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Propyl gallate first hit the laboratory bench in the 1940s. Food manufacturers and pharmaceutical firms were actively hunting for additives to slow down spoilage. At the time, oxidation sent batch after batch of oil- and fat-based products to the trash long before reaching consumers. Chemists synthesized propyl gallate by combining gallic acid, which comes from plant tannins, with propanol. After that, it started showing up everywhere, particularly in processed foods, thanks to its power to shield products from rancidity. The pharmaceutical world picked it up for its ability to fend off oxygen that ruins active ingredients. Global pharmacopoeias like BP, EP, and USP set expectations for purity and identity, but the root purpose always comes back to basic shelf life extension and protection from unwanted chemical changes.
Propyl gallate acts as an antioxidant. In tablets, it helps delicate compounds survive transportation and storage without breaking down. Even small amounts of this crystalline powder can keep fats from turning foul or active substances from weakening prematurely. Every pharmacy tech who’s spent time with softgel capsules will probably recall seeing this additive on the label or in the ingredients book. Though it rarely takes the spotlight, the drug supply chain relies on reliable performance and measured consistency, traits propyl gallate tends to deliver when sourced or manufactured according to industry standards.
Looking at propyl gallate, you notice a white to almost white crystalline powder, free-flowing and odorless. Chemically, its structure consists of a gallic acid backbone joined with a propyl group. It melts in the range of 148-153°C, dissolves a bit in water but much better in ethanol and many organic solvents, making it adaptable in both lipophilic and hydrophilic applications. Its molecular formula is C10H12O5 and the molecular weight runs at about 212.2. This stability offers a real advantage in formulations where oxidative breakdown would otherwise threaten product viability.
Manufacturers supply pharma-grade propyl gallate to meet tight guidelines on purity, typically not less than 98.0% and not more than 102.0% of the stated amount. Regulatory authorities inspect parameters, such as loss on drying (usually under 0.5%), residue on ignition, and heavy metals. Labels require not just identification and batch numbers, but also must declare intended use and compliance with pharmacopeial standards. Suppliers want to avoid confusion, so labeling conveys exactly how and where it can be applied, along with safety warnings and storage advice, often favoring tightly closed containers away from strong light and air.
Industry prepares propyl gallate by esterifying gallic acid with n-propanol in the presence of acid catalysts. The raw materials go into a reaction vessel, heated under controlled conditions, with constant stirring. Technicians monitor pH and temperature, tweaking conditions to push the reaction toward the ester product. After completion, the crude mass undergoes purification—often with recrystallization. Each batch passes strict controls so that pharmaceutical users get a consistently pure and effective ingredient.
Propyl gallate enjoys a reputation for stability but can break down under strong acid or base, cleaving back to gallic acid and propanol. The ester group doesn’t fend off every attack; with time and under harsh conditions, hydrolysis happens. In the lab, modifying propyl gallate to create new derivatives usually targets the side chain, hoping to fine-tune its solubility or antioxidant strength. Researchers keep exploring analogues, hoping for a next-generation antioxidant that can push shelf life out even further without trade-offs.
The chemical world seems to love synonyms. Propyl gallate goes by n-propyl gallate, E310 (for those working in food manufacturing), propyl 3,4,5-trihydroxybenzoate, or simply “PG.” Each name signals the same basic antioxidant. Depending on supplier, labels might call out USP, EP, or BP grades as proof that it meets global pharmacopoeia requirements—vital for regulators and procurement folks who trust only what meets book standards.
No surprise, strict rules cover propyl gallate’s use in medicine and food. Drug manufacturers must keep levels under regulatory thresholds and follow rules for worker exposure. Short-term exposure at recommended doses poses little risk to healthy users, but excessive intake brings mild irritant effects or rare allergic responses, like skin rashes. Factory staff handle it in dust-protected environments. OSHA, NIOSH, and national equivalents provide guidance about ventilation and PPE standards in case of bulk handling. Disposal as hazardous waste keeps environmental contamination in check.
Pharmaceutical firms reach for propyl gallate to protect vitamins, oils, ointments, and other susceptible formulations. You’ll also find it in food products—mostly oils, margarine, and snack items—where preservation counts just as much. Cosmetic companies use it for its oxidation-inhibiting properties in creams and lotions. I’ve worked on a few projects myself where customers needed antioxidants that would outlast the shelf life of bespoke ointments. In these cases, propyl gallate outperformed cheaper alternatives, especially when storability couldn’t be sacrificed.
Ongoing research keeps pushing for safer, stronger antioxidants, but propyl gallate holds its place in the toolkit. Scientists explore ways to tweak its molecule, seeking less toxic, even more effective versions that might outperform old standards. Encapsulation techniques have improved its stability and controlled release, giving manufacturers options for extending shelf lives further. Studies measuring interaction with excipients or other actives help formulators sidestep compatibility issues before a new product goes to market.
Toxicologists keep a close watch for issues in long-term studies. Most evidence so far puts propyl gallate at low risk in food and pharma use when conditions stick to legal norms. I’ve reviewed studies where rats and mice consumed high doses over months, with only minor effects at the highest exposures. Rare cases of allergic skin reactions come up in susceptible individuals. Regulators maintain strict ADIs to minimize risk and insist on thorough batch testing to catch contaminants or byproducts before reaching consumers.
Demand for clean-label, effective antioxidants keeps growing, yet constant market and regulatory pressure means any old additive could be replaced by plant-derived or enzyme-based alternatives. Propyl gallate’s production, stability, and low cost keep it popular. Future prospects may involve shifting sourcing to “greener” raw materials or developing blends with other antioxidants that reduce overall load. As analytical technology gets more precise, manufacturers will continue zeroing in on purity and trace contamination, aiming for even tighter tolerances and cleaner profiles. Pharma and food must keep up with consumer and regulatory demands for safety without compromising performance. Analysts and quality managers will keep turning over new results, so the evolution of this ingredient is far from over.
Every time I pass through the aisles of a hospital pharmacy, I notice rows of boxes labeled with complex names and codes. One name that keeps popping up on labels—tiny and almost hidden—is “propyl gallate.” This substance, with its multiple certifications (BP, EP, USP), quietly helps drug manufacturers fend off one of their main headaches: unwanted changes in products during storage. Pharmacies need reliable medicines, and propyl gallate steps in to keep things stable, helping medicines maintain their shelf life.
Oxidation turns fresh oil rancid, makes apple slices turn brown, and can ruin the active ingredients in a medication. My time working alongside pharmacists taught me this: tiny changes at the molecular level can upend the reliability of treatments for patients. Propyl gallate works like a safeguard, blocking oxygen’s path to sensitive ingredients. This keeps tablets, ointments, and even some cosmetics in the trusted condition doctors expect for their patients.
The letters BP, EP, and USP after propyl gallate aren’t just for show. They mean the material meets tough requirements set by British, European, and United States pharmacopeias. Regulators watch for this because people’s health depends on every batch working the way it should. Having seen the stacks of paperwork and endless test reports manufacturers collect, I know these aren’t small checkboxes. They serve as a signal to doctors, pharmacists, and patients that safety and quality remain at the forefront.
Open a box of tablets or creams, and you might find propyl gallate in the list of minor ingredients. It pops up in painkillers, vitamins, and even some injectables intended for carefully controlled releases. Drug-makers use it in both water-based and oil-based preparations. My pharmacist colleagues often choose products with this additive for medicines stocking up in hot, humid climates—because oxidation moves faster there.
Talk about food or drugs, and safety always comes up. Propyl gallate has been looked at by health authorities around the world. In my research, I found reports showing its safety margin is wide when used at recommended doses. Of course, new studies show we need to keep an eye on any ingredient used widely. Regulators regularly update risk assessments, checking for allergic reactions and potential interactions.
Propyl gallate does its job, but concerns exist about synthetic additives in both food and medicine. More patients and doctors now want to understand what goes into everyday treatments. Pharmaceutical companies could give clearer information about why additives like this matter. Investing more in research helps not just confirm safety, but also reveal long-term effects, especially for groups taking medications for years.
Misinformation can spread quickly. I’ve stood in line at the pharmacy and heard people worry about “chemicals” in their pills without realizing the science—and safety work—behind the scenes. Companies have a chance to help people make informed choices by sharing transparent data. Open access to manufacturing standards and results builds trust in every bottle on the shelf.
Propyl gallate makes its way into a surprising number of foods and personal care items. As someone who watches ingredient lists for what I put on my skin and in my body, I notice propyl gallate showing up in oils, cosmetics, and even packaged meats. Manufacturers lean on it for its antioxidant qualities. This ingredient doesn't just keep foods from spoiling too soon—it protects the look and taste of all sorts of products. With so many of us exposed daily, it matters how pure and well-controlled each batch is.
The British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) set tough standards for chemicals like propyl gallate. Each pharmacopoeia demands clean, consistent ingredients. I’ve read through these specifications before, especially BP and USP when consulting for supplement businesses.
Purity levels run high. Each standard expects the active ingredient to reach at least 98.0%. BP and EP often agree on that bottom line, while USP matches closely. Strict limits are placed on heavy metals, acids, moisture, and organic impurities. For example, most sources cap heavy metals at 10 parts per million or less. Any iron content stays below 0.001%. Many documents demand loss on drying to hover under 0.5%, which matters when a hygroscopic substance can absorb humidity and change its properties.
In practice, manufacturers test each batch for melting point—usually around 148°C to 150°C. Off-spec readings signal the possibility of contaminants or errors in production. Meeting that melting range means the substance fits what’s expected for identification and consistency.
Organic purity matters a lot, too. For BP and EP, tests sniff out related substances, capping the combined quantity to under one percent and any single unknown to half a percent or less. I’ve seen clients trip up when trace residues from manufacturing sneak past controls. Regulatory bodies look for those and expect detailed contaminant logs before giving the green light.
Seeing numbers on a spec sheet can feel abstract, but in practice, variability creates real-world issues. Imagine a low-grade batch in foods at a school cafeteria. Tiny contaminants become thousands of servings—with children at more risk for allergy or chemical sensitivity reactions.
Drawing on my time working with regulatory submissions, missed benchmarks can trigger rejected shipments, costly recalls, and worse—loss of consumer trust. Inspections aren’t one-off events. They unearth gaps in training, equipment, or source material almost every year.
Keeping to strict BP, EP, and USP standards only happens with reliable sourcing, and testing at several stages. Good manufacturers don’t just test final goods—they scrutinize raw materials and check in-process samples. They build audit trails so each gram of propyl gallate gets traced from manufacturing floor to end product. Investing in robust lab capabilities does more than check boxes; it protects reputations and public health.
For buyers, demanding full transparency and certificates of analysis from suppliers helps spot problems before shipments hit production lines. Having a clear batch release system and involving accredited third-party labs creates an extra layer of security. It reduces chances of contamination making its way into areas like baby food, cosmetics, or pharmaceuticals, where even trace mistakes could have wide consequences.
Trusting labels and ingredient claims comes down to more than just compliance. As more people read up on what’s in their food and everyday products, the demand for real accountability only grows. Those BP, EP, and USP numbers tell a story—and it’s one that needs regular, committed effort across the chain, from factories right up to the family dinner table.
Propyl gallate often enters pharmaceutical manufacturing as an antioxidant. The goal is to keep medicines stable, especially those with oils and fats that easily spoil. I’ve noticed that people rarely pay attention to minor ingredients, but those small additions carry big responsibility. Propyl gallate stands as one of those additives that protect medicines against oxidation, which could otherwise lead to useless or even unsafe products for patients.
The European Pharmacopoeia (EP), British Pharmacopoeia (BP), and United States Pharmacopeia (USP) all list propyl gallate as acceptable for use in drugs. That recognition points to plenty of research and robust oversight by experts in these regions. These bodies put out clear guidelines about its maximum daily intake—typically 1.4 mg per kilogram of body weight, set by the Joint FAO/WHO Expert Committee on Food Additives. Doctors and pharmacists have depended on these reference points for years, and patients have used medications containing propyl gallate without facing widespread safety problems.
Researchers have examined the potential for allergic reactions and the risk of toxicity. Reports of allergic reactions have cropped up, though cases remain rare. That’s not surprising—some people react to food dyes or other common ingredients as well. Long-term animal studies involve high doses, well above what pharmaceutical products contain. These investigations revealed no links to cancer or reproductive harm at normal usage levels. Across the board, findings support careful inclusion with well-defined limits.
Many people underestimate the differences between food-grade and pharma-grade ingredients. I’ve had conversations with manufacturers who cut corners by using cheaper, off-spec substances. Cutting costs by skipping pharma-grade quality checks just to save a few dollars trades financial savings for greater health risks. Only pharma-grade propyl gallate—meeting EP, BP, or USP requirements—avoids unwanted contaminants like heavy metals or residual solvents. Regular lab testing and documented chain-of-custody play a big part in proving ingredient purity and safety. Think about quality like buying bottled spring water versus scooping out of a ditch: end results differ even if the liquid looks similar.
Pharmaceutical companies carry serious obligations to patients. Skipping on robust supply chain checks or transparent documentation invites mistakes. Instead, open reporting, audit trails, and routine quality-control sampling anchor patient safety. Industry and regulators actually work best together when rules mirror current science and companies go beyond the minimum to protect their customers. I often see firms implementing real-time digital tracking for batches of ingredients, creating more accountability than old paper logs ever could.
Even as approved authorities endorse propyl gallate as safe within set limits, there’s room to push the envelope on vigilance. Encouraging independent labs to regularly confirm label accuracy builds public trust. Companies could develop tools that let consumers check batch certifications online. Exploring natural antioxidant options or blends might also further minimize rare side effect risks for sensitive patients. Informed consent, plain-language labeling, and ongoing ingredient reviews help anyone make safer decisions about their medicine, whether sitting in a doctor’s office or buying over-the-counter remedies.
A lot rides on something as simple as how Propyl Gallate arrives at a pharmaceutical facility. Moisture, light, and air all chip away at this antioxidant if it’s left exposed, sometimes making it less able to do its job. Working around chemicals for years, I’ve seen what happens when corners get cut—yellowing powders, odd odors, and entire batches wasted over preventable mistakes. Standard practice relies on tight, tamper-proof containers made of high-density polyethylene (HDPE) or glass. These materials block moisture and don’t react with the compound, so Propyl Gallate keeps its stability and safety profile.
Any holes in the packaging open the door for contamination or oxidation. Seals play a key role here. I remember one instance where a broken seal went unnoticed for days, which led to a costly batch recall. This simple extra layer—shrink bands or induction-sealed liners—served as an early warning system. In most well-run labs, teams inspect each drum for these safeguards on arrival. Some suppliers use nitrogen-flushed bags inside the container for extra protection, a practice that really cuts down the risk of degradation, especially in humid regions.
Opening a bulky drum again and again leaves Propyl Gallate exposed to the elements. Dividing stock into smaller, single-use containers goes a long way toward keeping the rest fresh. After seeing multiple issues from repeated scooping and measuring, a shift to pre-weighed bottles solved more headaches than any new gadget. Not only did it cut waste, but it also made dosing more accurate, which matters for regulatory inspections.
Propyl Gallate takes best to stable conditions. Failing to keep it below 25°C can reduce shelf life, and storing it next to heat sources speeds up oxidation. In practice, storing containers in well-ventilated, low-humidity rooms keeps out mold and helps prevent caking or clumping. I have seen more than one facility bring in dehumidifiers during the rainy season for this reason. Shelves made of metal or sealed plastic, raised off the ground, add a final layer of defense. The fewer surprises that crawl in from floor dust or spilled water, the better.
Accurate labeling isn’t just about paperwork—it keeps mistakes from snowballing. Every bottle or drum should display lot numbers, manufacturing or expiration dates, and clear composition information. During an audit, regulators dig into these details without mercy. In my former lab, a missing label caused a halt in production until the chain of custody could be proven, slowing everything down for days. When labels are clear and up to code, teams stay ahead of both quality assurance and compliance.
Training remains the best fix for packaging and storage mishaps. Staff need real reminders about what happens when Propyl Gallate meets water or gets left out in the sun. Anti-static packaging tackles another sneaky risk—stray sparks in dry conditions that could trigger a reaction or even a fire. Investing in climate-controlled storage pays for itself over time, especially in climates that swing between wet and dry seasons. Bringing in third-party auditors also helps; a fresh set of eyes has caught blind spots I’d missed after years on the same floor.
Taking Propyl Gallate packaging and storage seriously stretches far beyond rules on a page. These steps keep drugs safe for patients and costs down for companies. In a field where a single contaminant can spark a recall, careful packaging and thoughtful storage set the tone for trust throughout the entire supply chain.
Pharmaceutical manufacturing uses chemicals like Propyl Gallate, not just as ingredients, but as safety checkpoints along the supply journey. Before an API or excipient reaches the blender, everyone from procurement to the quality assurance team asks for documentation: COA (Certificate of Analysis) and MSDS (Material Safety Data Sheet). These requests aren’t just bureaucratic speed bumps. They mean the difference between regulatory compliance and a rejected batch.
Imagine ordering Propyl Gallate, trusted under BP, EP, or USP standards, for a production run. The COA feels like a handshake from the manufacturer—a technical handshake, sure, but a promise nonetheless. A review of the COA should match the specification to the actual regulatory text. It lists results for identity, assay, loss on drying, heavy metals, and residue. If those numbers align with pharmacopeia, the lab team can breathe a little easier.
The difference between a legitimate COA and a forged one often comes down to detail. Batch number, test dates, validated test methods, wet signatures or digital certificates: they all tell the story of how seriously the supplier is treating their product and, in turn, your final medicine. Regulators like the FDA and EMA have cited companies over “inadequate supplier qualification.” Data integrity isn’t just a buzzword—it’s the reason a hospital gets safe medication. The right COA backs up the producer’s claims with real results.
The MSDS goes beyond chemical compliance. Warehouse staff and line operators depend on the MSDS for real-world safety, especially with substances like Propyl Gallate, which comes with its own risks. Information covers flammability, exposure controls, accidental release, and proper PPE. Many experienced workers remember a time when a badly labeled drum led to skin irritation or a near miss in the warehouse.
Occupational safety teams rely on a current MSDS to train staff. The document highlights hazards, but it also contains clear guidance on disposal and storage. Compliance officers use this sheet to compare in-house procedures with global standards like OSHA and GHS. Pharmaceutical companies now often link MSDS access to internal training, encouraging every employee to read before handling any new chemical.
Demand for pharmaceutical transparency continues to grow across the supply chain. Patients aren’t the only ones asking questions. Trading partners and regulators now require full traceability for ingredients like Propyl Gallate, and proper documentation builds credibility at every stage.
Strong documentation practices protect everyone. Suppliers who keep COA and MSDS current not only support customer audits, but increase the chance of repeat business. Buyers who carefully review such paperwork are less likely to face regulatory warning letters or costly recalls. Where documentation is missing or inconsistent, the risk increases for both human safety and business continuity.
More companies are investing in digital systems that track, store, and retrieve COA and MSDS documents whenever they’re requested. With digital signatures and cloud repositories, accidental mix-ups decrease, and both suppliers and clients respond faster to audits. Pharmaceutical teams run mock audits to ensure they can produce for Propyl Gallate at a moment’s notice—this simple practice has saved more than one company from major non-compliance penalties.
The industry expects that requests for clear and verifiable documentation will keep rising. For those committed to quality, making COA and MSDS readily available builds a foundation for trust and regulatory resilience.
| Names | |
| Preferred IUPAC name | Propyl 3,4,5-trihydroxybenzoate |
| Other names |
Propyl 3,4,5-Trihydroxybenzoate E310 Gallic acid propyl ester n-Propyl gallate |
| Pronunciation | /ˈproʊ.pɪl ˈɡæl.eɪt/ |
| Identifiers | |
| CAS Number | 121-79-9 |
| Beilstein Reference | 136-45-8 |
| ChEBI | CHEBI:32011 |
| ChEMBL | CHEMBL1401 |
| ChemSpider | 6487 |
| DrugBank | DB03366 |
| ECHA InfoCard | ECHA InfoCard: 03-2119949269-23-0000 |
| EC Number | EC 202-764-5 |
| Gmelin Reference | Gmelin 83471 |
| KEGG | C07120 |
| MeSH | D017940 |
| PubChem CID | 4947 |
| RTECS number | UX3675000 |
| UNII | 85HG2G06K7 |
| UN number | UN3077 |
| CompTox Dashboard (EPA) | DTXSID2020779 |
| Properties | |
| Chemical formula | C10H12O5 |
| Molar mass | 170.14 g/mol |
| Appearance | White or almost white crystalline powder |
| Odor | Odorless |
| Density | 1.2 g/cm³ |
| Solubility in water | Slightly soluble in water |
| log P | 0.95 |
| Vapor pressure | 0.000081 mmHg (25°C) |
| Acidity (pKa) | 8.4 |
| Basicity (pKb) | 8.6 |
| Magnetic susceptibility (χ) | -94.5×10⁻⁶ cm³/mol |
| Refractive index (nD) | 1.450 – 1.455 |
| Dipole moment | 2.72 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 150.7 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -878.6 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -6531 kJ/mol |
| Pharmacology | |
| ATC code | A01AD12 |
| Hazards | |
| Main hazards | May cause respiratory irritation. Causes serious eye irritation. Causes skin irritation. May cause allergic skin reaction. |
| GHS labelling | GHS07, GHS hazard statements: H315, H319, H335 |
| Pictograms | GHS07, GHS08 |
| Signal word | Warning |
| Hazard statements | H302: Harmful if swallowed. |
| Precautionary statements | Precautionary statements: P261, P264, P270, P272, P273, P280, P301+P312, P302+P352, P305+P351+P338, P308+P311, P332+P313, P337+P313, P362+P364, P403+P233, P501 |
| NFPA 704 (fire diamond) | 1-1-0 |
| Flash point | 150°C |
| Autoignition temperature | 410 °C |
| Lethal dose or concentration | LD50 oral rat 3800 mg/kg |
| LD50 (median dose) | LD50 (median dose) of Propyl Gallate BP EP USP Pharma Grade: "3800 mg/kg (oral, rat) |
| NIOSH | GN0485000 |
| PEL (Permissible) | 10 mg/m³ |
| REL (Recommended) | 0.0025% |
| Related compounds | |
| Related compounds |
Gallic Acid Methyl Gallate Ethyl Gallate Octyl Gallate Dodecyl Gallate Tannic Acid |
Chengguan District, Lanzhou, Gansu, China
