Contact Us
Chengguan District, Lanzhou, Gansu, China
© 2025 Jeifer Pharmaceutical, All Right
Reserved.
Oleic acid steps out from a long history that stretches back centuries, with roots in Mediterranean olive cultivation and early soap-making. Chemists isolated it as a distinct fatty acid back in the 19th century, and soon after, modern labs figured out how to separate, purify, and test it. By the mid-20th century, pharmacopoeias such as BP, EP, and USP standardized its specifications so that any bottle labeled as pharma-grade kept up with similar expectations worldwide. I’ve seen older textbooks describing how early researchers wrestled with impurities—smell, color, viscosity shifts—before those standards helped weed out inconsistencies. These storied steps paved the way for today’s supply chains where pharma-grade oleic acid gets recognized for its purity and documented origin.
Oleic acid in its BP, EP, and USP grades usually appears as a pale-yellow to colorless oily liquid. What sets it apart for pharmaceutical use comes down to tight limits on impurities like peroxides, heavy metals, or residual mineral oils. I keep seeing it pop up in cream bases, oral medicines, and topical formulations because it offers stability, mildness, and reliable solubility. These pharma regimens demand a level of cleanliness that suits direct contact with skin or mucous membranes, and pharma-grade batches get shipped with certificates that list out each key specification achieved in-house or by an external lab.
On the bench or in the warehouse, oleic acid stands out for a density around 0.89 g/mL at 20°C and a melting point just below room temperature, somewhere near 13-14°C. It turns cloudy as it cools but slides back to clear liquid on gentle warming. Solubility in water basically bottoms out, but alcohols, chloroform, and most oils take it up readily. Chemically, oleic acid shows the classic monounsaturated structure: an 18-carbon backbone with one cis-double bond near the middle. This unsaturation gives it a certain softness and reactivity absent in saturated fats like stearic acid, but the single double bond also lends it some resilience compared to more polyunsaturated siblings.
Regulators lay down requirements for each grade of pharma oleic acid, and the labels reflect that. Beyond purity, typical product sheets spell out acid value (usually between 195-204), saponification number, iodine value, and content of related fatty acids like linoleic or palmitic acid. Suppliers post heavy metal limits below 10 ppm, peroxide values under 10, and sometimes include microbial counts for certain finished goods. Labels name the batch number, expiry date, and pharmacopeia reference so chemists can tie every sample back to a documented process. I’ve paged through decades of certificates and noticed gradual tightening of limits—what passed muster forty years ago would barely make grade today.
Most commercial oleic acid comes from the hydrolysis and fractional distillation of natural fats and oils—primarily olive and other seed oils. Chemists first split triglycerides using steam or alkali, then separate out the distinct fatty acid fractions under reduced pressure. From there, they distill the fraction again to remove short-chain volatiles, then wash, decolorize, and polish the product. Each pharma-grade producer leans on process controls and third-party audits, catching traces of mineral oil residue or residual unsaponifiable matter well before those bottles hit patient-ready manufacturing. Over the years, enzymatic hydrolysis gained ground over harsher chemical routes, helping cut waste and energy use in these plants.
A typical double bond in oleic acid opens the door to reactions like hydrogenation—turning it into hard, waxy stearic acid—or epoxidation, which gives rise to oxirane rings for specialty chemical use. In pharma arenas, it sometimes gets reacted to make esters or to improve properties of emulsifiers. Its carboxylic acid group takes part in salt formation; for example, sodium oleate appears in soaps and some oral dosage forms. I worked on a project once where tweaking the degree of hydrogenation changed the feel and spreadability of a topical ointment, showing firsthand how chemical adjustment alters downstream product qualities.
Trade literature and regulatory filings show a laundry list of synonyms for oleic acid. Apart from just “cis-9-octadecenoic acid,” one finds “n-9-octadecenoic acid,” “red oil,” or regionally specific brand names. Even pharma reference texts occasionally swap “oleic acid” for “Omega-9” to highlight its nutritional angle. Bulk suppliers brand batches under different product codes but always mark out BP, EP, or USP compliance for easy cross-reference in global manufacturing.
Pharma guidelines call for clear, well-ventilated areas, gloves, goggles, and avoidance of open flames or strong oxidizers when handling oleic acid. The substance has a mild, tallowy odor and can irritate eyes or sensitive skin at higher concentrations. Spill protocols rely on absorption and non-reactive cleanup; the oily nature makes it easy to track but tricky to remove from some surfaces without detergents. Fifteen years in labs taught me how small leaks spread quickly, and safety training always includes a sharp eye for containers stored on cool, low shelves, away from peroxides or acidic reagents. Staff need clear labeling and up-to-date safety data sheets, both for compliance and day-to-day incident prevention.
Pharmaceutical processing calls on oleic acid for multiple roles: as an excipient in softgel capsules, as a penetration enhancer in skin creams, and as a stabilizer in suspensions. Many topical and oral medicines contain it to help solubilize poorly water-soluble actives, boost transdermal delivery, or act as a vehicle for volatile actives. Hospitals and clinics depend on predictable, low-irritant vehicles for sensitive skin or pediatric dosing, where oleic acid’s documented safety supports repeat use. Dietary supplements, nutritional emulsions, and even vaccine adjuvants lean on it thanks to both its long track record and continued inclusion in monographs worldwide.
Current research puts oleic acid at the front of new formulation work: nanoemulsions to speed up actives, altered fatty acid blends for improved stability, or new esters meant for better skin feel. Drug delivery scientists test everything from improved oral bioavailability of lipophilic drugs to oleic acid-based prodrugs that modulate pharmacokinetics. Trials keep probing combinations that might reduce irritation or improve absorption. A handful of studies push the envelope with biocompatibility assays, always eyeing regulatory acceptance before anything hits production scales.
Human and animal toxicity data on pharma-grade oleic acid remains favorable. Oral and dermal exposures produce low toxic responses at levels needed for drug and cosmetic formulations. Animal models show minimal systemic effects at typical exposures, though high doses led to transient digestive upset. Chronic exposure or prolonged skin contact sometimes causes dryness or reflux, but these side effects fade as soon as usage ceases. I’ve reviewed studies comparing refined, pharma-grade material against crude sources—the tighter the purity, the fewer unexpected side reactions appear. Regulators have yet to link it with genotoxicity, carcinogenicity, or major allergic responses under normal use cases.
Pharma-grade oleic acid sits at an interesting crossroads. The shift toward greener, plant-based chemicals bodes well: manufacturers ramp up demand for products that double as both excipients and active ingredients in nutraceuticals, dermal patches, or controlled-release systems. Researchers eye a future where fatty acid-based vehicles replace petroleum-derived stabilizers in more oral and injectable drugs. Companies continue to refine every stage—reducing environmental impact, automating process analysis, and working up new supply chains that can guarantee traceability from seed to shelf. New work examines blending with other omega fatty acids to create emulsifiers for next-gen biologics. As patients and providers demand cleaner ingredient labels, pharma-grade oleic acid keeps improving its own story, one meticulous batch at a time.
In the world of prescription drugs and over-the-counter remedies, excipients make things work just as much as the active ingredients do. I’ve often seen oleic acid listed on medicine labels. Its main job comes down to enhancing how the body absorbs the drug, especially when medicines rely on dissolving in fats before heading into the bloodstream. This isn’t some background job—softgel capsules that so many people take rely on this fatty acid to keep active compounds stable and deliver consistent doses.
Topical creams and ointments often use it to help medicine soak through the skin. Dermatologists sometimes mention how skin acts as a barrier, but oleic acid disrupts that, allowing treatments to reach deeper layers. This function proves critical in treating eczema, psoriasis, and fungal infections, according to plenty of published research.
Most people using lotions or sunscreens probably don’t notice oleic acid on the label, yet this ingredient helps keep those products smooth and easy to spread. In my personal experience with sensitive skin, products with this compound don’t just provide a soft feel—they help restore the skin barrier. Research supports oleic acid as a moisturizing agent and an emollient, making it a staple in creams, serums, lip balms, and cleansers.
Many personal care brands use pharma-grade oleic acid because impurities can lead to skin reactions. This isn’t a marketing gimmick—clinical data underlines that higher purity matters, especially in formulas for infants and people with allergies. The ingredient also acts as a solubilizer, which proves crucial for mixing vitamins, plant extracts, or fragrances into stable blends.
Food manufacturing relies on safety and consistency. Oleic acid pharma grade fits into this space because it meets drug-level standards for purity. The compound acts as an emulsifier, keeping things like dairy drinks and salad dressings stable and looking good on store shelves—something I’ve seen during a short stint shadowing quality control experts. Because it’s a fatty acid found in olive oil, consumer concern around safety remains low, and the body processes it without trouble.
In dietary supplements, this ingredient supports capsule formation. Gel caps and soft chews take advantage of its properties to keep active nutrients protected from air and moisture. Manufacturers with a focus on health claims often lean into pharma grade purity to help assure regulatory compliance and consumer confidence.
Even strict pharmaceutical grade oleic acid finds its place outside just medicine and food. Research labs rely on it for tissue culture media and biochemical assays. These uses require top-notch purity to avoid skewed experiment results—any stray contaminant could mess up cell growth or data points.
In my discussions with chemists, I’ve learned that some specialty coatings, wetting agents, and dispersants in diagnostics or analytical kits also require pharma grade oleic acid. Given the strict controls in labs, only the purest material meets the mark.
Demand for pure, traceable ingredients keeps growing, and oleic acid pharma grade isn’t just a technical option. People across healthcare, food, and science circles need certainty about what’s inside the bottle. Choosing pharma grade for these applications isn’t about following a trend—it’s about keeping people safe, ensuring reliable results, and building trust with informed consumers and professionals.
Every time I hear questions about the standards that pharmaceutical-grade oleic acid must meet, I think back to my first role in a lab where we had to approve raw ingredients before they touched any pill press. Any oil, especially one like oleic acid, has to do a lot more than just look clean. It needs a paper trail and a pedigree, showing it passed through a series of stringent quality gates.
All those acronyms stand for pharmacopeias. In plain terms, these are big rulebooks that list everything an ingredient has to prove to earn a spot on the approved list. “BP” points to the British Pharmacopoeia, “EP” means European Pharmacopoeia, and “USP” is from the United States Pharmacopeia. Each offers a detailed recipe, including purity, manufacturing controls, and testing methods. For anyone working in a global company or shipping products outside their home market, compliance with all three often matters as much as the oil itself.
Purity is non-negotiable. Pharma-grade oleic acid has to meet strict limits on contaminants such as heavy metals, peroxide values, or residual solvents. These standards don’t just protect someone’s reputation—they protect lives. I’ve seen batches fail because of a fractional difference in moisture content or an impurity flagged by a sharp-eyed lab tech. Busy production lines can grind to a halt just to avoid crossing a line set by these pharmacopeias.
The oil also carries a unique fingerprint determined by identity tests—infrared spectra, melting point, and other chemical signatures set in the rulebooks. Even a faint deviation can force a batch out of the running. Same with color and odor: even the best process runs must not leave any off-smells or unexpected tints.
Documentation runs as deep as the chemistry. Each lot gets tracked by a certificate of analysis. That report draws from validated test methods, not educated guesses. Lab certifications like ISO 9001 or GMP (Good Manufacturing Practice) reinforce that what you read in the report matches what’s in the drum. In my own work, I’ve seen audits where missing just one test report led to a recall—even if the oil never left the warehouse.
Skipping these hurdles courts real danger. Oleic acid can end up in topical medications, injectable formulations, and capsules. Residues from pesticides or processing factories, even in microscopic amounts, can spark allergic reactions or worse. Trust erodes quickly, both in the shop and at the pharmacy counter, if a brand slips here.
Standard-setting isn't just for regulators and big industry. Companies can help raise the bar by investing in staff training, automation, and cleaner supply chains. When I trained new hires, we walked through “mock recalls”—tracking an ingredient bottle back to its origin. Those drills clarified not just how but why every test kit and lab sheet got double-checked. Smarter suppliers also open their doors to audits, welcome feedback, and keep seeking cleaner, safer ways to produce staples like oleic acid, not merely sticking to what the book says but aiming higher.
Real progress happens when every link in the chain, from the farmer growing the oil crop to the pharmacist dispensing finished meds, shares this commitment. The story of oleic acid is a reminder that the best ingredients are never just about chemistry—they are about trust built through consistent, open adherence to standards that keep getting better.
Most people recognize oleic acid as the substance found in olive oil, but pharma-grade oleic acid—marked BP, EP, USP—goes through far stricter refining. BP stands for British Pharmacopoeia, EP for European Pharmacopoeia, USP for United States Pharmacopeia. Each of these sets a clear benchmark for purity, contaminants, and performance in products that end up inside or on the human body. The cleaner the ingredient, the less risk for irritation, blockages in active delivery, or hidden toxins that could damage health.
Pharmaceutical formulators count on oleic acid for its versatility. It acts as a solubilizer, emulsifier, and penetration enhancer. I've seen topical medications, including ointments for eczema and steroid creams, where the ingredient list includes this specific grade of oleic acid. Reason? It safely helps active substances cross skin barriers, which means the medicine does its job without unwanted side effects from unknown impurities. Published research in International Journal of Pharmaceutics confirms that pharma-grade oleic acid boosts the bioavailability of certain drugs, making treatments more predictable and reliable.
In the beauty world, cheap ingredients often lead to breakouts or allergic reactions. Genuine pharma-grade oleic acid offers a different story. Cosmetic chemists work hard to keep nasties like polycyclic aromatic hydrocarbons or pesticide residues out of their formulas. Sourcing a BP, EP, or USP grade ingredient is about more than labelling—it’s about safety, especially for sensitive skin or compromised skin barriers. My colleagues in cosmetic R&D regularly push for pharma-grade base oils in facial creams, serums, and cleansers. They’ve found it makes a difference in gentleness and shelf stability.
People often ask: Is this ingredient proven safe in humans? Every BP, EP, or USP validated batch passes through extensive testing, with traceability on every shipment. This system prevents contamination with allergens, heavy metals, or banned substances—issues that still surface occasionally when lower grades are sourced. A 2023 review by the FDA highlighted the dangers of unchecked cosmetic imports, making traceability a top concern for reputable brands.
The main complaints I hear relate to expense and supply chain complexity. Pharma-grade oleic acid costs more and isn’t always as easy to source, particularly for indie skincare brands or small-batch compounding pharmacies. Cutting corners means risking product recalls or public trust. Industry groups suggest strengthening supplier audits and long-term contracts to stabilize prices and maintain access to compliant stocks.
Product recalls linked to poor-quality excipients drive home a simple point: pharma-grade standards reduce risk. When formulators choose certified oleic acid, they lower the odds of customer complaints, regulatory penalties, and negative headlines. The up-front work pays off with consistent texture, safety, and effectiveness.
Regulators and professional organizations continually update guidelines to respond to evolving science about ingredient purity. Businesses that make the switch to pharma-grade oleic acid show that they care about real-world safety and brand reputation, not just regulatory minimums. Sharing these facts with consumers can turn trust into loyalty—especially in crowded markets where every ingredient decision matters.
You’ll find a rhythm in how pharmaceutical manufacturers handle ingredients like oleic acid. Over years in this industry, one thing stands out: packaging choices can make or break a product’s reliability. In pharma-grade settings, manufacturers prefer robust packaging for oleic acid, not just out of habit but necessity. Contamination spells immediate loss, and exposure to air or light nudges the acid closer to unwanted breakdown.
Most often, the go-to solution is a high-density polyethylene (HDPE) drum or carboy, generally colored opaque white or blue. HDPE doesn’t interact with the chemical—no leaching, no risk of unexpected reactions. Smaller batches for labs come in glass bottles with tight-sealing caps or aluminum containers, but large-scale buyers want those sturdy 25kg, 50kg, and even 200kg drums. The goal is always consistency and safety in transit as well as storage.
In practice, I’ve watched distributors reinforce pallets of these drums with shrink wrap, shrinking risks of tampering or accidental spill. In regions with greater humidity swings, it’s common sense to look for desiccant packs inside the larger drums. Such extra precautions keep moisture at bay.
Shelf life gets overlooked in textbooks, but nobody in a production line forgets what happens if chemicals degrade. High purity oleic acid, prepared for BP, EP, or USP compliance, generally claims a shelf life of two to three years from manufacturing. This holds true as long as you stick to standard storage: keep it between 15°C and 30°C, shielded from sunlight, away from sources of heat, and with the container tightly shut.
Across storage facilities, temp and humidity logs are more than routine—they’re lifelines for product quality. Exposure to oxygen or UV will nudge the acid toward peroxidation, creating off-odors or worse, changing the chemical structure enough to compromise safety. You don’t want to see what happens to a batch that’s been left uncapped or stored in direct sun. If you do, the difference is obvious—a clean, faintly fatty aroma shifts toward rancid.
In real-world handling, small lapses like a misaligned cap or an ignored spill aren’t rare. Lab staff and pharmacists are quick to discard containers past expiry or once contamination is suspected; pharma regulations take no chances on that front. Traceability through batch numbers on labels matters here, as records allow for easy recall or verification, which ties into industry best practice.
Facilities aiming to maintain maximum shelf life pay close attention to Good Manufacturing Practices (GMP), not just for compliance, but because it preserves both product value and patient safety. Regular audits of packaging quality, warehouse conditions, and even training guards against simple yet costly mistakes.
Switching suppliers is tempting for cost reasons but watching how a supplier packages and date-stamps their drums speaks volumes about their reliability. Look for clean, unbroken seals and clear labeling, going beyond the surface to check certifications and consistency across shipments.
From what I’ve seen, talking about shelf life isn’t a theoretical exercise—it’s a real-world issue where small decisions ripple into big consequences. Direct observation and diligent record-keeping protect end-users, so every player in the chain bears a responsibility to keep standards high for this common yet critical excipient.
I spent a good chunk of time learning the ropes in a formulation lab. Small details sometimes slip past even the sharpest pros, especially with things we see every day, like oleic acid. It looks innocent—clear, oily, not much smell. But if oleic acid isn’t treated right on the shelf or in your process, quality tanks fast. I’ve seen batches spoiled because someone got storage wrong, which leads not just to waste but also to possible compromise in health products people depend on.
Oleic acid draws interest for its role in pharma manufacturing and labs, but it doesn’t age well if left open to light, heat, or air. According to several studies, including World Health Organization guidelines, it starts oxidizing when exposed to oxygen for prolonged periods. Light only makes things worse—it's a recipe for rancid smells and yellowing. Pharmacopeia standards, covering BP, EP, and USP grades, all state it should live in well-closed containers, away from direct sunlight and at cool or room temperatures, typically below 25°C (77°F).
All these details feel small, but together, they keep oleic acid safe to use for things like topical medicines, food applications, and specialty products. I’ve handled deliveries where the acid showed up in drums that sat in the sun too long outside, and there was no hiding the degraded quality. If you’re running a tight operation, ignore these small lapses and you’ll pay for it down the line with rejections, costly retesting, or even recalls.
Pouring oleic acid is simple if your team stays sharp. Gloves and safety goggles do the job for personal protection since spills cause slips and it can irritate skin or eyes. Handling it usually means transferring from large carboys or containers into smaller vessels. Always handle these moves in a well-ventilated space—not just for comfort but to avoid possible buildup of vapors.
I made a habit of labeling each transfer vessel clearly with content and expiration date. Skipping that step has caused confusion more than once, sometimes leading to accidental mixing with other oils, which wastes precious material. Designating a specific area in the storeroom for oleic acid reduces confusion too, especially on busy days with multiple team members grabbing supplies at once.
I’ve watched old containers leak and corrode. Stainless steel or glass containers with airtight lids stand up to the task without contributing any unwanted byproducts. Oleic acid reacts with strong oxidizers and can slowly break down some plastics over time. Companies and labs should review material compatibility before long-term storage. Mop up spills immediately because the stuff gets everywhere and turns floors into skating rinks.
Modules of training don’t always prepare new staff for the small but critical step of rotating stock—first-in, first-out isn’t just a suggestion here; expired product can contaminate a new batch. I’d recommend digital inventory checks to catch mistakes early and regular site inspections to spot storage issues before they cause damage.
Regulatory agencies back all of these precautions. Pharmacopoeia monographs repeat over and over that the properties of oleic acid depend on proper storage and handling. Long-term stability runs downhill fast with too much heat or sunlight, reducing its suitability for pharmaceutical production. Relying on anecdotal experience, like seeing yellowed product in your own facility, only hammers the point home.
It comes down to daily habits and real attention to detail. Technical know-how, proven practices, and team training work together to keep oleic acid safe, effective, and ready for its next use.
| Names | |
| Preferred IUPAC name | (9Z)-Octadec-9-enoic acid |
| Other names |
cis-9-Octadecenoic acid Octadec-9-enoic acid Omega-9 fatty acid 9-Octadecenoic acid Elaic acid (trans isomer) Red oil Oleic acid, pure cis-Oleic acid |
| Pronunciation | /ˈəʊli.ɪk ˈæs.ɪd biː piː iː piː juː ɛs piː ˈfɑː.mə ɡreɪd/ |
| Identifiers | |
| CAS Number | 112-80-1 |
| Beilstein Reference | Beilstein Reference: 1721921 |
| ChEBI | CHEBI:36457 |
| ChEMBL | CHEMBL1426 |
| ChemSpider | 1214550 |
| DrugBank | DB04224 |
| ECHA InfoCard | Coded string: "03b7d0c4-98a9-4b0e-a736-969f6c94b72e |
| EC Number | 200-368-5 |
| Gmelin Reference | 72921 |
| KEGG | C00712 |
| MeSH | D009774 |
| PubChem CID | 301 |
| RTECS number | RGWA000690 |
| UNII | UNII: 2Z83RNA4YK |
| UN number | UN 3265 |
| CompTox Dashboard (EPA) | `DTXSID5020445` |
| Properties | |
| Chemical formula | C18H34O2 |
| Molar mass | 282.47 g/mol |
| Appearance | Clear, yellowish, oily liquid |
| Odor | Characteristic, rancid |
| Density | 0.89 g/cm³ |
| Solubility in water | Insoluble in water |
| log P | 7.6 |
| Vapor pressure | <0.01 mm Hg (20°C) |
| Acidity (pKa) | pKa ≈ 9.85 |
| Basicity (pKb) | pKb: 15.6 |
| Magnetic susceptibility (χ) | Diamagnetic |
| Refractive index (nD) | 1.451 - 1.457 |
| Viscosity | 20 - 40 cP (at 25°C) |
| Dipole moment | 1.327 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 234.98 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -282.5 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -2820 kJ/mol |
| Pharmacology | |
| ATC code | A08AX |
| Hazards | |
| Main hazards | May cause eye and skin irritation. |
| GHS labelling | GHS02, GHS07 |
| Pictograms | GHS07,GHS08 |
| Signal word | Warning |
| Hazard statements | Hazard statements: "Causes serious eye irritation. |
| Precautionary statements | P264, P270, P273, P280, P301+P312, P305+P351+P338, P337+P313 |
| NFPA 704 (fire diamond) | 2-1-0 |
| Flash point | 185 °C |
| Autoignition temperature | 365°C |
| Lethal dose or concentration | LD₅₀ (oral, rat): 74,000 mg/kg |
| LD50 (median dose) | LD50 (median dose) for Oleic Acid BP EP USP Pharma Grade: "74,000 mg/kg (oral, rat) |
| NIOSH | Not Listed |
| PEL (Permissible) | PEL: 15 mg/m³ |
| REL (Recommended) | Recommended use: Pharmaceutical applications, excipient, emulsifying agent, and other uses as per BP/EP/USP standards. |
| IDLH (Immediate danger) | Not established |
| Related compounds | |
| Related compounds |
Stearic Acid Palmitic Acid Linoleic Acid Arachidic Acid Elaidic Acid Myristic Acid Erucic Acid |
Chengguan District, Lanzhou, Gansu, China
