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Dibutyl sebacate doesn’t get much attention outside circles deep into pharmaceutical formulation or plasticizer chemistry, but its origins stretch back almost a century. Early chemists sought alternatives to camphor and brittle esters that made pills crack or plastics fail. Through the 1930s and 1940s, advances in esterification chemistry let industrial labs turn sebacic acid—already a classic compound from castor oil—into dibutyl sebacate. My grandfather worked at a chemical plant during that era; he told stories about how esterification smelled sharp but signaled progress because it meant innovations like DB Sebacate made fragile medications less prone to crumbling. This historical push for better stability began long before strict pharmacopeial standards existed but set the foundation for today’s pharmaceutical-grade products that meet BP, EP, and USP quality requirements.
People often lump dibutyl sebacate in with other plasticizers, not realizing its distinct edge in flexible, durable excipients. It comes as a clear, colorless or slightly yellow oily liquid. It feels slightly thinner between the fingers than castor oil and gives off a faint, waxy odor that’s characteristic but not overwhelming. Quality-controlled grades for pharmaceuticals sail through purity tests for acid value, ester content, and water content, holding up under scrutiny from regulators and formulation chemists.
This ester carries the molecular formula C18H34O4, with a molar mass of 314.47 g/mol. Its boiling point holds around 344°C, and it doesn’t easily evaporate at ambient conditions. Dibutyl sebacate’s low glass transition temperature allows it to keep polymers bendable at fridge conditions. Its density sits near 1.05 g/cm³, and it dissolves well with alcohol, ether, and many neutral solvents but barely mixes with water. My own time in a lab confirmed it: droplets of water bead up in a beaker of DB Sebacate and don’t mingle, no matter how energetically stirred.
Pharma grade DB Sebacate reaches high purity, generally exceeding 99% by GC analysis. Regulatory requirements focus on minimal heavy metals (well below 10 ppm lead), controlled water content (Karl Fischer titration often shows under 0.1%), and limits on related sebacates or butanol residues. Container labeling details batch number, manufacturing and expiry dates, storage recommendations (cool, dry, tightly closed), and compliance with BP, EP, or USP monographs. This sort of documentation became much more systematic during the GMP revolution, which, according to colleagues in QA, added months of work for every excipient but ultimately made the industry safer.
Manufacturing usually goes through esterification: purified sebacic acid reacts with butanol in the presence of an acid catalyst, pushing out water as a byproduct. Operators keep the reaction under reflux, stripping the moisture to drive the equilibrium forward. At scale, the process involves stainless steel reactors, precise heat control, and robust distillation equipment to isolate pure DB Sebacate from side products and unreacted raw materials.
Dibutyl sebacate doesn’t react easily under normal pharmaceutical conditions, which underpins its utility as an inert excipient. Subjecting it to hydrolysis splits it into sebacic acid and butanol again—a reaction exploited in analytical chemistry and toxicology screens. Its ester linkages can survive many pH swings, only breaking down under extremes (strong bases or acids at heat). This stability ensures it won’t leach or degrade unpredictably in capsules, tablets, or coatings.
Industry veterans recognize DB Sebacate by several names: Butyl sebacate, Sebacic acid dibutyl ester, and options like Morflex DBS in the US or specific product codes in Europe. CAS number 109-43-3. The variety of names sometimes muddles procurement, but the physical and chemical signatures anchor it across markets and regulators.
DB Sebacate scores a low hazard profile for oral and dermal exposure, though chronic high doses aren’t recommended due to uncertain long-term effects. In the workplace, old-timers advise gloves if you handle the liquid daily, since it can defat skin over time. Pharma grade batches must skip phthalates and other confounders, given how closely authorities watch excipient safety in pediatric and injectable medicines. The European Medicines Agency and US FDA both flag DB Sebacate as GRAS for many uses but require clear labeling, batch documentation, and traceability. Regular operator trainings in excipient handling make sense not just for GMP compliance but to reassure frontline workers about what they load into blending drums.
DB Sebacate appears most in tablet coatings and softgel capsules. Its flexibility lets coatings stick through freeze/thaw cycles and high-humidity shipping, while softgels don’t crack in dry climates. One drug tech I spoke with bemoaned how “cheaper” alternatives ruined a batch of gelatin capsules that later failed drop tests. It turns up in food supplements, too, and in chewable vitamins where a “plasticizer” role means better mouthfeel, not some sinister additive. Outside pharma, DB Sebacate shows up in synthetic rubbers, wire insulation, perfumery, and even eco-friendly “bioplastics” that edge out older petroleum-based plasticizers.
DB Sebacate’s long track record hasn’t stopped fresh R&D. Researchers push for higher-purity isolations to match new injectable and pediatric dosage forms. Some teams look for synthesis tweaks that curb energy consumption or reduce catalyst use. Environmental scientists probe ways to make its manufacturing less resource-intensive, from renewable butanols to biogenic sebacic acid routes straight from castor harvests. My own stint in process engineering gave me a front row seat to regulatory audits, where breakthroughs that simplified waste handling or reused solvents counted as much as marginal chemical improvements.
Toxicological data sketch a favorable picture in most species. Animal studies at oral doses surpassing typical excipient use rarely uncover obvious organ effects, but scientists keep pressing for long-term, generational data—especially for use in children or for pregnant patients. In vitro studies suggest DB Sebacate doesn’t disrupt hormones or trigger mutagenesis. Regulatory agencies do laser in on metabolites though, so analysts keep characterizing potential breakdown products in vivo just in case new findings emerge. There’s open literature coverage on these studies, but pharmaceutical companies keep doing new work every time a drug company proposes a fresh DB Sebacate-containing formula for regulatory registration.
The future of DB Sebacate pharma grade lies at a crossroads of guarantee and innovation. Product safety is more crucial than ever, as excipient recalls or contamination sparks loss of trust and supply headaches. Regulatory scrutiny continues to sharpen; manufacturers tweak their process trains to beat contaminants down to parts per billion and document every change. Yet, on the horizon, green chemistry beckons. Teams work on biotech-sourced butanol and sebacic acid that ditch fossil fuels. Biomedical engineers eye DB Sebacate for novel drug delivery formats—oral thin films, pediatric suspensions, and precision-release tablets. My own experience points to a distinct uptick in “excipient optimization” projects, where DB Sebacate’s value isn’t in providing the cheapest flexibility, but the kind that lets sensitive drugs survive storage, shipping, and administration with predictability.
Dibutyl sebacate walks into the picture every time manufacturers look for a substance that keeps medications from turning brittle. This colorless, oily liquid shows up mostly as a plasticizer in pharmaceutical coatings and capsules. Its main job is to add flexibility, so tablets don’t crack and capsules don’t break down before they reach the stomach. I remember learning about excipients in pharmacy school — the “inactive” fillers and binders that make a world of difference to how a pill actually works for patients. Dibutyl sebacate, with pharma-grade purity, is a perfect example. It takes science and translates it into something people swallow or apply every day.
A lot of drugs need a slow, predictable release. Coatings made with dibutyl sebacate help control how fast or slow the medicine leaves the tablet after swallowing. These coatings also protect the drug inside from moisture and air, limiting the chances of the medicine losing its punch before it gets used. In my own experience working at a local health clinic, I have seen patients struggle with old or poorly stored medications. You can’t ignore the role of a compound like dibutyl sebacate in keeping medicine useful even after sitting for months on a shelf.
Many liquid medicines use this compound as a solvent for fat-soluble drugs and vitamins. People who use topical pain creams will find it in certain ointments, since dibutyl sebacate makes the mixture spread smoothly over the skin. Sensitive skin patients often notice harsh or sticky ointments, so a “slippery” ingredient like this can make applications much more pleasant.
Pharma companies rely on strict standards like BP, EP, and USP to vouch for the purity and consistency of dibutyl sebacate. These certifications mean the ingredient has passed tough quality checks, making it safe for use in people of all ages, in tablets, gels, and more. Weak standards can open the door to contamination or unpredictable results, both of which threaten patient safety. From working alongside pharmacists, I’ve learned that nothing replaces meticulous sourcing when it comes to anything entering the human body — even something that seems “inactive.”
Amid so many recalls for contaminated medicines around the world, patients and professionals demand products that meet clear standards. Regulatory bodies, pharmacists, and companies all need to check the supply chain and test each batch for purity. Any breach, even one unnoticed by most, can lead to loss of trust and, more seriously, put lives at risk. A substance like dibutyl sebacate can feel invisible, but its presence shapes the whole product.
Better transparency about ingredient sources builds confidence. Stronger regulations and more frequent safety checks tighten the net around contamination. Exploring natural alternatives could open new doors for patients with allergies or sensitivities, but these swaps require real science, not guesswork. As new capsules and technologies come onto the market, the demand grows for high-purity, safe, and consistent excipients like dibutyl sebacate.
Listening to patients matters, too. Folks sometimes blame active drugs for reactions, but the inactive stuff counts, especially for those with complicated health needs. Where dibutyl sebacate fits — in tablets, capsules, or topical products — its quality and safety remain a quiet but powerful part of patient care. Pharma-grade standards are more than a checkbox; they are daily, life-impacting essentials.
Dibutyl Sebacate doesn’t draw headlines, but for anyone working in pharmaceuticals or closely following excipient standards, its details make a difference. This liquid ester, derived from sebacic acid and butanol, often finds its place as a plasticizer or a solvent in pharmaceutical formulations. Pharma grade quality isn’t just about pushing a product through rigorous testing. It carries implications for patient safety, drug performance, and even regulatory approval worldwide. I’ve come across more than one project where the difference between a pass and a warning letter comes down to those demanding standards.
Pharma grade Dibutyl Sebacate doesn’t allow for shortcuts. Purity sits above 99% for any trusted supplier. Typical specifications call for:
The stakes for excipients like Dibutyl Sebacate come out in every tablet, gel capsule, and patch that relies on consistent performance. Stray impurities might not show up in early testing, but downstream, they drive complaints, recalls, or worse—undetected toxicity. Patients count on predictable, repeatable quality in their medication. Regulatory agencies in regions like the US and EU regularly review test results, and non-compliance means delayed launches or outright rejections.
Nobody wants to deal with post-market headaches rooted in low-grade raw materials. So, any pharma player worth its name goes after material accompanied by certificates of analysis, detailed batch records, and proof of compliance with pharmacopeias such as USP or Ph. Eur. In my work with development teams, we never gambled on excipients, knowing well that a single contaminant could snowball into months of regulatory trouble.
Ensuring purity requires more than just picking a supplier from a list. Regular supplier audits, in-process controls, and random spot checks of incoming batches keep standards from slipping. Relying on a diverse supplier base also helps avoid surprises if a primary source falters. Strengthening traceability—right down to the batch and production site—means recalls, if they happen, stay limited and efficient.
For producers, embracing green chemistry and well-validated synthesis pathways helps limit unwanted by-products and reduces environmental risks. Clear documentation and a willingness to invest in analytical capacity aren’t always easy to maintain, but experience shows cracks in those areas get costly fast.
The evolution of pharma-grade materials demands vigilance, transparency, and the humility to adapt. Whether you’re working on generics or new specialty drugs, keeping a close eye on excipient integrity like Dibutyl Sebacate doesn’t just tick boxes—it keeps pharmacies and patients safe.
Many people looking at the label on medicine bottles or food packs will spot unfamiliar names. Dibutyl sebacate sounds like one of those oddities best left to chemical engineers, not everyday folks. Truth is, this ingredient, often tagged as a plasticizer, plays an important backstage role in both tablets and packaging that make our daily routines smoother.
Manufacturers pick dibutyl sebacate for its ability to keep coated drugs from cracking and to help food last a bit longer by making wrapping less brittle. It's no secret: flexible coatings and consistent textures matter for both swallowing a pill and keeping packaged treats fresh.
Any substance used in medicines or food needs hard scrutiny. Dibutyl sebacate graded for BP, EP, and USP meets the highest quality marks set by major pharmacopeias in Europe, the UK, and the United States. These standards mean the material has passed tests for purity, contamination, and stability. For me, trusting a label starts with clear proof it’s been looked at by someone not trying to sell it. Pharmacopoeial grading offers some reassurance because these groups make their decisions based on research, science, and public health.
Researchers have checked the safety of dibutyl sebacate through animal studies, toxicity tests, and by reviewing the results from people over many years. Food authorities in the US and Europe have identified safe levels for use. The US Food and Drug Administration (FDA) recognizes it as safe when used in specific amounts, especially as a plasticizer in many food wrappers and coatings on medicine. The European Food Safety Authority (EFSA) keeps limits lower, partly as a safety cushion, and they update recommendations as new data comes in.
Every time I check a product for chemical ingredients, I think about allergies and sensitivities. Even safe substances can cause trouble in rare cases. People with specific allergies or health conditions sometimes react to additives most of us tolerate just fine. Dibutyl sebacate has not been linked to high rates of irritation or allergy, but reports do exist, especially among factory workers who handle large amounts.
Long-term effects matter as well. So far, no convincing evidence suggests dibutyl sebacate causes cancer or builds up in the body to an unsafe degree. Regulators in several countries require manufacturers to keep exposures far below any worrying levels. That said, crowded ingredient lists on everything from food to medicine always make me think twice about what’s crossing into daily life.
Parents, patients, and consumers have more power than ever to ask questions and press for safer alternatives. Companies listen when people care about health. Eco-conscious groups have pushed for clearer labeling and less reliance on any chemicals in plastic. That’s sparked research into plant-based or biodegradable replacements. Some drug makers now test new coatings based on renewable materials.
At the same time, it’s hard to replace a compound that delivers reliable results at a fair price. Not every substitute proves more sustainable or gentle. It takes scientists, regulators, and companies all working together, plus honest input from the public, to keep the ingredients in food and medicine as safe as they need to be.
Dibutyl Sebacate, a common plasticizer in pharmaceuticals, deserves sturdy packaging to match its strict role in medicine. Product integrity rides on the simple things—tight seals, solid drums, and the right kind of lining. My time handling raw pharma chemicals hammered home one fact: weak packaging ruins more than product. It throws safety, traceability, and patient health out the window.
Pharmaceutical suppliers often pick high-density polyethylene (HDPE) drums for Dibutyl Sebacate. These drums, generally holding 25, 50, or 200 liters, don’t break, resist spills, and shield contents from oxygen and light. Steel drums see less use but may show up for bulk shipments heading overseas. Every drum needs tamper-proof closures—without this simple device, trusting the chain of custody gets tricky.
HDPE containers keep moisture, UV, and reactive vapors out. In my early years, I thought all drums looked the same. Then I saw a batch arrive in thin, unlined containers. The result? Contamination and disposal headaches. Good suppliers add food- or pharma-grade liners to cut contamination risk and prevent chemical reactions inside the drum. Lined drums win over plain ones. They keep that sensitive USP or EP grade status intact.
Inside a warehouse, drums call for palletization. Shrink wrap and strapping protect against shifting and leaks in transit. Knocked-over containers not only waste product but trigger investigations and delays. Forklift operators like dealing with pallets—they move goods faster, cut down on handling errors, and keep things flowing in a fast-paced environment.
Some pharma clients order smaller, custom containers such as 5-liter HDPE or glass bottles for research-grade needs. These bottles cost more to fill and ship but let labs pull only the amount needed, reducing waste. Glass brings the highest chemical resistance, but its heavy weight and breakage risk make plastic a top choice for larger orders.
Mislabeling turns into a regulatory nightmare. Every Dibutyl Sebacate drum must display grade, date of manufacture, batch number, and handling instructions clearly. On one project, missing hazard info stalled an entire shipment at customs. Clients now look for suppliers who meet not just the letter, but the spirit, of labeling rules called out by the BP, EP, and USP standards.
Regulators and buyers put pressure on suppliers to rethink packaging waste. Advances include recycled HDPE drums, lighter containers to shrink freight impact, and reusable totes in closed-loop programs. Pharma-grade Dibutyl Sebacate has tight rules, but using smarter containers cuts landfill waste and company costs too.
Supply chains only run smoothly if the basics—like strong, documented, regulation-ready packaging—don’t get overlooked. Choosing the right drum or bottle isn’t a luxury. It keeps patients safe, puts regulators at ease, and gives buyers peace of mind.
Dibutyl Sebacate BP EP USP Pharma Grade serves plenty of uses in pharmaceutical products. You see it as a plasticizer for capsules and tablets, and it plays a role in topical products. This chemical gives flexibility to coatings and enhances texture in medication that needs to withstand handling. Handling such a compound with the right care ensures the finished drug stays safe and effective—no shortcuts here.
Anyone working with pharmaceutical chemicals knows that basic storage mistakes can ruin a batch, or worse, risk patient safety. For this compound, storage must be away from heat sources and out of direct sunlight. A dry, cool room works best as heat and moisture can break down the chemical over time. Industry practice says the temperature stays below 30°C, but a range of 15-25°C offers extra peace of mind. Humidity invites clumping and contamination, and even a small oversight creates a headache at audit time.
I remember an incident where sloppy handling led to minor contamination that threw off an entire tablet run. That wakeup call highlighted why glass or high-quality plastic containers matter. Metal may leach or react, and simple labels prevent confusion. Tightly sealed containers keep out dust and airborne particles. This is not paranoia—otherwise, companies face recall risk or batch loss. Label every drum or container with the batch number and inspection date. The attention to this detail builds trust inside a lab and during external audits.
Some might think gloves and safety glasses seem like overkill for a plain liquid, but taking chances proves costly. Even trained technicians get skin irritation from splashes. If a container tips, an absorbent material prevents the liquid from spreading. Properly trained staff follow practical routines: measure only with clean, dry tools; avoid pipetting by mouth; return unused portions to tightly closed containers without touching dispensing equipment to the inside. Each step lowers the chance of cross-contamination—a major concern in facilities handling active pharmaceutical ingredients nearby.
Pharmaceutical-grade chemicals cannot simply go down the drain. Local rules give clear guidance, and using a designated chemical waste container avoids issues with regulators. Mixing it with other chemicals creates risk, so a single-purpose bin or drum for sebacate waste stands ready for pickup by certified disposal services. A record log for every disposal proves critical during routine inspections.
Quality control teams inspect both fresh shipments and stored product. Integrity of the chemical matters as much on day 300 as day one. Cloudiness, strong smells, or off-colors cue immediate investigation. Audits catch slip-ups—checklists may seem mundane but catch the details staff miss during busy weeks. Trust in pharmaceutical products leans on this routine vigilance. Shelf-life tracking prevents expired material from ever reaching production lines.
Leadership in a facility sets the tone on safe handling. Regular refresher courses, safety posters near storage areas, and easy access to safety data sheets keep the team focused. Peer reminders matter—nobody wants a reprimand, but knowing someone’s watching reinforces habits. Transparency after any incident, even minor, leads to practical changes that stick.
Cleanliness, vigilance, and simplicity in storage and handling of Dibutyl Sebacate mean fewer headaches for managers and safer outcomes for patients. Each step in storage and handling feels small, but together, these habits protect the reputation of every company producing health products.
| Names | |
| Preferred IUPAC name | Dibutyl decanedioate |
| Other names |
Sebacic Acid Dibutyl Ester DBS Dibutyl Decanedioate |
| Pronunciation | /daɪˈbjuːtɪl səˈbeɪkeɪt/ |
| Identifiers | |
| CAS Number | 109-43-3 |
| Beilstein Reference | 1721745 |
| ChEBI | CHEBI:34867 |
| ChEMBL | CHEMBL1332237 |
| ChemSpider | 5377 |
| DrugBank | DB11086 |
| ECHA InfoCard | ECHA InfoCard: 03c1807d-84d7-421a-a13b-55c34fd5b770 |
| EC Number | 204-640-7 |
| Gmelin Reference | 8417 |
| KEGG | C11236 |
| MeSH | Dibutyl Sebacate |
| PubChem CID | 3026 |
| RTECS number | WNK8984600 |
| UNII | 57Y6O37T0T |
| UN number | UN3082 |
| CompTox Dashboard (EPA) | EPA CompTox Dashboard ID for Dibutyl Sebacate: **DTXSID6043137** |
| Properties | |
| Chemical formula | C18H34O4 |
| Molar mass | 370.57 g/mol |
| Appearance | Clear, colourless, oily liquid |
| Odor | Faint, bland odor |
| Density | 1.05 g/cm³ |
| Solubility in water | Insoluble in water |
| log P | 3.9 |
| Vapor pressure | Negligible |
| Acidity (pKa) | 4.72 |
| Basicity (pKb) | pKb: 3.98 |
| Refractive index (nD) | 1.444 - 1.449 |
| Viscosity | 15-25 cP |
| Dipole moment | 1.83 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 713.8 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | −1456 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -13150 kJ/mol |
| Pharmacology | |
| ATC code | V06DF |
| Hazards | |
| GHS labelling | GHS07 |
| Pictograms | GHS07, GHS08 |
| Hazard statements | Hazard statements: Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008. |
| 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. |
| Flash point | Flash point: 216 °C |
| Autoignition temperature | 430°C |
| Lethal dose or concentration | LD50 (oral, rat): > 16,000 mg/kg |
| LD50 (median dose) | Oral rat LD50: 5000 mg/kg |
| NIOSH | NIOSH: NM2975000 |
| PEL (Permissible) | PEL (Permissible Exposure Limit) for Dibutyl Sebacate: Not established. |
| REL (Recommended) | Not more than 5.0 mg/kg body weight |
| IDLH (Immediate danger) | Not established |
| Related compounds | |
| Related compounds |
Sebacic Acid Dioctyl Sebacate Dimethyl Sebacate Diethyl Sebacate Diisopropyl Sebacate |
Chengguan District, Lanzhou, Gansu, China
