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L-Lysine’s journey in the pharmaceutical world shows how something so crucial to life starts with humble origins. It first came to light in the early 20th century, pulled out of casein—milk protein—by the German chemist Emil Fischer. In its earliest days, L-Lysine existed more as a raw curiosity for scientists, yet its value for medicine and industry didn’t stay hidden. Demand for essential amino acids, once driven almost entirely by animal health and nutritional studies, soared after researchers linked lysine deficiencies to growth problems and immune dysfunction. Major advances happened as fermentation technology matured. By the late 1950s, companies designed scalable methods—moving away from pure chemical synthesis—that allowed routine production. This meant L-Lysine could enter human medicine and pharmaceuticals in ways never possible before. The pharmaceutical-grade standards, now known under BP, EP, and USP monographs, emerged from this move away from patchwork chemistry to robust quality assurance. Today’s tightly controlled production would not exist without those tough lessons and long years of refining.
L-Lysine, with its proper name 2,6-diaminohexanoic acid, stands as a basic building block for living organisms—one of those essentials the body cannot make for itself. The pharma-grade version is what sees use in medications, infusions, and sensitive supplements. You’ll hear it called by many names on supply sheets: lysine hydrochloride, lysine monohydrochloride, or just lysine HCl, depending on what salt or form is delivered. It turns up as a fine white crystalline powder, easy to spot by its clarity and absence of any strange odor. What makes pharma-grade L-Lysine different from feed or industrial grades comes down to purity, with BP, EP, and USP each laying down strict percentages and limits on potential contaminants. This level of consistency opens doors to direct application in formulas that enter the human body, particularly for injection or infusion, where even the smallest impurity could spell trouble.
L-Lysine in its pure hydrochloride form has a melting point near 263°C, though it tends to decompose before reaching this temperature. The powder flows easily, dissolving in water, leaving almost no residue. It stays stable under normal storage, resisting breaks and drifts in quality, as long as it doesn't face excess humidity. The molecular formula C6H14N2O2·HCl translates to a precise molecular weight—important for calculations in the lab. Its isoelectric point hovers close to pH 9.8, which means it takes on certain behaviors in solution that chemists use to separate or analyze it. What draws me most to this molecule, though, is its simplicity: where other ingredients feel mysterious or complex, L-Lysine looks like something you could find in a child’s chemistry set but holds enormous value for every cell and tissue in the body.
Pharma-grade L-Lysine comes with certificates that show purity above 98.5%, backing up this number with proofs against heavy metals and microbial limits. Each delivered lot shows off standardized loss on drying, usually not more than 0.4%. The pH in a 10% water solution hovers around 5.0 to 6.0, as set by pharmacopeia standards. Technical datasheets reveal not just how much lysine sits present, but also limits for endotoxins, bioburden, and residual solvents—none of which can stray above the sharply drawn thresholds laid down by regulatory authorities. I’ve seen how experienced formulators check lot numbers and full traceability data, right down to country and process of manufacture, and this habit keeps patients safe. Bottles and bags leave facilities with labels in line with BP, EP, and USP codes, showing the batch, expiration date, and precise storage needs—many setups require dark, cool, and dry environments.
Most of the pharmaceutical-grade L-Lysine used in modern medicine comes off bioreactors working full tilt with strains of Corynebacterium glutamicum, chosen for their efficiency. Scientists seed these reactors with simple sugars and nitrogen sources, leaving the bacteria to churn out pure lysine over days. After fermentation finishes, purification moves in several stages: first removing cells with filters, then spinning down the broth, catching almost every impurity, and concentrating the clear lysine solution. Once concentrated, lysine hydrochloride crystallizes out, arriving in the form that’s easy for testing, storing, and mixing. The chemical method—starting from caprolactam or protein hydrolysis—still exists in some facilities but rarely meets today’s purity demands for injectables or infusions. Fermentation not only gives cleaner product but cuts down the environmental load, a bonus that matters for anyone thinking about the planet.
L-Lysine carries two primary amine groups and one carboxyl, making it ready for all sorts of chemical tweaks. It acts as a nucleophile in reactions, often used for peptide synthesis, or to attach active groups in targeted drugs and diagnostics. Research teams use protected forms—such as Boc- or Fmoc-Lysine—when building chains in solid-phase synthesis. Structural chemists look at modifications like methylation, acetylation, or ethylation of its amines to build derivatives for unique medical uses, such as treating herpes or improving uptake of other drugs. Interaction with aldehydes, for example, allows the creation of Lysine Schiff bases, important for cross-linking in collagen-based medical devices. The sheer adaptability makes L-Lysine more than a protein builder; it acts as a cornerstone in the hands of synthetic biologists.
Depending on its use and the region, L-Lysine appears with multiple names. The pharma sector usually asks for "L-Lysine Hydrochloride" or "L-Lysine HCl," while nutritional products might just say “L-Lysine” or “L-Lysin.” The scientific community, meanwhile, catalogs it as “2,6-diaminohexanoic acid,” “Lys,” or “C6H14N2O2·HCl.” In research and product listings, you’ll see CAS numbers such as 657-27-2, which help buyers zero in on the exact compound needed. It doesn’t matter if you’re in Europe, North America, or Asia; cross-referencing by product name and code ensures researchers and pharmacists are working with the right grade, every time.
Workers in contract manufacturing outfits recognize that handling pharma-grade L-Lysine requires adherence to strong operational standards. Safety data points to only mild irritant potential, but airborne powder can cause minor respiratory effects with large spills. Facilities use closed transfer systems, dust control tools, and personal protective equipment—not just to match regulatory audits, but to build confidence and protect health. Storage areas keep temperatures below 30°C and stay shielded from moisture, since amino acids like lysine draw water from the air if left exposed. Quality labs routinely run tests for both microbial contamination and cross-contamination, catching any trace of foreign active ingredients before batches ever leave the door. For injectable uses, endotoxin testing stands as a mandatory checkpoint. Experience tells me that five minutes saved skipping a procedural step leads to days of scrambling if a contaminated lot has to be recalled.
Demand for pharma-grade L-Lysine stretches across diverse sectors. Intravenous nutrition, covering parenteral nutrition solutions, leans heavily on sterile lysine to support patients who aren’t able to eat by mouth, helping them avoid muscle wasting and immune suppression. Pharmaceutical research includes it in peptide drugs and vaccines, where its purity and safety matter just as much as its function. Supplement makers also use this grade in tablets and capsules marketed to people with dietary lysine gaps—whether from vegan diets, old age, or absorption issues. Dermatologists feature lysine-based formulas for cold sore treatments, and nephrologists include it in special diets for patients with urea cycle issues. From animal models to frontline patient care, the ability to rely on a genuine pharma-grade source matters, as lives hang in the balance if substitutes don’t match quality.
Recent years have shown no slowdown in research into new applications and modifications of L-Lysine. Investigative teams look at improving bioavailability of peptide therapies, where adding a lysine moiety can help direct drugs to certain tissues. Cancer researchers keep exploring lysine-conjugated drug conjugates that deliver chemo agents with precision, minimizing side effects. New vaccine delivery platforms also experiment with lysine-based linkers, merging traditional antigens to nanoparticle carriers, hoping to achieve better immune activation at lower doses. I’ve seen academic and private labs partnering with advanced fermentation startups, aiming to push production yields higher while using renewable substrates, which brings fresh hope to both affordability and sustainability.
Toxicity studies for L-Lysine in pharma-grade form reveal reassuring results. Doses common in medicine rarely cause side effects; the body simply repurposes or discards what it doesn’t need. Large excesses, consumed over years, sometimes link to gallstone issues or may stress kidneys in those with existing renal problems. Preclinical evaluations show low acute toxicity, and animal models fail to demonstrate cancer-promoting or DNA-damaging effects. Clinical supervisors still track long-term use, especially among those on kidney dialysis or early pediatric patients, erring on the side of caution. The lesson from the literature—and from my time tracking formulations—is that purity matters: adulterants, not the main compound, usually stir up safety alarms. Regulatory bodies keep watch on manufacturers to ensure contaminant controls remain strict.
Looking at L-Lysine’s path forward, there’s reason for optimism grounded in both science and need. Global demand from hospitals, homecare providers, and emerging economies rises every year, in concert with better diagnostic standards and broader appreciation for amino acid therapy. With more personalized medical approaches taking hold, patients often require specialized nutrition tailored to their genetic profiles, and L-Lysine stands poised to play a major role here. Ongoing work focuses on process improvements for sustainable and local production—think fermentation systems running on agricultural byproducts—and fresh clinical trials into lysine derivatives as drug carriers, anti-inflammatories, or metabolic regulators. If I draw on my own experience seeing pharmaceutical supply chains tested by shocks—pandemics, trade disputes, shifting regulation—I know manufacturers who invest now in cleaner, traceable, and flexible L-Lysine production will carry enormous advantage. At its root, this molecule’s story proves that a single building block, made well, ripples through every level of care, discovery, and innovation.
L-Lysine stands out as an essential amino acid, and the body counts on it for building proteins. Since people cannot make lysine naturally, they have to get it from food or supplements. In the pharmaceutical world, L-Lysine labeled as BP, EP, or USP Pharma Grade carries strict standards set by organizations like the British Pharmacopoeia (BP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP). Each of these ensures what people take is pure, safe, and meets tough quality checks. Anyone who's ever bought a vitamin or supplement might notice these grade markers. They point to a product that can be trusted in terms of purity and intended use.
L-Lysine shows up most in treatments for people who struggle to eat enough protein or who deal with illnesses that keep them from absorbing nutrients. Hospitals use L-Lysine in intravenous infusions for patients who cannot eat, often as part of total parenteral nutrition (TPN). Children with growth issues or older people with muscle loss benefit here—not just in theory, but in countless real hospital rooms. In my own life I’ve seen older relatives prescribed amino acids to help heal after surgery, or to keep their muscles from fading during a long illness.
Walk into a pharmacy and you might spot lysine ointments and supplements, especially for people prone to cold sores. Scientists have found that supplementing with lysine lowers the rate of herpes simplex virus outbreaks. Some doctors recommend it for patients with recurring sores, mainly because research shows viruses need another amino acid, arginine, to grow. Lysine blocks that, so outbreaks don’t come as often. No one likes dealing with a cold sore, and it can be a real relief when a treatment actually cuts down on flare-ups without heavy side effects.
The pharma grade marks—BP, EP, USP—mean more than a badge to fill space on a product label. Companies test their batches for contaminants like heavy metals or bacteria. That’s what gives doctors confidence to inject it or pharmacists the security to pack it into capsules. During shortages or supply chain hiccups, finding genuine pharma grade L-Lysine is tough, and that directly affects patients who rely on it for recovery or ongoing care. Hospitals need a steady supply, especially during prolonged illness outbreaks or after surgeries where nutrition matters more than ever.
In places with less access to medicine, the absence of safe, certified L-Lysine leads to missed opportunities for growth, healing, and disease prevention. It makes sense for manufacturers and healthcare providers to push for more education about amino acids—not just among other professionals but with families, too. People need to know why these supplements matter, and not only after problems appear. From experience, I’ve seen well-informed families ask for specific supplements and treatments that sped up recovery or prevented further issues.
Improving how L-Lysine gets to those who need it most depends on strong supplier relationships and sound regulation. Doctors, nurses, and buyers in hospitals need fast, clear information on quality and origin. For long-term impact, health workers, caregivers, and even patients should get involved in questions about nutrition support. The practical details—how to store, mix, and administer L-Lysine—matter as much as the science. At its core, this is about caring for people during growth, recovery, and prevention, not just filling out another item on a prescription sheet.
A lot of people glance at technical sheets, see numbers listed as “purity” or “specification”, and move on. But for those working with chemicals or materials every day, those details can have outsized impacts on both performance and safety. From pharmaceuticals to electronics and food processing, tiny impurities can trigger big problems, or, in some cases, produce desired effects. Since many folks only see specs on a sheet, it’s easy to overlook the day-to-day impact these details have.
In simple terms, specifications define the makeup, concentration, and key properties of a product. For something like industrial sodium chloride, specs list minimum purity, moisture content, and impurities allowed. For pharmaceutical-grade products, the requirements get even tighter. The U.S. Pharmacopeia or European Pharmacopoeia each contain strict tables showing what counts and what doesn’t. In practice, these standards reflect a long process of scientific review, practical use, and sometimes, painful lessons from quality failures.
Having worked with supply teams, I’ve seen good specs make life much easier, especially if you’re troubleshooting a bottleneck or tracking the root of an issue. People like consistency because it saves time and avoids risk. Specs act as an anchor for both producer and customer: one side knows what needs to be delivered, the other what can be expected. This helps limit unpleasant surprises during production or research.
Purity isn’t just a number— it’s a statement about trust and assurance. Think about injectable medicines. If something’s labeled 99.9% pure, that remaining 0.1% could be dozens of trace chemicals. If those aren’t monitored tightly, patients pay the price. The semi-conductor industry sits at another end of the spectrum, with silicon requiring purity so high its contaminants are measured in parts per billion.
Even in less sensitive uses, like making soap, the presence of certain impurities changes everything— from color to performance. I learned early on from a chemist colleague that even an invisible contaminant in laboratory salts can skew research results or ruin a simple reaction. That’s not just theory— it’s ruined batches, lost time, and missed deadlines.
It’s not enough to trust the label. Buyers, especially those in critical sectors, dig deeper— requesting supporting certificates, checking for third-party verification, and sometimes running their own laboratory checks. Regulatory enforcement can’t catch everything. Stories still surface about mislabeling or dilution, especially as global supply chains stretch out and regulation standards clash.
So, companies and end-users have a role to play. If I buy a batch of raw material, I ask for recent, signed certificates showing actual batch results. And I stay wary if I don’t see clear lot traceability or frequent re-testing results. These habits matter even more in times of crisis, when cutting corners is tempting and oversight is stretched.
One step that would improve trust is sharing more batch-level data, not just generic numbers from previous years. Digital record systems can tie a specific lot to each delivery, so if an issue crops up, tracing the root takes hours, not weeks. Regularly communicating updates on changing methods or stricter impurity controls also lets customers plan for shifts in their own processes.
People on the ground know a spec isn’t a piece of paper; it’s a tool for quality, safety, and trust. Whether you’re working in a high-stakes lab or making consumer products, focusing on the substance of specifications and purity keeps everyone safer and protects the bottom line.
Most people sitting around a kitchen table want to trust the food on their plate and the medicine in their cabinet. That trust doesn’t grow on its own. It’s built on years of science, regulation, and hard choices about what can go into these products. When a company talks about a new material for use in food or pharmaceuticals, the first question isn’t about price or branding. It’s about safety.
Decisions start with the raw data. Anyone can claim something’s safe, but proving it means digging up toxicology reports, allergen screenings, and any trace of heavy metals or residual solvents. People need to see clear limits—numbers that mean something—and check that independent labs confirm them. Food and pharmaceutical companies spend big on these reports, not because they have to impress regulators, but because customers depend on them. Mistakes in this realm get people hurt. There's no gray area where consumer safety is on the table.
If you walk through a factory making tablets or baking bread on an industrial line, you see strict controls at every step. Raw material consistency is non-negotiable. Products for these sectors require detailed certificates of analysis. Each batch should match the last, edge-to-edge, in purity and particle size. The difference between a smooth tablet coating or a gritty texture depends on whether suppliers manage this level of detail.
Some manufacturers chase international certifications—like GMP (Good Manufacturing Practice) or ISO standards—not to add an extra badge to their conference booth, but to demonstrate control over their process. Auditors check that equipment stays sterile, shipments don’t cross-contaminate, and storage temperatures remain stable. Consumers might not notice these routines, but they benefit from them every time they unwrap safe food or receive a prescription.
Few markets test a company’s honesty quite like the food and drug sectors. Without clearance from trusted regulatory bodies such as the FDA, EMA, or CFDA, there can be no claim that something belongs in a pill or a snack. Regulatory review isn’t just a formality; inspectors pore over every line of documentation and source. A rejected application means heading back to the drawing board. Failure can become a headline or, worse, a courtroom drama.
Companies that earn approval don’t stop there. They work with traceability systems, recall plans, and customer education. Responsible players don’t hide behind jargon or brush off tough questions about their sourcing. They share results from stability studies, ongoing safety tests, and field reports. These updates reassure buyers who decide whether to rely on their product day after day.
People support brands that respect their health. The food and pharmaceutical markets place a high value on reputation because lost trust rarely returns. Problems from quality lapses or safety oversights ripple through the news, draining confidence built over years. Firms that listen to feedback, respond to concerns, and engage experts shape better products and industry standards.
Any supplier who aims for these industries should bring their A-game: transparent sourcing, airtight documentation, and real accountability for the outcome. There are no shortcuts. Anyone asking if a product is right for these critical applications should prioritize testing, openness, and learning from industry best practices. It’s not about meeting a checklist—it’s about caring for everyone’s well-being.
L-Lysine BP EP USP pharma grade keeps its value because of attention to detail. Picture a warehouse stacked with raw materials for formulations. Only a fraction holds as much significance as amino acids that end up in pharmaceutical products. L-Lysine isn’t just another white powder. Moisture, high temperatures, and even brief moments of sunlight can slowly reduce its potency. A pharmacist or chemist understands the difference between a clean label and a compromised ingredient. Efficiency rests on keeping this compound in a cool, dry spot, away from sunlight and strong-smelling chemicals.
Loose protocols invite risk. Cross-contamination looms over storage rooms packed with excipients and active pharmaceutical ingredients. Even trace amounts of other powders or volatile compounds can tweak a batch’s results. Always store L-Lysine BP EP USP pharma grade in tightly closed, original containers. These drums or bags should live on clean pallets, never the floor, to minimize risk from dust or accidental spills. Every step, from warehousing to transfer, shapes the end product's reliability.
Water acts like a magnet for many raw ingredients, especially fine powders. Dampness causes caking or clumping—a problem I've seen turn an entire day's mixing session into a loss. Ensure relative humidity in storage rooms stays low, ideally below 60%. Standard pharma practice says room temperature is best (between 15°C and 25°C), so the ingredient avoids temperature swings. Facilities using temperature and humidity monitors spot problems before they escalate. This approach delivers real trust in the supply chain.
Gloves, aprons, and even hair nets sound like overkill until you find a batch spoiled from one careless transfer. Employees can introduce microscopic bits of lint, dirt, or even sweat. Over time, small mistakes add up. Training staff on cleanroom habits—and not letting up—cuts back on failed quality checks and lost material. Weighing L-Lysine in a separate, dedicated space protects integrity. Each move counts, from weighing to final addition in the blend. Scrupulous attention isn’t red tape. It’s essential.
Rotating stock prevents a world of trouble. Stick to "first in, first out." Label each delivery with batch numbers and clear expiration dates. I’ve watched teams chase down issues only to find an expired drum slipped into the workflow. Accurate logbooks and batch traceability help spot and recall potential problems faster—a key point for any company committed to public safety. Health authorities expect it, and so do patients depending on safe, consistent medicine.
Securing L-Lysine BP EP USP pharma grade boils down to practical choices: controlled temperature and humidity, worker training, meticulous labeling, and separation from incompatible materials. Long experience shows these basics serve as the front line against costly recalls or product instability. Pharmacies, manufacturers, and warehouses who keep details in focus never regret it, especially as regulations tighten and customer expectations rise. Reliable medicine starts at the warehouse door, long before it reaches a tablet or capsule.
Walk into any store, and you’ll see an endless line of products sitting snug in their packages. Big tubs, tiny sachets, vacuum-sealed bags, glass jars — the options seem endless. When you’re the one buying, size becomes more than a convenience. It directly impacts quality, cost, and sometimes, your safety. After working with food products for years, I’ve seen how packaging choices influence waste, freshness, and even trust in a brand.
Let’s use a staple, like flour, to make things clear. In supermarkets, you’ll usually see one-kilogram or two-kilogram bags. Bakers and restaurants, on the other hand, go for 10 or 20 kilograms, sometimes even bulk sacks up to 50 kilograms. The same goes for cleaning solutions — single-liter bottles for households, five-liter jugs for small businesses, and massive drums for factories.
Packaging size often lines up with how fast you use the product and what’s practical to handle. No one grabs a barrel of ketchup for a backyard cookout. Restaurants don’t want to restock every few hours. These choices help reduce waste — both in the product itself and the material wrapping it.
Many forget just how much environment, packaging, and even how you store a product can change its shelf life. Years back, I managed a bakery and discovered flour loses flavor and nutrition sitting too long, especially when stashed in warm, humid corners. Unopened, flour typically lasts six to eight months in a paper bag. In a sturdy, sealed container or a vacuum pack, it can last up to a year. Oils, on the other hand, spoil quickly in heat or if their seal gets broken. Anything perishable pays the price when packaging is poor or storage slips.
Shelf life doesn’t just help you plan — it keeps you safe. Poorly stored medicine loses its punch. Spoiled dairy can bring on food poisoning. Expired chemicals risk accidents. Big companies often stamp every package with a date, and in many countries this isn’t just best practice — it’s the law.
From my time in the food industry and talking with teachers, home cooks, and business owners, I’ve found a few simple habits beat fancy promises. Smaller sizes work better for rare or special items because you’re less likely to leave leftovers sitting for months. Bulk packaging only pays off if the product moves fast or you have airtight storage. Clear date labeling helps everyone keep track; color-coded labels make quick checks simpler in busy kitchens.
Environmental impact deserves special mention. Packaging waste has become a real headache in modern cities. Cartons and plastics pile up in landfills. Recyclable and compostable options offer small but real benefits. Small businesses switching to these solutions often report happier customers and less guilt tossing out empty wrappers.
Store what you use, use what you store. That old bit of wisdom still holds up, whether you’re running a factory or just keeping your family safe. Small changes in how we package and store products pay long-term dividends — both for your wallet and for the planet.
| Names | |
| Preferred IUPAC name | (2S)-2,6-diaminohexanoic acid |
| Other names |
2,6-Diaminohexanoic acid H-Lys-OH L-2,6-Diaminohexanoic acid L-Lys |
| Pronunciation | /ˌelˈlaɪ.siːn biː piː iː piː juː es piː ˈfɑːrmə ɡreɪd/ |
| Identifiers | |
| CAS Number | 56-87-1 |
| 3D model (JSmol) | `3D:CC(CN)CCCC(N)C(=O)O` |
| Beilstein Reference | 17159 |
| ChEBI | CHEBI:18019 |
| ChEMBL | CHEMBL603 |
| ChemSpider | 5464 |
| DrugBank | DB00114 |
| ECHA InfoCard | 03bb87c2-607a-4188-9fbb-786ba8eb61ee |
| EC Number | 200-711-8 |
| Gmelin Reference | 3734 |
| KEGG | C00047 |
| MeSH | D-Lysine |
| PubChem CID | 5962 |
| RTECS number | **OJ5975000** |
| UNII | YLUFJRFFDKEPLY-UHFFFAOYSA-N |
| UN number | UN3077 |
| CompTox Dashboard (EPA) | DTXSID4044252 |
| Properties | |
| Chemical formula | C6H14N2O2 |
| Molar mass | 146.19 g/mol |
| Appearance | White or almost white, crystalline powder |
| Odor | Odorless |
| Density | Density: 0.98 g/cm³ |
| Solubility in water | Soluble in water |
| log P | -4.15 |
| Vapor pressure | Negligible |
| Acidity (pKa) | 10.79 |
| Basicity (pKb) | pKb: 5.05 |
| Dipole moment | 0.0 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 226 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | -248.2 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -3913 kJ/mol |
| Pharmacology | |
| ATC code | A16AA08 |
| Hazards | |
| Main hazards | May cause respiratory irritation. May cause eye, skin, and respiratory tract irritation. |
| GHS labelling | GHS07, GHS08 |
| Pictograms | GHS07 |
| Signal word | Warning |
| Hazard statements | Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008. |
| Precautionary statements | Precautionary statements: P261, P305+P351+P338, P264, P280, P302+P352, P312 |
| NFPA 704 (fire diamond) | 0-1-0 |
| Lethal dose or concentration | LD50 (oral, rat) > 5,000 mg/kg |
| LD50 (median dose) | 5000 mg/kg (oral, rat) |
| PEL (Permissible) | Not Established |
| REL (Recommended) | Not less than 98.5% and not more than 101.0% |
| Related compounds | |
| Related compounds |
L-Lysine hydrochloride L-Lysine monohydrate L-Lysine sulfate DL-Lysine L-Arginine L-Ornithine |
Chengguan District, Lanzhou, Gansu, China
