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As someone who watched the growth of pharmaceutical and chemical solutions from the sidelines of university labs to the hustle of commercial manufacturing floors, I’ve seen a handful of excipients shape the industry. Kolliphor RH 40, often turning up under scientists’ noses in clear bottles, stands out among them. This material, which Bayer first registered decades ago as Cremophor RH 40, reflects the increasing drive to dissolve what once seemed impossible to dissolve, not just in pharmaceutical formulas but in cosmetics, agrochemicals, and food tech too. Its birth rides the wave of post-war chemical innovation, when researchers focused on transforming castor oil—a raw, ordinary commodity—into something sophisticated enough for multiple industries. A mass of scientific circles worked tirelessly to hunt down surfactants capable of blending fat- and water-based compounds. Kolliphor RH 40 was born of this pursuit, and since then, it’s adapted to countless formulation trends where hydrophobic and hydrophilic meet and clash.
Tackling the role of Kolliphor RH 40 means appreciating how it merges the worlds of lipids and water. Most folks in the lab know it as a non-ionic emulsifier running on a foundation of hydrogenated castor oil polyethoxylation. This isn’t just chemical jargon; it means the material holds a bunch of polyethylene glycol chains between castor oil’s natural glycerides. This structure gives it the gumption to wet, mix, and stabilize oily and aqueous ingredients without drawing too much attention to itself, letting actives shine through in a finished product.
Kolliphor RH 40 flows with a yellowish, somewhat viscous look, which chemists often liken to a thick syrup or melted butter that cools slowly. Its melting point usually lands in the low to mid-20s Celsius, which keeps it pourable at room temperature but ready to solidify if chilled. The high hydrophilic-lipophilic balance (HLB), typically above 14, sets it apart from older castor derivatives, giving it solid muscle for forming oil-in-water emulsions and solubilizing hydrophobic compounds. Its solubility in both water and many organic solvents makes it a forgiving partner in all sorts of formulations. The pH range doesn’t cause headaches: Kolliphor RH 40 resists breakdown across a broad band, so it sticks around and does its job without drama, whether you’re working in slightly acidic or near-neutral conditions.
Labels and certificates only tell half the story, but users want to grasp what to expect every time they open a drum. Kolliphor RH 40’s quality grades hinge on residual ethylene oxide, acid number, saponification, and heavy metal content. These tight specs spring from a century of quality control—consistency breeds trust, especially for regulated industries like pharmaceuticals and personal care where variability spells disaster. In the United States, Kolliphor RH 40 usually meets GRAS (Generally Recognized As Safe) status for specific uses, but not universally, so producers dance carefully between FDA and EMA guidelines, disclosing the exact chemical structural elements and additive potentials on technical data sheets. In my own practice, I’ve seen regulatory audits look past shiny certificates and dive into batch chromatograms to confirm purity and consistency.
Industrial manufacture of Kolliphor RH 40 centers on the ethoxylation of hydrogenated castor oil. Companies run castor oil through hydrogenation to knock out double bonds, producing a more stable backbone. At this point, they push ethylene oxide under high pressure and moderate heat into the melted oil. Catalysts steer the addition toward the right number of ethoxy units. This part always required vigilance in the labs I worked in—safety concerns when handling ethylene oxide aside, the product quality turns on how well technicians manage time, temperature, and pressure. Even a brief deviation can turn smooth, reliable surfactant into a stubborn mass that refuses to play nice in a formulation.
Tinkering with Kolliphor RH 40’s chemical structure means adjusting the ratio of ethoxy groups to fat molecules—each tweak shifts the balance between oil- and water-loving properties. Chemists play with these ratios to meet new regulatory hurdles or push the performance curve for solubilizing next-generation, poorly-water-soluble drugs. Derivatives sometimes get capped with extra functional groups for stability or anti-oxidant properties. I’ve been in meetings where teams debated trading off a percent or two of efficiency for stability in extreme pH or high salt. Once, a supplier switched their catalyst and the change swept through the product’s performance, forcing a hasty round of reformulation for several clients.
If you flip through the literature, Kolliphor RH 40 pops up under older monikers like Cremophor RH 40, Polyoxyl 40 Hydrogenated Castor Oil, PEG-40 Hydrogenated Castor Oil, or even the occasional “Solutol.” Each of these tags points to essentially the same ingredient but might reflect subtle differences in manufacture, registration, or regional preferences. Navigating this name game often left me clarifying to junior chemists or procurement teams that, no, these aren’t different beasts, just different chapters in a long regulatory and commercial history. Marketing departments can add to the noise, but solid analysis brings clarity in any blend or formulation.
No one relishes a toxicological surprise on their hands. Kolliphor RH 40’s widespread use owes a lot to its safety track record in recommended doses, but plenty of studies remind us not to get lazy. Skin and eye irritation tend to come up if you pour pure Kolliphor RH 40 over tissue culture plates or if splashbacks happen during transfer. I once witnessed a slip-up where a technician, distracted during bottling, ended up with a rash that sent her home for three days. Gloves, goggles, and careful handling make for a much smoother day in production. Fire hazards rarely pop up in daily work, but industry protocols keep everything locked down, especially given trace flammability from residual ethylene oxide. Storage comes down to clean containers, mild temperatures, and avoiding acid or bleach mixing nearby.
Kolliphor RH 40 crops up across a surprising patchwork of industries. Pharma brands value it for its gift at wrapping up hydrophobic actives in clear, reliable oral solutions, clean injectables, and opaque, stable creams. My time consulting for a dietary supplement firm revealed how few surfactants measure up when it comes to masking taste and mouth feel in high-dose omega-3 and turmeric oil blends. Personal care manufacturers rely on it for stable shampoos and lotions, where it blends in without drawing attention, supporting luxurious and stable product lines that customers admire at first squeeze. In crop protection, companies take advantage of its emulsifying and wetting power for everything from herbicides to foliar feeds, squeezing better results from active molecules facing rough outdoor environments. Even in food production, small, highly controlled amounts stabilize flavor emulsions, clouding agents, and nutrient beverages.
Every R&D project I’ve touched in the last decade touched on solubilization at some point. As drug pipelines fill up with poorly soluble compounds, Kolliphor RH 40 keeps popping up as a workhorse to get these molecules from powder form into bioavailable solutions. Biotech firms lean heavily on surfactants like this during early-stage research, where materials need to pass quick screening tests before deeper toxicology. Cosmetic labs lean in too, tweaking Kolliphor RH 40’s ratios to match new plant-derived oils or herbal extracts caught up in the next big green trend. For all the curiosity around natural, plant-based emulsifiers, Kolliphor RH 40 continues to set benchmarks that few green alternatives match on price, scale, and performance.
Stories about Kolliphor RH 40’s toxicity surface almost every time a new drug using it hits the market. Early research flagged risks of anaphylactoid reactions, especially with rapid intravenous administration. The old debate centered on Cremophor-based formulations, like certain cancer chemotherapies, where reactions forced doctors to premedicate patients or switch to slower infusion. Most oral and topical applications, in my own experience, fall comfortably under safety thresholds, but researchers don’t lose sight of rare reactions or emerging environmental concerns. As regulations tighten, toxicologists continue running studies to track metabolites, bioaccumulation, and subtle impacts on gut flora or skin microbiomes.
Kolliphor RH 40 won’t fade anytime soon. Developers keep finding new ways to stretch its capabilities—co-formulation with cyclodextrins, nanoparticles, or biologics broadens its horizon beyond historic limits. Pharmaceutical researchers hope to pair it with green chemistry tactics, cutting down residual impurities and energy use during manufacture, to answer global calls for sustainable production. Quality and environmental credentials shape the discussions in technical and regulatory circles, driving chemical manufacturers to tweak processes, chase higher purity, and guarantee that future generations of surfactants outperform the current workhorses. In meetings worldwide, industry veterans and bright new minds debate whether a plant-based, biotechnologically produced emulsifier can ever fully outshine Kolliphor RH 40’s century-long winning streak. For now, this workhorse keeps setting the standard—and the bar just keeps rising.
You pick up any bottle of cough syrup, a capsule from your daily vitamins, or even a sensitive cream for your baby’s skin, and there’s a good chance that Kolliphor RH 40 plays a hidden but crucial role. Its strange name sounds a bit like a sci-fi robot, but really, it’s a substance derived from castor oil, modified with ethylene oxide. So what’s it doing on the ingredient list of your medicine or your moisturizer?
Ask any pharmacist about poorly soluble drugs and you’ll hear the same repeated headache. Many active ingredients in modern drugs don’t mix well with water. So picture a patient needing a medication for pain, but their body can’t absorb it effectively because the pill or liquid just won’t dissolve.
Kolliphor RH 40 does something pretty impressive in these situations: it helps oily or fat-loving substances dissolve into water. This means that drugs that wouldn’t normally mix now slip into the body easier. Patients see better results, drug manufacturers can actually deliver accurate doses, and a lot fewer people skip their medicine from frustration.
It’s not just about disease. Kolliphor RH 40 gets along with many different cosmetic and food products too. Take sunscreens or beauty creams—brands want them to feel smooth, not greasy or gritty. Kolliphor RH 40 helps oil-based vitamins, delicate perfumes, or colorants blend into lotions, washes, and gels until they feel pleasant to touch and use. The same principle lets beverage makers mix in vitamins and flavors without them floating to the top or settling at the bottom.
A lot of folks worry about synthetic-sounding ingredients, and that’s valid. Kolliphor RH 40 has a long track record of research behind it. Regulatory agencies like the FDA and European Medicines Agency have repeatedly reviewed data showing that, for the vast majority of people, this emulsifier stays safe across a wide range of uses, especially in the amounts found in food or pharmaceuticals.
Rare cases of allergies or intolerance exist, as with almost any additive. No substance fits every body. Companies have an obligation—ethically and legally—to stay transparent, keep allergy lists accurate, and regularly review new safety data. Any action less than that risks real harm to vulnerable patients or customers.
Even with a solid safety profile, the field keeps pushing for options that are just as effective but made from more sustainable sources. While Kolliphor RH 40 is already based on castor oil, many scientists aim to tweak its structure or source to be even friendlier for long-term health and the environment. At the same time, pressure mounts for all pharmaceutical and cosmetic companies to be upfront about every ingredient they use. New apps and online databases let anyone scan a product and track these substances back to their origins.
As people learn more about where their medicines and self-care items come from, demand rises for transparency and better choices. Kolliphor RH 40 isn’t the only answer, but it’s a workhorse for good reason. Balancing utility, safety, and the move towards greener chemistry will shape what comes next on our labels—and in our bodies.
Pharmaceutical companies use many ingredients so that tablets, capsules, and solutions do their job properly. With oral drugs, the spotlight often falls on additives like Kolliphor RH 40, a non-ionic surfactant made from hydrogenated castor oil and ethylene oxide. This ingredient gets used for its strong solubilizing power. Making insoluble drugs available in water-based solutions smooths the manufacturing process and improves how medicines act in the body. But people do want to know if putting something like Kolliphor RH 40 into products you swallow is safe.
The clue to Kolliphor RH 40’s safety profile lies in a few years of research data and how regulatory agencies rate it. The material has been in oral and injectable drug products for decades. The International Pharmaceutical Excipients Council lists Kolliphor RH 40 as an approved pharma excipient. In Europe, drug authorities have signed off on it in dozens of prescription products, especially those where the active drug needs a boost to dissolve well.
Recent peer-reviewed studies dig into toxicity reports. The results keep stacking up: at doses used in medicines, Kolliphor RH 40 doesn’t trigger major harmful effects. Large doses in animal testing—more than what humans ever consume—lead to some irritation or gut upset, but at much higher levels than found in pills or syrups. No evidence has linked normal doses to carcinogenicity or lasting health risks.
Regulation doesn’t mean complacency. Every oral formulation affects thousands, maybe millions, of people. Kolliphor RH 40’s reputation for safety doesn’t mean it suits every person. Those with allergies or past sensitivities to polyoxyethylated castor oil do need caution—though allergic reactions are rare, labeling helps those at risk.
There have been reports of gastrointestinal complaints. These pop up at higher than average doses. As a pharmacist, I’ve had patients worried after reading long ingredient lists. One mother once brought in an anti-nausea syrup, apprehensive about the unfamiliar chemical names. I explained that most additives—including Kolliphor RH 40—show reliable safety results in real-world use, plus they pass strict regulatory review. She appreciated the walk-through, especially when learning the alternative was a less effective medicine.
Nearly one third of new small-molecule drugs don’t dissolve in water. Kolliphor RH 40 acts almost like a team player here. It boosts the solubility of stubborn drug compounds, making sure a medicine delivers its benefit without slow or uneven absorption. This is crucial in life-saving drugs given orally, such as some anti-cancer medications and immunosuppressants. Without a solubilizer, many of these pills would sit untouched in the gut, offering little help.
In my experience behind the pharmacy counter, many of the most reliably effective liquid medications for children and elderly patients rely on this kind of solubilizer. Patients swallow a teaspoon of strawberry-flavored syrup, not a mouthful of powder. The upside is real, especially for people who have trouble swallowing pills.
Transparency in pharma labeling goes a long way. Patients benefit when drug companies break down added ingredients with plain language. More real-world studies might help clarify rare side effects and uncover new data in special groups such as children, pregnant people, and those with immune deficiencies.
On the manufacturing side, open communication between research labs and health authorities should keep changing as new data appears. Safety monitoring isn’t a one-and-done process. Drug regulators can update recommendations whenever evidence suggests even a hint of a problem.
From my vantage point, the main risk remains rare sensitivities, not widespread danger. Kolliphor RH 40 holds up well in both lab testing and everyday use, provided everyone involved stays honest and vigilant about the science behind each batch that ends up in a patient's medicine cabinet.
People working in pharmaceuticals run into Kolliphor RH 40 all the time. It shows up in oral, topical, and even injectable formulas. Behind the trademark, it’s a chemical brew based on hydrogenated castor oil. Think of it as castor oil that’s been processed by reacting it with ethylene oxide, giving it many of its special properties.
Kolliphor RH 40’s main chemical identity comes from hydrogenated castor oil, also known as the triglyceride of ricinoleic acid. This material acts as the backbone. Next up is ethylene oxide, which reacts with the fatty acids from the castor oil. This process forms a collection of polyoxyethylated chains attached to the natural castor oil structure. The outcome is polyoxyl 40 hydrogenated castor oil, which contains a mix of molecules where, on average, 40 ethylene oxide units hang off each molecule.
Stepping back from formulas, this matters because every batch ends up with a mix of different chain lengths and components. Some molecules keep more of the original triglyceride structure than others, and a few aren’t as evenly reacted. This lack of total uniformity actually gives Kolliphor RH 40 a broader utility. It emulsifies oil and water, helping oily drugs dissolve in water-based environments. This helps medicines reach the bloodstream or skin more easily.
Kolliphor RH 40’s mix brings practical value. Too many drugs fail before they even get tested in people because they stubbornly refuse to dissolve. Pharmaceutical labs often fight with solubility issues that stall product development. Here’s where Kolliphor RH 40 picks up the slack. The blend of hydrophilic (water-loving) and lipophilic (fat-loving) groups in its molecules means it can bridge the gap between oil and water, increasing the reach and delivery of active ingredients.
From my own time in pharma R&D, I saw teams turn to this material when newer excipients failed to deliver consistent results. Sometimes the simplest solutions, like tweaking the ratio of hydrogenated castor oil to ethylene oxide chains, improved absorption or cut down irritation in sensitive patients. Years of trial and error led to a rough rule: the degree of polyethoxylation impacts how gentle or effective the excipient turns out. Kolliphor RH 40 with its “40” average chain length lands right in a sweet spot for many drugs.
No chemical comes without questions. Regulatory bodies expect detailed breakdowns of excipients. Kolliphor RH 40 gets a long look because, while its components have safety records, the way it’s produced leaves trace amounts of by-products. Pharmaceutical companies need to monitor and minimize those. The industry increasingly demands transparency about not just the main ingredients, but also possible residual reactants and side-products.
As treatments advance, the pressure grows to develop excipients with fewer impurities and improved performance. Some researchers look for bio-based or more precisely engineered variants. New manufacturing methods, cleaner ethylene oxide reactions, or switching to different starting oils promise to refine these old workhorses. Still, Kolliphor RH 40 hangs on in drug development toolkits for its flexibility and a safety profile built up through decades of use.
Any conversation about excipients comes back to patient safety and how small chemical tweaks shift performance. Those of us in the trenches have watched Kolliphor RH 40 stick around for good reason. Understanding what goes into each batch means better medicines in the long run.
Anyone who’s spent time working in a pharmaceutical lab or a formulation facility has probably handled Kolliphor RH 40 more than once. It’s a key emulsifier, relied on to keep active ingredients evenly dispersed in all sorts of medicines and supplements. Every batch of an emulsion or softgel counts on consistent quality, and that starts with keeping the raw materials in good shape. Storage decisions can make the difference between a flawless end product and a recall-worthy disaster.
Kolliphor RH 40 doesn’t like being ignored. This material contains polyethylene glycol esters and sorbitan fatty acid esters. These components break down in the presence of moisture, high heat, or exposure to light. Left on a shelf in a humid warehouse, the product absorbs water from the air like a thirsty sponge. Before long, the performance can falter. Put simply, this means tablets, capsules, or syrups may not deliver what’s printed on their labels. In the real world, that comes down to patient safety and trust in every dose.
Throughout my time in the lab, overlooking a drum of Kolliphor RH 40 was sometimes tempting. Space constantly feels tight, and convenience often leads teams to place small ingredients within arm’s reach. But storage rooms exist for a reason. Over time, leaking caps, sunlight through windows, or even a slightly damaged container have made for costly clean-ups and re-testing.
The gold standard for Kolliphor RH 40 storage is a sealed container, protected from light and kept at 25°C or below. Manufacturers highlight the risk of product alteration if temperatures swing too much. In hotter regions, air conditioning in the warehouse isn’t a luxury; it’s a requirement. Facilities running with poor ventilation or frequent opening and closing of warehouse doors invite condensation. Humidity management becomes as critical as temperature checks.
Whenever someone opens a drum, things get risky. Air sneaks in, bringing water vapor and sometimes microscopic debris. It helps to move what’s needed into clean, secondary containers if the whole lot isn’t being used at once. Desiccant packets and regular auditing cut down on the threats. Avoiding direct sunlight and keeping the original packaging intact serve as quick wins. Labels matter too—each container should carry clear dates and batch information to sidestep mix-ups later in the process.
This isn’t just a matter of ticking off compliance boxes. Quality failures happen in the dark corners of storage rooms more often than most outsiders realize. One time, I remember a supplier shipped a batch that had spent days in an unventilated shipping container and the chemical smelled wrong even before testing. Tracing the error came back to how long the barrels had waited under the sun.
That’s why I always urge people to take storage protocols seriously—these don’t just protect the company’s reputation. They safeguard pharmacists, patients, and anyone counting on the finished product to do its job.
Risk doesn’t stop at one facility. A breakdown in storage standards anywhere along the chain multiplies problems. It signals the need for training and clear standard operating procedures. Staff turnover erodes good habits; regular walk-throughs and refresher sessions bring home the message that storage is more than just putting stuff on shelves.
Kolliphor RH 40 is an unsung hero in formulations, but only if every step from delivery to dispensing treats it with respect. Good storage keeps everything else on track.
Parenteral drugs, meaning those delivered by injection or infusion, rely on every ingredient in the formulation to keep patients safe. Kolliphor RH 40, a synthetic surfactant made by reacting castor oil with ethylene oxide, helps dissolve poorly soluble drugs in liquids. It has found a home in oral and topical medications, and some manufacturers have pushed to use it in intravenous or other injectable products.
Pharmaceutical teams sometimes run into molecules that simply refuse to dissolve in water. Kolliphor RH 40 makes it possible to transform these stubborn compounds into injectable solutions. As someone who has read regulatory filings and sat through more than one manufacturing line review, I get the allure of using a well-known excipient. More drugs could reach patients by using excipients like Kolliphor RH 40 to make them injectable.
Regulatory agencies like the FDA and EMA look twice at every material that goes directly into the bloodstream. Kolliphor RH 40 has some data showing good tolerance when used in humans and animals. Published studies out of Europe and Asia suggest it doesn’t break down into anything alarming in the body. Even the World Health Organization has included it in a list of ingredients considered safe for parenteral use, under controlled conditions and with proper dose limits.
Still, risks have surfaced. Large amounts of Kolliphor RH 40 in an IV infusion can trigger allergic reactions, including anaphylaxis. There are rare reports of hypersensitivity in patients receiving products containing the excipient, although these usually involve much higher concentrations than typical. For anyone with a history of allergies, careful screening and monitoring become essential if doctors decide to use a drug containing Kolliphor RH 40.
Pharmaceutical developers can pick from an array of solubilizers, many with long track records in parenteral drugs, including polysorbate 80, PEGs, and lipids like soybean oil. Still, each has its own baggage. Polysorbate, for instance, is notorious for particle formation over time. PEGs bring renal clearance issues, especially for those with kidney trouble. Kolliphor RH 40 doesn’t escape scrutiny, but it holds potential in situations where nothing else works as well.
Injecting any foreign material carries risk. Sterility, purity, and patient safety always trump convenience. Kolliphor RH 40’s toxicity profile, while not perfect, gives comfort where traditional excipients fall short. Product developers need to run extra checks with every new batch, watch for known impurities, and keep concentrations at the lowest effective amount.
Hospitals and patients count on drug makers to track rare events and adjust risk management plans as new data rolls in. I’ve spoken to pharmacists who appreciate seeing published evidence supporting safety at relevant dosages, particularly for patients who may have multiple health issues. Medical teams watch closely for signals of allergic reactions and stay ready with alternatives for those who don’t tolerate the ingredient.
Industry must continue funding studies and sharing real-world data. Regulators want transparency around manufacturing controls and long-term patient outcomes. Only then can teams make science-driven decisions, balancing the benefits of novel delivery methods with the ongoing duty to protect patient health.
If drug developers respect these safeguards, Kolliphor RH 40 can serve as a valuable tool in making injectable drugs that help people live longer, healthier lives.
| Names | |
| Preferred IUPAC name | Polyoxyl 40 hydrogenated castor oil |
| Other names |
Polyoxyl 40 Hydrogenated Castor Oil PEG-40 Hydrogenated Castor Oil |
| Pronunciation | /ˈkɒlɪˌfɔːr ɑːtʃ ˈfɔːrti/ |
| Identifiers | |
| CAS Number | 61788-85-0 |
| Beilstein Reference | Beilstein Reference 1705404 |
| ChEBI | CHEBI:131107 |
| ChEMBL | CHEMBL3833256 |
| ChemSpider | 2296572 |
| DrugBank | DB11132 |
| ECHA InfoCard | 100.223.241 |
| EC Number | 616-440-0 |
| Gmelin Reference | Gmelin Reference: **"80939"** |
| KEGG | C13586 |
| MeSH | Polyethoxylated Castor Oil |
| PubChem CID | 3016535 |
| RTECS number | GGN6856000 |
| UNII | UBM8V6V0AP |
| UN number | UN3082 |
| CompTox Dashboard (EPA) | Kolliphor RH 40 CompTox Dashboard (EPA) identifier is: **DTXSID9021736** |
| Properties | |
| Chemical formula | (C₂₅H₅₂O₆)n·C₂H₄O |
| Appearance | Clear, yellowish, viscous liquid |
| Odor | Slightly fatty |
| Density | 1.06–1.10 g/cm³ |
| Solubility in water | miscible |
| log P | 1.96 |
| Vapor pressure | <0.01 hPa |
| Acidity (pKa) | 7.0 |
| Basicity (pKb) | 14.5 |
| Magnetic susceptibility (χ) | -8.16E-6 cm³/mol |
| Refractive index (nD) | 1.453 – 1.457 |
| Viscosity | 60–90 mPa·s (20 °C) |
| Dipole moment | 2.1 D |
| Thermochemistry | |
| Std enthalpy of combustion (ΔcH⦵298) | -31.1 kJ/g |
| Pharmacology | |
| ATC code | A06AD15 |
| Hazards | |
| Main hazards | Causes serious eye damage. |
| GHS labelling | GHS07, Exclamation mark |
| Pictograms | GHS05, GHS07 |
| Signal word | Warning |
| Hazard statements | H319: Causes serious eye irritation. |
| Precautionary statements | Precautionary statements: P280, P305+P351+P338, P337+P313 |
| Flash point | > 113 °C |
| Autoignition temperature | > 320°C |
| Lethal dose or concentration | LD50 (oral, rat): >5000 mg/kg |
| LD50 (median dose) | LD50 (median dose): 4,200 mg/kg (rat, oral) |
| NIOSH | Not Listed |
| PEL (Permissible) | PEL: Not established |
| REL (Recommended) | 2 – 10% |
| Related compounds | |
| Related compounds |
Polyethylene glycol Glyceryl monooleate Kolliphor EL Kolliphor HS 15 Cremophor RH40 |
