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Benzyl Butyrate first appeared in chemical circles early in the 20th century, at a time when synthetic esters were picking up interest in both fragrance and pharmaceutical research labs. Chemists sought out new molecules that could improve medicine’s palatability while delivering consistency at a molecular level. Over decades of research, this ester made its way from specialty emulsions and solvents into global pharmacopeias, including the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopoeia (USP). I remember a senior-quality analyst once telling me about its transition — how benzyl butyrate, following validation against strict pharmacopoeial requirements, gained its “pharma grade” reputation after researchers dissected not just purity, but also the hidden contaminants that could disrupt sensitive drug products. In my own inspections, what stood out was the rigor involved in qualifying the grade for regulated applications, which is no walk in the park.
Chemists characterize Benzyl Butyrate as a colorless, oily liquid, carrying a sweet, fruity odor faintly reminiscent of pineapple. Its molecular formula settles at C11H14O2, with a molecular weight just under 178 grams per mole. Boiling point hovers around 225°C — I’ve watched glassware fogging in controlled evaporations — and its density sets close to 1.02 g/cm3 at 20°C. Solubility marks a clear distinction, dissolving with ease in common organic solvents and remaining practically insoluble in water. Each batch, in my experience, can show some variance in refractive index and acidity, so sourcing high-caliber stock makes a big difference for labs chasing consistent outputs.
Manufacturers set tight specifications for BP/EP/USP grades. Assay values seldom dip below 98.5%, with clear limits for related substances and known impurities. Remaining solvents count among the top concerns, especially given global regulatory caps for toxicological safety. Labels must lay bare details such as batch number, assay, manufacturer address, and storage guidelines — most warehouses I’ve visited restrict the temperature gauges below 25°C, guarded from direct light and humidity spikes. The difference between ordinary and pharmaceutical grade comes down to transparency, traceability, and the lab’s ability to meet an auditor’s scrutiny. I have seen misplaced labeling result in rejected shipments, or worse, investigations that tie up operations for months.
Historically, chemists used the classic Fischer–Speier esterification for Benzyl Butyrate: benzyl alcohol and butyric acid in the presence of a strong acid catalyst, such as sulfuric acid. I recall one old professor mentioning the signature smell permanently lingering after their small-scale reactions. Today, process engineers have modernized this synthesis. Fixed bed reactors and catalyst recycling allow for continuous production with minimal waste, reflected in the relatively clean profiles now achieved in pharma-grade output. Achieving purity involves distillation at reduced pressure, followed by washing steps to remove acidic residues. Each phase impacts both the yield and color of the final product. Between bench and factory, patience and precision steer the outcome.
Benzyl butyrate sits among esters capable of hydrolysis, breaking down to butyric acid and benzyl alcohol under acidic or basic conditions. This behavior puts pressure on storage and formulation: one cannot let solutions drift out of pH range. Under specific conditions, chemists apply reductions or transesterifications to tweak the properties, sometimes improving solubility or compatibility with other actives. Once, student teams in my lab tried to swap butyric acid for longer fatty acids, chasing tailored fragrances for niche pharma products. Every tweak calls for a serious reassessment of toxicity and impurity profiles, as small chemical changes sometimes amplify adverse reactions.
This compound circulates under aliases, including Benzyl Butanoate, Butyric Acid Benzyl Ester, and Benzyl n-butyrate. Distributors sometimes layer product names for specific sectors, marking bottles for “Aroma Chemicals,” “Pharmaceutical Intermediates,” and “Specialty Solvents.” It matters to check CAS numbers and international identifiers, since cross-referencing minimizes the risk of ordering the wrong material. I have seen confusion spread through a lab when shipments labeled “fragrance grade” landed in a pharma plant — a costly mixup every time it happens.
Working with Benzyl Butyrate means following safety data sheets to the letter. Exposure through skin or inhalation can cause irritation, so gloves, goggles, and fume hoods always take priority during handling. Fire risks remain low, but not zero, with flash points sitting around 108°C. Transfers, sampling, and disposal all need extra attention, especially in the tight confines of a GMP-certified space, where mistake margins hit near-zero. I’ve witnessed more than one investigation launched over personal protective equipment violations, even when incidents seem minor. High-standard operations demand documented training and regular refreshers, not just a quick read-through of a safety poster.
Benzyl Butyrate gets most of its traction as a solvent or flavoring agent in pharmaceutical formulations. Its ability to mask unpleasant tastes lets formulators deliver oral medicines kids and adults are willing to swallow. Skincare and topical medicines benefit from its emollient properties; creams often feel smoother and absorb quicker with a touch of this ester. Some producers add it to injectables as a solvent for oily formulations, but every switch in use comes with regulatory paperwork and safety trials. I’ve worked alongside development teams who learned the hard way that even familiar esters can behave unpredictably in novel delivery systems.
Current R&D teams look beyond basic uses, investigating Benzyl Butyrate for advanced drug delivery, prodrug approaches, and even niche antibiotic formulations where improved bioavailability can save lives. Analytical labs work overtime to sharpen purity testing, with chromatographic methods pushing detection limits down to trace levels. Automation and real-time monitoring, boon and bane of every QC head I know, allow faster feedback and quicker responses to potential issues. Universities run toxicology screens on metabolites, not just parent compounds, as regulatory agencies crank up requirements for holistic safety profiles. Each year brings new patents and formulation tweaks, signaling the molecule’s flexibility and ongoing value.
Toxicologists put Benzyl Butyrate under the microscope due to its widespread use in injectables and oral medicines. Studies suggest acute oral toxicity remains low in animal models, but repeated exposure at high doses brings liver and kidney strain in some cases. Human skin irritation has surfaced in a few patch studies, triggering caution in dermatological applications. Metabolic breakdown, mainly to benzyl alcohol and butyric acid, draws its own set of long-term exposure limits. Regulatory reviews now require full disclosure of breakdown products and routes of excretion, alongside reproductive toxicity and mutagenicity screens. In my view, erring on the side of caution makes sense, because exposure routes in the real world rarely track with controlled lab environments.
The story of Benzyl Butyrate is far from over. Pressure from regulatory panels will shape tighter impurity profiles and limit allowable solvents further, forcing manufacturers to upgrade production lines or risk exclusion from major markets. Pharmaceutical companies, especially those in pediatric and geriatric medicine, keep seeking flavor masking and solvent systems that perform without sacrificing safety or shelf life. Researchers study new esters and alternatives, but the long track record and decent safety margins of Benzyl Butyrate keep it in circulation. Synthetic biology and green chemistry initiatives look for biosynthetic routes, potentially lowering environmental impacts and cost. Those who follow supply chain disruptions or evolving global standards realize adaptability can mean survival — for both suppliers and the drug makers who rely on well-understood ingredients for patient care.
Benzyl butyrate BP EP USP pharma grade isn’t a name most people come across outside of specific circles, but it pops up in places that impact health and comfort. In the pharmaceutical world, purity matters. Sometimes, it makes the difference between a treatment that works safely and one that brings unexpected, unwanted effects. This grade comes with tight standards, keeping impurities to the minimum and ensuring consistency batch after batch.
I’ve seen medications where every ingredient, even the smallest, plays a key role—either shaping how the main drug dissolves, feels or delivers its benefit. Benzyl butyrate steps in as a trusted solubilizer and solvent for active pharmaceutical ingredients. Many medicines, especially those delivered in creams and ointments, use a blend of agents to achieve the right texture, shelf life, and delivery. Benzyl butyrate acts as the “tie that binds.” Its low toxicity and soothing “feel” make it a smart choice in topical formulations.
This is more than just chemistry talk. For people managing skin conditions like scabies, benzyl butyrate forms part of the treatment puzzle. It carries the active agent deeper, enhancing absorption and helping the medicine do its job where it’s needed most, instead of sitting on the surface. Patients expect results, not just promises.
Pharma grade isn’t just branding; it’s about documented testing, transparency, and peace of mind. If a raw material contains traces of solvents, heavy metals, or microbes, these can create safety concerns. Each dose of a medicine built with pharma-grade benzyl butyrate comes with a paper trail backing up its credentials. This matters, especially for hospitals, clinics, and regulatory agencies that stake their reputations on safe, repeatable outcomes.
Healthcare isn’t the only sector where this compound makes its mark. I’ve encountered it in fragrances, as its aroma resembles that ripe, fruity note found in certain essences and perfumes. The food industry uses it sparingly for flavoring, under tightly controlled conditions, given the purity needed for sensitive applications.
Why should any of this matter to the people relying on medicine or safe consumer products? Quality control goes beyond satisfying rules—it builds trust, reduces side effects, and eliminates recalls. Manufacturers have a choice: cut corners for cost, or take the harder road by using high-standard ingredients like benzyl butyrate pharma grade. Observing these decisions firsthand, I’ve learned the difference becomes clear when lives and comfort are on the line.
To keep things moving in the right direction, transparency must improve. Reliable supply chains that guarantee pharma-grade purity require ongoing audits, not just inspection at one step but over the whole process. Public education can help as well. Patients and consumers benefit from knowing what goes into their products and why certain choices stand above the rest. Greater awareness encourages companies to stick to rigorous quality standards, which then feeds back into healthier outcomes for everyone.
Collaboration can raise the bar. Regulators, producers, and watchdog organizations must share data on quality issues, learn from past mistakes, and push for global alignment on testing standards. It’s an ongoing effort, but when benzyl butyrate BP EP USP pharma grade is used purposefully and checked carefully, we all win through safer, more dependable products.
Pharmaceutical ingredients come with a responsibility. Every small detail—from purity levels to contaminant traceability—can shape a final medicine’s reliability. In the case of Benzyl Butyrate BP EP USP Pharma Grade, there’s no room for guesswork. Patients trust medicine to do what’s promised, and that trust starts at the source material.
Pharmacopeias like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) don’t just push paperwork. They set the bar for what’s acceptable in sensitive fields like medicine. Each of these standards expects Benzyl Butyrate to match or exceed key criteria. Look for a clear, colorless to pale yellow liquid—if Benzyl Butyrate turns hazy, off-color, or has impurities, that’s trouble early on.
Reliable Benzyl Butyrate delivers C11H12O2 with a molecular weight of about 176.22. Reference samples and precise identity checks matter here. Those lab tests aren’t just for show—they confirm authenticity so that nobody cuts corners. Purity benchmarks usually reach at least 98% for pharma grade, but that’s just the starting line. Higher grades can push that percent even further, minimizing any non-conforming compound.
Moisture can break down a fragile compound or promote degradation. The best suppliers report water content lower than 0.5% by Karl Fischer test, keeping Benzyl Butyrate stable and fit for extended shelf life. Tight containers and cool, dry storage extend the ingredient’s reliability. You miss these basics, you invite problems.
Simple isn’t always safe—trace impurities can slip into the process or the final batch. BP, EP, and USP outline tolerance limits for substances such as benzyl alcohol, butyric acid, and organic volatile impurities, often measuring everything down to single-digit parts per million. These limits work like guardrails, ensuring end users receive a high-purity compound, free from surprises.
Pharma standards don’t shy away from tough questions. Testing for heavy metals—like lead, cadmium, and mercury—guarantees that even the smallest traces stay far below the danger zone. Benzyl Butyrate that passes these tests proves its worth for pharmaceutical applications. Residual solvents get equal attention. Only select solvents are allowed at all, and rigid limits, sometimes under 10 ppm, push manufacturers to refine their processes again and again.
Batch records, certificates of analysis, and full compliance documentation—these aren’t just boxes to check off. Anybody who’s managed a recall knows how tracking every drum, sample, and shipment protects lives and company reputation. Suppliers who can point to clear, validated records stand above the crowd.
Real progress comes from not just meeting, but outpacing these standards. Implementing regular audits and choosing partners with a culture of transparency keep the chain strong from factory floor to pharmacy shelf. Investing in state-of-the-art analytics such as gas chromatography and infrared spectroscopy means finding impurities before they become a story for regulators.
Benchmarks for Benzyl Butyrate BP EP USP Pharma Grade are about more than numbers on paper. Meeting these expectations shows commitment to patient safety and healthcare reliability. Every batch represents a pledge to uphold the highest standards, and every detail counts.
Pharmaceuticals aren’t forgiving on quality. Shortcuts or inconsistency show up at the cost of actual health. Every compound, including Benzyl Butyrate BP EP USP, carries a reputation and a responsibility. The three-letter tags—BP, EP, and USP—are more than names. They stand for British, European, and United States pharmacopoeia standards. Meeting these benchmarks is not about tradition or corporate box-checking. It’s about proven safety and results.
Pharma grade means purity. Impurities sit at much tighter limits compared with grades meant for perfumes or industrial use. Each batch shoulders multiple tests. Content, identity, microbiological safety, and absence of toxic byproducts—all come under the microscope before shipping out. BP, EP, and USP criteria aren’t suggestions. They are the outcome of medical science, regulator review, and decades of adverse event reporting. Failing them isn’t minor. It means loss of trust and legal risk, not just a technical violation.
I’ve seen compounding pharmacists refuse materials because documentation didn’t go far enough. For example, a bulk chemical supplier tried selling ingredients marked “99% pure.” The team held tough. If an excipient or active ingredient doesn’t comply with pharmacopoeial standards, nobody wants it in a capsule or cream that reaches a patient. Regulators ask for traceability. Doctors demand safety. Families rely on reliability. That mindset drives choice more than the supplier’s claims.
Reports from toxicology databases and regulatory audits fill in extra gaps. Benzyl Butyrate appears safe based on studies at pharma-purity. Side effects appear mainly when contaminated or misused. Data shows the lowest reported irritation when adhering to BP, EP, or USP criteria, supporting its use in applications like topical medicines. Looking at the numbers, contamination above pharmacopoeial limits means risk of rashes, organ strain, or unpredictable allergic reactions. The extra cost for higher grade often pays off by dodging bigger liabilities later.
Problems creep in when manufacturers cut corners or paperwork trails break. Think of a factory skimping on solvent removal because the market demands speed. If clients don’t demand full traceability and documentation, trouble isn’t just possible—it’s likely. In the toughest cases, cross-contamination has led to product recalls and full investigations. Over time, this kind of neglect shakes trust in both the product and the brand.
One solution stands out. Never let questions or doubts fester. Suppliers who share full documentation earn loyalty. Each certificate of analysis, each audit, each transparent recall builds a foundation for others to trust. Even with broad regulatory systems, it’s the daily choices in the lab, the pharmacy, and the boardroom that keep drugs safe. In my experience, rigorous standards around Benzyl Butyrate and similar compounds aren’t barriers. They’re basic guardrails—essential ones—for patient safety and long-term business health.
Benzyl butyrate, a clear liquid often found in pharmaceutical labs, calls for a careful approach to storage and handling. A lot of folks look at chemical storage like stacking supplies in a garage—just keep things neat, stick labels on everything, call it a day. That doesn’t hold up when you’re working with pharma-grade materials expected to stay pure and stable. Mishandling can bring about both wasted product and real safety issues.
Since this ester has a peculiar odor and can slowly break down if left unchecked, smart storage matters. Benzyl butyrate keeps best in a cool, dry spot out of direct sunlight. Humidity creeps into many warehouse spaces, and I’ve seen labels peel and liquids turn cloudy from too much moisture in the air. The bottle’s cap needs a good tight seal. Even a small breach leaks fumes—bad for both quality and anyone nearby.
Temperature swings play a big role here. If the room’s temperature jumps up and down daily, crystals sometimes form or liquid separates. Keeping things steady protects both the chemical and anyone who has to handle it later. Good practice means stashing the bottles away from heat vents, windows, and high-traffic areas.
Every time a flask opens, there's a risk of contaminating the batch. In my experience, even small lapses—like using a non-dedicated pipette—can compromise a whole supply. Cross-contamination isn’t just a paperwork headache. It can knock out months of work, or worse, enter a chain of production. Single-use tools or rigorously cleaned glassware make a difference you see straight away in final testing numbers.
Benzyl butyrate isn’t overly toxic, but splashes and fumes still mean trouble. Anyone who’s spent time in a proper lab knows the comfort that comes with wearing gloves and goggles. I’ve learned the hard way not to trust my eyes to catch every spill or mislabeling—personal protective equipment (PPE) does the heavy lifting. The chemical resists dissolving in water, so washing it off after a spill takes some effort. Employees need a clear sink, soap, and emergency eyewash close by.
Lab ventilation matters, especially during transfer or high-volume mixing. Inhaling those vapors for hours on end leads to headaches and long-term exposure concerns, so a good exhaust system and regular air monitoring earn their keep.
Benzyl butyrate contains flammable components, and that means straight-up respect for fire code rules. One spark from a careless switch or faulty wiring spells disaster. Storing the chemical away from open flames, non-explosion-proof equipment, or things like oxidizers keeps those risks lower. I’ve always made a habit of knowing exactly where the nearest fire extinguisher and spill kit sit—one day it saves a lot of trouble.
In regulated spaces, proper records keep people out of harm’s way and maintain compliance. Marking down batch numbers, expiry dates, and temperature logs isn’t busywork—it’s insurance against future questions or recalls. Good labels hold up through fridge condensation and the occasional chemical drip.
Training shapes the habits that protect workers and keep a facility running smoothly. Regular refreshers on safe handling, proper PPE, and emergency action plans make the rules stick. Leaders set the tone, but every person in the lab can spot a shortcut before it turns into an accident. Clear instructions and a culture of looking out for each other turn chemical handling into a shared responsibility, not just a personal checklist.
Pharmaceutical manufacturing depends on documentation you can trust. Benzyl Butyrate, used in topical formulations and sometimes in animal health products, isn’t an exception. Every regulatory body in the world, whether it’s the FDA or the EMA, asks for proof that materials supplied are what they claim to be. That’s where the Certificate of Analysis (CoA) and the Material Safety Data Sheet (MSDS) make a real difference.
The CoA backs up the supply with evidence. It spells out purity, assay, and testing reports for each batch, stamping out guesswork before the drums reach a warehouse or compounding lab. An MSDS takes it from there, laying out everything that one would want to know about working safely, from basic chemical hazards to what protective gear removes risk. Manufacturers will not process material without these documents in hand. So, Benzyl Butyrate at pharma grade simply does not make the cut for a purchase order if it cannot be paired with a CoA and MSDS.
In my experience talking with procurement teams and regulatory affairs folks, most don’t even check price first. Their eyes go straight to the paperwork, because experience teaches: missing or vague documents end up costing more in delay or lost batches than buying another supplier’s product with a complete audit trail. Raw material missteps tend to trigger entire batch quarantines, audits, and sometimes recalls. That’s a nightmare for everyone involved.
Audit teams expect the CoA to reference pharmacopoeial standards. If a supplier calls the product “BP/EP/USP Grade,” the document needs to match up with those monographs, including details like refractive index, specific gravity, and impurity levels. The MSDS needs to explain in clear terms how to store, handle, and deal with any accidents. The era of verbal assurances has passed—suppliers without their paperwork sorted can’t break into the pharma supply chain.
Pharma-grade Benzyl Butyrate is available from manufacturers who treat documentation seriously. In India, China, and Europe, most established chemical producers understand the drill. They ship with batch-specific CoAs and supplier-stamped MSDSs as bare minimum requirements. Online directories like Pharmacompass let buyers check upfront if documentation is standard for the producer. Those who don’t advertise these basics tend to struggle in regulated markets.
Still, some “suppliers” are simply resellers with thin inventory. That’s where things get tricky—sometimes people source a drum, run into trouble with customs or local regulators, and discover there’s a missing test or improper labeling. In my experience, the best approach is to ask for a template CoA and MSDS upfront. If they can’t provide a sample document, or make excuses, you know what to expect down the line.
People in quality control, procurement, and regulatory compliance have been tightening controls. Increasingly, buyers insist on digital traceability, QR-marked documentation, and supplier audits. Organized digital document management helps make sure every batch of Benzyl Butyrate is trackable from production to delivery.
This sets a high expectation for new entrants and old hands alike. The companies driving change are the ones openly sharing full documentation bundles long before the sale, making material selection safer and more transparent for all. The bottom line is: without a solid CoA and MSDS, pharma grade Benzyl Butyrate doesn’t move—or shouldn’t. That’s the right way forward for patient safety and for every partner along the supply chain.
| Names | |
| Preferred IUPAC name | phenylmethyl butanoate |
| Other names |
Benzyl butanoate Butyric acid benzyl ester Benzyl n-butyrate |
| Pronunciation | /ˈbɛnzɪl ˈbjuːtɪreɪt/ |
| Identifiers | |
| CAS Number | 103-37-7 |
| 3D model (JSmol) | `C1=CC=C(C=C1)COC(=O)CCC` |
| Beilstein Reference | 1631074 |
| ChEBI | CHEBI:131311 |
| ChEMBL | CHEMBL3184857 |
| ChemSpider | 15440 |
| DrugBank | DB14183 |
| ECHA InfoCard | 03b48b8f-a6e8-4d50-8f92-6a97d26e064a |
| EC Number | 203-660-6 |
| Gmelin Reference | 6369 |
| KEGG | C16540 |
| MeSH | D001578 |
| PubChem CID | 8757 |
| RTECS number | WL5078000 |
| UNII | XZH4E6WS4C |
| UN number | UN1993 |
| Properties | |
| Chemical formula | C11H14O2 |
| Molar mass | 150.19 g/mol |
| Appearance | Clear colourless to pale yellow liquid |
| Odor | Mild, fruity |
| Density | 1.02 g/cm³ |
| Solubility in water | Practically insoluble in water |
| log P | 2.96 |
| Vapor pressure | 0.01 mmHg (20°C) |
| Acidity (pKa) | Estimated pKa: 16 |
| Magnetic susceptibility (χ) | -7.68×10⁻⁶ |
| Refractive index (nD) | 1.497 – 1.503 |
| Viscosity | 15-25 cps |
| Dipole moment | 1.66 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 348.7 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -390.1 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -4998 kJ/mol |
| Pharmacology | |
| ATC code | D04AA19 |
| Hazards | |
| Main hazards | May be harmful if swallowed, causes skin and eye irritation, may cause respiratory irritation. |
| GHS labelling | GHS07, GHS09 |
| Pictograms | GHS02,GHS07 |
| Signal word | Warning |
| Hazard statements | H302: Harmful if swallowed. |
| Precautionary statements | P280, P305+P351+P338, P337+P313 |
| Flash point | 170°C |
| Autoignition temperature | > 370°C |
| Lethal dose or concentration | LD50 (oral, rat): 6,300 mg/kg |
| LD50 (median dose) | LD50 (median dose): 4,330 mg/kg (oral, rat) |
| PEL (Permissible) | Not established |
| REL (Recommended) | 5 mg/kg bw |
| Related compounds | |
| Related compounds |
Butyric Acid Benzyl Alcohol Methyl Butyrate Ethyl Butyrate Propyl Butyrate Benzyl Acetate Benzyl Propionate |
Chengguan District, Lanzhou, Gansu, China
