Ethylparaben sits among a group of compounds that made their mark early in the 20th century. Chemists once scouted for a way to prevent creams and syrups from spoiling on pharmacy shelves. They discovered that parabens, a group of alkyl esters of p-hydroxybenzoic acid, could halt mold and bacterial growth. Ethylparaben became especially popular thanks to its balance of preservative power and mildness. Over time, demand grew fast as consumer goods like skin lotions, shampoos, and cough syrups appeared in every home. Regulations stepped in through British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) to ensure safety and high standards. No other category of preservative has played such a broad role in preventing contamination across so many products for so long.
Ethylparaben stands out in the pharma grade segment thanks to rigorous screening for purity and low impurity levels. In the manufacturing world, this means tighter controls and standardized checks. It shows up as a white, crystalline powder—easy for weighing, mixing, and processing in industrial environments. The chemical’s popularity comes down to its effectiveness in low concentration and wide pH compatibility, making it adaptable in both liquid and solid forms, including tablets, creams, and suspensions. Many large-scale drug and cosmetic makers count on ethylparaben as a reliable, consistent ingredient, drawing trust from decades of clinical use and quality benchmarks set by various pharmacopeias.
Looking at the fine details, ethylparaben’s melting point hovers around 115°C to 118°C, and it dissolves easily in alcohol and ether, but poorly in water. This explains why creams and lotions take it up with no effort, while manufacturers working with water-based systems must consider solubility tricks like co-solvents or surfactants. Chemically, ethylparaben features the classic ester bond that brings both hydrophobic and hydrophilic aspects into play. Its molecular formula, C9H10O3, and a light fragrance sometimes emerging in raw form, hint at its role as both a preservative and a possible disruptor in delicate formulations. In storage, the compound holds up under reasonable temperature and humidity, yet performs best when kept airtight and shielded from sunlight.
In pharma use, ethylparaben labeling goes beyond just naming and concentration. Standards from the BP, EP, and USP demand a high level of purity—often above 99%. Impurity profiles must be tightly mapped, including related substances and residual solvents. Labels call out batch numbers, manufacturing dates, expiration, and storage instructions. Some companies print QR codes for instant access to certificates of analysis and supply chain data. Allergen warnings and source disclosures cater to growing transparency demands, helping operators trace batches from finished goods all the way back to the raw chemical input. In my years helping set up quality systems, thorough labeling never happens by accident; firms invest in clear, precise marking systems to avoid cross-contamination, mix-ups, and regulatory headaches.
Industrial ethylparaben production usually starts with p-hydroxybenzoic acid and ethanol. Manufacturers employ either acid catalysis or esterification with sulfuric acid, driving the reaction at elevated temperatures under controlled settings. Post-reaction, purification cycles include distillation and recrystallization, squeezing out contaminants and side-products. Years ago, I toured a batch facility running these steps—the process felt both artful and exacting, since minor adjustments in reaction time or temperature could tip the balance from high-purity product to a batch needing rework. On the sustainability front, several plants have begun recycling ethanol and sulfuric acid residues, cutting both costs and chemical discharge.
Beyond making ethylparaben itself, labs often investigate how it reacts with bases, acids, and light. Alkaline conditions can hydrolyze the ester back to its acid and alcohol, so formulators keep a tight rein on pH, especially in finished products targeting long shelf life. In the presence of heat or metal ions, ethylparaben may form colored byproducts, which matters in transparent gels or syrups. Researchers tweak the structure—sometimes adding longer or branched alkyl groups—to create variants with altered solubility or broader antimicrobial scope. Each modification brings new tests and a round of stability checks, emphasizing the chemical’s flexibility but also the challenges of unintended reactions during storage or use.
Over the years, ethylparaben has gathered a long list of names: Ethyl-p-hydroxybenzoate, 4-Hydroxybenzoic acid ethyl ester, and even E214 in the food additive world. In pharma and cosmetics, labeling can show names such as Nipagin A or the straightforward “ethylparaben.” Some ingredient indexes list it alongside methylparaben and propylparaben, a sign of its close chemical relatives. Cross-referencing these names in regulatory filings becomes part of the job in any compliance office, especially across borders where legal or trade names may shift. Keeping this list handy cuts down on confusion and clarifies formulation sheets for the many hands they pass through.
Any talk about ethylparaben ends up circling back to safety. Manufacturers face strict exposure limits in workspaces—gloves, goggles, and proper air extraction stay non-negotiable in all the plants I’ve seen. Allergic reactions remain rare, but operators keep incident logs and seek medical input for unusual symptoms. Pharmacopeia guidelines require purity and microbial limits high enough to support medicines, which means every batch undergoes sterility and toxicity screens before release. Waste disposal takes high priority to avoid ecosystem buildup; many factories treat output streams to neutralize leftover compounds, a practice now widely expected in advanced manufacturing. Employee training sessions reinforce protocols every quarter, pulling from accidents and audits industry-wide to keep standards sharp.
Ethylparaben’s biggest impact lies in preservation. It extends shelf life for creams, antibiotics, tablets, oral solutions, and even eye drops. Producers in personal care—soaps, toothpastes, makeup—use it to keep products fresh, as do food manufacturers in sauces and baked goods. Its resistance to high temperatures makes it useful for heat-processed and sterilized products. Veterinary medicine draws on the same preservation strengths, particularly in livestock treatments with long supply chains. In laboratory kits and research reagents, ethylparaben stabilizes enzymes and buffers, ensuring results match reality. Based on firsthand experience working with both pharma and cosmetic firms, I’ve seen costly recalls avoided by robust paraben systems pinned to real-world data on contaminant prevention.
R&D around ethylparaben never slows. Some labs test novel delivery forms—micellar gels, nanoparticle suspensions—to get more steady release or better skin compatibility. Academic groups map out the mechanisms of microbial inhibition, especially as resistant strains challenge older preservatives. Other researchers run head-to-head trials pitting ethylparaben against synthetic and natural competitors, tracking not just effectiveness but distribution in tissues, potential metabolites, and impacts on hormonal systems. Developing analytical methods, such as high-performance liquid chromatography, carries special value given the need for tiny contaminant detection. Collaboration between universities, government regulators, and drug makers pushes continuous improvement and transparency.
Debate around paraben safety spans decades. Most toxicology studies show rapid breakdown and excretion after oral or dermal exposure, keeping accumulation low in usual doses. Yet some animal trials have raised questions about long-term hormone effects; as a result, regulatory panels check updated data on a rolling basis. Maximum permitted levels vary from country to country, and watchdog groups monitor new research for any shifts. Clinical case reports of allergies or irritations stay infrequent, mostly limited to repeated exposure at higher concentrations. Worldwide, the scientific shift has moved toward even more public release of research data, so workers and end users alike can weigh risk and benefit clearly.
Future discussion around ethylparaben in pharma grade hinges on two big levers: innovation in alternatives, and rising consumer demand for transparency. Plant-derived and biodegradable preservatives continue drawing investment, pressuring traditional suppliers to up their safety and disclosure practices. Modified parabens tackling solubility or antimicrobial range may broaden uses, but face just as many regulatory hoops. Technology such as blockchain could soon anchor supply tracking, giving everyone in the supply chain—from plant floor operator to pharmacist—real-time batch data and origin details. As someone who’s watched new standards roll in, I know companies that focus on evidence-based audits and proactive risk management will keep shaping the conversation. Outsiders may predict a drop in paraben use, yet data-driven decisions will keep ethylparaben a staple in many settings, at least as long as it can balance effectiveness, affordability, and safety.
Walk into any pharmacy and you notice the sheer scale of products lining the shelves. Each has a list of ingredients that seems almost impossible to memorize. In the world of pharmaceuticals, ethylparaben holds a quiet but vital spot. Ethylparaben BP EP USP pharma grade stands as a preservative. The grade names — BP, EP, USP — link back to pharmacopoeia standards, not just marketing fluff. These quality labels matter, as they show a level of chemical purity verified for medicine use.
Ethylparaben fights spoilage. No patient wants to discover mold or bacteria have found a home in their cough syrup or tablets. Without suitable preservatives, microbes invade. This can turn a life-saving medicine into something harmful. The FDA and health ministries worldwide monitor such risks closely.
In my years spent working in a community health setting, I have seen how essential shelf life is for drugs meant for remote clinics. Medications sometimes spend months in harsh weather, far from modern refrigeration. Preservatives like ethylparaben mean antibiotics, syrups, or creams reach patients with their effectiveness and safety intact.
Ethylparaben dissolves well and does not easily threaten the flavor or texture of medicine, making it a natural fit for liquid and solid drugs. By acting across a broad spectrum of bacteria and mold, it gives drug makers a way to keep things safe with very small concentrations.
No discussion of parabens in medicine escapes the safety question. Concern sometimes arises from studies linking long-term paraben use to possible hormone disruption, especially in cosmetics. Drug regulators keep a watchful eye on the data. Until now, ethylparaben remains permitted at strict limits because larger, reliable studies have not shown harm at the amounts used in licensed medicines.
Surveys show most adverse reactions come from very rare cases of skin allergy, and almost never from pharmaceutical use at approved doses. Diversity in human biology matters; what gives one person an issue passes unnoticed in millions of others.
Engineers and scientists keep searching for newer preservatives that tick every box: effectiveness, stability, and safety. In busy hospital pharmacies, I have chatted with pharmacists who wish they could ditch all synthetic preservatives but admit none are as cost-effective or versatile yet. Natural alternatives often break down quicker or need higher doses to work.
Some health professionals choose preservative-free medicines for vulnerable groups, such as neonates or those with known allergies. Clear labeling lets doctors make informed choices for their patients.
Companies follow rigorous testing, keeping a close eye on every batch. Regulators hold them to account with surprise inspections and product recalls if standards drop.
Ethylparaben BP EP USP pharma grade remains a staple ingredient because it meets day-to-day demands. Drug makers value predictability and proof in every shipment. Patients care most about safety and having their needed treatments unspoiled. Tossing out what works because of overhyped headlines does a disservice to the science and to people who live far from the nearest doctor.
Ethylparaben doesn’t usually make headlines, but anyone who has stood in front of a bathroom cabinet has likely encountered it. Used as a preservative, ethylparaben keeps bacteria and mold out of creams, syrups, and tablets. From what I’ve seen as a health and science writer, this is one ingredient manufacturers double-check, especially when the final product is going in or on the human body.
Pharmaceutical-grade ethylparaben has to pass much more stringent tests than its industrial cousins. If it’s not pure enough—as defined by standards like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia)—companies can’t use it in medicine. Consistency here isn’t just technical nitpicking; impurities can trigger allergic reactions or reduce the shelf life of medicines. Getting purity wrong can lead to expensive recalls or put patients at risk.
For ethylparaben, the pharmacopoeias spell out purity levels in detail. British and European standards both require that ethylparaben appears as a white, almost odorless crystalline powder. It should contain around 99.0% to 100.5% of C9H10O3, when measured on the dried substance. The USP expectation matches closely, calling for not less than 98.0% and not more than 102.0% on the anhydrous basis. Moisture matters too: dryers bring the water content to below 0.5%, since anything higher risks unwanted chemical reactions during storage.
Acidity or alkalinity stays within a narrow range. Even a slightly off pH can spell trouble for drug stability. Residue after ignition— what’s left behind after burning—needs to be less than 0.1% for BP/EP and 0.5% for USP, ruling out heavy contamination from raw ingredients. The pharmacopoeias also put strict limits on related substances and contaminants, including parabens with longer or shorter chains and traces of heavy metals. For example, BP and EP require each impurity to be below 0.5%, while total impurities remain under 1.0%. Any test for sulphated ash shows tiny, nearly invisible residues, because an excess signals leftover manufacturing chemicals.
Researchers and regulators keep updating these standards because science moves fast. Over the years, cases of contamination—think of diethylene glycol or made-in-the-backyard painkillers—have shaped tough modern pharmacopeia rules. If a lab finds a new kind of impurity, whether from shipping stress or raw material changes, the rulebooks get revised to match real-world conditions.
Pharmacists and manufacturers depend on transparency from suppliers. Certificates of analysis offer detailed breakdowns, but they only work if the testing labs follow the accepted standards in method and calibration. The best producers invest in their own quality systems, using high purity solvents and strict environmental controls to wipe out contamination before it happens.
Many companies use third-party testing to double-check their main suppliers. It’s a practical step, given the stories of supply chain mix-ups and raw material fraud in recent years. Investment in digital track-and-trace tech helps too, recording every batch’s history from factory to delivery. More open reporting from auditors and more international data sharing raise the bar for quality worldwide.
Safe medicines depend on small, behind-the-scenes ingredients like ethylparaben meeting the highest standards. It’s worth the effort, because one weak link can undo the work of a whole supply chain.
Ethylparaben belongs to the paraben family, a group of compounds used to stop fungi, bacteria, and yeast from growing in products. This preservative keeps medicines shelf-stable and safe from spoilage, especially in liquid or cream formulas. In my own time working in community health, I have seen how important these preservatives become, especially in countries with warm climates and limited refrigeration. Without them, many life-saving drugs can go bad before they ever reach the patient.
Not all ethylparaben is equal. Pharmaceutical grade labels like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) aren't just marketing terms. Manufacturers follow strict procedures that limit levels of toxins, related substances, and heavy metals. This means each batch used in drugs meets internationally recognized safety standards. The batch gets tested for clarity, melting point, identification by chemical reaction, and purity. Companies that ignore these protocols risk contamination, which could turn a basic preservative into a public health hazard.
Parabens, including ethylparaben, have drawn a lot of scrutiny. Some studies link parabens to hormone disruption because the chemicals can mimic weak estrogen-like activity in lab models. Headlines often highlight these concerns, and people wonder if something added to their medicine can cause harm. The science gives a broader context. Regulatory agencies like the US FDA and European Medicines Agency look at data from animal studies, toxicity reports, and past human use. Based on the weight of evidence, current pharmaceutical guidelines allow ethylparaben at specific levels that are not expected to cause harm. Used within recommended concentrations, the risk to patients remains low.
Consumers ask for fewer chemicals in their products, and nobody likes the idea of unnecessary additives. Experience shows the real danger is often the thing you can’t see—microbes sneaking into medicine and multiplying. Parabens have decades of safe use behind them and tend to work well with many drug types. Removing preservatives without a solid replacement would leave medicines at the mercy of fungal or bacterial contamination.
Scientists keep searching for natural or less controversial options—sometimes glycols or organic acids. Each substitute must jump through the same safety hoops. Some alternatives don’t last as long or can cause irritation in sensitive patients. Any move away from established preservatives pushes up research costs, slows medicine approval, and might not guarantee safer medicines.
Doctors, pharmacists, and pharma companies need to share clear information about which preservatives are used and why. Plenty of people are wary because communication has lagged behind ingredient changes. Full ingredient disclosures and updates on new research give patients more control and peace of mind.
In decades of medicine, I have learned that preserving drugs safely supports public health far more than most realize. Ethylparaben remains one of the more reliable and studied choices in pharmacy. Keeping watch for new data, investing in purer raw materials, and taking patient concerns seriously can keep medications both safe and trusted moving forward.
Ethylparaben, with its widespread use in pharmaceuticals as a preservative, shows remarkable stability compared to some other chemical ingredients. Still, how and where you store it shapes not only how well it does its job but also how safe it remains for the patients counting on those products. Anyone who’s spent time in a pharmacy or a lab knows: keeping such compounds stable isn’t just about following rules — it’s about protecting health, supporting public trust, and sometimes saving money by avoiding waste.
Start with temperature. Pharmacopeias including BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) agree: store ethylparaben in a cool place, usually below 25°C. Heat speeds up degradation, which can lead to reduced effectiveness or even breakdown into unwanted byproducts. I’ve seen batches go bad on a shelf that was just a bit too close to the radiators. Anyone managing a chemical inventory set-up knows that a well-monitored environmental control system pays off in preserved potency.
Light exposure matters, too. Direct sunlight, fluorescent bulbs, or even ambient brightness can trigger changes in paraben structure over time. Opaque or amber containers protect the powder from light; I always recommend storing the bulk supply in these, even if it's tempting to leave materials visible for inspection. Once I saw a shelf where sunbeam hit four or five bottles across the day — those bottles failed analysis weeks ahead of the others stored in darkness.
Air-tight packaging isn’t just about keeping the product from spilling out; it's about stopping moisture, dust, and airborne contaminants from sneaking in. Ethylparaben, even in solid form, absorbs water. In humid conditions, clumping or changes in consistency develop over time, which doesn’t just make measuring difficult; it can alter the chemical profile. Desiccants, like silica gel packs, inside containers provide a low-cost option for moisture control — something every storeroom needs year-round.
Too many times, I’ve opened up old-fashioned bags or under-sealed jugs to find spoiled paraben that’s now a loss to both the business and anyone relying on it downstream. Tightly-sealing lids and clear labeling go hand-in-hand with proper storage. Cross-contamination often comes down to careless scoop use and shared equipment, so I always encourage separate stock tools to prevent such slip-ups.
Storing paraben away from reactive chemicals and aggressive cleaning agents cuts the risk of unwanted reactions. Acids, alkalis, and strong oxidizers, if stored nearby, could spell disaster if there’s a spill. I remember nearly missing a situation where incompatible chemicals sat together purely through oversight; fixing that before anything went wrong felt like dodging a bullet.
Label containers with batch numbers, expiry dates, and source details. If a recall or stability concern arises, traceability saves everyone involved from scrambling or second-guessing. Reliable suppliers always share full details on storage needs in product documents, and I’ve found checking these regularly against actual practices in the storeroom highlights both oversights and opportunities for safer, smarter storage.
Investing in proper shelving, temperature monitoring, and routine inspections pays off by extending shelf life and protecting users. Basic steps — keeping the substance dry and cool, blocking light, sealing tight, labeling well, and checking for errors — all matter. Pharmaceutical supply chains depend on vigilance, and it often comes down to small daily habits in how materials like ethylparaben get handled.
Ethylparaben is a common preservative. Manufacturers rely on it to help prevent the growth of mold, yeast, and bacteria in a range of products. Business labels like BP, EP, and USP stand for British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia. Standards from these organizations confirm a substance meets purity and safety guidelines for medical and pharmaceutical use. This level of scrutiny matters since any contamination in medicines can lead to severe health outcomes. Not all uses demand that same quality, though.
Ethylparaben shows up most often in pharmaceuticals, such as syrups or ointments. People ask about its use in food and cosmetics because the preservative works well in those places, too. The story gets tricky. Regulatory bodies in different regions don’t always agree on what’s safe.
In the United States, the FDA allows ethylparaben in certain foods, capping the amount to protect consumers from high intake. The substance keeps foods like baked goods or sauces shelf-stable. The FDA also approves ethylparaben for cosmetic products, finding it helps slow down spoilage in lotions and creams.
European regulations offer a similar story, with a slightly tighter leash. The European Food Safety Authority and Cosmetic Regulation (EC) No. 1223/2009 both keep watch here. Cosmetics in Europe must use parabens within specific concentration limits, since studies have questioned whether regular exposure may disrupt hormone function. To date, consumer exposure remains well below levels that cause concern.
Pharmaceutical grade means the compound is especially pure and has gone through more detailed checks. In practice, this makes it more expensive. No safety issue shows up if a food or cosmetic product uses pharma-grade ethylparaben, since regulations treat purity as an extra safeguard. Still, businesses do not always pick this grade for foods or personal care, since food and cosmetic grades are available at a lower price.
I’ve worked in both personal care distribution and restaurant supply. Some buyers will ask for the highest quality because regulations in their home country demand it, or because they want to offer premium products. Others want to control costs and rely on food- or cosmetic-grade suppliers, trusting the regulators. Both choices depend on strict rules and safety tests set by independent agencies.
People should feel comfortable checking ingredients on labels. If a product contains ethylparaben, it likely follows local rules on how much is safe, set by regulatory agencies and supported by toxicological research. If you have allergies or sensitivities, avoid products with ingredients that have caused you trouble in the past and report any problems to health authorities.
Relying on strong oversight and evidence helps guide smart decisions. Ethylparaben BP EP USP Pharma Grade can work safely in food or cosmetics, assuming the producer meets national and international law. Manufacturers should always be transparent about grade and sourcing, because people want clarity about what goes in their foods or on their skin. As scientific knowledge grows, staying curious and forward-thinking helps everyone—from companies to everyday shoppers—make better health choices grounded in facts.
Names | |
Preferred IUPAC name | ethyl 4-hydroxybenzoate |
Other names |
ethyl 4-hydroxybenzoate ethyl p-hydroxybenzoate paraben A ethyl paraben ethylparabenum |
Pronunciation | /ˌiːθ.ɪlˈpær.ə.bɛn/ |
Identifiers | |
CAS Number | 120-47-8 |
3D model (JSmol) | `ethylparaben;CCOC(=O)C1=CC=CC=C1O` |
Beilstein Reference | 635078 |
ChEBI | CHEBI:32056 |
ChEMBL | CHEMBL1407 |
ChemSpider | 5499 |
DrugBank | DB03626 |
ECHA InfoCard | ECHA InfoCard: 027-774-6 |
EC Number | 120-47-8 |
Gmelin Reference | 8603 |
KEGG | C07329 |
MeSH | Ethylparaben |
PubChem CID | 3228 |
RTECS number | DJ3150000 |
UNII | 5HV44009K6 |
UN number | UN1993 |
CompTox Dashboard (EPA) | DB02375 |
Properties | |
Chemical formula | C9H10O3 |
Molar mass | 166.18 g/mol |
Appearance | White crystalline powder |
Odor | Faint characteristic odor |
Density | 1.18 g/cm³ |
Solubility in water | Slightly soluble in water |
log P | 2.47 |
Vapor pressure | 0.0002 mmHg (25°C) |
Acidity (pKa) | pKa = 8.47 |
Basicity (pKb) | 8.34 |
Refractive index (nD) | 1.506 |
Viscosity | Viscosity: 1.24 mPa·s (at 20°C) |
Dipole moment | 2.85 D |
Thermochemistry | |
Std molar entropy (S⦵298) | 309.0 J·mol⁻¹·K⁻¹ |
Std enthalpy of formation (ΔfH⦵298) | -538.5 kJ/mol |
Std enthalpy of combustion (ΔcH⦵298) | -6354 kJ/mol |
Pharmacology | |
ATC code | A07AX01 |
Hazards | |
Main hazards | May cause skin and eye irritation; harmful if swallowed. |
GHS labelling | GHS07, Warning, H315, H319, H335 |
Pictograms | 🛢️⚗️💊🚫🔥⚠️ |
Signal word | Warning |
Hazard statements | Hazard statements: Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008. |
Precautionary statements | Precautionary statements: P264, P270, P301+P312, P330, P501 |
Flash point | 96 °C |
Autoignition temperature | 530°C |
Lethal dose or concentration | LD50 (Rat, oral) 8,000 mg/kg |
LD50 (median dose) | LD50 (mouse, oral): 6700 mg/kg |
NIOSH | Not Listed |
PEL (Permissible) | PEL (Permissible Exposure Limit) for Ethylparaben: Not established |
REL (Recommended) | 10 mg/kg |
IDLH (Immediate danger) | Not established |
Related compounds | |
Related compounds |
Methylparaben Propylparaben Butylparaben Isopropylparaben Isobutylparaben |