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Dioctyl Phthalate, known among chemists as DOP, stands as one of those legacy chemicals that carved out its place in industrial history well before regulatory spotlights started to follow plasticizers around. Developed in the early 20th century, after the world saw a need for flexible plastics, DOP quickly became the backbone for manufacturing softer PVC goods. By the 1940s and 50s, large-scale use of DOP in wire insulation, medical devices, and food packaging swept across Europe and the United States. Pharmaceutical compendiums like BP, EP, and USP caught up, standardizing specifications to match the demands of industries—from tubing production to coatings for medicinal tablets. These standards still echo through today's pharma supply chains, reminding manufacturers how entrenched this compound is in global commerce and daily life.
Anyone working with pharmaceutical excipients knows DOP by its clear, oily appearance and faint odor, hinting at its role as a plasticizer in pharmaceuticals and plastics. In its purest BP EP USP grade, DOP stays colorless and virtually odorless. Manufacturing plants prize this ultra-high purity, achieved through advanced distillation and rigorous analysis, since trace impurities could spell trouble for sensitive applications. The pharma grade DOP used in medical or food-contact products follows stricter documentation and control compared to more basic industrial versions. Chemical facilities track everything from raw material sourcing to packaging, understanding that even a small slip-up could jeopardize patient health.
DOP looks and feels oily, with a slick consistency, and stays liquid at room temperature due to a melting point below zero. Boiling kicks in around 385°C. With a molecular formula of C24H38O4 and a molecular weight of 390.56 g/mol, DOP shows up on spectra and chromatographs as a clean, well-characterized compound. It doesn’t dissolve in water, but mixes well with most organic solvents, which plays a key role in applications where DOP interacts with polymers. DOP resists hydrolysis under standard conditions, allowing it to survive in formulations that face changing humidity and pH. These traits might sound dry, but they define why DOP became so popular, especially for formulations meant to last on the shelf or survive tough manufacturing conditions.
The numbers tell the story here—assays of not less than 99.5% by GC, acid value below 0.07 mg KOH/g, and water content under 0.1%. Specific gravity checks out at 0.982–0.988 at 25°C, alongside refractive index values between 1.485 and 1.489. A clear appearance and low color index matter, since any discoloration might flag contamination or breakdown. Pharma-grade DOP comes with precise labeling: batch numbers, manufacturer address, manufacturing and expiry dates, purity grade, and all the warning labels required for handling and storage. For companies shipping bulk containers, traceability sits front and center, because the risk of mix-up or cross-contamination never goes away.
The classic route to DOP involves reacting phthalic anhydride with 2-ethylhexanol in the presence of an acid catalyst, often sulfuric acid or p-toluenesulfonic acid. The mixture heats up, water splits off as a byproduct, and engineers carry out the reaction under controlled temperatures to avoid side-products. Distillation steps pull out product fractions with purity often topping 99.5%. Process engineers sample each batch multiple times, and advanced plants use real-time analytics to catch deviations before final filtration and polishing. This straightforward synthesis fits well into both batch and continuous plant designs, making production scalable and consistent.
While DOP resists breakdown during storage and use, chemists still find ways to modify the molecule. Alkaline hydrolysis would split it back to phthalic acid and 2-ethylhexanol. Exposure to strong oxidizers changes its chemical backbone, impacting performance if mixed with reactive agents in formulations. Research labs sometimes use DOP as a starting point for new esters or as a medium where controlled functionalization takes place—particularly in exploratory pharma or materials science settings. These reactions, while less common in mainstream production, matter more as manufacturers and researchers explore alternatives or biodegradable derivatives.
Talk to suppliers or scan chemical catalogs and you’ll encounter a handful of names: di-2-ethylhexyl phthalate, DEHP, and bis(2-ethylhexyl) phthalate line up next to DOP. Some labels borrow from trade names like Platinol DOP or Octyl Phthalate. European and American lists usually stick with DEHP as shorthand. This wide collection of synonyms can trip up buyers, especially in countries switching from DOP to alternatives due to new regulations. Any form intended for pharmaceutical use needs explicit stamps—BP, EP, USP grades—reflected on the certificate of analysis, not just on the main container label.
Handling DOP on an industrial scale means paying close attention to spills and inhalation risks. While the chemical stays fairly stable, chronic exposure links to liver and reproductive effects, pushing pharma manufacturers to adopt strict exposure limits—OSHA’s guidelines put airborne limits at 5 mg/m³. Gloves, goggles, and fume hoods count as standard gear in formulation labs and filling lines. Storage needs a cool, well-ventilated warehouse, far from oxidizers, acids, and flames. Pharmacies and hospitals requiring plasticized infusion tubing or blood bags push suppliers to deliver DOP that meets heavy metal and phthalate residue standards, validated by independent labs before shipment.
DOP dominates PVC-based product lines from flexible pharmaceutical packaging, IV bags, to tablet film coatings. The medical devices sector, decades deep in the use of DOP, continues to rely on it for soft, bendable plastics. Tablet and capsule manufacturers use it to modulate the release of drugs or protect actives from humidity and mechanical stress. In the broader chemical world, DOP shows up in adhesives, inks, cable insulation, but its medical legacy stays strongest in applications where flexibility, biocompatibility, and high purity intersect. Medical innovators know it remains cost-effective, even though stricter rules in some countries encourage the shift to non-phthalate alternatives.
Scientists now keep a closer eye on DOP’s impact on human health and the environment, spurring a wave of new formulations and testing protocols. Research teams at universities and regulatory bodies focus on refining analytical techniques for measuring ultra-trace levels of phthalates. Polymer chemists experiment with DOP substitutes that match flexibility and durability while lowering the risk profile, such as DOTP and DINCH. R&D groups in pharma companies reevaluate legacy excipients, assessing whether established DOP-based coatings can be switched out for newer, less controversial compounds. Some research also focuses on recycling and reusing DOP in circular manufacturing models to address environmental concerns without driving up costs.
Mounting evidence from animal studies and epidemiological surveys linked chronic DOP exposure to liver and reproductive issues, mostly in populations exposed through contaminated air, food, or medical devices. Regulatory agencies in the EU and many Asian nations flagged DOP as a potential endocrine disruptor, leading to tighter controls—especially in baby toys, food-contact plastic, and medical devices for children. Toxicologists discuss safe limits and push for deeper, longer-term studies into how low-level exposure shapes health outcomes over time. In my own work overseeing materials in healthcare facilities, concerns about patients exposed during long infusions often push us to request test data going beyond standard batch certificates.
Tighter regulations and fresh public awareness keep the search for DOP alternatives alive. Researchers and regulatory groups want safe, affordable replacements that won’t disrupt manufacturability or compromise product quality. Plastics engineers work on blending new bio-based plasticizers with PVC to match legacy performance. Pharmaceutical companies carry out migration testing and clinical reviews to confirm new plasticizers don’t leach or interact with actives in unpredictable ways. Investment in green chemistry signals a longer arc away from old phthalate chemistry, promising a future where high performance and lower toxicity run on parallel tracks. The pharma supply chain, facing stricter audits and reporting, adapts quickly, as no one wants recalls or litigation traced to outdated, poorly controlled excipients.
Dioctyl Phthalate, often called DOP, plays a crucial part in pharmaceutical manufacturing, though many outside the industry rarely hear its name. For decades, chemists and process engineers have relied on DOP as a reliable plasticizer in the creation of medical devices and pharmaceutical coatings. Its pharma grade—meeting BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) standards—guarantees an extra level of purity and safety. Quality standards like these keep us, as professionals and patients, on the safe side of health innovation.
In layman’s terms, a plasticizer gives certain materials, like PVC, the flexibility they need for specific medical and pharmaceutical uses. Tablets and pills, for instance, carry special coatings to help protect the active ingredient or delay its release. DOP, blended into these coatings, ensures that they stay smooth and break down at the right moment in the digestive tract. My early days handling raw material checks in a pharmaceutical facility hammered home the need for consistency—patients count on medicine acting as intended, every single dose. And that starts with trusted ingredients such as DOP.
If you’ve ever spent time on a hospital floor, you’ve seen soft, bendable IV bags, catheter tubes, and other disposable equipment. Manufacturers use pharma grade DOP in these to get just the right balance of strength and flexibility. Imagine an IV tube that cracks or leaks under stress—the fallout could be more than a little inconvenient; it can put patients at risk. Safety and comfort matter, and the choice of ingredients like DOP isn’t something companies take lightly.
Safety concerns around phthalates have drawn plenty of attention in recent years. Not all phthalates serve the same purpose or appear in similar concentrations. Scientific reviews and ongoing surveillance shape how, and where, DOP gets used. Regulatory bodies periodically re-examine approved levels in finished products. Some trends now lean toward alternatives and stricter controls, reflecting the latest in toxicology research.
Trust in pharmaceuticals and medical products rests on rigorous testing, transparency, and constant innovation. Years ago, a colleague shared stories about process audits at our facility and highlighted the effort poured into keeping records airtight and cross-checks frequent. Pharma DOP use isn’t immune from this rigor. Regulatory agencies push companies to use only the purest grade, verify every batch, and document every step.
Alternatives such as citrate-based plasticizers or other phthalate-free materials continue to emerge as technology advances. Industry leaders now run comparative studies to weigh the pros and cons—flexibility, cost, risk—before switching to newer materials. But for applications where only DOP delivers the required combination of strength and protection, only pharma-grade purity makes the cut.
Much of the debate around DOP rests on new science and a commitment to safer patient care. Whether it’s a life-saving tablet or a simple saline bag, the minor players behind the scenes matter just as much as the breakthrough drugs or high-tech gadgets. DOP’s journey—through scrutiny, regulation, and innovation—mirrors the change that defines today’s health care landscape. And in every hospital, every distribution center, these decisions shape lives every single day.
Dioctyl Phthalate, known as DOP, shows up often in pharmaceutical manufacturing, especially in creating coatings, capsules, and certain controlled-release drugs. It acts as a plasticizer, softening polymers so that tablets don’t crack or crumble in production or storage. But the industry never gambles on quality. Medicines rely on ingredients that consistently meet tight specifications, and DOP for pharmaceutical use gets checked and double-checked before going anywhere near a facility.
Content in pharma grade DOP stays at a minimum of 99.0% by mass, according to BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) standards. That tells you you’re not getting a cocktail of mystery compounds. Color stays water-clear — the standard lists “maximum 10 APHA” on the color scale, meaning any yellow or other off-shades get flagged for investigation.
Moisture in DOP needs to stay below 0.1%. Water in a plasticizer leads to breakdown, clumping, and short shelf life for finished medicines. Pharmaceutical companies tend to run Karl Fischer titrations or loss-on-drying tests—anything over this tight limit sends a bad batch back.
Acidity gives another red flag. The pharma spec caps free acidity at 0.01%, measured as phthalic acid. Companies look out for acidity because even a small drift can alter how a drug dissolves or tastes, risking patient compliance and stability. Assays using titration or infrared spectroscopy sniff out any irregularities.
Heavy metals get zero tolerance. Lead stays capped at 2 ppm, and other metals like arsenic must duck under 1 ppm. Heavy metals build up in the body, so quality labs run regular atomic absorption spectrometry checks to catch any slip in purification.
BP, EP, and USP each demand the absence of unreacted alcohols and other phthalate types. Spot tests chase down phthalic anhydride, and gas chromatography tracks any deviation from di-n-octyl content. DOP for pharma often requires an almost single-peak chromatogram. Ghost peaks set off alarms and invite a full audit.
People often forget how a single contaminated batch can trigger supply disruptions, not to mention recalls or regulatory heat. Several companies learned the hard way after off-spec solvents appeared in the supply chain. When this happens, confidence erodes — not just with procurement managers, but with patients and doctors expecting safe, predictable medicines.
Laboratories can tighten up acceptance criteria still further, especially if they’re crafting medicines for pediatric or immunocompromised patients. Robust supplier audits, up-to-date documentation, and cross-verification between lots save endless headaches. A few pharma plants have gone further, investing in on-site rapid testing instead of relying only on certificates of analysis from bulk suppliers. Adopting newer purification steps, like multi-stage distillation or ultrapure inert gas blanketing, drives down the odds of contamination.
In the end, pharma-grade DOP is more than just a number on a spec sheet. For those who work on real production lines and in busy hospital pharmacies, each measured value stands for patients’ peace of mind—and, sometimes, their lives.
In the pharmaceutical world, safety draws sharp focus when evaluating any ingredient. Dioctyl Phthalate (DOP), used as a plasticizer, sits on regulatory radars across the globe. Some folks remember DOP from older pill blister packs or medical tubing, where it delivered flexibility and transparency. Yet, not every use in pharmaceuticals suits today's standards, and understanding where DOP lands on the safety spectrum matters, especially as regulations evolve and new studies surface.
DOP’s main draw comes from its ability to soften polyvinyl chloride (PVC). For years, you’d spot it across medical and pharmaceutical supplies. Later studies raised flags over its toxicity. Research published by the European Chemicals Agency lists DOP as a Substance of Very High Concern (SVHC). Animal studies link phthalates, including DOP, to possible hormone disruption and developmental issues. That’s not just science at work — it’s a glimpse into what goes into packaging that delivers essential medications every day.
The U.S. Food and Drug Administration and the European Medicines Agency both monitor phthalate content in drugs and packaging. In 2012, the FDA advised limiting the use of certain phthalates, including DOP, particularly for products aimed at children, pregnant women, or those needing long-term therapy. This isn’t just nitpicking; real-world cases have shown phthalates can migrate into the medicines themselves, albeit at low levels. In my years of industry reading, I’ve followed several recalls where drug makers adjusted packaging to comply with new phthalate limits or switched outright to safer alternatives.
The scramble for safer replacements becomes obvious when you step into a manufacturing facility. Chemical engineers tend to choose compounds well supported by safety data. For flexible packaging, ingredients like triethyl citrate or polyethylene-based alternatives gain favor, especially in pediatric medicines. Drug developers weigh stability, cost, and safety, but if there’s a chance for harm, most companies won’t risk their reputation. Watching the trend, phthalates get nudged out in favor of polymers or natural substances, even if it takes more R&D investment upfront.
For patients, the contents of a pill’s coat or a package’s lining often stay out of sight and mind. Only after regulatory alerts do concerns reach the public. In recent years, more consumers ask about ingredient lists and potential risks; they want transparency and assurance. My own family doctor answers packaging questions more than ever before, reflecting a broader movement toward patient empowerment. Brands that proactively address these worries—switching to phthalate-free packaging or openly sharing test results—foster more trust.
DOP once found widespread support for its role in producing flexible, low-cost packaging. Now regulators, watchdog groups, and pharmaceutical firms treat it with skepticism. Anyone responsible for drug delivery systems faces decisions rooted in new evidence and tight restrictions. Moving forward, innovation points to less risky plasticizers and even biodegradable materials. While not every patient reads ingredient sheets, the safety of hidden chemicals should never become an afterthought for those who do.
Dioctyl Phthalate, often known as DOP, finds its way into many pharmaceutical manufacturing processes. Anyone working with this plasticizer recognizes the value it brings in flexibility and consistency. But, for all its benefits, DOP comes with its own set of risks, including irritation to skin and eyes, and possible long-term health effects with prolonged exposure. Relying on experience in chemical storage and lab safety, I know that basic respect for proper handling goes much further than regulatory checklists.
Most pharmaceutical labs juggle dozens of chemicals at any given time. DOP requires cool, dry, and well-ventilated spaces away from direct sunlight and sources of heat to prevent breakdown or leaks. I once worked in a facility where poor storage led to an unexpected spike in ambient temperature. The result was fugitive chemicals and cleanup headaches that could have been avoided if chemicals like DOP sat in temperature-controlled areas. Flammable materials should always stay distant from DOP containers. Spacing out incompatible chemicals isn’t just wise; it helps prevent incidents you never want to see firsthand.
People sometimes overlook the importance of the right container. DOP doesn’t play well with every type of plastic. Containers made of high-density polyethylene or stainless steel guard against leaks or contamination. Everything must carry clear, easy-to-read labels that stand out even if a splash or spill occurs. Supervisors should check containers regularly for signs of cracking or softness. In the rush of daily production, complacency exposes everyone to unnecessary risks.
Personal protective equipment always matters, no matter how busy the shift gets. Gloves and safety glasses, paired with proper ventilation, reduce exposure to vapors or spills. In my years around labs, complacency grew easily—someone would skip gloves once, and next thing you know, chemical burns or allergic reactions sent folks to the on-site nurse. Spill kits must remain accessible, and emergency showers can’t play hide and seek in the back of the warehouse.
Routine drills and safety reminders help cement good habits. I advised every new team member to treat every chemical as potentially hazardous until proven otherwise. For DOP, every container should remain sealed when not in use. Any spill, large or small, demands immediate cleanup using recommended absorbents and disposing of them according to hazardous waste regulations. Workers should get trained not just in procedures but in recognizing the early signs of trouble—a slippery floor from minor leakage, a sharp smell, or a container that feels sticky or warm.
Regulatory guidance ties every good practice together. The U.S. Occupational Safety and Health Administration (OSHA) and the European Medicines Agency issue detailed recommendations for chemical health and safety protocols. Auditors sometimes visit unannounced. Facilities that keep their protocols sharp every day, not just before an inspection, minimize the risk of fines or forced shutdowns.
Organizing chemicals by compatibility charts, supplying enough PPE, updating written safety procedures, and fostering a work culture where anyone can speak up about storage issues—these steps build a safer workplace. People who feel empowered to report issues help prevent costly mistakes.
Safe storage and careful handling of Dioctyl Phthalate isn’t just a regulation. It’s a sign of respect for co-workers, the surrounding community, and the patients who depend on quality pharmaceutical production.
Anyone working in pharmaceutical manufacturing pays attention to packaging—not just for compliance, but for real-world results. Dioctyl Phthalate, used as a plasticizer, asks for special handling. If a drum lets in moisture or reacts with the chemical, you get product problems and safety headaches that don't just stay in the warehouse.
Let’s look at practical options. Steel drums come up often because they hold shape, shield contents from sunlight, and put up with shipping bumps. Food-grade HDPE drums get picked where strict chemical compatibility remains a must. Small-scale setups or places focused on dosing reach for HDPE carboys or jerry cans. Cardboard or fiber containers almost never show up for a chemical like this—leak risks just override any cost cutting.
In my work with pharma-grade chemicals, regulatory scrutiny shapes every packaging decision. Companies don't risk recalls over a leaking drum. Regulatory standards such as BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) include rules about packaging materials, cleanliness, and labeling. Mishandling means more than wasted product—patient safety rides on every batch.
Long-term storage presents its own set of problems. Dioctyl Phthalate doesn’t just sit around; the material can degrade if conditions fail. Well-sealed steel drums with inner coatings stop contamination and leaching. HDPE containers come into play to keep things lightweight and stackable, but not all plastics meet pharma purity guidelines. I have seen cheap plastics warp or introduce taints, so qualified suppliers matter more than ever.
Shipping chemicals like this tests the limits of any packaging. A steel drum offers the surest way through a rough distribution chain: heavy, stackable, less likely to spring a leak on a hot day in a truck. Modern HDPE drums add ergonomic handles and lighter weight, so warehouse staff won't throw out their backs moving them. UN certification pops up here because any hazardous material crossing borders needs to pass international safety standards.
Smaller operations benefit from HDPE carboys. They fit better in smaller storage rooms and reduce the risk of spillage when measuring out doses. Handling remains critical—spilled phthalates set off a chain of health and environmental worries, so tamper-evident lids and sealed valves end up being more than just nice extras.
Supervising budgets brings pressure, but the hidden costs of cut-rate packaging expose a business to legal, reputational, and operational meltdown. Once, I saw a company swap out drums for cheaper flexitanks. The savings dried up after the first contamination incident; written-off inventory and insurance claims wiped out any margin.
Steel drums cost more upfront but make insurance renewals easier, and compliance headaches go down. HDPE drums save on freight and storage while still meeting chemical safety tests—if you choose pharma-grade certified plastics. Smart companies press suppliers on documentation and site audits, knowing weak packaging turns routine orders into emergencies.
Manufacturers now ask for custom options: UV-blocking coatings, RFID tags for tracing, and tamper-evidence as standard. All of this adds a layer of trust—no one wants recalls or regulatory visits breathing down their necks. Real progress means honest talk along the supply chain, robust vendor checks, and ongoing staff training.
Consumers and patients stand at the far end of these decisions. Thoughtful packaging choices keep them safe; no one in pharma can afford to overlook that responsibility.
| Names | |
| Preferred IUPAC name | bis(2-ethylhexyl) benzene-1,2-dicarboxylate |
| Other names |
Di-n-octyl phthalate DOP Bis(2-ethylhexyl) phthalate DEHP |
| Pronunciation | /daɪˈɒk.tɪl ˈθæl.eɪt biː piː iː piː juː ɛs piː ˈfɑː.mə ɡreɪd/ |
| Identifiers | |
| CAS Number | 117-81-7 |
| Beilstein Reference | 1911136 |
| ChEBI | CHEBI:35428 |
| ChEMBL | CHEMBL1507821 |
| ChemSpider | 9853 |
| DrugBank | DB09448 |
| ECHA InfoCard | 55e84190-5c7b-4b81-bc07-c89b1d3f64ee |
| EC Number | 204-211-0 |
| Gmelin Reference | 85328 |
| KEGG | C07290 |
| MeSH | Dioctyl Phthalate |
| PubChem CID | 8343 |
| RTECS number | TI0350000 |
| UNII | 78F1CY90V3 |
| UN number | UN3082 |
| CompTox Dashboard (EPA) | DTXSID9020637 |
| Properties | |
| Chemical formula | C24H38O4 |
| Molar mass | 390.56 g/mol |
| Appearance | Clear, colourless, oily liquid |
| Odor | Odorless |
| Density | 0.983 g/cm³ |
| Solubility in water | Insoluble in water |
| log P | 8.3 |
| Vapor pressure | < 0.1 mm Hg @ 20°C |
| Acidity (pKa) | 3.56 |
| Basicity (pKb) | 6.85 |
| Magnetic susceptibility (χ) | -9.11×10⁻⁶ |
| Refractive index (nD) | 1.485 - 1.487 |
| Viscosity | 40-50 cP |
| Dipole moment | 2.75 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 471.6 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -1156 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -12310 kJ/mol |
| Pharmacology | |
| ATC code | A06AA11 |
| Hazards | |
| Main hazards | May cause eye, skin, and respiratory irritation; suspected of causing reproductive or developmental toxicity. |
| GHS labelling | GHS02, GHS07 |
| Pictograms | GHS07,GHS08 |
| Signal word | Warning |
| Hazard statements | Hazard statements: May cause damage to organs through prolonged or repeated exposure. Suspected of damaging fertility or the unborn child. |
| Precautionary statements | P210, P261, P281, P301+P310, P305+P351+P338 |
| NFPA 704 (fire diamond) | Health: 1, Flammability: 2, Instability: 0, Special: - |
| Flash point | 210°C |
| Autoignition temperature | 385°C |
| Lethal dose or concentration | LD50 (oral, rat): 22000 mg/kg |
| LD50 (median dose) | LD50 (oral, rat): 30 g/kg |
| NIOSH | NIOSH: not listed |
| PEL (Permissible) | 5 mg/m³ |
| REL (Recommended) | 5 mg/m³ |
| IDLH (Immediate danger) | Unknown |
| Related compounds | |
| Related compounds |
Phthalates Dibutyl Phthalate Diisobutyl Phthalate Diisononyl Phthalate Diethyl Phthalate Benzyl Butyl Phthalate Dimethyl Phthalate |
Chengguan District, Lanzhou, Gansu, China
