponification, and iodine values. Labels list not only the concentration and batch number but all relevant purity grades, warning symbols, and storage conditions. High-quality suppliers keep full documentation on supply chain origin, solvent use, and non-animal source guarantees to stand up to audits and regulatory checks.
Most labs prepare monolinoleic acid glyceride through controlled esterification. Technicians combine pure linoleic acid with glycerol under mild catalytic conditions, using either enzymes like lipase or chemical catalysts such as sodium methoxide. Temperature control sits at the center of the process, as it avoids side reactions leading to di- and tri-glycerides. Once the main esterification run ends, the batch undergoes purification, sometimes by distillation, chromatography, or even microfiltration to hit pharmaceutical thresholds. Each step removes unreacted acid, glycerol, or side products, resulting in a product that passes every key assay for clinical use.
In R&D or customized formulations, chemists might run mild acylation or transesterification on monolinoleic acid glyceride to adjust its solubility profile or enhance drug delivery features. Oxidation is not a friend—linoleic double bonds will oxidize in the wrong storage or mixing conditions, which is why antioxidants sometimes get introduced for shelf stability. Derivatization happens rarely in pharma, as modifications can impact both absorption rate and tolerability. Chemically, it resists saponification under neutral conditions but reacts swiftly with strong alkali, a trait leveraged in certain diagnostic reagent kits.
Search through product catalogs, chemical registries, or regulatory filings, and monolinoleic acid glyceride appears by several labels. You might see it listed as glyceryl monolinoleate, 2-Monolinolein, or monoacylglycerol C18:2. These names often reflect source or composition, but confusion sometimes crops up when regulatory naming conventions differ. For pharma buyers, staying alert to both the IUPAC name and common English name ensures right-ordering and safe substitution between grades.
Lab and production workers get exposed to strict handling requirements, not only for peace of mind but due to risk of contamination during processing. Storage temperature falls below 30°C, and oxygen exposure should be minimized to avoid oxidation. BP/EP/USP guidelines require closed containers, with supplier-provided batch records and certificates of analysis on hand. Personnel wear gloves and eye protection, as pure fatty acid esters can irritate the eyes or mucosa over prolonged exposure. Spills get wiped quickly to avoid slip hazards. Every quality control run checks for oxidative decomposition, heavy metal content, and microbial load, so any deviation from standards results in a full batch halt.
You’ll catch monolinoleic acid glyceride across multiple pharmaceutical delivery platforms. Drug formulators prize its dual solubility: it carries hydrophobic drugs in oral soft gels and enhances skin penetration in topical creams. Injectable emulsions tap its mild surfactant properties to suspend oil-phase drugs. Veterinarians reach for it in certain animal health tonics. Beyond pharma, food technologists use the food-grade variant as a safe emulsifier and texture adjuster in margarine and non-dairy creamers, though pharmacopeial grades stay in heavily regulated spaces. Research universities rely on its purity and low toxicity in cell culture media and in vivo drug delivery trials.
New research focuses on further unlocking the molecule’s potential in advanced drug delivery, especially with poorly soluble APIs (Active Pharmaceutical Ingredients). Scientists engineer nano-emulsions, solid lipid nanoparticles, or self-emulsifying drug delivery systems (SEDDS) utilizing monolinoleic acid glyceride as a cornerstone. Its long fatty chains promote microstructure formation and impact bioavailability, an area highlighted in peer-reviewed journals in the last ten years. Collaborations between academic institutions and corporate R&D push safety studies and process optimizations, seeking out green chemistry routes for synthesis to minimize waste and improve cost-effectiveness. Synthetic biology also edges in, as labs weaponize genetically-engineered lipases to coax higher monoester yields at lower temperatures with reduced byproduct formation.
Toxicologists from regulatory agencies to private labs keep an eye on how long-term ingestion or administration affects both cells and animals. Acute toxicity remains low, with large animal studies showing no strong links to organ system damage at standard dosage levels. Skin irritation can occur at high concentrations, but reactions usually resolve quickly. Genotoxicity panels aim to rule out DNA damage, especially as lipid oxidation products sometimes prompt safety concerns. Regulators often demand data on breakdown products, so researchers profile metabolic fates in both human and animal models. The consensus among current toxicology reports points to safety for humans in properly formulated and controlled applications, although impurity control during manufacturing never gets neglected.
Looking at what’s next, future work heads toward even greater purity levels, automated in-line quality control, and applications in personalized medicine. As oral and injectable drugs take on more complex structures, demand climbs for excipients that both preserve drug potency and improve uptake. Fermentation-based production, already stirring up buzz for vitamins and amino acids, could provide more sustainable pathways for large-scale monolinoleic acid glyceride synthesis. Regulatory frameworks keep evolving, steering suppliers toward transparency, tighter environmental controls, and better documentation. If the past is any guide, expect new molecular modifications — perhaps with antioxidant payloads or targeted delivery motifs — cementing monolinoleic acid glyceride’s role not just as a helper molecule but a building block in advanced therapeutic strategies.
Walk into any pharmacy, pick up a bottle of capsules, and you’ll notice those little pills are rarely just the active drug. What holds them together or coats them often does as much for patient health as the medicine inside. Monolinoleic Acid Glyceride—meeting the strict BP, EP, and USP standards—shows up here more than many imagine. Rigid purity standards guarantee it fits safely into health products without tipping the balance or sparking side effects.
No pharmacist hands monolinoleic acid glyceride straight to a customer. It sits in the background, playing support. It makes its mark by helping drugs dissolve once swallowed, moving from stomach to bloodstream more smoothly. For example, drugs that struggle with water don’t break down easily. I watched a pharmacist in a community pharmacy depend on excipients just like this to unlock tough formulations. Poor solubility often stands between a patient and relief. Add the right ingredient and medicine can finally get to work.
Pharmaceutical products often spend weeks, months, or even years on shelves before reaching those who need them. Small shifts in temperature and humidity threaten to destabilize fragile drugs. Fatty acid glycerides, like monolinoleic, offer a protective barrier. Industry researchers noticed how these molecules shield actives from unwanted reactions. Without such measures, drugs may lose power long before someone takes them.
Looking at reports from the European Pharmacopoeia, experts point out the dual purpose: it supports both structure and chemical safety. Capsules hold their shape better. Tablets break apart in the right place—not in transit or storage. Patients trust that what their doctor prescribes will still deliver as promised months down the road.
Some drugs punish the gut; others barely absorb at all. Monolinoleic acid glyceride steps in as a surfactant, helping spread and mix ingredients inside the body. Pharmaceutical scientists often mention how this characteristic smooths the process for oily or fat-soluble compounds. For pediatric and geriatric care, tiny improvements in how a drug disperses can mean the difference between taking medicine as directed or skipping doses. In one clinic I worked with, nurses noticed fewer complaints and better outcomes when formulations used trusted excipients.
Patients and regulators share questions about what goes into each pill. Reliable pharmaceutical supply chains matter most with ingredients like monolinoleic acid glyceride. Adherence to BP, EP, and USP standards reassures buyers that sources stick to ethical and rigorous testing procedures. Poor traceability risks health. At a conference, I saw quality assurance teams walk through months of paperwork and lab tests just to sign off on a new batch. It’s a reality check—no shortcut replaces transparency or documentation.
Pharmacists, scientists, and quality managers share a goal: better medicine with fewer downsides. Demand grows for compounds that work across tablets, capsules, and even topical treatments. Teams in pharmaceutical research push for ingredients that both handle chemistry well and keep patients safe. Monolinoleic acid glyceride carves out its place for that reason. Looking at daily practice, from hospital to health store, its presence signals relentless attention to both science and well-being.
Monolinoleic acid glyceride comes from the esterification of glycerol with linoleic acid. For anyone working in pharmaceuticals, purity and clarity matter as much as chemical structure. In practice, leading firms demand clear, verifiable standards before accepting a batch into the pipeline, with the core focus on safety and consistency.
Top-tier monolinoleic acid glyceride needs more than just a high content of the main molecule. Pharma teams want heavy data showing minimal levels of related fatty acid monoesters, diesters, and triesters. Specifications for pharma grade usually require at least 90% monolinoleic acid monoester, measured by gas chromatography. Impurities like diglycerides, triglycerides, and free fatty acids must be held in check—well under 10% total for the rest, with free fatty acids typically under 1%.
Each batch should show almost no water (less than 0.2%) and extremely low heavy metals, especially iron and lead. The tough regulations on lead and arsenic, often below 0.1 ppm, keep products suitable for injectable or ingestible formulations. In my own experience with pharma ingredient selection, the presence of unresolved peaks or off-spec impurity spikes can send hundreds of kilos of material back to the manufacturer, regardless of price or supply pressure.
Manufacturers must back every claim with reliable, up-to-date certificates of analysis and a full panel of analytical data: HPLC for identity and purity, GC-MS for residual solvents, and even microbiological screening. Endotoxin testing becomes important when parenteral use is on the table. GMP certification shows that a plant follows quality control procedures throughout the production chain, from raw material sourcing to packing.
Pharma teams often ask for extra details, like methods of synthesis or possible traces of allergens, even if guidance doesn't strictly require it. One regulatory setback from a missing data line can slow or halt drug development. Suppliers who make the process transparent—opening their labs to inspections and audits—stand a better chance of long-term supply agreements.
High-purity monolinoleic acid glyceride usually comes as a pale yellow to nearly colorless oil, free of visible particulates. Extended storage doesn't cause off-odors or cloudiness if manufacturers keep moisture, light, and oxygen away. Stability studies cover heat exposure and packaging validation. Regulatory submissions expect these data to prove safety and predict how an excipient might change, especially for injectable products.
Pharmaceutical ingredients need clear answers around allergenicity, potential contamination, and country-of-origin statements. Full disclosure of residual solvents (less than ICH Q3C Class 2/3 limits) and pollutants, including PAHs or PCBs, gives drug-makers and regulators peace of mind. Products without unnecessary stabilizers or synthetic antioxidants fit the European Pharmacopoeia or US Pharmacopeia standards for excipients.
Direct relationships with GMP-certified suppliers, regular audits, and spot lot testing help pharma companies prevent costly recalls. Digital batch records let quality teams trace each step. Supply chain gaps, inconsistent documentation, or off-spec values remain red flags. The strict specs pushed by health authorities drive real safety and performance in modern drug development and delivery. Reliable monolinoleic acid glyceride isn't just a chemical—it's a guarantee that patients and regulators can trust.
Monolinoleic acid glyceride shows up in pharmaceutical ingredient catalogs, promising a range of functions mostly centered around improving the way medicines work in the body. Most folks outside the chemical industry rarely hear of it, yet this molecule plays a key role as an emulsifier and stabilizer. Because medicines go through a rigorous process before they reach the pharmacy shelf, it’s worth examining if this compound truly fits the bill for products that end up in human bodies.
Some medicines need oily and water-based parts to mix. Monolinoleic acid glyceride helps these substances come together, which solves a real problem for both pill makers and patients. Tablets, capsules, and liquid suspensions benefit because the active ingredients end up more evenly distributed. This translates to more predictable results—vitally important for proper dosing and safety.
When I worked in a compounding pharmacy, we constantly ran into the challenge of keeping ingredients mixed. Using the right excipient made the difference between a gritty, hard-to-swallow suspension and something a patient could actually take as prescribed. Not all emulsifiers behave the same way or offer the same level of safety. Monolinoleic acid glyceride sticks out for its low toxicity and long record in FDA and European Pharmacopeia listings. From a practical perspective, safer ingredients build trust—nurses, doctors, and patients won’t settle for less.
Pharmacists and manufacturers rely on compendial standards, like those set by BP, EP, or USP. These aren’t just alphabet soup acronyms. They represent strict quality, purity, and testing guidelines. Monolinoleic acid glyceride, qualified under these standards, comes with a solid safety track record. This matches my experience: ingredients meeting USP and EP monographs pass a much higher bar than generic, food-grade additives.
Still, quality control isn’t just about a stamp on a certificate. Any company producing this material for pharmaceuticals needs to keep its processes transparent, with traceability from plant to final bag or drum. Contaminant levels stay low, batch-to-batch variation shrinks, and impurities don’t surprise anyone. The stakes are higher when someone’s health is on the line, and any slip in purity can end up as a recall or, worse, a patient risk.
No substance suits every application. Rare allergies or sensitivities can emerge, although these seem uncommon. Sometimes, cost or supply chain hiccups prompt companies to use alternatives. In my own work, I’ve seen manufacturers make substitutions not for safety, but because of pricing spikes or tariff changes. Communicating these swaps transparently helps health professionals and patients stay in the loop. Better labeling, clear sourcing information, and open communication matter as much as any laboratory test.
Greater awareness around environmental and ethical sourcing never hurts. Patients ask more questions about where their medicine comes from and what’s inside each pill, and manufacturers who take this seriously build credibility. Monolinoleic acid glyceride, sourced responsibly and tested thoroughly, still fits into the modern pharmaceutical landscape. If the industry keeps its focus on science, patient safety, and integrity, this ingredient won’t go out of fashion soon.
Monolinoleic acid glyceride finds its biggest use in the pharmaceutical industry because of its emollient and emulsifying properties. From my own years working in a busy chemical lab, the details in its handling stick out. A high-purity pharmaceutical compound like this reacts to air, moisture, and light in all the sneaky ways that threaten its stability and safety. That’s exactly why packaging cannot be an afterthought. It matters as much as the process used to make the substance in the first place.
Good-quality monolinoleic acid glyceride is not poured into random containers. Manufacturers who care about safety seal it in high-density polyethylene (HDPE) or amber glass containers. These options do a solid job of keeping out both water vapor and UV light. Clear plastics and thin paper bags don’t cut it—the risk of oxidation grows if light or oxygen can reach the product. Moisture can start hydrolysis, and UV light degrades fatty acids quickly, especially when purity is on the line for injectable or oral uses. I’ve seen products go off because someone grabbed the wrong bottle. No one wants to explain why an expensive shipment had to be ditched.
A strong container does half the job. Proper seals—usually tamper-evident closures—take care of the rest. A break in the seal means questions about contamination. Drug inspectors and pharmacists watch for this. Legible labeling is key too. Every container needs a batch number, manufacturing and expiry dates, clear storage guidelines, and hazard identification. In my early days, I saw colleagues struggle with faded labels, hunting for missing batch numbers during an audit. Details like this protect patients, uphold traceability, and give everyone involved some peace of mind.
Monolinoleic acid glyceride likes to stay cool and dry, at a steady 15–25°C. Outside this range, as many have learned the hard way, quality drops. Some warehouses in hot climates push the upper temperature limit, which risks turning a premium ingredient into a problem. Humidity above 60% increases the chance of microbial growth, and storing the substance anywhere that gets direct sunlight is a no-go. Temperature excursions—especially during transport—should be logged. Warehouses manage this with digital temperature and humidity monitors, with alert systems for sudden spikes. Years of working in labs taught me to obsess over these controls.
Stock rotation helps a lot. Following “first in, first out” (FIFO) means nothing sits too long and catches the edge of expiration. Countless times I’ve pulled stock to the front of a shelf, only for new staff to shove fresh bottles in front. A quick audit shows that inventory discipline avoids losing good product, supports safety, and saves everyone involved from headaches during regulatory checks.
During logistics, shippers line containers with insulation or use gel packs if the weather turns warm or cold on the way to the destination. Proper manifests and handling instructions support drivers and handlers who may never touch pharma products otherwise. I’ve seen trucks stuck on the road for hours, and unless these steps are taken, the batch inside can turn useless before it even arrives. Every handoff multiplies risk, so clear communication and tight documentation aren’t optional.
Upgrading storage looks simple—choose the right materials, train staff well, and log conditions around the clock. Surveys of pharma warehouses show that combining physical checks with digital records cuts mistakes. Tighter controls and new systems like RFID monitoring let teams catch mishaps before they affect the product. Good packaging and careful storage are lessons learned by every chemist over years on the job. They protect patients, save costs, and keep industry standards high.
Quality matters in pharmaceuticals. Not only do regulators keep a close eye on ingredients, but patients ultimately rely on consistent products. Monolinoleic acid glyceride, often used as an emulsifier or excipient, has to answer more than a simple “what is it?” question. It faces some demanding rules set by the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). Each pharmacopeia brings its own benchmarks, with tests covering purity, residual solvents, and process contaminants. Labs in the pharmaceutical world run into these standards every time they source an ingredient.
Over the last decade, the global push for clean-label pharmaceuticals only picked up steam. More manufacturers tap into monolinoleic acid glyceride, especially for oral solid doses and topical formulations, since it supports stable dispersions. But I notice one hard fact: not every supplier stands behind their monolinoleic acid glyceride meeting BP, EP, or USP grade.
Taking the BP as a base, the tests go well beyond appearance. There’s a set of purity tests, peroxide value, acid value, saponification value, and identification by infrared spectroscopy. Ethylene oxide and dioxane residues can’t show up past vanishingly low thresholds, and heavy metals remain a no-go. Getting a “pass” on BP takes more than a quick certificate—it means manufacturers demonstrate that their production process gets these markers right batch after batch.
The EP builds on many of these standards, paying attention to overall fatty acid composition, microbial purity, and identification by chromatographic means. My conversations with quality assurance managers hint at a sticking point: unless a company operates a GMP-licensed plant with real-time monitoring, consistency teeters on the edge. Even storage conditions factor strongly since monolinoleic acid glyceride can oxidize if mishandled.
USP, known for its rigorous identity and impurity standards, looks closely at fatty acid profiles too. The monolinolein content—the proportion of the monoglyceride of linoleic acid—can’t drift outside a set range. Peroxide values highlight oxidative changes, while the USP test portfolio screens for pesticides and other modern-day contaminants. I recall an excipient supplier sweating over batch-to-batch variation because their upstream raw oil source kept shifting.
For me, trust flows from knowing what goes into each capsule or ointment. Inconsistent excipient quality—such as off-spec monolinoleic acid glyceride—has real risks. Patients living with chronic illnesses expect their medicine to dissolve, absorb, and act in the body as promised. A contaminated or unstable batch can cause headaches from regulatory recalls and even loss of trust for prescribers.
In recent years, regulatory agencies like the FDA and EMA signaled they want more transparency in excipient sourcing. Plants mixing food and pharma grades can create blind spots unless internal audits and routine pharmacopeial testing form a regular pattern. Some suppliers build a strong reputation by publishing certificates of analysis for every batch, detailing compliance with BP, EP, and USP requirements. Others invest in robust traceability so every drum of excipient can be traced back to the field where the original oilseed was grown.
Meaningful change requires closer ties between manufacturers and vetted suppliers. Drug developers can audit ingredient sources, demanding real documentation—not just a data sheet—showing regular success at clearing BP, EP, and USP hurdles. Routine batch analytics, staff training, and process control upgrades keep compliance from slipping. In my experience, those who stick to strict standards enjoy smoother product launches and fewer surprises during site inspections.
True compliance with BP, EP, and USP isn’t a checkbox—it’s a daily discipline. Trusting a supplier’s word doesn’t replace regular, clear evidence from updated labs and routine site visits. For patient safety and regulatory confidence, pharmaceutical teams push for full clarity from field to finished product.
| Names | |
| Preferred IUPAC name | 2,3-Dihydroxypropyl (9Z,12Z)-octadeca-9,12-dienoate |
| Other names |
Glyceryl Monolinoleate Monolinolein Glycerol Monolinoleate 1-Monooleoyl-rac-glycerol Glycerin Monolinoleate |
| Pronunciation | /ˌmɒnə.lɪn.əˈliː.ɪk ˈæsɪd ˈɡlɪsəˌraɪd/ |
| Identifiers | |
| CAS Number | 1323-95-5 |
| Beilstein Reference | 1721047 |
| ChEBI | CHEBI:53174 |
| ChEMBL | CHEMBL3311029 |
| ChemSpider | 589407 |
| DrugBank | DB11110 |
| ECHA InfoCard | ECHA InfoCard: **03-2119955551-39-0000** |
| EC Number | 91744-28-4 |
| Gmelin Reference | 111221 |
| KEGG | C06427 |
| MeSH | Glycerides |
| PubChem CID | 5283136 |
| RTECS number | MK7050000 |
| UNII | J38W2A111B |
| UN number | UN3082 |
| Properties | |
| Chemical formula | C21H38O4 |
| Molar mass | 354.56 g/mol |
| Appearance | Clear oily liquid |
| Odor | Odorless |
| Density | 0.94 g/cm³ |
| Solubility in water | Insoluble in water |
| log P | 2.9 |
| Vapor pressure | Negligible |
| Acidity (pKa) | ~4.8 |
| Basicity (pKb) | > 14.00 |
| Refractive index (nD) | 1.473 – 1.478 |
| Viscosity | 70 – 90 cP at 25°C |
| Dipole moment | 1.742 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 770.6 J·mol⁻¹·K⁻¹ |
| Std enthalpy of combustion (ΔcH⦵298) | -3785 kJ/mol |
| Pharmacology | |
| ATC code | A05BA02 |
| Hazards | |
| GHS labelling | GHS07, Warning, H315, H319, P264, P280, P305+P351+P338, P337+P313 |
| Pictograms | GHS07 |
| Signal word | Warning |
| Hazard statements | H315: Causes skin irritation. H319: Causes serious eye irritation. H335: May cause respiratory irritation. |
| Precautionary statements | Precautionary statements: P264, P280, P301+P312, P305+P351+P338, P337+P313 |
| NFPA 704 (fire diamond) | 1-1-0 |
| Flash point | > 285°C |
| Autoignition temperature | 430°C |
| LD50 (median dose) | LD50 (median dose): > 5,000 mg/kg (rat, oral) |
| NIOSH | Not listed |
| PEL (Permissible) | PEL: Not established |
| REL (Recommended) | Up to 40 mg/kg body weight per day |
| IDLH (Immediate danger) | Not established |
| Related compounds | |
| Related compounds |
Linoleic Acid Monoolein (Glyceryl Monooleate) Monostearin (Glyceryl Monostearate) Glyceryl Monoarachidate Glyceryl Monopalmitate Diglycerides Triglycerides |
Chengguan District, Lanzhou, Gansu, China
