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Linoleic acid's story starts in the late 19th century. Chemists isolated the compound from seed oils, especially poppy and linseed, searching for molecules behind fats and oils that shaped both nutrition science and pharmaceutical development. Its structure—a double unsaturated omega-6 fatty acid—led biologists to class it as essential, because the human body cannot synthesize it. This realization, backed by textbook data on deficiencies in early nutrition experiments with rats and humans, placed linoleic acid at the center of nutritional science and industry fortification drives in the 20th century. Pharmaceutical standards such as BP, EP, or USP have raised the bar for purity and traceability, linking every batch to authorized labs and pushing the industry to craft protocols against contamination.
Linoleic acid appears as a clear to pale yellow liquid with a faintly greasy feel. Industrial producers derive it from refined vegetable oils, choosing sunflower, safflower, or corn oil for their high linoleic content. As pharma grade, it hits rigorous specs for purity, ensuring it meets British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) standards. Drug designers value this product for excipient purposes: it acts as a basic component in ointments, topical preparations, and advanced drug delivery, but it also underpins nutritional formulations that depend on strict labeling and validated safety.
At room temperature, linoleic acid remains liquid, thanks to its two double bonds on the 9th and 12th carbon. Its melting point hovers near -5°C, flash point around 227°C—significant for plant-based oil stability. Solubility pairs best with organic solvents like chloroform, ether, or hot alcohol, not water. As a polyunsaturate, linoleic acid oxidizes readily in air, producing peroxides and short-chained acids. Lab workers monitor peroxide values tightly, as even a small spike downgrades grade and utility. Molecular weight sits at 280.45 g/mol, lending itself to predictable calculations in formulation work.
BP EP USP grades demand nearly 98-101% purity by titration, low peroxide value (often below 10 mEq O2/kg), and accurately labeled content. Labels feature full nomenclature, batch number, manufacturing date, provenance, and purity certification—key to audits and recalls. Aluminum or amber glass containers ban UV exposure, guarding against peroxide formation. Strict spec sheets detail heavy metals (lead, arsenic under 1 ppm), acid value, saponification number (typically 190-200 mg KOH/g), and residual solvent limits—critical for pharma and clinical end-users.
Most linoleic acid destined for pharma relies on hydrolyzed triglycerides. Chemical or enzymatic hydrolysis splits oil-derived triglycerides, releasing mixed fatty acids. Distillation then isolates linoleic acid. Molecular distillation under vacuum produces a clean, clear distillate, while nickel-catalyzed hydrogenation transforms unsaturated compounds into stable esters where needed, ensuring a long shelf life. Some labs invest in further chromatography to pull off minor fatty acids. The process demands scrupulously clean equipment since trace solvents or metals spell trouble for regulatory compliance.
Chemists appreciate linoleic acid for its reactive double bonds. Hydrogenation, turning linoleic into stearic or oleic acid, brings interest to trans fat debates in foods, though pharma sticks with the parent compound for most uses. Epoxidation—reaction with peracids—creates diepoxides vital for certain coatings or analytical standards. Conjugation, moving double bonds together under base or heat, produces CLA isomers, which research groups describe as having metabolic impacts far different from the parent acid. Oxidative cleavage, via ozonolysis, chops the molecule, forming useful aldehydes and shorter acids. Each modification finds a niche, but the base compound's omega-6 structure dominates pharma interest.
Linoleic acid goes by several names—cis,cis-9,12-octadecadienoic acid appears in chemical catalogs, sometimes simply "LA" among biochemists. Pharma circles use “Pharma Grade Linoleic Acid,” while food technologists tag it as “Vitamin F component.” Its inclusion in excipient listings or as a component in branded topical products often slips under proprietary names, though regulation increasingly insists on transparent ingredient listings.
Handling pharma grade linoleic acid rarely brings acute danger. Staff wear lab coats and nitrile gloves, dodging spill hazards or skin defatting effects. Vendors deliver certificates detailing limits on heavy metals, solvent residues, and particulate matter, as health agencies audit each batch. Good Manufacturing Practice (GMP) underpins production, extending to facility hygiene, equipment calibration, and secure warehousing. As linoleic acid oxidizes easily, storing in nitrogen-flushed tanks and using antioxidants like tocopherols limits degradation, preserving both safety and compliance.
Pharma companies use linoleic acid as a base in topical creams, lotions, and even investigational lipid nanoparticles for mRNA vaccines. Dermatology circles draw on its skin barrier support, exploiting its role in restoring ceramide function in eczema and psoriasis patients. Nutritional supplement brands incorporate it in essential fatty acid blends, especially when aiming for label claims targeting omega-6/omega-3 ratios. Wound care products and hospital nutrition feeds draw directly from pharmacopeial stocks, counting on validated sourcing. In research labs, linoleic acid stands at the center of cell culture work and metabolic pathway studies, underpinning decades of medical discoveries.
Research on linoleic acid pivots each decade. Early work mapped its essentiality. Fatty acid biochemists traced its role in prostaglandin and eicosanoid synthesis, tying intake to inflammation and cellular signaling. More recently, teams have focused on its epidemiological role in chronic diseases—atherosclerosis, metabolic syndrome, and neurodegenerative disorders. State-of-the-art efforts probe controlled delivery, nanoparticle encapsulation, and the development of synthetic analogues that preserve function but resist unwanted oxidation. The pipeline continues to evolve, targeting unmet needs in skin care, nutrition, and targeted drug delivery.
On toxicity, the record remains steady at moderate, dose-appropriate use. Acute toxicity rarely emerges in clinical data, but chronic high intake—far past dietary levels—links to shifts in inflammatory markers, oxidized lipid metabolites, and, in sensitive models, hepatocellular changes. Injection of concentrated linoleic acid boluses, tested mainly in animal models, highlights risks of local irritation, oxidative stress, and rare pulmonary effects. Pharmacovigilance for pharma grade linoleic acid includes routine peroxidation testing and specification of upper daily intake limits, in line with international risk assessments.
Looking ahead, linoleic acid will keep shaping clinical and pharma innovation. Its utility in skin repair, delivery vehicles, and clinical nutrition continues to bring new product launches. Researchers eye synthetic modifications and stable analogues to address storage and oxidation issues, a key barrier in hot climates. Regulatory drivers stress even tighter standards—demand for allergen-free, traceable, and fully validated excipients has never stood higher. Digital traceability and real-time analytics may reach mainstream soon, letting manufacturers detect impurities before products leave the lab. With chronic diseases on the rise, demand for omega-6 and its better-balanced formulations is set to keep rising, keeping linoleic acid at the core of pharmaceutical development for the foreseeable future.
Linoleic acid often shows up as an ingredient in products that need to meet high purity standards. Pharmaceutical grade linoleic acid passes quality checks set out by the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). This means anyone working with it can trust what’s in the bottle. A fatty acid sourced mainly from vegetable oils, it’s colorless or pale yellow and feels oily to the touch. In the pharmaceutical world, people seek out this grade for its safety profile and predictable performance in applications where human health is a priority.
Drug makers often turn to linoleic acid as an excipient. An excipient isn’t just a filler. It works as a carrier, giving medications a reliable form and helping the active ingredients reach their target. In soft gel capsules, for example, linoleic acid serves as an essential component for encapsulation. Its physical stability helps the capsules stay effective over shelf life, avoiding classic problems like ingredient leakage. Used as a solubilizer, it helps dissolve compounds that are otherwise tough to distribute, making them more available for the body to use.
Some medications rely on topical delivery. Here, linoleic acid steps up as an absorption enhancer and skin softener. Scientific reviews point out that the skin incorporates linoleic acid into its barrier structure, supporting moisture balance and aiding recovery where the barrier gets damaged. For people with atopic dermatitis and similar skin problems, formulations containing this ingredient offer much-needed relief. With millions affected by skin barrier diseases, using something our bodies recognize and handle well just makes sense.
Research points to linoleic acid’s role in wound-healing ointments, especially for burns and ulcers. Its anti-inflammatory effect supports the body’s natural recovery processes. Certain intravenous nutrition solutions include linoleic acid to supply essential fatty acids, vital for cell function, immune health, and growth. Some patients, like those on long-term parenteral nutrition, rely on this compound to avoid deficiency. A lack of linoleic acid can lead to dry skin, poor wound healing, and reduced infection resistance—the kind of problems no patient wants.
Many countries regulate pharmaceutical ingredients closely, and rightfully so. Poor quality means contamination risk. Strict pharmacopoeia standards build trust, especially in treatments used by vulnerable groups like children or people with weakened immune systems. Companies cannot afford shortcuts. Impure or inconsistent linoleic acid can compromise both product effectiveness and safety. The attention paid to purity isn’t just bureaucracy—it protects lives.
The push for even safer and more effective formulations never stops. Linoleic acid-based emulsifiers help make new delivery methods possible. For instance, researchers look at how these systems can improve the stability and absorption of poorly soluble drugs. More sustainable sourcing is on scientists’ radar, too. Plant-based extraction methods could reduce contamination chance, reduce reliance on animal products, and decrease the impact on the environment. Pharma companies and food technologists alike stand to benefit if these methods scale up.
As knowledge grows, so does demand for ingredients that do more than just meet minimum specifications. Clinical studies continue to reveal more about how linoleic acid can be used in targeted therapies or advanced cosmetic medicine. Patients with unique needs—like allergies or skin conditions—count on reliable, high-purity options backed by science. As long as people need safer, more effective medications and health products, demand for refined, trusted sources of linoleic acid isn’t going anywhere.
Doctors prescribe medicines, skincare brands promise results, and supplement shelves claim purity. Each of these depends on what goes into the product, right down to the grade of a single ingredient like linoleic acid. Behind the grade label—BP, EP, or USP—are rules set by different organizations. These rules have teeth. They guide chemists, pharmacists, and quality managers on what counts as “pure enough” and “safe enough” for each country’s regulations. A difference in grade can change how a product gets approved, the label it wears, and sometimes, the results someone gets from using it.
BP stands for British Pharmacopoeia. EP means European Pharmacopoeia. USP refers to United States Pharmacopeia. Each book gives a set of rules for how pure a substance like linoleic acid must be for that region. BP and EP often look similar because European medicine regulations overlap, but there are small tweaked values for impurities or limits on heavy metals. USP takes a slightly different path, focusing on what meets the legal and scientific standards for medicine in the United States.
Here’s what experience in a chemistry lab taught me: a specification isn’t just a checklist. One missing test matters. Oils, for example, can degrade and pick up unintended byproducts along the way. In one batch of linoleic acid, an extra point in peroxide level pushed a product from “acceptable” to “reject.” The grade set by the pharmacopeia protected people down the line, from pharmacists filling capsules to patients using creams on sensitive skin.
Not every company uses the strictest grade for every purpose. Food companies look for food-grade—not always pharmacopeia grade—ingredients. Pharmaceutical and hospital users need stricter proof of safety, especially for anything that ends up injected or used on open wounds. That’s where the subtle differences come into play. For linoleic acid, BP or EP might require extra purity for certain byproducts, while USP holds its own in specifics like labeling and identification.
There’s a real risk if the right grade isn’t followed. A supplier once sent the lower food-grade version instead of the promised pharmaceutical grade, and the oversight got caught during an audit. Using the wrong grade could mean batch recalls, regulatory fines, or—worst of all—harm to a patient.
People often forget what goes on behind the label. It’s more than a rulebook. Auditors visit factories, scientists check finished product, and every grade gets documented. When companies show records of compliance—such as Certificates of Analysis tied to BP, EP, or USP standards—it builds trust. I’ve seen countless buyers demand independent lab results before signing a purchase order. Lives depend on those details.
Pharmacopeial standards keep changing. Scientists, regulators, and industry reps review contaminants from new raw materials and set lower limits for anything known to cause health trouble. This process sometimes frustrates manufacturers, as tighter rules mean higher costs. Switching suppliers, setting up better purification, or investing in new lab equipment are all steps needed to deliver the correct grade. Yet, cutting corners puts everyone at risk—consumers, companies, and public health at large.
Companies benefit by training staff to understand each grade’s requirements. Partnering with trusted suppliers removes a lot of worry. On the regulatory side, sharing more test results with buyers gives everyone a fuller picture of product safety. For those handling procurement, digging deep into certificates and asking probing questions will keep surprises to a minimum.
Few ingredients draw as much scrutiny as linoleic acid when it’s destined for pharmaceutical use. Simple food or industrial grades don’t cut it. For medical applications, every detail counts. The purity level usually hits 99% or higher. Scientists and pharmaceutical teams understand that even trace contaminants might impact both safety and performance. The stakes get even higher when linoleic acid plays a role in sensitive drug delivery systems or topical medications.
High purity linoleic acid reduces the risk of side reactions. I’ve seen teams in labs run extra chromatographic checks on every batch. The aim: weed out peroxides, heavy metals, and other residual solvents. For regulatory bodies like the US Pharmacopeia (USP) and European Pharmacopeia (Ph. Eur.), specs aren’t just nice to have. They’re required. These guidelines set maximum allowable levels for moisture—often under 0.5%—and set sharp limits on substances such as hexane, arsenic, and lead. Any manufacturer that values patient safety and batch-to-batch reliability aims to keep these markers far below the allowed thresholds.
Anyone who’s worked with linoleic acid knows that color and odor matter. Pharma grade comes clear to pale yellow, free from rancid or “off” smells. Neutral scent usually means the sample hasn’t oxidized. A sharp nose and sharp tools both play their part. Simple colorimetric methods or even standard gas chromatography can reveal impurities that the eye might miss. Authentic samples show a high content of cis,cis-9,12-octadecadienoic acid—anything less looks suspicious, especially if the fatty acid profile skews toward saturated fats. I once saw a reject pile grow tall because a vendor’s batch didn’t match the stated isomer ratios. Nobody wanted to risk patient safety or product stability over a shortcut.
Trusted pharma suppliers issue Certificates of Analysis with every barrel or bottle, showing not only purity but breakdowns for peroxides, heavy metals, and acid values. Acid value usually sits below 1 mg KOH/g for pharma-grade material, showing minimal free fatty acids or hydrolytic breakdown. This kind of detail isn’t some bureaucratic hurdle. It keeps every actor—researcher, pharmacist, and doctor—in the loop. Reliable traceability means easier audits and faster recalls, if some problem ever does turn up. It also shines a spotlight on the importance of GMP-certified production facilities, where cleanrooms and stainless steel keep cross-contamination out of the story.
Sometimes it can be tempting to grab cheaper, less-regulated alternatives. I’ve seen the aftermath—a few points lost on purity turns into cloudiness in the solution or unpredictable patient reactions down the line. To sidestep these risks, responsible suppliers use fractional distillation, validated filtration, and regular audits. Beyond chemistry and regulation, there’s an underlying ethos: put end-users first. For anyone considering switching suppliers or tightening their requirements, straightforward communication with vendors, on-site inspections, and third-party audits have helped many firms weed out unreliable sources.
In pharma, nobody argues with a clear, clean safety profile. Linoleic acid, when held to strict standards, supports innovation, protects patients, and sharpens a company’s reputation. High purity isn’t just a checkbox. It’s the backbone for every downstream application, from topical ointments to injectable solutions.
Linoleic acid finds its place in pharmaceutical work because it’s an essential fatty acid. Our cells rely on it for building healthy membranes. It ends up in products from ointments to oral medicines, with strict benchmarks often stamped by BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia). Those certifications signal that a substance’s purity matches the standards regulators expect for products touching human health.
Pharma-grade usually isn’t just a buzzword. With linoleic acid, certification under BP, EP, or USP means labs have checked for heavy metals, microbial content, residual solvents, and unusual byproducts. Pharmacopeias update and adjust these rules based on new research and industry feedback, so criteria evolve. These rules don’t guarantee every preparation will suit everyone, but they cut down the risk of contamination or unpredictable reactions.
Topical treatments often use linoleic acid. It helps skin heal, especially where the barrier’s broken. Wound gels and moisturizers use pure forms because anything less may trigger inflammation. In my experience, compounds that don’t meet pharma grade can irritate patients or break down too quickly, so they never make it past early testing. For oral pharma products, manufacturers stick to BP/EP/USP-certified material to dodge toxins and guarantee batch-to-batch similarity. This consistency builds trust among doctors and patients alike.
Pharma-grade linoleic acid is safe for the vast majority, based on regulatory scrutiny and decades of use. Allergic reactions can happen with natural substances, but allergies to purified linoleic acid remain rare. Purity reduces those risks. Some research suggests overconsumption in diets may nudge up inflammation, but in regulated doses, this fatty acid plays its part in cell health. The biggest worry comes when manufacturers cut corners. Using industrial or cosmetic grade instead of pharma-certified linoleic acid can introduce pesticides, metals, or dangerous breakdown products.
Good Manufacturing Practices (GMP) control every stage from sourcing to packaging. Audits and documentation make sure linoleic acid batches line up with certificates. Pharmacists and researchers check paperwork and run spot assays, especially with sensitive patient groups like newborns or the immunocompromised. These steps aren’t foolproof, but they catch most issues before products reach shelves. My own background in quality control has taught me that vigilance and traceability matter more than any brand promise.
Long-term, more transparency helps. Public databases showing exactly where pharmaceutical ingredients come from would let hospitals and clinics ask tough questions before buying. Increased random batch testing by independent labs would pull up any safety drift faster. Digital tracking right down to the farm or chemical supplier could help weed out counterfeiters sneaking unregulated substances into the system. Doctors and pharmacists need clear reporting channels so patients harmed by impurities can alert regulators quickly.
Linoleic acid, when it meets high standards, supports a wide range of treatments without much fuss. If we keep a close eye on production, enforce real-world quality testing, and keep supply chains honest, patient safety stays front and center. Reliable pharma-grade ingredients are the foundation for trust in medicine.
Linoleic acid is a staple in pharmaceutical manufacturing, especially in topical formulations and nutritional products. From my time working alongside pharma supply chain experts, it’s clear that keeping raw materials in top shape is more than just ticking off a checklist — it keeps patients safe and labs compliant.
Linoleic acid, especially at pharma grade quality, acts as a sensitive fatty acid. It faces two main enemies: light and oxygen. Left exposed on a shelf, the oil slowly oxidizes. That sharp, rancid scent anyone working around oxidized fats would recognize signals chemical changes. Even a minor decline in quality at the warehouse stage ripples out — finished medicines may lose stability, and analytical results turn unreliable. Nobody wants a phone call saying the batch failed tests after all that work.
Rooms storing linoleic acid shouldn’t swing like a yo-yo between hot and cold. Pharma teams often invest in climate control for a reason. Fatty acids keep their properties best in a cool, dry place, ideally near 2-8°C. I’ve seen more than one large batch degrade in open warehouses on a warm day. Sunlight is one more hazard; transparent containers or direct sunlight speed up spoilage. Amber glass bottles or lined drums provide a shield, keeping photo-oxidation in check.
Open-top drums in a drafty storeroom? I’ve come across that and saw why it creates contamination risks. Always use airtight, dedicated containers that prevent contact with air and moisture. After pouring, cap the vessel tightly and label with the date opened. This habit pays off, especially in a busy lab where dozens of samples and solvents share a workspace.
Gloves prevent accidental skin contact, since linoleic acid — like most laboratory agents — can irritate sensitive skin. Standard safety goggles protect the eyes. Any spills should be cleaned up quickly, using absorbent materials suitable for oils. Rags soaked with linoleic acid left in the open become a fire hazard; oily residues and hot surfaces don’t mix. Safe disposal means oily rags and unused product go into designated containers far from ignition sources.
Proper documentation sets strong labs apart from the rest. Recording each storage temperature check and logging every container transfer increase accountability. Every staff member handling linoleic acid should know the material’s hazards and safety procedures. A clear standard operating procedure (SOP) isn’t just paperwork — it’s part of day-to-day safety and quality.
No laboratory or production space can afford to let product quality slip through poor storage or handling of linoleic acid. Periodic audits, staff refreshers, and ongoing monitoring ensure the integrity of the raw material and ultimately help patients receive medicine they can trust. Investing in proper management upfront avoids the headaches of failed batches, recalls, or more serious consequences down the line.
| Names | |
| Preferred IUPAC name | (9Z,12Z)-octadeca-9,12-dienoic acid |
| Other names |
cis,cis-9,12-Octadecadienoic acid LA 9,12-Octadecadienoic acid Vitamin F essential fatty acid C18:2 (n-6) All-cis-9,12-octadecadienoic acid |
| Pronunciation | /laɪˈnoʊ.li.ɪk ˈæs.ɪd biː-piː iː-piː juː-ɛs-piː ˈfɑːr.mə ɡreɪd/ |
| Identifiers | |
| CAS Number | 60-33-3 |
| Beilstein Reference | 2039957 |
| ChEBI | CHEBI:17351 |
| ChEMBL | CHEMBL2779 |
| ChemSpider | 5370110 |
| DrugBank | DB00132 |
| ECHA InfoCard | ECHA InfoCard: 01-2119485289-22-XXXX |
| EC Number | EC 200-568-3 |
| Gmelin Reference | Gmelin Reference: 123365 |
| KEGG | C01595 |
| MeSH | D002198 |
| PubChem CID | 5280450 |
| RTECS number | OI1750000 |
| UNII | 6Z333F7R1Z |
| UN number | UN 3082 |
| CompTox Dashboard (EPA) | DTXSID5024679 |
| Properties | |
| Chemical formula | C18H32O2 |
| Molar mass | 280.45 g/mol |
| Appearance | Clear, colorless to pale yellow oily liquid |
| Odor | Oily odor |
| Density | 0.92 g/cm3 |
| Solubility in water | Insoluble in water |
| log P | 7.05 |
| Vapor pressure | <0.01 mmHg (20°C) |
| Acidity (pKa) | 4.77 |
| Basicity (pKb) | ~11.0 |
| Magnetic susceptibility (χ) | -8.72 × 10⁻⁶ cm³/mol |
| Refractive index (nD) | 1.461 – 1.473 |
| Viscosity | 1.5-1.6 cPs (at 25°C) |
| Dipole moment | 0.715 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | Entropy = 439.7 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -174.6 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -3900 kJ/mol |
| Pharmacology | |
| ATC code | A05AD01 |
| Hazards | |
| Main hazards | May cause eye and skin irritation. |
| GHS labelling | GHS labelling: "Danger; H315: Causes skin irritation. H318: Causes serious eye damage. H335: May cause respiratory irritation. P261, P280, P305+P351+P338, P310 |
| Pictograms | GHS07,GHS08 |
| Signal word | Warning |
| Hazard statements | H315: Causes skin irritation. H319: Causes serious eye irritation. |
| Precautionary statements | Precautionary statements: P210, P233, P240, P241, P242, P243, P261, P264, P270, P280, P301+P312, P303+P361+P353, P304+P340, P305+P351+P338, P312, P321, P331, P332+P313, P337+P313, P362, P370+P378, P403+P235, P501 |
| NFPA 704 (fire diamond) | 2-1-0 |
| Flash point | > 113 °C |
| Autoignition temperature | 343°C |
| Lethal dose or concentration | LD50 (Rat, oral): > 28,000 mg/kg |
| LD50 (median dose) | LD50 (median dose): > 5000 mg/kg (oral, rat) |
| PEL (Permissible) | PEL: 15 mg/m³ |
| REL (Recommended) | 1.0 mg/m³ |
| IDLH (Immediate danger) | Not established |
| Related compounds | |
| Related compounds |
Linolenic acid Oleic acid Palmitic acid Stearic acid Arachidonic acid |
Chengguan District, Lanzhou, Gansu, China
