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Chemists developed glyceryl distearate years ago as part of a push to improve texture and stability in pharmaceuticals and personal care products. I remember walking into my first formulation lab and finding products on the shelves that depended on glyceryl esters for their creamy consistency. The search for excipients that don’t just act as fillers, but actively improve how a final product feels and hold together, has always fueled innovation in the industry. Glyceryl distearate, synthesized from stearic acid and glycerol, quickly stood out due to its ability to bridge hydrophilic and lipophilic phases. Official pharmacopeias like BP, EP, and USP established standards that forced manufacturers to consistently meet high purity demands. The reliance on such standards wasn’t just for show; as global manufacturing took off, batch-to-batch consistency turned into a necessity for product safety and consumer trust.
Known under a handful of names like 1,2,3-Propanetriol distearate, Octadecanoic acid ester with glycerol, and E471, glyceryl distearate marks its presence in both pharma and food. It acts as more than a background ingredient. In tablets and creams that consumers use daily, this molecule serves as a lubricant and thickening agent, lending stability where needed. The move from crude, mixed esters to highly refined, pharma-grade material represented a leap in both function and trust. The pharma grade label means reduced impurities, reproducible properties, and a safety record needed for drug and supplement development.
Glyceryl distearate usually appears as a white waxy solid or flake, faint in odor, with a melting point ranging from 54-58 °C. Unlike materials that break down under typical storage, glyceryl distearate stands up well against light and oxidizing conditions. The long-chain stearic groups give it a hydrophobic backbone, but the molecule as a whole balances this with enough polarity to emulsify water-oil mixtures. This combination made it a favorite for products that demand smooth appearance and good shelf stability. Solubility remains low in water but high in organic solvents, so handling and incorporation into hydrophobic environments go smoothly.
Regulations in Europe, India, and the US specify glyceryl distearate BP, EP, and USP grades, each with slightly different analytical requirements, but all focusing on minimizing free fatty acids, ash, and unacceptable trace contaminants. Each batch must pass identity, melting point, acid value, saponification value, and purity tests. These are not bureaucratic hurdles; they directly tie to performance in tablet lubrication, capsule production, and emulsion stabilization. From my own time collaborating with regulatory affairs, I know label accuracy matters. A pharma label that says glyceryl distearate BP or USP assures buyers that the product they’re using will act predictably.
Manufacturers produce glyceryl distearate by reacting stearic acid with glycerol under specific catalytic conditions, usually under vacuum to drive off water and achieve a high yield of the distearate, limiting mono- and tristearate byproducts. Batch reactors remain a mainstay, with tight process controls needed to prevent saponification and preserve a neutral, pure ester product. The method matters because downstream users like myself check for consistency and purity every time a new shipment arrives. Oversights during preparation can leave behind reactants which risk product failures or patient harm, so most pharma companies integrate in-line monitoring technology now.
Glyceryl distearate undergoes controlled hydrolysis, transesterification, or oxidation in some manufacturing steps or research settings. Its backbone can accommodate addition of other fatty acids or polar groups, allowing for customization in specialty applications. I once worked on a team that experimented with blending glyceryl distearate with other glyceryl esters to fine-tune rheology in topical drugs. The chemistry isn’t just academic; these tweaks translate directly into how a cream spreads, how stable a suspension remains, or how a tablet punches out of machinery.
Worker safety and patient safety tie together in the glyceryl distearate supply chain. The pharma-grade material needs not only to be low in toxins and allergens but also packaged, stored, and transported under strict standards. Good Manufacturing Practices (GMP) set the foundation, with additional requirements from REACH and various international chemical safety boards. In my current role, seeing vendors with ISO certifications and traceable lot numbers makes a difference. Accident-free records and product recalls hinge on chemical stability, correct labeling, and robust documentation. On the user end, formulated products remain stable without risk of acute toxicities, but ongoing vigilance over impurities like formaldehyde or nitrosamines means no company can rest easy.
Pharmaceuticals find glyceryl distearate especially useful in solid oral doses, where it helps tablets release from molds and presses, improving overall yield. Nutraceutical companies turn to it for encapsulation, with its low reactivity and stabilizing qualities protecting sensitive actives. Skin creams and lotions benefit from its role as an emollient and consistency agent, improving skin feel and resisting separation during storage. I’ve seen bariatric foods, infant formulas, toothpaste, and even chewing gum formulations specifying glyceryl distearate precisely because it carries both approval from food and pharma regulatory bodies. That breadth of application rarely comes from excipients that fly under the radar.
Research teams continue to experiment with new ways to process and modify glyceryl distearate for targeted drug release, improved absorption, or lower environmental impact. Formulation scientists don’t just follow monographs; they test new blends and process routes to overcome common hurdles like manufacturability and scale-up. I remember a project that relied on controlled crystalline forms of glyceryl distearate to slow down drug release in a once-daily oral tablet. Each tweak required robust characterization using techniques like DSC and FTIR, illustrating the ongoing interplay between raw material supplier and formulation scientist.
Long-term studies in animals and monitoring through pharmacovigilance databases suggest glyceryl distearate presents a low risk profile when purified to pharmaceutical standards. Experts keep an eye on exposure thresholds, paying special attention to impurities and degradation products. I follow published reviews from toxicology panels, which consistently rate glyceryl distearate as safe for human use at permitted levels. Scrutiny increases over each contaminant—residual catalysts, trace solvents, or unexpected byproducts—so successful companies don’t just rely on generic COAs, but commission additional impurity profiling as routine.
Industry momentum now leans toward better traceability, greener synthesis, and grades customized for next-generation drug delivery forms. As personalized medicine and plant-based sourcing climb in importance, glyceryl distearate will need to evolve alongside consumer expectations and sustainability benchmarks. I see trends toward biobased raw materials, more detailed supply chain disclosure, and functional modifications that go beyond standard lubrication or emulsification. No ingredient can rest on its previous success—constant improvement and research into long-term exposure as well as process side products will shape which excipients become trusted standards in the years ahead.
Moving through the world of pharmaceutical ingredients, it’s easy to gloss over the names printed in tiny letters on medicine packaging. Glyceryl Distearate, especially when tagged with BP, EP, or USP grades, often gets overlooked. Still, this compound shapes the texture, feel, and sometimes even the safety of products we count on when we’re unwell.
Pharmaceutical applications rely on ingredients that do more than just “fill space.” Glyceryl Distearate is formed from glycerin and stearic acid. That particular combination allows it to act like a bridge between oil and water. Medicines and topical products include this compound to help blend their ingredients, giving each dose consistency. Anyone who’s ever opened a tube of cream and found watery liquid separating from the thicker parts knows how unpleasant—and potentially unreliable—a product can become without something to hold it together.
The quality marks—BP (British Pharmacopoeia), EP (European Pharmacopoeia), USP (United States Pharmacopeia)—matter. Each stamp means the ingredient passed specific purity and manufacturing standards. Someone might look at Glyceryl Distearate and think “just another chemical,” but these quality grades set it apart from food or cosmetic versions. When prescribed a cream or pill, users trust that the contents are safe. Adherence to these standards cuts risk of contamination or inconsistent performance.
In my years of working alongside pharmacists and talking with patients, I’ve seen issues arise where formulations without the right emulsifiers led to unpredictable results. A lotion starts out thick and soothing, then loses that smooth feel or splits apart on the shelf a month later. Some folks stop using their medicine, doubting if it’s still good. Glyceryl Distearate addresses this exact problem in ointments, creams, and sometimes even tablets. It stops the separation, keeps dosing even, and ensures every application gives users the same result, day after day.
People often ask why so much attention gets paid to these “extra” substances in medicine—aren’t the active ingredients all that matter? Experience says otherwise. Excipients like Glyceryl Distearate don’t cure disease, but they help maintain the medicine’s stability, flavor, or texture. That means fewer recalls, less confusion over whether a product is safe to use, and higher odds that patients finish their course of treatment as prescribed. Poor stability in a capsule, for instance, could mean some pills are too weak, others too strong. That unpredictability isn’t safe for anyone.
Transparency about what goes into our medications needs attention. Pharmacies and healthcare providers have started sharing more about which excipients play a role and why. In a time where drug recalls and contamination issues make the news, using pharma-grade Glyceryl Distearate reassures the public. It’s not about marketing—it's about trust, patient comfort, and dependability. Policymakers and manufacturers ought to keep prioritizing these high standards across the whole supply chain.
Glyceryl Distearate BP EP USP pharma grade may lack the glamour of cutting-edge therapies, but its role holds up under the microscope. As medicines become more tailored and complex, paying attention to the ingredients that set the foundation will matter even more. Patients, caregivers, and makers of medicine have a stake in keeping these standards front-and-center.
Glyceryl distearate shows up in a lot of products, from face creams to some tablets. Chemists use it mainly as an emulsifier, which helps oil and water mix. That makes lotions feel smooth and stops liquids from splitting into layers in your medicine or your shampoo. It is made from glycerin and stearic acid, two ingredients humans have relied on for decades. Those ingredients come from vegetable or animal fats, breaking down into harmless substances inside our bodies. In the lab, glyceryl distearate wears a few official names, like BP, EP, and USP grade. These labels connect back to quality standards set in big pharmacopeias in Britain, Europe, and the US. Following those rules means you’ve got a product free from dangerous levels of heavy metals, microbes, or strange chemicals.
I spend time reading research before trusting anything that goes on my skin or into my mouth. The safety track record for glyceryl distearate reassures me. Studies reviewed by the US Food and Drug Administration indicate this material rarely causes irritation on even sensitive skin. You won’t find glyceryl distearate among the top causes of allergies, either. Cosmetic Ingredient Review experts have dived into data on regular use at levels as high as 15% in lotions and 3% in oral drug products. They did not flag any real risks for healthy users. These institutions back their decisions with international testing and a history of safe use, not just with theoretical calculations.
What about people who already have issues with certain ingredients? Research suggests glyceryl distearate rarely causes contact dermatitis. Reports of side effects in medical literature pretty much only show up when someone’s allergic to a related ingredient, or if the product carries some other contaminant. It doesn’t mean risks are zero, but after so many years on store shelves, serious problems would be showing up by now if this was a common culprit.
Just because the raw material is safe, the whole picture still matters. Sometimes, lower grade glyceryl distearate can show up with traces of industrial solvents or other problematic byproducts if proper controls aren’t followed. Reputable brands test batches for these impurities and stay within international limits. Drug products need an extra level of supervision. Makers have to show their formulation holds up under stress, so the glyceryl distearate doesn't break down into new chemicals under heat, sunlight, or during long-term storage.
Anyone with a history of skin allergies, especially to other stearic acid derivatives, should check labels and maybe talk to a dermatologist. Pharmacies and skin care brands have a responsibility to list their full ingredients and respond to customer questions. Testing on small skin patches at home can help rule out personal sensitivities.
Clean beauty and pharmaceutical movements push companies to keep checking their ingredient sourcing and test protocols. While glyceryl distearate generally passes safety checks, companies can show leadership by sharing test results for trace contaminants or providing extra information about ingredient origins. Regulatory agencies help by routinely updating guidance as new scientific findings emerge. Consumers can stay informed by consulting health professionals or trusted scientific studies before making choices.
Glyceryl Distearate shows up in many pharmaceutical products and often goes unnoticed. It lends a hand as an emulsifier and thickening agent, blending oil and water to create smooth, stable creams and tablets. Its role doesn’t stop there—formulators rely on its safety record and versatility. Those qualities only come through strict adherence to pharmacopeial grades: BP, EP, and USP. Each book lays out clear guidelines, so only high-quality material reaches patients.
All pharma-grade Glyceryl Distearate falls under basic chemical specs. The formula, C21H42O5, means it’s a diester of glycerol and stearic acid. On the shelf, it looks white to off-white, flaky or powdered, free from any strange smell or taste. Pharmacopeial standards expect strict physical and chemical traits, and having worked with excipients, these measures keep everyone on guard.
Here's what turns up in any quality control sheet:
You know you’re dealing with a pharmaceutical-grade product if the allergens and contaminants stay out, and the number on the certificate matches what the pharmacopeia wants. In my stint at a formulation site, even a slight slip on saponification or acid value could stop production for hours—no half measures. Every incoming batch gets GC or IR fingerprinting, confirming it’s the genuine article before a single dose gets made.
Regulatory agencies expect that these grades are honored. Miss one mark, and the drug may not make it out of the warehouse. For chronic medicines, purity isn’t just preference—it’s protection. Policing heavy metals and organic impurities ensures every tablet or cream delivers active ingredient without extras that don’t belong in the body.
Improvements often start with open communication between manufacturers and suppliers. Site audits help sniff out weak points in the production chain. My years in pharma taught me the value of surprise inspections—catching issues at the source saves headaches down the line. On the lab side, upgrading analytical tools keeps standards tight. Isothermal titration, advanced GC/MS, and digital record-keeping shrink the chance for error and catch problems early.
More transparent reporting between quality control, procurement, and production teams goes a long way too. Digital batch tracking eases recall and error investigations if a spec isn’t met. By sticking to these habits, companies earn trust—from regulators and from people counting on safe, effective medicines.
I still remember working in a small pharmaceutical lab, right out of school, where careless handling of excipients would lead to wasted time, failed batches, and even safety concerns. Glyceryl Distearate deserves careful attention—this compound, found in many creams, tablets, and lotions, relies on staying dry, clean, and cool. Whenever moisture crept into open bags, the powder turned clumpy and sticky. Rooms kept around 20 to 25°C preserved its texture and performance, and dry storage spaces prevented chemical changes that can spoil a good raw material.
Letting Glyceryl Distearate sit near windows or hot pipes isn’t just about inconvenience. Excessive heat can cause it to degrade, resulting in impurities that may reduce the shelf life of products or even prompt regulatory headaches. A temperature-controlled area, equipped with accurate thermometers and dehumidifiers, shields it from most climate risks. These precautions align with guidelines published in pharmacopeias, including the USP and EP, which strongly recommend cool, dry, and sealed storage for excipients sensitive to air and humidity.
Every time a drum or bag opens, the risk of contamination rises. I’ve seen seasoned technicians overlook gloves, thinking their hands were clean enough. Then trace oils or sweat picked up by the Glyceryl Distearate batch made it unsuitable for mixing in high-purity pharmaceuticals. Standard practice calls for wearing gloves, hairnets, and lab coats, but thorough staff training builds habits stronger than any checklist.
Scoops and utensils used must stay spotless. Our team always cleaned tools using isopropyl alcohol, not water, to steer clear of adding any moisture. Storing tools separately kept cross-contamination in check, especially important in facilities handling multiple excipients. Spilled powder sticks to shoes and clothes, too, risking contamination elsewhere in the facility. Sticky mats at entry points caught stray particles, while closed bins for powder waste limited the spread.
Strict storage and handling rules aren’t just picky bureaucracy. Glyceryl Distearate, graded BP, EP, or USP, lands in products given to immunocompromised patients. Any slip in hygiene or storage can translate into drugs that don’t meet purity specs or fail stability tests. Regulatory audits focus on record-keeping—logs should show storage temperatures, humidity levels, and expiration checks. Any deviation, no matter how mild, needs quick correction and documentation.
Current Good Manufacturing Practice (cGMP) guidelines recommend temperature logs and regular inspections. Automated sensors paired with alarms can help spot even subtle shifts in storage conditions, giving teams time to react. Pharmacopeia monographs also highlight the significance of FIFO (First-In, First-Out) rotation, so older material doesn’t linger and degrade unnoticed. In my experience, staying organized with a clean inventory system always paid off, making recalls or audits easy to handle.
Even small pharmaceutical operations can set up robust systems for storage and handling. Climate-controlled cabinets or rooms, clear labels with batch numbers and expiry dates, and strict access control stand out as basics. Investing in simple training sessions encourages everyone to treat excipients like Glyceryl Distearate with respect, reducing errors and waste.
At the end of the day, keeping this compound safe starts with recognizing its value—not just for the lab, but for every patient relying on the finished product. Staff engagement, clean workspaces, and regular checks protect both quality and reputation. Experience shows: small lapses can lead to big costs, but steady habits build reliable supply chains.
Anyone working with pharmaceutical ingredients like Glyceryl Distearate knows how important packaging can be. This white, waxy substance helps in everything from tablet production to creams. Proper packaging isn't just about keeping powder off your hands; it preserves the ingredient’s quality and safety from the factory to the lab or manufacturing floor.
It’s no secret that Glyceryl Distearate BP EP USP Pharma Grade shows up in different forms—powder, flakes, sometimes even pellets. Each version brings its own set of needs. Based on my years working alongside procurement teams and R&D labs, here’s what actually ends up on pallets and shelves.
The most common sight is the heavy-duty fiber drum, usually holding 25 kilograms. These drums seal up tight with liners, fighting off moisture and minimizing contamination. They’re manageable with a hand truck and sturdy enough to survive freight.
For outfits experimenting in smaller batches or producing specialty products, manufacturers offer this ingredient in 5 or 10 kilogram plastic pails. I’ve seen researchers breathe a sigh of relief opening a clean, resealable pail instead of wrestling a giant drum on a bench crowded with delicate glassware. Pails cut down on waste, and the material stays fresh longer if you’re not flying through bulk amounts.
Some regional suppliers turn to heavy-gauge polyethylene bags, boxed up for shipping. It’s a cost-saving move and works well for businesses with internal storage systems that already protect from humidity. Though the bags seem basic, quality vendors line them with certified food-grade plastic, which matters a lot for compliance and product stability.
Not too long ago, pharma ingredients came almost exclusively in drums or sacks. With regulations tightening and customer audits becoming routine, sturdy, traceable packaging has become standard. Some customers—especially in Europe and North America—now ask for tamper-evident seals and serialized barcodes right on the container. This lets them track every shipment, and any slip in the chain is a big problem to explain in audits.
Global shipping headaches, like container shortages and disrupted timelines, have nudged suppliers to offer more flexible, smaller packages. Small and mid-sized companies often can’t tie up cash in a mountain of one chemical, so kilo packs and pails end up saving the day, letting them keep stock but manage budgets.
In my experience, the smartest buyers always push for details before signing off on supplier specs. What kind of liner stands between Glyceryl Distearate and the drum or bag? Does the packaging carry clear batch info—printed, not scribbled with a marker? How do they handle heat-sensitive shipments in summer? A well-sealed container and smart labeling stop a lot of future headaches.
For those scaling up, it helps to ask vendors if they’ll customize packaging to fit existing production lines—maybe swap a drum for a dispensing box. This can slash downtime on the plant floor. Sometimes tough conversations now save mountains of lost time and money later.
Many in the industry keep pushing for greener options. Recyclable drums and pails, as well as biodegradable liners, make a difference, especially for companies serious about sustainability. With regulators looking over everyone’s shoulder, the safest, clearest, and cleanest packaging wins in both compliance and daily operation.
| Names | |
| Preferred IUPAC name | 2,3-Dihydroxypropyl octadecanoate |
| Other names |
Octadecanoic acid, monoester with 1,2,3-propanetriol Stearic acid, glyceryl ester Glycerin distearate Glyceryl stearate diester 1,2,3-Propanetriol, distearate |
| Pronunciation | /ˈɡlɪsɪrɪl dɪˈstɪəreɪt/ |
| Identifiers | |
| CAS Number | 627-83-8 |
| 3D model (JSmol) | `CCCC(=O)OCC(COC(=O)CCC)O` |
| Beilstein Reference | 1728736 |
| ChEBI | CHEBI:53652 |
| ChEMBL | CHEMBL1209987 |
| ChemSpider | 13447402 |
| DrugBank | DB14166 |
| ECHA InfoCard | 100.247.266 |
| EC Number | '203-492-7' |
| Gmelin Reference | 60468 |
| KEGG | C16148 |
| MeSH | D02.455.326.271.700 |
| PubChem CID | 24699 |
| RTECS number | TH0945600 |
| UNII | 5M0K92O4PT |
| UN number | UN3082 |
| CompTox Dashboard (EPA) | DTXSID2020145 |
| Properties | |
| Chemical formula | C39H76O5 |
| Molar mass | 631.01 g/mol |
| Appearance | White or almost white waxy solid |
| Odor | Odorless |
| Density | 0.970 g/cm³ |
| Solubility in water | Insoluble in water |
| log P | 6.88 |
| Vapor pressure | Negligible |
| Basicity (pKb) | 6.17 |
| Refractive index (nD) | 1.445 – 1.455 |
| Viscosity | 30 mPas |
| Dipole moment | 1.4302 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 721.7 J/mol·K |
| Std enthalpy of combustion (ΔcH⦵298) | -16221 kJ/mol |
| Pharmacology | |
| ATC code | AWWW000513 |
| Hazards | |
| Main hazards | May cause eye and skin irritation |
| GHS labelling | GHS07, GHS08 |
| Pictograms | GHS07 |
| Hazard statements | Not a hazardous substance or mixture according to the Globally Harmonized System (GHS). |
| Precautionary statements | Keep container tightly closed. Store in a cool, dry place. Avoid contact with eyes, skin, and clothing. Wash thoroughly after handling. Use with adequate ventilation. Keep away from sources of ignition. |
| NFPA 704 (fire diamond) | 1-1-0 |
| Flash point | > 285°C |
| Autoignition temperature | > 400°C |
| Lethal dose or concentration | LD50 (oral, rat) > 5,000 mg/kg |
| LD50 (median dose) | LD50 (median dose): > 20 g/kg (oral, rat) |
| NIOSH | Not Listed |
| PEL (Permissible) | Not Established |
| REL (Recommended) | ≤ 0.1 mg/kg bw/day |
| IDLH (Immediate danger) | NIOSH has not established an IDLH for Glyceryl Distearate. |
| Related compounds | |
| Related compounds |
Stearic Acid Glyceryl Monostearate Glyceryl Tristearate Mono- and Diglycerides PEG-100 Stearate Cetyl Alcohol Cetearyl Alcohol Propylene Glycol Stearate |
Chengguan District, Lanzhou, Gansu, China
