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Maltodextrin made its mark back in the early twentieth century, spun from the ongoing effort to optimize starch hydrolysis techniques. Corn, potato, and wheat starches once stood at the core of industrial applications, getting tweaked to unlock useful byproducts for food and health care. Research teams in Europe and North America sought not only stable energy sources but also neutral-tasting excipients. They fiddled with enzymes and acids, dialing in on the methods to produce a powder easy to store and dissolve. By the time food science took off in the 1970s, pharmaceutical companies grew fond of maltodextrin’s simple structure and easy handling. With rising regulatory frameworks, the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP) standards entered the picture, setting the bar for purity and reproducibility. These standards proved useful, especially when the demand for batch consistency increased with the growth of the generic drug market and medical nutrition.
Maltodextrin earns its reputation in pharmaceuticals and foods for its mild sweetness and smooth mouthfeel, driven by a carbohydrate base with dextrose equivalent (DE) values sitting below 20. It shows up as a creamy white, odorless powder—looks simple, yet businesses turn to it for its blendability and strength to mask bitter flavors. In pharmacy labs, its ability to carry wet and dry actives in tablets and powders helps more than one kind of medicine go down easier. Large manufacturers rely on maltodextrin to bind and stabilize products, using it because it behaves predictably under pressure and heat. Even dietary supplement makers find value in its capacity to improve flow in powder blends and spray-drying mixes. Having handled maltodextrin in a small-batch compounding lab, I saw how its granular form cut down on dust and caking, which certainly improved workflow and safety.
Solid maltodextrin feels dry and free-flowing to the touch. The powder carries a faintly sweet taste but lacks a defined smell. Solubility stands out among its strengths, quickly dispersing in hot or cold water to form clear solutions, which makes it friendly to both tablet press operations and beverage manufacturers. It doesn’t clump readily in reasonable humidity, thanks to a low, stable hygroscopic profile. The molecular chain runs shorter than native starch but longer than simple glucose, with polymers made of glucose units linked by alpha-1,4 and alpha-1,6 bonds. These chains impact its digestibility and energy value as a complex carbohydrate source. In analytical labs, dextrose equivalent values and moisture content set the benchmarks for quality, typically below 6% moisture for pharma-grade batches. Bulk density, pH in solution, and heavy metal content often land on spec sheets, shaping decisions for filler and diluent use.
No two maltodextrins bear the same exact signature, as the DE score, color, particle size, and microbial purity shift with the source and process. BP, EP, and USP rules demand low microbiological counts and an absence of extraneous matter. Pharmaceutical lots label their origin and batch, along with tests on moisture, sulfated ash, reducing sugars, and protein traces. Valid documentation also tracks the absence of genetically modified organisms (GMO) and allergens for compliance with food and drug labeling. In a plant I visited during a quality audit, each container displayed a clear lot code and expiry, leaving no question about traceability if a recall ever became necessary. These practices avoid confusion and anchor supply chain trust, which buyers in regulated sectors often check more closely than the ingredient’s physical traits.
Most manufacturers turn to acid or enzyme-catalyzed hydrolysis of natural starch, using heat and controlled pH to break down the starch into shorter chains. Alpha-amylase and glucoamylase feature often as the enzyme workhorses. The liquefied starch undergoes filtration, carbon treatment, and evaporation, before drying—typically via spray-drying or drum-drying. The resulting powder meets desired granular ranges through sieving or milling. Small changes in these steps tweak the end product, making some runs more suitable for tableting and others for spray-dried powder mixing. This tailored preparation shapes the cost and quality, as higher purity and control carry a premium. Hands-on experience shows these processes can run efficiently so long as temperature and pH stay consistent, since swinging too far risks off-colors or a sticky product batch.
Maltodextrin, on its own, sits quietly inert — resisting direct reaction under standard processing but slowly hydrolyzing in the presence of strong acids or enzymes. Some producers enhance its gelling capacity or solubility by chemical or physical means, such as cross-linking with phosphates or treating with mild oxidizing agents. Modified maltodextrins push into specialized uses, with carboxymethyl or hydroxypropyl variants helping in sustained-release or high-moisture tablet formulations. These tweaks broaden its footprint in diverse pharmaceutical and food applications. In formulation experiments, unmodified maltodextrin often proves enough, but chemists reach for specialties when tasked with fine-tuning release rates or blending properties for complex finished products.
You spot maltodextrin on ingredient labels under more than a dozen names. Standard trade references list it as dextrinomaltose, artificial dextrin, and spray-dried starch hydrolysate. Some catalogs simply list the DE score — Maltodextrin 10, 15, or 19 — where the number captures the degree of hydrolysis. Different regulatory circles may swap the order, but all point back to a product, powdered and hydrolyzed, somewhere between starch and pure glucose in makeup. In bulk supply houses, buyers may see regional names keyed to the starch source or processing plant, such as corn maltodextrin or potato maltodextrin.
Safe manufacturing requires close tracking of temperature, humidity, and cross-contamination. Pharma-grade maltodextrin holds a clean bill of health for toxic contaminants, owing to tight raw material inspections and validated cleaning cycles. Production areas mandate strict gowning, hair covers, and allergen controls, especially to avoid gluten where wheat starch sources come into play. Storage in sealed, food-grade bags, away from light and moisture, keeps the powder from spoiling or picking up off-odors. Workers in the field learn quickly how dust can build if airflow fails, underscoring the need for proper handling tools like glove boxes and vacuum transfer lines. These best practices not only protect finished product quality but also worker health and downstream patient safety.
Pharma-grade maltodextrin shows its value across tablet manufacturing, oral solutions, and powdered drink mixes. It acts as a binder, making tablets more robust and less likely to crumble during transport—no small thing for generic drug manufacturers shipping globally. Nutritional supplement makers tap it for controlled energy boosts in powders and drink mixes, thanks to its moderate glycemic index. The medical nutrition sector finds maltodextrin especially helpful for hospital feeding formulas where precise calorie counts matter, avoiding allergens and off-flavors. In some pediatric supplements, the powder’s quick dissolving saves time and frustration for caregivers. Even topical products occasionally harness maltodextrin’s thickening powers for ointments and creams. My early work with hydrating oral rehydration solutions found maltodextrin performed better than plain glucose for maintaining consistency and taste.
R&D labs keep digging into new maltodextrin modifications for site-specific drug delivery and sustained-release forms. Hydrophobic modifications and smart polymer gels made from maltodextrin backbones open new routes for encapsulation and taste masking. Edible film research looks to this compound for its clear, non-reactive structure, promising new types of orally disintegrating tablets and thin strips. Clinical researchers probe its role in gut absorption especially for patients with digestion challenges. Some groups focus on lowering the glycemic index further, eyeing diabetic-friendly products. Repeated testing and improvements show up year after year at trade conferences, as the ingredient adapts to changing regulations and consumer trends. Having met with teams running test-pilot synthesis reactors, the trial-and-error of recipe changes, enzyme swaps, and scale-up demonstrates a hunger for innovation rarely visible outside the lab.
Stability studies and in vivo models confirm the low toxicity of maltodextrin, provided raw materials start clean and the process avoids cross-contaminants. Oral dosing trials in rats and dogs show few problems until reaching unusually high intake levels. Human studies back its status as generally recognized as safe (GRAS), though doctors keep an eye out for rare allergic or intolerance responses, particularly with wheat-derived batches. Some nutritionists raise flags about overuse in high-sugar diets, warning that complex sugars still count toward daily carbohydrate loads. Regulatory agencies like the FDA and EFSA require continuous monitoring of new data, especially when modifications alter its metabolic profile or interaction with medications. In the allergen-heavy environment of modern processing plants, careful lot tracking helps head off adverse event clusters. As a compounding pharmacist, I occasionally encountered patient queries about blood sugar spikes, underscoring the ongoing need for clear communication and labeling.
Pharmacies and food manufacturers will likely keep leaning on maltodextrin for years to come, but trends point toward finer purity, eco-friendly sourcing, and smarter blending with functional actives. Green chemistry may bring new enzymatic methods that slash water and energy use on the production floor, aligning with company sustainability goals. Health-conscious consumers continue pushing for lower-glycemic variants and alternatives that still deliver the handling benefits of classic maltodextrin. Regulatory bodies look poised to tighten standards around allergens, purity, and traceability, prodding both big and small suppliers to keep up with the times. In collaborative efforts with dietary supplement makers, product development meetings buzz with talk of plant-based versions, oat and rice starch sources, and ultra-low-sugar profiles for sensitive markets. The research pipeline won’t slow any time soon, as new delivery forms and patient groups come under the lens.
Maltodextrin sounds more like something you’d pick up at a bakery than an ingredient you’d find in medicine. Still, it’s there, and frankly, it plays a bigger part than most folks notice. In my years of reading countless labels and learning how pharmaceutical products come together, the presence of maltodextrin keeps popping up, especially in pharma-grade quality under BP, EP, and USP standards. This isn’t the same as the food-grade powder that lands in energy drinks or instant mashed potatoes. Instead, this highly purified type must meet strict purity, safety, and consistency demands that protect patient health.
Manufacturers turn to maltodextrin because of its reliability and neutral profile. Pills, capsules, and powders need a carrier or “filler”—something that holds everything together and delivers a consistent dose. Maltodextrin checks off the boxes that pharmaceutical companies look for: it dissolves in water quickly, tastes pretty neutral, and blends seamlessly with other ingredients. Sometimes, it acts as a stabilizer or binder so the medicine doesn’t crumble or separate. This means the shape and content of that tablet you swallow today match the last bottle you had—a big deal when every milligram counts.
Standard-setting bodies in Europe (EP), Britain (BP), and the United States (USP) test every batch of pharma-grade maltodextrin. They check for heavy metals, bacteria, and even small variations in sugars that could throw off how a medicine behaves. This holds special importance for folks with diabetes or digestive problems, and for older adults who often juggle multiple meds. If the base substances in pills introduce contaminants or hold hidden calories, patient safety is at risk. Top-notch maltodextrin undergoes enough checks to assure doctors, pharmacists, and end-users that it's as inert and safe as possible.
Ever try to swallow a chalky, bitter pill with a weird aftertaste? I have, and so have most people. In this area, maltodextrin helps improve flavor and mouthfeel, making tablets or powders less likely to stick in your throat or leave you running for a glass of water afterwards. It doesn’t take away from the active ingredients—just makes taking medication a bit less unpleasant. This seems trivial until you consider how patient compliance drops when medication tastes awful or feels uncomfortable to take.
There’s ongoing debate on what “safe” additives look like, especially with hypersensitivity or long-term exposure. People with rare genetically determined allergies could react to corn- or wheat-derived maltodextrins, so full transparency on labeling helps. While regulators worldwide monitor how excipients like maltodextrin make their way into drugs, quality requirements keep dangers in check and show up in detailed chemical audits.
Doctors, pharmacists, and the medicine-making industry just want consistency and safety in every pill or powder put out there. Pharma-grade maltodextrin delivers because it follows a chain of custody and purity as tight as anything else in the medicine cabinet. Looking at the future, ongoing research into cleaner, even safer excipients might one day create better options, but for now, maltodextrin stands as a silent pillar in the medicine world—one many people don’t even know they use every day.
Pharmaceutical companies use a range of ingredients for more than just the active chemicals. Maltodextrin pops up across tablets, powders, and even some injectable products. This ingredient often acts as a carrier, a binder, or a filler. High standards must be met before anything goes near a patient. Regulatory bodies like the US Pharmacopeia (USP), British Pharmacopoeia (BP), and European Pharmacopoeia (EP) set out these standards for what counts as pharmaceutical grade.
Maltodextrin labeled as BP, EP, or USP pharma grade passes through several rounds of scrutiny. Labs test for heavy metals, microbial contamination, loss on drying, and system suitability, checking each batch before use. Guidelines ensure the maltodextrin doesn’t bring hidden toxins or allergens into the finished drug. In my work with research trials, I saw firsthand the amount of paperwork and cross-checking every “inactive” excipient underwent, even for those as common as maltodextrin.
Big regulators place strict upper limits on both known and possible contaminants. Public access to pharmacopeia monographs lets healthcare workers double-check the exact requirements, offering full transparency on what goes into the meds on pharmacy shelves.
Maltodextrin acts as a well-tolerated excipient for most people. Reports of allergic reactions or sensitivities stay rare. It’s derived from corn, potato, rice, or wheat, with careful steps to control protein contamination during manufacturing. Those steps matter for people with true food allergies.
I’ve worked with pharmacists who check the excipient lists on behalf of patients with celiac disease or severe food restrictions. Finding pharma-grade suppliers that publish clear sourcing info helps patients and doctors stay confident in therapy choices. As an example, a friend with celiac disease asked about her new prescription. The pharmacist pulled the manufacturer’s certificate of analysis — peace of mind that the medicine was gluten-free.
Occasionally, headlines raise questions about “sugar-based” ingredients or digestive issues tied to fillers. Studies have demonstrated that pharma-grade maltodextrin breaks down quickly into glucose. Most people process those sugars just fine. Oral medications contain much lower amounts compared to a can of soda or a sports drink. The FDA, EMA, and other agencies continue watching for any risk signals. At present, documented adverse events stemming from pharma-grade maltodextrin remain extremely rare.
Debate over “additives” in medicine often stems from confusion between food and pharmaceutical standards. Unlike snack foods, pharma-grade supplies get tested batch-by-batch for residue solvents, bio-burden, and even DNA traces.
Pharmacists and formulators can request full documentation from their suppliers. Certificates of analysis, traceability reports, and allergen statements have become standard tools for ensuring patient safety. Manufacturers need strong relationships with trusted suppliers and invest in frequent audits. Patients deserve open answers about ingredients. Local pharmacy teams can call manufacturers to check details — an extra layer of reassurance for anyone with specific allergies or intolerances.
Science-backed regulation and open communication keep trust strong in pharmaceutical manufacturing. Relying on proven pharma-grade sources stays the best path for safe and effective health products.
Maltodextrin carries a reputation in the pharmaceutical world for a good reason. I’ve seen it stretch far beyond the food sector and serve as a backbone in tablets, syrups, and even in IV solutions. Manufacturers turn to maltodextrin for its ability to hold drugs together, help medicines mix well with water, and keep the dosage reliable from pill to pill. But this sort of reliability has to come with proof. With pharma grade ingredients, expectations for purity and consistency sit sky-high. If the product fails, people could get sick, drugs lose their effect, and trust evaporates fast.
Maltodextrin earns its spot in pharmacology with strict, measurable standards. Only by hitting these markers can a batch carry the badge of “BP” (British Pharmacopoeia), “EP” (European Pharmacopoeia), or “USP” (United States Pharmacopeia) compliance. These global references keep everyone on the same page—whether you’re in manufacturing, quality control, or regulatory affairs.
Pharma grade maltodextrin comes as a white to off-white powder, neutral in taste and odor. Chemically, it sits on the spectrum between starch (not sweet) and glucose (sweet), depending on the degree of hydrolysis, often described by its DE (Dextrose Equivalent) value. Most pharma applications call for a DE range of 3–20. If the number strays too far, the product can get sticky, taste wrong, or behave unpredictably during processing.
To meet BP, EP, or USP criteria, maltodextrin must not wander off from these numbers:
Sugar profile gets a spotlight, too. Reducing sugars and dextrins should hover within a controlled range, or the maltodextrin can throw off drug stability, especially for serious injections or solutions.
Lab teams get no shortcuts in releasing a pharma batch. Every shipment of pharma grade maltodextrin faces testing for bacteria, fungi, and chemical impurities before it leaves the factory. Chromatography and spectrophotometry don’t just prove the identity; they pick up tiny amounts of contaminants or leftover reactants, protecting patients on the receiving end. Potency and consistency come under extra scrutiny for injectables, where even the tiniest mistake can turn dangerous fast.
Despite all the checks, mistakes still happen. I’ve walked through plants where a leaking valve or a dirty silo ruined a perfect batch. Small lapses turn into big headlines when drug recalls follow, and the ripple effect lands on patients. I learned to appreciate strict vendor qualification, traceability, and regular audits—not as cost drivers, but as insurance for public health.
Improvements happen when suppliers invest in dedicated pharma production lines, free from the risk of cross-contamination. Regular employee training, strict hygiene controls, and automated tracking of raw materials all help cut out surprises.
No one wants inconsistencies in their medicine. By holding maltodextrin to BP, EP, and USP purity levels, manufacturers can back up their promise to regulators, health workers, and everyday patients. With tight control over every molecule, the risk of allergies, infections, or dose failures drops dramatically. Patients depend on safe, predictable products, and these specifications help the industry deliver—day after day.
Walk into any supermarket and you’ll spot maltodextrin on ingredient lists—chips, puddings, soft drinks and more. In most cases, food companies turn to food-grade maltodextrin, but some might wonder whether pharma grade, carrying BP, EP, or USP designations, has a place in our food or drinks. Pharma grade signals compliance with pharmaceutical industry standards set by top pharmacopeias—the British Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopeia, respectively. These products go through tight quality controls, including stricter impurity limits and comprehensive traceability. Anyone with a background in pharmaceutical manufacturing, like myself, knows these standards bring peace of mind that contaminants like heavy metals, microbes, or residual solvents stay well below the strictest limits.
On paper, pharma grade sounds safer than food grade. "If something passes the most cautious tests, why not use it in everything?" That line of thought crops up among food manufacturers now and then. The truth is, for day-to-day food production, pharma standards tend to be overkill. Food regulations—managed by agencies like the FDA or EFSA—design their requirements around typical consumption patterns and safety factors specific to eating. Food-grade maltodextrin from trusted suppliers already meets those safety and purity demands.
Price plays a role, too. Pharma grade ingredients cost more. Those extra dollars come from more intensive testing, controlled manufacturing environments, and detailed documentation trails. Food companies, aiming to balance quality and cost, rarely see a reason to pay the premium for standards their products may not require.
Suppose a food manufacturer opts for pharma grade maltodextrin. The product will be free from detectable contaminants above pharma limits. For food aimed at the most vulnerable—preterm baby formulas, clinical nutrition products for immunocompromised patients, or perhaps specialty foods for people with severe allergies—an extra margin of safety feels justifiable. In these cases, tighter impurity controls give an added layer of confidence beyond food code minimums.
Still, every regulatory agency makes clear that safety often comes down to proper sourcing, transparency, and testing, regardless of grade. Even pharma grade can spoil or degrade if handled poorly after production.
On my own visits to food plants, ingredients arrive with thick packets of certificates—country of origin, allergen status, microbial counts. Processes for acceptance are rigid; food companies demand certificates of analysis for each batch, whether the maltodextrin is food or pharma grade. Supply chain reliability and documentation win more trust than a pharma label alone.
If a manufacturer moves to pharma grade maltodextrin, they update product labels and traceability systems to reflect the switch. Customers and regulators expect transparency about ingredient changes, especially when there's an uptick in grade or supplier. These changes bring necessary record-keeping costs and procedural updates in manufacturing.
Pharma grade maltodextrin meets every safety criterion for food use and even raises the bar. For makers of specialized nutrition products, it’s a logical pick. For mainstream food and beverage, the upgrade in purity rarely matches the extra cost. The wisest move remains investing in safe sourcing, rigorous tests, and clean plant operations, since that’s what keeps final products safe and trusted on shelves. That’s been my observation working with both pharmaceutical and food ingredients—integrity and diligence matter more than just specification alone.
Quality packaging isn’t just for show. With an ingredient like pharma grade maltodextrin, careful packaging guards against moisture, contamination, and physical damage. I’ve worked around food and pharma warehouses long enough to know: one careless move or a rip in the wrong bag and the whole batch can hit the landfill. Usually, this ingredient comes packed in high-strength, multi-layer bags—often paper bags with a tough plastic lining—or even sealed drums. Big names in the industry rely on these formats, since humidity loves to sneak in anywhere it can, and maltodextrin loves to soak it up.
Bags run 25 kilograms most of the time, stacked up on pallets and shrink-wrapped tight to resist punctures and spills during transport. It’s not just about making it through a truck ride; regulations keep a tight leash on traceability, so decent packaging will always be marked with batch numbers, manufacturing and expiry dates, and supplier information. That way, in some unexpected recall, tracking down details doesn’t turn into a nightmare.
Once maltodextrin leaves the plant and lands on warehouse shelves, the clock starts ticking. Under the right conditions—cool, dry storage and unopened packaging—it can stay good for about two to three years. This shelf life isn’t just a marketing promise. It comes from stability studies that test how long the product holds up under various conditions. The villain in this story? Moisture. If water vapor sneaks into the bag, caking, loss of flow, or even microbial growth can strike long before the printed date runs out.
In my experience, careful handling after opening makes or breaks shelf life. After opening a bag, it’s best to reseal it tightly and store it away from high heat or humidity. In hospital or pharmacy environments, where contamination carries real-world risk, staff treat open bags almost like perishable goods. Some facilities split large bags into smaller containers, labeled and sealed, to cut down on spoilage. A small investment in airtight containers can save thousands in wasted ingredients.
The British, European, and American pharmacopeia standards aren’t just fancy letters. They hold manufacturers to strict purity, identity, and microbial limits. Pharma grade maltodextrin should look like a white or mildly off-white powder, flowing easily if kept dry. Contaminated or caked product doesn’t just lose its value; it can turn up in quality control failures or even put patients at risk if left unchecked in formulations.
Surveys by industry watchdogs show that lapses in storage conditions sit behind a large number of ingredient recalls. The World Health Organization urges all supply chain partners to respect temperature and humidity parameters to protect the compound’s properties. From my time consulting with quality managers, the best-run operations live by this: check warehouse logs and environmental controls, and train staff on proper closure and labeling of every container.
The world isn’t short on ways to protect ingredients like this. Automated humidity controls, better insulation, and clear training on warehouse best practices help to stretch shelf life toward the optimistic side of those printed expiry dates. Tamper-proof packaging adds another layer of protection, catching leaks or breaches before products reach downstream users. Regular audits also help keep everyone sharp, from manufacturers to the folks handling the raw material in the back of the hospital pharmacy.
Quality packaging and good shelf life depend on more than printed promises. They rely on everyday vigilance—and small moments of care—at every step from plant to product. Keeping maltodextrin safe and stable isn’t just paperwork; it’s part of the ongoing fight for quality and safety that every pharmaceutical operation needs to win.
| Names | |
| Preferred IUPAC name | D-Glucopyranose, oligomers |
| Other names |
Maltodextrin Maltrin Dextrine maltée Hydrolyzed starch |
| Pronunciation | /ˌmæl.təˈdɛk.strɪn ˌbiːˈpiː ˌiːˈpiː ˌjuːˈɛsˈpiː ˈfɑː.mə ɡreɪd/ |
| Identifiers | |
| CAS Number | 9050-36-6 |
| Beilstein Reference | 39962 |
| ChEBI | CHEBI:47444 |
| ChEMBL | CHEMBL1201497 |
| ChemSpider | 21531506 |
| DrugBank | DB09415 |
| ECHA InfoCard | 03bdaed3-3bd9-45b6-92e5-46008510db44 |
| EC Number | 200-559-2 |
| Gmelin Reference | 60755 |
| KEGG | C00208 |
| MeSH | D009054 |
| PubChem CID | 24744459 |
| RTECS number | WKJ1AR71NA |
| UNII | D65LTF2VTI |
| CompTox Dashboard (EPA) | DTXSID1020079 |
| Properties | |
| Chemical formula | (C6H10O5)n |
| Molar mass | 342.30 g/mol |
| Appearance | White or almost white powder |
| Odor | Odorless |
| Density | D=0.4-0.5 g/cm3 |
| Solubility in water | Soluble in water |
| log P | -5.0 |
| Basicity (pKb) | 8.6 |
| Refractive index (nD) | 1.333 |
| Dipole moment | 1.52 D |
| Thermochemistry | |
| Std enthalpy of combustion (ΔcH⦵298) | -16.5 kJ/g |
| Pharmacology | |
| ATC code | A11JB |
| Hazards | |
| Main hazards | Not hazardous. |
| GHS labelling | GHS07 |
| Pictograms | GHS07, GHS08 |
| Signal word | Not Classified |
| Hazard statements | Not a hazardous substance or mixture according to the Globally Harmonized System (GHS) |
| NFPA 704 (fire diamond) | NFPA 704: 1-0-0 |
| Autoignition temperature | > 400°C |
| LD50 (median dose) | > 21900 mg/kg (rat, oral) |
| PEL (Permissible) | 10 mg/m3 |
| REL (Recommended) | Not more than 10 mg/kg |
| IDLH (Immediate danger) | No IDLH established. |
| Related compounds | |
| Related compounds |
Dextrin Cyclodextrin Glucose Syrup Corn Syrup Solids Starch Polydextrose Amylose Amylopectin |
Chengguan District, Lanzhou, Gansu, China
