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Stories about personal care and pharmaceuticals started shifting once preservatives like butylparaben entered the scene. The early discoveries surrounding paraben chemistry go back to the early twentieth century, when researchers noticed that esters of p-hydroxybenzoic acid showed better stability and longer shelf life in products. Butylparaben grew out of this innovation, giving producers a tough way to stop microbial growth without spending a fortune. Product makers and regulatory authorities shifted focus toward purity and standardized testing, which led to the pharmaceutical-grade material we see today—graded and checked under the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) rules. Working with these standards, manufacturers opened the door for more quality-driven products, even as regulatory debates evolved. Each generation of chemists has had to balance function, acceptability, and consumer safety.
For many, butylparaben might only show up on a product label, but the substance itself brings more to the table. As an ester derivative of p-hydroxybenzoic acid, it serves as a reliable barrier against bacteria and fungi in medicines, creams, shampoos, and countless more. Drug makers have built their preservative routines around butylparaben's clean dosage forms and compatibility with pharmaceutical excipients. The desire for consistent performance in changing environments gives butylparaben an edge in multilayered manufacturing processes. Generations of lab workers have reached for butylparaben to protect active ingredients during storage and shipment, crediting its staying power in a range of humidity and light conditions. Its ongoing use shows how professionals still value direct, trustworthy antimicrobial performance in both topical and oral use products, localizing treatments without missed beats.
Butylparaben shows up as a white, crystalline powder, sometimes leaning off-white depending on the supplier’s process. It carries a faint, characteristic odor that doesn't muddle product aromas in the finished blend. With a melting point squarely between 68 and 72°C, this compound stands firm in both hot and cool environments during manufacturing runs. Its moderate solubility shows up in alcohol and ether, letting formulators work it into a slew of solutions, suspensions, and emulsions. Only slight solubility in water means some tweaks are needed if a water-based formula forms the foundation. The chemical structure—4-hydroxybenzoic acid butyl ester—means it maintains a basic ester backbone with a butyl side chain, giving it greater oil solubility than its methyl or ethyl cousins. This quality lets it offer longer-term protection in fatty bases like ointments, making it a backbone for both pharmaceutical and personal care applications.
A proper batch of butylparaben pharmaceutical grade answers to some strict numbers. Most monographs set purity at or above 99% by HPLC, ensuring it doesn’t bring in side products or contaminants. Residual solvents and moisture content both follow tight limits—often under 0.5%—while heavy metals have defined maximums, driven by safety data. Each supplier prints label data with clear batch number, grade, expiry date, and manufacturing origin, along with hazard identifications that line up with worldwide standards. Pharmaceutical customers count on these numbers, because dosage errors or unknown impurities can push adverse reactions or failed quality tests. Reliable documentation lets biotech, hospital, and contract manufacturers keep audit trails tight and ready for inspection.
Making butylparaben in a lab doesn’t call for fancy tricks, but producers take pride in process controls anyway. They start by reacting p-hydroxybenzoic acid with n-butanol using an acid catalyst like sulfuric acid. The mixture heats up, which helps the esterification along. Once done, distillation pulls away excess alcohol, then water washes and filtration break out pure crystals of butylparaben. Careful control of reaction time, temperature, and molar ratio keeps impurities in check. Pharmaceutical suppliers throw in extra purification techniques—often recrystallization and vacuum drying—to meet the high bar for injectable or skin-contact products. Waste minimization efforts matter, too, since by-products and spent acid need careful disposal. These steps take root in every major pharma supplier’s routine.
Butylparaben sits ripe for modification by hydrolysis, oxidation, or transesterification. Exposed to strong acids or bases under heat, it breaks down into butanol and p-hydroxybenzoic acid, the backbone for many other paraben forms. Oxidative conditions can chop the aromatic ring, though that pathway doesn’t often show up in controlled pharmaceutical storage. Skilled formulators sometimes tweak the base structure to adjust solubility or antimicrobial timeframes, shaping derivatives with slightly different chain lengths or branching. Combinatorial chemists turn these building blocks into multi-functional preservatives or prodrugs, tailoring bioavailability or skin penetration as needed. Looking past synthesis, researchers often study the breakdown products and their safety, since patient contact brings long-term metabolic questions to the table.
The familiar term “butylparaben” shows up interchangeably with names like n-butyl p-hydroxybenzoate, butyl p-hydroxybenzoate, or simply BP. On the pharma supply market, packagers stamp their own trade names—often combining “Pharma,” “USP,” or “EP” in the label description. Technical data sheets might note the CAS number 94-26-8. Researchers and purchasing managers speak in all these terms, yet mean the same backbone molecule every time. Some product brands also blend butylparaben into multi-preservative systems, building in combinations under various names like Germaben or Euxyl ranges.
Working with butylparaben takes grounded risk assessment, mainly focused on inhalation of powders or direct skin contact with the undiluted substance. Industrial hygiene standards call for gloves, dust masks, and eye protection—especially in high-volume blending or weighing steps. Regulatory bodies cap concentrations for direct-to-skin or oral use. The European Commission, for instance, draws a line at 0.14% for individual parabens in most leave-on cosmetics and even lower in some special-use categories. Feeding this into audit trails and worker training programs keeps legal and safety standings on the right path. Many suppliers build document packs—SDS, COA, TDS—that spell out not just what’s in the container, but how to act when spills, fires, or adverse exposures happen. Long-term environmental releases face restrictions, so proper waste neutralization and vent-air filtration sit at the core of any compliant operation.
Butylparaben holds ground in personal care, medicine, and food contact films. Skincare brands keep reaching for it to knock out bacteria and mold, holding the promise of longer shelf lives for creams and lotions. In pharmaceuticals, it anchors preservative systems in eye drops, syrups, and stable ointments. Veterinary formulations and even some injectable drugs lean into its compatibility and mild flavor profile, which doesn’t mask or distort active ingredients. The food industry, though more restricted these days, still keeps tabs on butylparaben’s use for specialized packaging applications and non-ingestible components, thanks to its low reactivity with plastics and rubbers. In lab diagnostics, it preserves standards, progeny samples, and test reagents that sit for extended periods on shelves.
Most researchers aiming at butylparaben dig deep into its mechanism of action and its fit with safer, less allergenic preservative alternatives. Ongoing work tests new delivery formats that can stretch preservative lifespans while using lower concentrations. Drug product developers play with encapsulation techniques and hybrid preservatives that can deliver butylparaben only in response to microbial signals or pH shifts. Chemists branch out by attaching new side chains to the core molecule, probing for better safety or more robust performance profiles. Surveillance studies track patient and consumer reaction trends, looking for rare cases of contact allergy or resistance development, then feeding the results back to regulatory files. Animal models and in vitro systems map metabolic breakdown and the pathways for excretion and elimination in humans. Academic journals make room for thorough reporting on the fate of paraben residues in surface waters and their impact on ecological health, giving policy drivers real-world data to update usage limits or replacement campaigns.
Toxicological studies on butylparaben have bounced back and forth over the years, with some early alarms around hormone mimicry and others showing negligible risk at low concentrations. Many toxicity panels focus on reproductive toxicity, endocrine disruption, and allergenic risk in both animals and humans. The majority of evidence points to safety at typical topical and oral concentrations, but risk-based assessment—especially for newborn and pediatric populations—remains cautious. Studies measuring bioaccumulation, excretion half-life, and metabolism continue to shape global regulatory standards. Some regions have adopted stricter cumulative limits when butylparaben pairs with its methyl and propyl analogs, in part based on animal studies that noted additive effects. Analytical scientists lean on advanced LC-MS and GC techniques to measure trace residues in urine and tissue samples, expanding the foundation for both health and environmental regulations.
Looking at the landscape ahead, butylparaben stands at a crossroads familiar to many legacy chemicals. Some manufacturers are searching for full replacements, driven by consumer demand for paraben-free products and tighter EU safety bands. At the same time, pharmaceutical plants and diagnostic labs keep pushing for high-purity supplies and consistently reliable performance. Advances in green chemistry may deliver milder preparation routes, renewable feedstocks, and biodegradable replacements that hold the preservation line without lingering environmental baggage. Regulatory teams in North America, Europe, and Asia will keep tuning standards as epidemiology and environmental science releases new insights on exposure and long-term safety. Product formulators and quality professionals tackle these shifts by lining up backup systems—testing combinations, exploring encapsulation, and readying new compliance paperwork. For working chemists, keeping close tabs on the latest science, labeling standards, and government updates matters, not just for market access, but for patient and consumer trust in the finished product.
Pharmaceutical products face a constant battle against bacteria, yeast, and mold. Butylparaben BP EP USP pharma grade takes a front seat in that fight. I’ve come across countless over-the-counter creams and oral medications listing this preservative in the ingredients. Why do manufacturers trust it? Microbes love water, and so many formulations—cough syrups, creams, gels—include enough water to invite spoilage. A broad-spectrum preservative like butylparaben keeps these products safe and shelf-stable. There’s real relief in knowing a medicine stashed in a bathroom cabinet won't turn dangerous or ineffective before its expiration date.
Health isn’t just pills and capsules. Personal care products deserve the same consideration. Every morning, millions start the day with moisturizers, sunscreens, and cleansers—products that improve skin health or comfort. But open a jar or squeeze a tube and each exposure can invite contamination. Butylparaben keeps those products usable longer and helps make sure bacteria won’t sneak their way back to your face or hands. The need for this preservative grows with multifunction products: imagine a moisturizer and SPF blend, destined for warm, bright bathrooms, often touched with wet fingers. Preservatives protect both users and product consistency.
Every pharmaceutical or cosmetic company must answer to a web of global safety regulations. Butylparaben BP EP USP stands out because it meets pharmacopoeial standards from respected authorities. The “BP” in its name means British Pharmacopoeia, “EP” is for European Pharmacopoeia, and “USP” signals the United States Pharmacopeia. These standards demand strict purity and safety checks. Companies catering to global markets don't just want—but need—an ingredient that holds up in compliance audits. Choosing ingredients with these credentials backs up their safety record and gives prescribers and patients one less thing to worry about.
Some medicines come blended as emulsions, creams, or suspensions, where active drug molecules aren’t just dissolved in water. These formats often provide better delivery or absorption, but they complicate the microbiological risk. I’ve seen pharmacists struggle with compounded creams, anxious about spoilage and patient safety. Using butylparaben simplifies things because it performs across several types of pharmaceutical bases. As a chemist, I’ve found it especially effective in products with oils and waxes where other preservatives falter.
Parabens, including butylparaben, sometimes get a bad rap in social media debates. Some people worry about long-term effects, but broad safety data from decades of use keep it firmly in many formularies. Regulators still allow its use in both drugs and personal care, at levels far below any proven harm. I believe that ongoing research and transparent labeling address these concerns without sacrificing the safety margin for people who rely on stable, microbe-free medications or creams.
Pressure grows for alternatives in the preservative world, but many newer options can't yet match butylparaben’s robust safety record and effectiveness. Research keeps looking for replacements, especially for sensitive users. Until something better comes along, this tried-and-true ingredient continues to protect the medicines and products that millions use every day.
As someone who has spent years dealing with different chemicals across labs and manufacturing, I understand why clear information about specification and purity is so important. It goes beyond just a number on a certificate. Every batch tells a story about where it came from and the hands it passed through before reaching its destination. In today’s market, questions about purity show up almost every week. It’s not just curiosity—it’s about trust, safety, and quality.
A chemical specification lays out what you can expect. It covers the main compound’s concentration and also shines a light on the impurities. For example, pharmaceutical-grade sodium chloride must meet certain limits for heavy metals and other contaminants. Lax standards in specification can lead to recalls and entire batches scrapped. I have seen how a vague or incomplete certificate can cause a domino effect—costly delays, extra testing, and in some rare cases, failed regulatory audits.
One time I ordered a common solvent from two trusted suppliers for comparison testing, assuming similar specs. Their reports looked identical, yet one batch threw off our results by a surprising margin. Digging in, I found an unnamed impurity at trace levels. That’s the real-world impact a small difference in chemical specification can have. Even if standards like ACS, USP, or Reagent Grade exist, it pays off to examine each certificate closely and ask for full impurity profiles.
A label reading “99.9% pure” grabs attention, yet purity isn’t the whole story. What’s left in that 0.1% can cause trouble or harmlessly pass through—context always matters. Take hydrogen peroxide, for instance. Food processing, medical, and industrial uses each call for different grades and levels of stabilization. One workplace I visited switched suppliers only to find that residual stabilizers kept interfering with catalyst reactions. That experience taught me to treat purity numbers as a starting point, not the full answer.
Labs demanding high sensitivity need to know about even minuscule contaminants, sometimes measured in parts per billion. An environmental lab screening for metals orders high purity acids, yet contamination from a poorly cleaned container can wipe out days of analyses. That’s why I always encourage clear questions about storage, traceability, and batch-specific data before making any purchase, especially for critical work.
It’s tempting to trust a familiar supplier, but the pressure to deliver faster at lower costs sometimes leads to corners being cut. An open paper trail—spectra, chromatograms, independent third-party testing—goes a long way. Consistent transparency not only prevents costly mistakes, but also helps build long-lasting buyer-supplier relationships. Regulations from organizations like the FDA or EPA don’t just protect end users; they force everyone in the supply chain to stay honest.
Pushing for more transparency from chemical suppliers doesn’t just shield against accidents. It offers peace of mind for those relying on the end product, brings accountability, and supports scientific rigor. Making accurate chemical specification and purity information a basic demand benefits researchers, manufacturers, and ultimately end users. Everyone deserves to know the true contents of the chemicals they depend on.
Pharmaceutical companies search for ways to keep medicines free from unwanted bacteria and mold. Butylparaben, a chemical that's been around since the 1920s, helps by stopping the growth of microbes. Its use in medicine comes with high purity benchmarks, meeting standards set by BP, EP, and USP. Some folks worry about long-term safety, especially since it’s used in everything from creams to eye drops. There’s a lot to consider about its impact, both for patients and the people making the pills.
Having family members who rely on prescription creams, I've studied ingredient labels myself. Most people don't question the list of "inactive ingredients." When I see butylparaben, I remember why it’s there—it stops bad things from growing. Patients often focus on the active chemical, but the behind-the-scenes work by preservatives keeps the medication stable until it’s used up. Without something like butylparaben, you’d throw out half-full bottles before they expired. Doctors and pharmacists check every ingredient for risk, because they know patients count on more than just the medicine itself.
Numerous studies examine how butylparaben behaves in the body. Most show that the small amounts used in pharmaceuticals move through our systems and get processed by the liver. The World Health Organization and European Medicines Agency cap the maximum allowable amount based on animal studies and real-life human data. Doses in tablets and creams stay well below these lines. Side effects rarely appear at levels used in drugs, and most people tolerate these preservatives just fine. Safety reviews happen often, and if the research changes, so do regulations.
Some critics worry about possible hormone disruption. Butylparaben can mimic estrogen under lab conditions if applied in huge doses—amounts much higher than found in medical products. The U.S. FDA, Health Canada, and EU regulators keep a close eye on this topic. They’ve set intake limits far lower than what triggers hormone activity. Allergic reactions sometimes pop up, but are rare and usually involve sensitive skin or overuse. For most people, the risk sits closer to a mild rash than to anything dangerous.
In today’s world, people want medications they trust. Pharma producers test substitutes like potassium sorbate or phenoxyethanol. Sometimes, replacements don’t protect as well, or aren’t as gentle on the skin. It takes heavy investment and time to find new options that beat what butylparaben offers in shelf-life and safety. Yet, with so many people asking questions about chemical exposure, it makes sense to keep the conversation going. Safety reviews and open labeling build trust, and that’s good for everyone—especially patients looking for medicine that works without surprises.
In the lab, nothing frustrates more than reaching for a key ingredient—only to find it’s lost its punch. Butylparaben, used in many pharma and personal care products, plays a critical role in keeping things safe from microbes. Its shelf life stretches up to three years when treated right. Letting time slip past that marker can mean risking contaminated batches or failed preservative tests. Some might see expiry dates as conservative, but I’ve seen enough failed assays to respect the manufacturer’s timeline.
Manufacturers run accelerated and long-term stability trials to set these expiration dates. They examine real loss of potency, monitor for degradation products, and assess whether color or odor signals trouble. Standard studies show that Butylparaben performs best when kept in its original, sealed packaging and shielded from environmental extremes. Letting that bottle sit open, or moving it into humid storage rooms, will only invite headaches.
Butylparaben doesn’t fare well with moisture, heat, or sunlight. In my experience, a storage closet that holds around 20-25°C (room temperature) and blocks out sunlight works well. I've seen warehouses get lazy with climate control and end up with lumpy powders or product that smells faintly off. These changes point to possible hydrolysis, which leads to breakdown. Anyone storing larger quantities needs to focus on airtight containers, preferably made from glass or high-density polyethylene. Screw caps, not loose lids, keep product dry.
Forget a casual attitude toward open bags or half-closed drums. Exposure even over a weekend can start pulling in humidity, which eventually clumps the powder. Humid conditions accelerate hydrolysis and reduce antibacterial power. Laboratory staff sometimes use desiccators or silica gel packets as insurance, a step that pays off when storage areas can’t hold a steady climate year-round.
Neglecting proper storage can ruin more than raw materials—it undercuts the foundation of high-quality pharmaceutical development and production. A compromised preservative means greater risk of microbial growth in finished products, wasted materials, regulatory trouble, and safety concerns for patients. In my work, I’ve seen batches recalled because a single ingredient failed stability, wasting thousands of dollars and hours. The path to consistent quality passes through disciplined handling and respect for shelf life.
Many pharmaceutical teams set up routine checks: keeping fresh silica gel in supply bins, checking temperature and humidity logs, and cycling inventory with a first-in, first-out system. These simple habits reduce the chance of sticky or degraded Butylparaben sitting on shelves until crunch time. I’ve gotten in the habit of sealing smaller amounts in secondary containers to lessen the risk each time I reach for a scoop.
Buying only as much Butylparaben as a facility can expect to use before expiry also matters. Warehouse managers who resist bulk discounts and instead order quarterly have fewer surprises. Less waste, less hazard, fewer compliance headaches.
Labeling every container, tracking expiration, and setting storage protocols don't require fancy infrastructure; just consistent follow-through. Butylparaben holds up as a reliable preservative, but it rewards teams that store it right and respect the clock. These habits weave into a stronger safety record and tighter process control down the line—a win for everyone from chemist to patient.
Any product claiming a place in pharmacies or hospitals attracts a tougher spotlight than most. I’ve spent years watching how pharmaceutical manufacturers juggle regulations, raw materials, and endless documentation. The title of “BP, EP, or USP compliant” isn’t just a shiny sticker. It brings peace of mind to doctors, patients, and regulators who trust that medicines are high quality and safe.
Pharmacopeias—like the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP)—write the rulebook for medicines. These standards don’t only set limits for how much of a certain compound can be in a tablet or vial. They ask pointed questions about the way a product is made, how stable it stays over time, and whether there’s anything in it that shouldn’t be there.
To call a product “compliant,” the manufacturer must match the test methods, purity expectations, and identity checks outlined in these books. Having worked in drug development, I’ve watched teams pore over pages of test methods—measuring loss on drying, checking pH, looking out for impurities. Pharmacists and regulatory managers examine batch records and question suppliers every step of the way. Sometimes, only a small difference in a test method or raw material can bump a product out of compliance.
Few realize that pharmacopeias update their chapters frequently. Today’s compliant product might slip behind after the next revision. Companies aren’t just sending samples to the lab. They keep up with method changes and sometimes invest in new equipment so the next batch fits the latest standards. An audit may uncover gaps if a company relies on old methods while the official books have moved forward.
I’ve seen shipments held up at borders because a product didn’t meet the right pharmacopeia’s assay or impurity profile. Sometimes, entire production runs need to be destroyed. More than lost money, there’s the risk of patient harm if a drug doesn’t behave the way doctors expect. Global supply chains add another layer of risk, with differences between regional standards tripping up even skilled companies. If your product isn’t up to scratch with the BP, but you’re selling into Europe, questions come thick and fast. The same holds for the USP in the United States market.
Staying compliant doesn’t rest on paperwork alone. Testing must be regular, transparent, and repeatable. I’ve watched quality teams examine certificates of analysis, challenge strange test results, and send samples for third-party confirmation. Emerging companies sometimes struggle to get it right without experienced hands guiding their quality programs.
If there’s any uncertainty, contacting the pharmacopeia compendial services for clarification or using authorized reference standards removes doubt. Open communication with regulators also helps sort out tricky situations—especially when standards in different regions don’t line up perfectly. Ongoing training, close relationships with suppliers, and readiness to upgrade equipment or methods help keep compliance strong.
Calling a product “BP, EP, or USP compliant” means far more than ticking a box on a form. It signals a serious investment in people, equipment, and honesty. For patients and healthcare professionals, that trust can shape life-or-death outcomes.
| Names | |
| Preferred IUPAC name | butyl 4-hydroxybenzoate |
| Other names |
Butyl p-hydroxybenzoate Butylparabenum Butyl 4-hydroxybenzoate Butoben E209 |
| Pronunciation | /ˌbjuː.tɪlˈpær.ə.bɛn/ |
| Identifiers | |
| CAS Number | 94-26-8 |
| Beilstein Reference | 1918985 |
| ChEBI | CHEBI:34756 |
| ChEMBL | CHEMBL1567 |
| ChemSpider | 6740 |
| DrugBank | DB02129 |
| ECHA InfoCard | 100.120.2 |
| EC Number | 202-318-7 |
| Gmelin Reference | The Gmelin Reference for Butylparaben is **"83277"**. |
| KEGG | C10792 |
| MeSH | Butylparaben |
| PubChem CID | 7037 |
| RTECS number | WN0110000 |
| UNII | 9P6J255G1O |
| UN number | UN3077 |
| CompTox Dashboard (EPA) | DTXSID0020062 |
| Properties | |
| Chemical formula | C11H14O3 |
| Molar mass | 194.23 g/mol |
| Appearance | White crystalline powder |
| Odor | Odorless |
| Density | 1.24 g/cm³ |
| Solubility in water | Slightly soluble in water |
| log P | 1.96 |
| Vapor pressure | <0.1 mmHg (20°C) |
| Acidity (pKa) | 8.47 |
| Basicity (pKb) | 8.47 |
| Refractive index (nD) | 1.500 - 1.510 |
| Dipole moment | 2.85 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 385.8 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -584.0 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -6358 kJ/mol |
| Pharmacology | |
| ATC code | R02AA19 |
| Hazards | |
| Main hazards | May cause eye, skin, and respiratory irritation. |
| GHS labelling | GHS labelling: "No pictogram, Not classified as hazardous according to GHS |
| Pictograms | GHS07 |
| Signal word | Warning |
| Hazard statements | Hazard statements: H317: May cause an allergic skin reaction. |
| Precautionary statements | Precautionary statements: P264, P280, P305+P351+P338, P337+P313 |
| Flash point | 103°C |
| Autoignition temperature | 410°C |
| Lethal dose or concentration | LD50 oral rat 2230 mg/kg |
| LD50 (median dose) | LD50 (median dose): 16,000 mg/kg (oral, rat) |
| NIOSH | Not Listed |
| PEL (Permissible) | PEL (Permissible Exposure Limit) for Butylparaben is not specifically established by OSHA. |
| REL (Recommended) | 3 mg/kg bw |
| IDLH (Immediate danger) | Not established |
| Related compounds | |
| Related compounds |
Methylparaben Ethylparaben Propylparaben Isobutylparaben Benzylparaben |
Chengguan District, Lanzhou, Gansu, China
