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More than a century ago, L-Lysine was first isolated from casein, marking a real turning point in amino acid research. For a long time, lysine’s role as a nutritional building block didn’t get widespread recognition. In the decades after its discovery, production advances moved at a slow burn until the late 20th century, when demand soared for food fortification in rapidly growing populations. As the essential amino acid found missing from cereal-based diets, lysine shifted from mere research curiosity into a global staple, with fermentation methods overtaking chemical synthesis to meet pharmaceutical and dietary needs. The use of monohydrate forms arose from requirements for precise dosing and purity, reflecting how scientific progress and nutrition policy can meet on common ground. The string of international standards—BP, EP, USP—reflects global alignment on quality, so that whether being pressed into tablets or entering animal feed, purity won’t become a regional gamble.
L-Lysine Monohydrate, especially in BP, EP, and USP pharma grades, appears as a white crystalline, nearly odorless powder. This isn’t just for show; the texture and solubility matter in real-world handling. Behind its simple appearance, lysine locks in dietary and therapeutic purpose. Each monohydrate molecule brings along a single water molecule, a subtle but important touch that ensures accurate dosing by pharmaceutical standards. This product isn’t a generic amino acid; pharma grade means every milligram has to meet ironclad criteria for quality, absence of contaminants, and batch-to-batch reliability. That becomes crucial in sensitive applications—think injectable nutrition, infant formulas, and tailored dietary supplements, where trust and traceability trump low price.
L-Lysine Monohydrate carries a molecular formula of C6H14N2O2·H2O and weighs in at 182.24 g/mol. In the hand, it feels like most pharmaceutical powders, but beneath the surface, its solubility in water (about 1g in 5ml) and crystalline consistency make it suitable for rapid absorption in the body. With a melting point around 215°C where it decomposes, it keeps shape under most manufacturing conditions and won’t lose potency under moderate storage. The monohydrate form helps buffer moisture-related clumping, a practical plus during shipping and storage. These details matter in formulation design, since manufacturers need a material that flows smoothly into blending operations and won’t gum up equipment.
Looking at a genuine pharma grade label, you might see not just the percentage purity (98.5% minimum), but tight control over heavy metals (less than 10 ppm), chloride, sulfate, and related substances. Coloration and optical rotation numbers (from +20.5° to +21.5° in 6M hydrochloric acid) validate its identity and quality. Pharma labeling carries the batch number, expiry, storage instructions, and approved manufacture date. Nothing left to chance in a system where recalls or contamination could risk lives. Current Good Manufacturing Practices—cGMP—aren’t just acronyms, but regular, sometimes surprise, audits. I’ve seen how much scrutiny these pharma suppliers go through, compared to standard feed or technical grade materials.
Fermentation rules the modern production of L-Lysine Monohydrate. Using strains of Corynebacterium glutamicum, feedstocks like glucose or molasses get converted in large fermentation tanks. Careful engineering keeps yields high and impure byproducts in check. After fermentation, lysine gets separated, usually by crystallization and filtration, and then purified through ion-exchange columns and drying phases. Adding a controlled amount of water produces the monohydrate, which stays stable through final packaging. This process embodies decades of microbiology and chemical engineering, tightly linked to output quality. Handling and purification steps matter more here than some realize: any shortcut or contamination could upend the entire batch, particularly as pharma buyers demand evidence for every material input and process step.
L-Lysine’s main reactions center on its ε-amino group, which makes it a ready player in peptide synthesis and a range of chemical derivatizations. Its reactive side chain is a backbone for making dipeptides (like Lys-Gly) and specialty compounds—acetylated lysines, for example, are crucial in cell biology research. Industrial chemists take lysine through Maillard reactions in food applications for browning effects, but in pharma, the focus is on maintaining its free base form, to avoid side reactions that could impair its nutritional or therapeutic functions. Pharmacopeial standards make sure any byproducts remain far below thresholds that would raise health concerns. In my own work, I’ve tested lysine for impurities that could arise from careless storage, such as diketopiperazines, which signal moisture or heat abuse.
L-Lysine Monohydrate goes by a handful of labels across the globe—2,6-Diaminohexanoic acid monohydrate, Lys, and sometimes plain “lysine H2O” on export documents. Names reflect more than language or branding; they signal its conformation (L, not D, which lacks bioactivity in human enzymes) and hydration state. Pharma suppliers usually provide the IUPAC and CAS listings—what seems like minor paperwork actually smooths compliance with authorities around the world, especially as customs and regulatory bodies check these details when consignments cross borders.
Worker and patient safety frame the whole lifecycle of L-Lysine Monohydrate. Though it qualifies as a low-toxicity material, pharmaceutical grade standards demand gloves, goggles, and dust controls during handling, especially in filling and blending. Inhalation of fine dust can irritate airways for operators, so closed transfer systems and HEPA filtration mark any top-tier production room. Strict hygiene and trailer traceability are standard in the logistics chain. GMP documentation provides a paper trail between raw material intake and finished pill. In facilities I’ve seen, cross-contamination controls get special attention, since lysine’s widespread use could present allergen risks if sourced from impure or mislabeled materials. Disposal of production waste follows local environmental guidelines, with lysine-rich effluents kept out of groundwater systems.
Pharmaceutical grade lysine stretches across clinical nutrition, oral supplements, infusion products, and even topical wound care. Hospital TPN (total parenteral nutrition) solutions can’t do without it. Some companies gear their formulations toward immune system boosting and cold sore suppression, since lysine plays a role in viral replication cycles. Beyond direct human consumption, lysine finds a place in veterinary medicine, especially for young animals lacking strong growth from grain-heavy diets. In my own experience, nutritionists regard it as an “index amino acid”—when lysine is optimized, the rest of the essential amino acids usually fall into balance.
Scientific exploration keeps pushing the boundaries for lysine. Today’s research investigates its effect on anxiety, stress, and even early cognitive decline. Some studies examine gene-edited strains of bacteria that turbocharge yields and reduce residual impurities, pushing purity beyond current pharmacopoeial minimums. Advances in crystallization and drying promise less thermal degradation and lower production costs. Analytical labs keep refining methods for detecting all known impurities and isomer content, leveraging HPLC and mass spectrometry to pick up what old colorimetric tests would have missed. Pharmaceutical innovators dig deeper into delivery systems, looking to improve palatability or extend shelf life, especially in regions where refrigeration remains scarce.
Published data confirms that L-Lysine Monohydrate earns its low-risk status at recommended doses—oral LD50 in rats trends above 5 g/kg. Problems only start with chronic, massive overdose, where gastrointestinal upset or subtle renal impacts could occur, most often in patients with pre-existing kidney issues. Toxicologists scrutinize batches for trace-level mutagens or allergens—microbial leftover DNA from fermentation, if unchecked, can trigger regulatory recalls. My review of monitoring data shows side effects in humans remain rare and mild, typically linked to stomach upset when taken without food. Precaution remains a watchword in clinical nutrition, as at-risk populations sometimes receive lysine in higher concentrations, where cumulative exposure could change risk calculations.
L-Lysine Monohydrate remains on a growth path. With personalized medicine gaining traction, expect custom blends of essential amino acids, where lysine joins tailored mixes targeting specific genetic or metabolic profiles. Climate-resilient crops and fermentation advances aim to drive feedstock costs lower—critical as lysine production ramps up to meet global protein needs without extra farmland. Green chemistry pushes for bioproduction routes that cut waste and energy use, reflecting environmental priorities in the supply chain. Regulatory alignment remains a moving target, as pharmacopoeias periodically update monographs and reference impurity profiles. In my view, the next leap may come from lysine analogs with improved absorption or targeted delivery, giving clinicians more tools for treating conditions from inherited metabolic defects to aging muscle loss. The story isn’t finished yet; it’s still being written by technologists, farmers, regulators, and patients alike.
Walk through any pharmacy aisle, and you’ll notice bottles of supplements touting L-Lysine as a critical building block for the human body. L-Lysine Monohydrate, often stamped BP, EP, or USP Pharma Grade, fits snugly into the world of modern health care. This isn’t your average vitamin pill. At its core, L-Lysine is an essential amino acid—your body cannot produce it naturally, so everything comes from diet or supplements.
Pharmaceutical-grade L-Lysine has proven value in producing intravenous and oral solutions as well as nutritional supplements. Formulators and pharmacists choose this grade because it’s safe for patients and tightly regulated for purity and potency. L-Lysine joins up with other amino acids to promote tissue repair and help keep skin, bones, and muscle structure strong—something most people don’t realize until an injury or deficiency sneaks up.
Hospitals and clinics rely on this particular grade for more than nutritional support. L-Lysine therapy helps patients who battle herpes simplex infections, cutting down the frequency of outbreaks and speeding up healing. The recurrence of cold sores can be painful and a source of embarrassment. L-Lysine steps in to turn that cycle around for many, sometimes with quick, observable results.
Children, especially those recovering from malnutrition or illness, benefit from L-Lysine’s well-established role in supporting growth. Doctors often turn to this pharmaceutical form because they want to trust what they’re prescribing. The body uses L-Lysine to absorb calcium more effectively—stronger bones and teeth follow. I’ve seen young patients with stunted growth surge forward after a few weeks with a supplement regimen backed by this precise grade.
For older adults facing the threat of osteoporosis, every bit of egg-white protein, soy, and meat helps, but it doesn’t always close the gap. L-Lysine supplements, properly sourced, fill that space. Anyone who has watched family members struggle with brittle bones knows how important early preventive nutrition can be.
Countries where protein-rich foods are scarce often import pharmaceutical-grade L-Lysine to fortify foods. This keeps populations healthier and reduces the impact of dietary shortcomings. There’s a tangible difference between an adult who received proper nutrition from foods fortified with L-Lysine and someone who missed out—both in physical energy and long-term resistance to illness.
Animal nutrition benefits too. Livestock and poultry producers use L-Lysine to enhance feed efficiency—stronger, healthier animals mean better food security for communities. It took years for nutrition science to catch up to the ancient practice of fortifying feed, but the impact on local economies and food supplies runs deep.
Access to pharmaceutical-grade L-Lysine still isn’t as widespread as it should be, especially in the regions that would benefit most. Nonprofits and international agencies work hard to close this gap, but more local investment is needed. Affordable, reliable supply chains make the difference for clinics, schools, and families trying to give children a better start.
I’ve met nutritionists and doctors who wish that the conversation about supplements focused less on trendy wellness and more on real-life impact. L-Lysine Monohydrate BP EP USP Pharma Grade brings that reality into medicine, nutrition, and humanitarian relief quietly, but powerfully.
Pharma grade L-Lysine Monohydrate does more than act as a building block in protein formation. Its purity and quality affect both safety and performance in finished medicines, and people who depend on these products deserve real consistency. Years spent in pharmaceutical quality control have left a clear impression—oversights in sourcing or spec integrity often spark cascading problems. Sharp buyers and regulatory auditors keep a close watch to avoid risks in the supply chain.
Pharmacopoeia standards tell a plain story—there is little room for distortion in the numbers. The BP (British Pharmacopoeia), EP (European Pharmacopoeia), and USP (United States Pharmacopeia) all set benchmarks:
Getting L-Lysine with high test results means nothing if handling during shipping or storage lapses. I’ve seen poorly packaged product come in contact with moisture, ruining entire batches and throwing off loss-on-drying numbers. Proper inspection and supplier qualification count as much as initial specs, especially in a regulatory environment where documented chain-of-custody forms the backbone of traceability. GxP (Good Practice) frameworks in manufacturing and warehousing keep these risks in check.
Pharma customers look for a clear Certificate of Analysis showing compliance not just with assay, loss on drying, and specific rotation, but also with tests for endotoxins and microbial counts. Labs use titration, infrared spectrometry, or HPLC to validate these claims; these methods have their roots in decades of regulatory refinement.
Raw material quality scandals cost more than money—they hit trust and public health. To keep L-Lysine at true pharma grade, buyers often require more frequent audits and batch-by-batch verification. Working with suppliers who invest in full GMP certification helps. On-the-ground audits in China and India, for example, helped our teams catch improper handling many years back, long before packaged products got close to consumers.
Strong supplier partnerships, regular lab testing, and firm adherence to established specs all support a robust supply chain. Spot-checking new sources with in-house analysis gives an extra layer of insurance, because corners do get cut, especially if price gets prioritized over long-term consistency.
Pharma grade means putting patient safety first. Complying with BP, EP, and USP standards doesn’t just keep regulatory agencies satisfied—it helps ensure medicine-makers and patients work with amino acids that truly meet intended quality. In every quality-focused company I’ve worked with, vigilance pays off. The risks of contaminated or subpar raw material are too high to ignore.
L-Lysine Monohydrate often catches attention in two big sectors—food and pharmaceuticals—because it helps meet both nutritional and therapeutic needs. Every ingredient in these fields stands up to tough scrutiny, mostly because a small mistake can ripple out to affect real lives. Nobody wants an amino acid with hidden contaminants in their medicine, and nobody wants a food additive that falls short on purity. If you’ve ever talked with someone working in quality assurance at a pharmaceutical company, you’ll know the conversations don’t start with talk about “optimization” or “efficiency.” They jump right to purity tests, microbial counts, and batch records.
Quality ties directly into the factory and lab standards behind L-Lysine Monohydrate. Those seeking a product for human use often ask about certifications. Does the manufacturer follow Good Manufacturing Practice (GMP)? Have independent labs checked each batch for heavy metals, bacteria, and other impurities? Documentation should detail everything, from the origin of raw materials to storage protocols. Nobody in food or drugs compounds wants to roll the dice with an ingredient that carries risks—especially not after the public health scares we’ve seen in recent years around contaminated products.
Based on conversations with technical managers and dieticians, companies use certificates of analysis as their guide. These certificates should verify that the lysine meets standards set out in the Food Chemical Codex (FCC), United States Pharmacopeia (USP), or similar. Pharmaceutical buyers, in particular, want assurance this isn’t just an industrial-grade powder that found its way into a different bag.
Trust doesn’t come from words on a label. Companies demand transparency. Traceability means knowing exactly where each ingredient comes from, and if a problem shows up—say a spike in lead or E. coli shows up in a batch—investigators can trace it back step by step. Food companies and drug makers check supplier audits and look for full transparency in reporting. In the past, brands caught selling unapproved or contaminated lysine have faced harsh penalties, and lost public trust takes years to rebuild.
If you’ve been in a plant that processes food additives, you’ll know how often talks focus on allergens and cross-contamination. One missed line on an allergen control form, and the product can't go to market. Pharmacies and food brands ask about the proximity of peanut processing, gluten sources, or even traces of soy. The best suppliers prove they maintain strict segregation in their facilities.
The public doesn’t just count on regulators; they want transparency from brands. As consumers get more knowledgeable—reading ingredient labels and checking sourcing—companies can’t cut corners. Recent health trends lean toward “clean labels,” and the reputation of each ingredient makes a real difference. If a batch of L-Lysine Monohydrate fails compliance or lacks the right documentation, it rarely makes it to store shelves or pharmacy drawers anymore.
Suppliers who target both food and pharma sectors need regular audits, open channels for customer questions, and ongoing investment in testing technology. Food technologists and pharmacists both tell me that a single lapse can lose a multi-year contract. Certification systems like ISO, HACCP, GMP, or FSSC may seem like paperwork, but those stamps often mark the line between trust and skepticism.
Ultimately, every step—the fields where the ingredients start, the lines that process them, the vials they ship in—must stand up to a kind of scrutiny most outsiders never see. Buyers and consumers look for a clean, verifiable bill of health before accepting L-Lysine Monohydrate for their food or their medicine. No shortcut works in a business where safety and health form the only real bottom line.
Packaging does more than just hold powder. In the pharma world, every container acts as the first defense against moisture, air, and light, all factors known to degrade L-Lysine Monohydrate. You’ll often see pharmaceutical grade L-Lysine packed in double-layered polyethylene bags, sealed tight, and then dropped into either fiber drums, sealed aluminum cans, or HDPE drums. Each packaging method leans on proven materials that shrug off humidity and leaks. It’s common to spot 25-kilogram drums lined in plastic—large enough for manufacturers, but still small enough to control contamination risks as product gets used. For smaller quantities, you’ll see powder in 1 kg to 5 kg heat-sealed pouches, bag-in-box setups, or vacuum-sealed foil packs for labs who don’t want to gamble on spoilage. This isn’t about looks; it’s about making sure moisture, dust, and temperature swings can’t mess with the powder inside.
L-Lysine Monohydrate doesn’t last forever on a shelf. The stuff draws water from the air over time, and as humidity rises, purity falls. Most reputable suppliers mark a 2 to 3-year shelf life from the manufacture date, if you keep the stuff cool and dry, away from sunlight. Quality control teams watch for any signs of caking, discoloration, or chemical breakdown before shipping out drums. Once tampered packaging or clumped powder gets spotted, the whole batch faces scrutiny. Even climate-controlled warehouses run checks to keep microbe or oxygen exposure at bay, since degradation hurts both product quality and trust.
I’ve learned over years working with pharma ingredients that once moisture sneaks into a drum, quality goes south fast. Opening drums only when needed, measuring out what you need, and resealing tightly after each dip keep spoilage at bay. Desiccant packs tossed into drums, or pouches, pull stray water out of the air, extending life. Avoiding sunlight or wild temperature swings in your storage space pays off in fewer complaints about potency loss. I remember a client who stored drums near a loading dock; just a month in, he found a third of his batch unusable due to humidity seepage. His lesson: location in the warehouse matters as much as the container.
Packaging trends keep evolving. Some companies move beyond basic drums, turning to laminated aluminum pouches or smaller tamper-evident tubs for higher-risk environments and frequent handling. Seal integrity gets tested for leaks before anything leaves the line. Even simple QR codes on packaging make lot tracking and recall management easier—one scan reveals batch history, shelf life, and storage warnings. Smart packaging can save both the manufacturer and the end user from the mess of expired or contaminated material. It pays to ask for details, since not all packaging holds up the same under real-world stress.
It sounds simple, but separating stocks by expiry date, keeping inventory off damp floor, and not over-ordering help cut losses. Sometimes buyers grab the cheapest bulk bag, thinking it’ll save cash, only to watch a good chunk go stale before use. Learning from experienced handlers, following supplier handling guides, and regularly checking on old stock builds good habits that protect both budgets and product safety. In the end, the right packing decisions and smart storage mean less waste, better quality, and fewer compliance headaches for everyone down the line.
Buying anything that could impact health and safety should come with some level of proof. That’s where certificates of analysis, or COAs, step in. These documents offer real numbers—actual measurements of what’s inside the bag, jar, or bottle you’re buying. Whether looking for supplements, extracts, chemicals for research, or even products like CBD oil, a COA acts as a receipt that verifies quality.
Regulatory documents go one step further. They show a company’s products match up with government standards. No one likes red tape, but rules exist for a reason: to keep dangerous or contaminated products out of the marketplace. It’s easier than people think to cut corners, and people have gotten hurt before. Several years ago, supplements laced with pharmaceuticals made headlines because companies skipped proper oversight. With solid documents, nobody needs to wonder what’s in the package.
Any consumer, not just scientists in a lab, can benefit from digging into these documents. There’s a real human side to quality assurance. Someone might have allergies or an immune disorder. The label might say “gluten-free,” but only an honest COA shows test results. For cannabis and hemp products, a COA tells if the THC levels cross the legal threshold or if pesticides slipped in somewhere during production. Mistakes, or even outright fraud, can find their way into the market. Having a certificate means you aren’t just taking someone’s word for it.
On the regulatory front, knowing a product follows national and international laws unlocks access to global markets. For export and import, customs officials almost always ask for these proofs. It cuts down on delays and headaches. For buyers, it means someone has checked that the makers follow the rules—whether those come from the FDA, EPA, European authorities, or regulators in Asia. No one wants to risk fines or product seizures, especially for high-value shipments.
Earned trust makes a difference here. Companies with nothing to hide make these files readily available, sometimes right on their websites. I’ve dealt with vendors who wouldn’t share a COA—I moved on to a competitor who offered everything up front. There’s no good reason to hide ingredients or lab results if everything is clean. This open approach signals a business stands by its process.
It’s not always easy to spot a real COA, either. The best ones list batch numbers, detailed measurements, and the testing lab’s accreditations. Genuine documents include signatures and contact information for the lab. Manufacturers who provide full reports, not just summaries, deserve the benefit of the doubt. Beware of missing pages, redactions, or company-provided “test results” lacking lab details. That’s a red flag.
More people have begun asking for these documents. This public pressure works—companies step up when customers get vocal. Sometimes it means contacting a lab directly or using QR codes for instant verification. I’ve worked with organizations that include COAs and regulatory paperwork in every shipment. The return on effort is higher confidence and fewer disputes down the line. For businesses, offering proof up front cuts down on customer complaints. For buyers, there’s peace of mind.
The bottom line: if the seller avoids providing a COA or regulatory paperwork, keep looking. Reliable products carry real proof, not just promises.
| Names | |
| Preferred IUPAC name | (2S)-2,6-diaminohexanoic acid monohydrate |
| Other names |
L-Lysine HCl L-Lysine Hydrochloride 2,6-Diaminohexanoic acid monohydrochloride L-Lysine Monohydrochloride L-Lysine HCl Monohydrate |
| Pronunciation | /ɛl ˈlaɪsiːn ˌmɒnəʊˈhaɪdreɪt biː piː iː piː juː ɛs piː ˈfɑːrmə ɡreɪd/ |
| Identifiers | |
| CAS Number | 60343-69-3 |
| 3D model (JSmol) | `3D model (JSmol)` string for **L-Lysine Monohydrate**: ``` CC(C)[C@@H](N)C(=O)O.O ``` This is the **SMILES** string representing the 3D structure used by JSmol for visualization. |
| Beilstein Reference | 1720991 |
| ChEBI | CHEBI:86651 |
| ChEMBL | CHEMBL280658 |
| ChemSpider | 15378 |
| DrugBank | DB00114 |
| ECHA InfoCard | 13e2e615-58b6-4cd6-b179-b0c7c5a54cea |
| EC Number | EC 200-711-8 |
| Gmelin Reference | 1086 |
| KEGG | C00047 |
| MeSH | D-Lysine |
| PubChem CID | 22201792 |
| RTECS number | WH7000000 |
| UNII | 9DLQ4CIU6V |
| UN number | UN3077 |
| Properties | |
| Chemical formula | C6H14N2O2·H2O |
| Molar mass | 182.24 g/mol |
| Appearance | White crystalline powder |
| Odor | Odorless |
| Density | 0.5 g/cm³ |
| Solubility in water | Freely soluble in water |
| log P | “-3.0” |
| Vapor pressure | Negligible |
| Acidity (pKa) | pKa = 2.18 (α-COOH), 8.95 (α-NH3+), 10.53 (ε-NH3+) |
| Basicity (pKb) | pKb: 4.14 |
| Dipole moment | 6.2 D |
| Thermochemistry | |
| Std molar entropy (S⦵298) | 189.01 J·mol⁻¹·K⁻¹ |
| Std enthalpy of formation (ΔfH⦵298) | −1226.1 kJ/mol |
| Std enthalpy of combustion (ΔcH⦵298) | -3932 kJ/mol |
| Pharmacology | |
| ATC code | A11AA03 |
| Hazards | |
| Main hazards | May cause respiratory tract irritation. May cause eye irritation. May cause skin 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 | Keep container tightly closed. Store in a cool, dry place. Avoid contact with eyes, skin, and clothing. Wash thoroughly after handling. Use with adequate ventilation. |
| NFPA 704 (fire diamond) | NFPA 704: 1-0-0 |
| Lethal dose or concentration | LD₅₀ (oral, rat): > 5,000 mg/kg |
| LD50 (median dose) | LD50 (oral, rat): 5000 mg/kg |
| NIOSH | Not Listed |
| PEL (Permissible) | PEL (Permissible Exposure Limit) for L-Lysine Monohydrate: Not established |
| REL (Recommended) | 300 mg/kg |
| IDLH (Immediate danger) | Not Established |
| Related compounds | |
| Related compounds |
L-Lysine L-Lysine Hydrochloride L-Lysine Sulfate DL-Lysine L-Lysine Acetate L-Lysine Dihydrochloride |
Chengguan District, Lanzhou, Gansu, China
