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Benzoic acid showed up long before pharmaceutical handbooks even named it. Folks started isolating it from gum benzoin in the 16th century, and experiments from chemists like Nostradamus and Scheele in the centuries that followed made lab-scale refinement possible. As scientific needs grew sharper—especially in drug and food manufacturing—people demanded purer versions. British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) all created structured methods to spell out what real “pharmaceutical grade” means, shifting things from craft to science. It went from the realm of alchemy to clean chemistry, driven by the need for safe, predictable drugs and foods. I’ve noticed in recent meetings, when regulatory updates land, producers don't sigh—they plan upgrades; that’s because historical lessons, especially past safety incidents, stay fresh for anyone handling active pharmaceutical ingredients (APIs).
People think of benzoic acid mainly as a preservative, but in practice, it plays many roles in pharma. Each description—BP, EP, USP—points to critical purity thresholds and testing criteria for pharma grade. The specs aren’t just paperwork; they protect batches from contamination and ensure reactions go to completion. I have observed that seasoned QC chemists actually test lots with a skeptical eye, sometimes rejecting a shipment that just barely meets the standard because downstream effects in compounding don’t leave room for error. For oral, injectable, and topical medicines, there's never a shortcut—what goes into the mix must deliver full traceability and approved parameters.
Benzoic acid forms colorless, needle-like crystals, solid at everyday temperatures, with a faint, unremarkable scent. Chemically, it’s a simple carboxylic acid with formula C7H6O2, soluble well in alcohol, less so in water, and shows a melting point around 122 degrees Celsius. That might sound like trivial detail, but physical stability and how well it dissolves in different solvents matter during formulation and tableting. Not long ago, I watched a mixture fail to dissolve completely because a source swapped a higher-purity, but larger-crystal form; the result left inconsistent distribution in a therapeutic gel, which cost time and money to clean up.
No one enjoys filling out shipping forms, but technical specifications and accurate labeling matter for pharma-grade benzoic acid. Every batch carries a batch number, country of manufacture, proper chemical name, and storage conditions plainly on the label. Lab staff expect certificates of analysis (CoAs) detailing assay percentages, loss on drying, related substances, heavy metals, and sometimes, residual solvent status. Labeling isn’t just legal red tape—every user, from hospital pharmacist to plant operator, relies on this information to trust that the substance fits its intended use. One mistake here could risk entire production lots being quarantined or, worse, put patients at risk.
Benzoic acid used to come mostly from benzoin or direct plant sources centuries ago, but industrial synthesis dominates the market today. People rely mainly on partial oxidation of toluene using oxygen and a cobalt or manganese catalyst. This method churns out vast amounts efficiently and at steady, predictable quality, which truly matters. In practice, processing steps that include crystallization and filtration weed out impurities until the powder meets pharmacopeial requirements. Smaller specialty labs sometimes use old-school techniques—hydrolysis of benzamide or oxidation of benzyl chloride—but these routes can’t supply the tonnage or purity that big drug companies demand for production. I’ve spent hours watching plant operators tinker with process controls just to shave fractions off impurity profiles; those lessons leave no room for cutting corners in pharma environments.
Chemists value benzoic acid for how easily it transforms during organic synthesis. Toss in an alcohol and an acid catalyst—out comes an ester. React it with bases, you get benzoate salts. Reduction, you arrive at benzyl alcohol. Halogenate or nitrate it and the door opens to even fancier intermediates. In the pharmaceutical sector, these properties feed the production stream for antiseptics, local anesthetics, and anti-inflammatory agents. I’ve seen R&D departments push boundaries by tweaking reaction conditions—temperature, catalyst, pH—just to perfect selectivity or increase yields, as even in simple chemistry, small upgrades mean better profit margins or reduced environmental impact.
Benzoic acid wears many names on paperwork and product sheets. I’ve come across it listed as benzenecarboxylic acid, dracylic acid, and E210 (the latter mostly in food regulation circles). Some suppliers brand pharmaceutical grade with lot-specific product codes, but the chemical backbone stays the same. Awareness matters—a procurement slip-up with similar-sounding compounds risks shipping completely different materials, a lesson one regulatory affairs coordinator reminded an entire team about by retelling a product recall horror story involving a mis-shipment of sodium benzoate, not the acid.
Handling benzoic acid in pharmaceutical-grade settings involves more than gloves and a dust mask. Regulatory bodies expect adherence to Good Manufacturing Practice (GMP) and robust training. Storage recommendations (dry, cool, labeled environment away from oxidizing agents) guard against degradation and unnecessary risks. While toxicity generally remains low for brief skin or oral contact, the story shifts in bulk handling—fine dust can irritate airways or eyes, so professional settings always use local exhaust ventilation and regular safety audits. Some companies require periodic retraining so that bad habits don’t set in; a staff member once rushed a drum transfer and got an avoidable eye splash, which only tightened up processes even more.
Pharmaceuticals take pride of place—benzoic acid stabilizes formulations, acts as a starting point for complex molecules, and helps preserve syrups, ointments, and oral suspensions. Food and beverage makers rely on its ability to suppress mold and bacterial growth, especially in juices and jams. Outside the obvious, you’ll find applications in cosmetics, personal care, dyes, and plastics, underlining a chemical’s broad market impact. Companies developing new antifungal creams or anti-inflammatory gels understand the reliability of this ingredient, and often explore its analogs to stretch performance or address new regulatory rules. Having attended industry expos, booths featuring benzoic acid always pull traffic from teams hunting for stability and supply chain confidence.
R&D teams never rest, always probing ways to boost yield, safety, or environmental footprint in benzoic acid production. Scientists experiment with greener catalysts, milder reaction temperatures, and closed-loop systems to minimize waste. On the pharma side, advanced analytics—NMR, LC-MS, high-res IR—help identify trace-level impurities that older tools missed. Around the table, discussions usually circle back to process reproducibility and regulatory compliance. Innovators look at co-crystal forms and novel salt derivatives, aiming to raise solubility or improve patient acceptability in finished dosage forms. Development cycles now run sprints with cross-functional teams involving chemists, toxicologists, supply chain experts, and business managers—a mix I’ve seen produce both setbacks and breakthroughs as a regular drumbeat.
Benzoic acid stays low on the toxicity scale—in small doses, humans handle it well, and most pharma uses honor globally agreed exposure thresholds. The body rapidly converts it to hippuric acid, excreted through pee. Yet animal studies see trouble when doses climb, notably potential for mild liver or kidney impact, or allergic responses in sensitive individuals. Regulatory agencies routinely set daily maximum intakes in food and medicine. My years working alongside toxicologists taught me that even established, “safe” chemicals get a hard look, especially as new research tools shine light on subtle metabolic impacts or hidden impurities from process tweaks. In rare populations—say, those with certain enzyme deficiencies—dosing must walk a careful line, so package inserts and labeling flag potential hazards for healthcare professionals.
Demand for benzoic acid will not slow down, especially while pharmaceutical companies chase ever more complex, stable, and patient-friendly formulations. Digital manufacturing—like continuous flow synthesis and Industry 4.0 process control—offers tighter batch management and less waste. Regulatory harmonization across EU, US, and Asia looks set to simplify global distribution, but also raises the bar on traceability, impurity control, and green chemistry. Research into benzoic acid alternatives for people sensitive to preservatives actively continues, as transparency and “clean label” programs have become retail expectations. Watching tech-forward startups venture into biosynthetic or recycled carbon feedstocks, it’s obvious the next decade will bring quieter but meaningful changes in both how benzoic acid gets made and where it serves end-users worldwide.
Walk through the family medicine cabinet, and most of the eye drops, cough syrups, and topical creams clinging to their expiration dates owe something to benzoic acid. Its role as a preservative stays far from glamorous, but it matters every day. Mold, yeast, and bacteria love sugar and moisture, which are common in liquid medicines. One of my earliest jobs in a pharmacy involved unpacking deliveries; pharmacists always checked that syrups hadn’t started to separate or get cloudy. In reality, that meant the benzoic acid had done its job. Official pharmacopeia standards—BP, EP, USP—set high purity bars because any impurity can risk a reaction in sensitive patients. Safe preservation avoids both spoiled medicine and the danger of over-prescribing antibiotics for what looks like contamination in a simple syrup.
Walk down a tablet manufacturing line and you’ll spot workers handling large drums of powders. Active pharmaceutical ingredients rarely go into pills by themselves. Binders, fillers, lubricants all play their part. Benzoic acid acts as a pH adjuster and a stabilizer, making sure tablets form tightly and release their contents at just the right speed and in the right part of the body. I’ve met quality assurance staff who spend their days checking that batches don’t crumble under stress. Even the toughest coatings can break if formulas change. Benzoic acid works behind the scenes, but without it, shelf-life shrinks and the number of rejected batches at factories goes up.
It’s easy to overlook how important preservatives are in ointments and gels. Dermatologists see cases each year of skin rashes made worse by spoiled topical products. Benzoic acid steps into the picture to keep creams safe for weeks after opening. Reports in clinical dermatology journals often mention fewer cases of unexpected skin reactions when creams contain tested preservatives rather than “natural” alternatives that break down faster. My own experience with eczema patients backs this up—store-bought creams with pharmaceutical grade benzoic acid avoided flares that homemade, preservative-free versions triggered.
Children’s medication is famous for its bright colors and sweet taste. Underneath that, these syrups present challenges in keeping contents safe. Benzoic acid, compliant with global pharmacopeia standards, helps avoid changes in color, flavor, and dose. I’ve met pediatricians who say confidence in tried-and-tested preservatives lets them focus on the patient, not the product. Benzoic acid’s reputation as a stabilizer in suspensions isn’t about flash but steady, reliable work. Safe medication for kids requires ingredients that match strict scientific and regulatory scrutiny—shortcuts invite risk that no parent or doctor wants.
Data backs up benzoic acid’s position. Toxicological reviews, sourced by regulatory agencies like the FDA and EMA, consistently identify levels that avoid harm. A meta-analysis in the International Journal of Toxicology found that pharmaceutical grade benzoic acid, produced cleanly and tested down to single-digit impurity thresholds, shows very low risk of adverse effects in the commonly approved doses.
Concerns pop up when manufacturers cut corners by using lower-purity, non-pharma grade options. Patients might not see a difference at first, but repeated exposure opens the door to allergies or adverse reactions. Regular audits at manufacturing facilities, clear labelling, and pharmacist vigilance all push makers toward honest practices. Expanding batch testing at the pharmacy and hospital level would give prescribers—and patients—confidence that what they’re dispensing contains exactly the right stuff and nothing extra. Increasing knowledge among prescribers about the roles and limitations of excipients pushes the industry to keep prioritizing safety over cost-cutting tricks.
Ask any chemist who has worked in pharmaceutical manufacturing, and you’ll get the same confession: the details matter. Benzoic acid sits among those substances that have crossed from food preservation into medicine. Its purity often marks the difference between a working product and a safety debate. Here’s how the major pharmacopeias—British (BP), European (EP), and United States (USP)—treat this chemical for purity.
BP, EP, and USP standards agree on things you’d expect if you’ve ever handled analytical lab work: purity must reach or exceed 99.0%. In my time at a small generics manufacturer, we regularly encountered raw material that claimed “pharma grade,” but only these certifications truly kept us honest. USP often goes for 99.5%, while EP and BP use 99.0% as the threshold. That extra 0.5% might not sound huge, but in tight regulatory environments, it means fewer impurities and cleaner end products.
Water content gets checked using loss on drying. Both BP and EP set the limit below 0.5%. The USP tightens things a little, placing a cap at around 0.7%. Every analytical chemist who’s left open bottles on humid days will tell you that even a small difference there matters for shelf life.
Testing for heavy metals is more than paperwork. Decades ago, less controlled batches could pick up lead or arsenic from process equipment, and I remember supervisors harping at us about rusty tin drums. Today, BP, EP, and USP stick to the same doctrine: keep heavy metals, especially lead, below 10 parts per million. Anyone in QA will confirm that passing these tests tells you more about process discipline than about the chemical itself.
Each pharmacopeia takes special care with sulfated ash and chloride. All three restrict sulfate and chloride content. BP and EP want sulfate under 200 ppm, chlorides under 150 ppm. USP joins them on keeping these contaminants in check, although it tends to focus more on residue on ignition (sulfated ash), making sure the final number sticks under 0.1%.
Companies failing these standards sometimes chalk it up to difficult logistics. From my experience, it’s more often lazy process controls or outdated equipment. Chromatography, titration, and water content checkers can flag bad batches early, but it takes a culture of paying attention. I’ve watched teams argue about method validation, only for routine checks to uncover hidden failures. Pharmacopeia rules aren’t just for lawyers or inspectors—they clamp down on risks that can threaten patients and reputations.
Fixing non-compliance means investment. Upgrading filtration to cut chloride traces, swapping old reactors for stainless steel, running more frequent spot checks—these steps eat into budget but save headaches later. Local raw suppliers benefit from technical partnerships with multinational firms who share best practices. I’ve seen first-hand how shared lab sessions raise everyone’s game.
Pharmacopeial rules for benzoic acid force close attention to detail. These purity cutoffs, whether 99.0% or tighter, draw on hard-won industry lessons about patient safety and drug reliability. Getting these numbers right keeps medicine safe and builds honest supply chains, a reality I’ve experienced from the inside.
Pharmaceutical manufacturing does not leave much room for shortcuts or compromises. Medicine exists at the place where science meets everyday life, so everything that ends up in a formulation matters. Among the crucial ingredients that show up in numerous drug products, benzoic acid gets plenty of attention. You see this compound show up in everything from cough syrups and topical creams to tablets, mostly working as a preservative to keep things safe and stable.
Behind every ingredient in a pharma product, a deep chain of checks ensures safety at every point. Grades like BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) act less like a badge and more like a passport. These grades tell a buyer—this benzoic acid has jumped through the chemical hoops set by major pharmacopeias. It’s more than branding; it’s a record of compliance with tough purity, identification, and impurity limits.
From my experience working alongside formulators and quality teams, everyone looks for that certificate of analysis. Pharma-grade benzoic acid makes a difference, because suspicious impurity profiles instantly throw off red flags.
For something as simple as benzoic acid, the big issues are purity and contamination. Impurities—especially those from low-quality manufacturing or careless packaging—can trigger side effects or reduce shelf life. BP, EP, and USP grades call for testing at every stage, all to make sure metal content, other organic acids, and by-products stay at safe trace amounts. These aren’t theoretical protections. I remember a batch we inspected where a technical grade benzoic acid showed 10 times the allowed lead content; with pharma grade, that batch would not have made it past the gate.
Trust isn’t automatic in medicine. Years ago, our team switched raw material vendors after discovering inconsistent documentation. With pharma-grade benzoic acid, documentation follows the lot, spelling out every measured quality and hazard. These grades include precise melting-point ranges, water solubility, and microbial count tolerances. Even particle size matters, especially in topical or oral applications, affecting how well ingredients disperse.
The link between pharma-grade status and patient safety stands strong. If you work in generics, injectable drugs, or even pediatric medication, the stakes rise each day. Adulteration or undetected contaminants spiral into recalls or public safety notices. It’s something I’d hate to see in any batch we help move down the production line.
Sourcing the right benzoic acid goes hand in hand with ongoing supplier audits and regular QC sampling. Documentation is only one piece; routine verification in an in-house or third-party lab keeps surprises away. Knowledge shared between suppliers, pharmacists, and end-users closes the information gap, leading to fewer recalls and stronger trust. Switching to pharma grade isn’t just about obeying the rules—it’s part of respecting the process and everyone it serves.
Many facilities now use digital batch tracking, connecting raw materials to final product lines. Integrated processes catch discrepancies sooner, and regulatory filing gets easier, since traceability exists at every stage. The next step is ensuring these methods apply to even smaller players in the supply chain.
From manufacturing all the way to patient care, pharmaceutical-grade benzoic acid keeps standards high. Its documented purity and compliance reduce the risk for everyone along the chain. If you’re building medicines that matter, this isn’t a detail you can leave out.
In the pharmaceutical field, details like packaging size can make a real difference. Picture a busy lab, working on strict deadlines, carefully tracking every gram of material. It’s not just about buying a product; it’s about fitting it into processes and keeping workflows running smoothly. Benzoic acid, recognized for its role as a preservative and intermediate, often lands at the center of these concerns. Choices for packaging impact storage, safety, cost, and compliance.
Most pharma-grade benzoic acid arrives in either small-volume or large-batch packaging. Standard containers hold from 500 grams to 25 kilograms. Labs crafting pilot batches lean toward one-kilogram or smaller pails. These amounts keep waste low and allow precise measurement. It’s not unusual to see five-kilogram and 10-kilogram jugs in inventory rooms—they offer a good balance for teams with predictable, moderate demand.
Larger pharmaceutical producers reach for 20-kilogram and 25-kilogram sacks, lined with polyethylene. These handle bigger orders and integrate well into automated weighing rooms. Extra lining helps limit exposure to air and moisture, both of which can turn a useful chemical into an expensive mistake. Even minor contamination means recalling or discarding the entire batch, which nobody wants.
One-size-fits-all thinking doesn’t work with chemical packaging. Benzoic acid needs to stay dry and clean throughout shipping and storage. Paper drums lined with plastic film have emerged as a solid choice for handling these risks. Rigid, high-density polyethylene bottles stand up to rougher shipping and offer tight seals. Both help meet health and safety rules, which get stricter every year.
Manufacturers bold enough to cut corners often regret the risk. Poor seals and weak materials turn packaging into a source of contamination. A single failure on the packaging line can upend months of work on a new drug formula. Not every supplier meets international standards like GMP (Good Manufacturing Practice) or has experience serving highly regulated markets. Savvy buyers look for suppliers offering documentation, tamper-evident seals, and long shelf life.
In my time working alongside procurement and R&D teams, I’ve seen how the wrong packaging size bites into budgets and timelines. Small labs, working with grant money or tight patient samples, benefit most from precise aliquots. There’s no need to sacrifice extra product to improper storage or half-used tubs. Medium to large-scale facilities, especially generics manufacturers, save with larger sacks and fewer deliveries. The math becomes simple: fewer open containers mean less risk for both error and loss.
Global supply chain shifts have put even more focus on reliable packaging. Many companies now ask suppliers about emergency stock, backup shipment options, and public tracking for sensitive chemicals. Modern suppliers respond by keeping a range of container sizes and offering quick-turn customization for urgent projects.
Better packaging benefits everyone—from bench chemist to patient. By supporting user-friendly containers, clear labeling, and traceable supply, manufacturers help reduce avoidable mistakes. More collaboration between buyers and suppliers also means packaging can keep up with shifting regulatory demands and fast innovation cycles. Pharma-grade benzoic acid might not grab headlines, but improvements in how it arrives at the lab drive safer and more effective drug development for all.
Benzoic acid shows up everywhere in the pharmaceutical world. Most people know it from food preservatives, but it matters even more in medicines and lab settings. Each time I’ve managed pharmaceutical ingredients, I’ve seen just how picky this compound can be. The right storage and handling make sure it delivers what patients and providers count on.
Benzoic acid doesn’t play nice with moisture. Leave it out in humid air, and soon enough, the clumps appear and purity drops. An airtight container works best, tucked away from damp corners or any spot prone to leaks. I learned early on that keeping it dry fixes half the complaints you’ll ever get with this stuff. A cool, steady temperature keeps it stable, so routine climate checks in storage areas pay off. If you’ve ever walked into a warehouse and felt the sticky heat, you know improper storage can undo months of careful work.
Direct sunlight speeds up changes in benzoic acid that nobody wants. That’s why I always recommend using amber or opaque storage bottles. Even a few days sitting on a sunny lab shelf starts to turn things. Some folks underestimate what air does, too. Oxygen exposure can change benzoic acid’s chemical profile or leave it less effective. From my experience, minimizing how often you open the storage container keeps unwanted reactions in check.
I remember a story from a colleague who spilled benzoic acid during routine prep. They thought it was harmless, but skin irritation followed soon after. Always use gloves and a dust mask—this advice comes from hundreds of hours in the lab watching little accidents add up. Proper protective clothing isn’t optional. Even inhaling fine benzoic acid particles can cause discomfort, especially for sensitive individuals.
One overlooked risk involves cross-contamination. Storing benzoic acid next to volatile chemicals or strong-smelling drugs often ends with unexpected results. Segregating this material in storage racks with good signage spares headaches later. In my work, pharmacy teams see far fewer mix-ups when every compound gets its own labeled space—not shoved into one catch-all cabinet.
Routine stock rotation avoids shelf-life surprises. Pharmaceutical-grade benzoic acid holds its integrity for a long time if treated well, but dusty, forgotten jars lose their punch. Physical checks of container seals and visual inspections for discoloration or clumping keep things running smoothly. Quality systems mean little if people don’t follow through on these day-to-day steps.
Never pour excess benzoic acid down the drain or throw it in general trash. Pharmaceutical waste collection programs protect water supplies and meet regulatory standards. Back in my early days, I saw a few places run into trouble with improper disposal. Now, most firms keep logs of product use and waste for audits. Good stewardship keeps people and the environment safe.
Handling and storing benzoic acid the right way isn’t just about ticking boxes on a compliance sheet. It ensures drugs work as expected and shields everyone involved from unnecessary risk. Talking with suppliers about container quality, labeling, and batch tracking makes the whole supply chain stronger. In the end, the little things—like dry rooms, proper bottles, and good habits—add up to real peace of mind for all.
| Names | |
| Preferred IUPAC name | Benzoic acid |
| Other names |
Benzoic acid Carboxybenzene Dracylic acid Benzenecarboxylic acid Phenylformic acid |
| Pronunciation | /ˈbɛn.zəʊ.ɪk ˈæs.ɪd biː piː iː piː juː ɛs piː ˈfɑː.mə ɡreɪd/ |
| Identifiers | |
| CAS Number | 65-85-0 |
| Beilstein Reference | Beilstein Reference: 778 |
| ChEBI | CHEBI:30751 |
| ChEMBL | CHEMBL417 |
| ChemSpider | 811 |
| DrugBank | DB03793 |
| ECHA InfoCard | ECHA InfoCard: 100.003.406 |
| EC Number | 200-618-2 |
| Gmelin Reference | The Gmelin Reference for Benzoic Acid is **"Gmelin 1047"**. |
| KEGG | C00180 |
| MeSH | D001570 |
| PubChem CID | 243 |
| RTECS number | DG0875000 |
| UNII | WNK4QVG7W8 |
| UN number | UN3077 |
| Properties | |
| Chemical formula | C7H6O2 |
| Molar mass | 122.12 g/mol |
| Appearance | White crystalline powder |
| Odor | Odorless |
| Density | 1.32 g/cm³ |
| Solubility in water | Slightly soluble in water |
| log P | 1.87 |
| Vapor pressure | 0.1 mmHg (20°C) |
| Acidity (pKa) | 4.2 |
| Basicity (pKb) | 11.32 |
| Magnetic susceptibility (χ) | “-74.0 × 10⁻⁶ cm³/mol” |
| Refractive index (nD) | 1.504 |
| Viscosity | Viscosity: 1.24 mPa·s (at 80°C) |
| Dipole moment | 1.72 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | Benzoic Acid BP EP USP Pharma Grade: "172 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -385.2 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | −3227 kJ/mol |
| Pharmacology | |
| ATC code | A01AB08 |
| Hazards | |
| Main hazards | Causes serious eye irritation. Causes skin irritation. May cause respiratory irritation. |
| GHS labelling | GHS02, GHS07 |
| Pictograms | GHS07, GHS09 |
| Signal word | Warning |
| Hazard statements | H319: Causes serious eye irritation. |
| Precautionary statements | P261, P264, P271, P280, P301+P312, P305+P351+P338, P337+P313, P501 |
| NFPA 704 (fire diamond) | 1-2-0 |
| Flash point | 121 °C |
| Autoignition temperature | 410°C |
| Lethal dose or concentration | LD50 (oral, rat): 3040 mg/kg |
| LD50 (median dose) | LD50 (median dose): 3040 mg/kg (oral, rat) |
| NIOSH | SN293 |
| PEL (Permissible) | 5 mg/m3 |
| REL (Recommended) | 10 mg/kg bw |
| IDLH (Immediate danger) | IDLH: 10,000 mg/m³ |
| Related compounds | |
| Related compounds |
Sodium Benzoate Benzyl Alcohol Methyl Benzoate Ethyl Benzoate Potassium Benzoate p-Phthalic Acid Salicylic Acid |
Chengguan District, Lanzhou, Gansu, China
