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H-Lys-OH·2HCl

    • Product Name H-Lys-OH·2HCl
    • Alias Lysine Dihydrochloride
    • Einecs 205-749-9
    • Mininmum Order 1 g
    • Factory Site Tengfei Creation Center,55 Jiangjun Avenue, Jiangning District,Nanjing
    • Price Inquiry admin@sinochem-nanjing.com
    • Manufacturer Sinochem Nanjing Corporation
    • CONTACT NOW
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    Specifications

    HS Code

    747024

    product_name H-Lys-OH·2HCl
    chemical_formula C6H14N2O2·2HCl
    molecular_weight 221.12 g/mol
    appearance White to off-white powder
    solubility Soluble in water
    storage_temperature 2-8°C
    pH_of_1_percent_solution 4.5-6.5
    cas_number 657-27-2
    synonyms L-Lysine dihydrochloride, Lysine·2HCl
    melting_point 263-264°C (decomposes)
    purity ≥98%
    application Amino acid for peptide synthesis
    stability Stable under recommended conditions
    inchi_key KZSKWZQFJJYOLO-UHFFFAOYSA-N

    As an accredited H-Lys-OH·2HCl factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing H-Lys-OH·2HCl is supplied in a 100g amber glass bottle, sealed with a plastic cap, and labeled with safety information.
    Shipping H-Lys-OH·2HCl (L-Lysine dihydrochloride) should be shipped in tightly sealed containers, protected from moisture and light. It is classified as non-hazardous but should be handled with appropriate safety precautions. Package with cushioning materials to avoid physical damage and label in accordance with relevant chemical shipping regulations. Store at room temperature upon arrival.
    Storage H-Lys-OH·2HCl (L-Lysine dihydrochloride) should be stored in a tightly sealed container, protected from moisture and light, at room temperature (typically 15–25°C). Store in a cool, dry, and well-ventilated area, away from incompatible substances such as strong oxidizers. Follow all safety protocols for chemical storage, and keep the container clearly labeled and out of reach of unauthorized personnel.
    Application of H-Lys-OH·2HCl

    Applications of H-Lys-OH·2HCl in Industrial Manufacturing

    We supply H-Lys-OH·2HCl (L-Lysine hydrochloride) to specialized industrial customers with strict production and regulatory requirements. The following sections outline verified manufacturing scenarios where this amino acid derivative is utilized as a key ingredient, supported by industry standards, evidenced dosage practice, precise process considerations, and downstream finished product types.

    1. Pharmaceutical Grade Peptide Synthesis

    Peptide drug manufacturers employ H-Lys-OH·2HCl as a protected lysine building block in solid-phase peptide synthesis, enabling precise sequence assembly in compliance with international GMP guidelines. The raw material meets stringent purity and traceability demands for active pharmaceutical ingredient (API) intermediates in therapeutic peptide production, where minor formulation adjustments respond to specific target molecule requirements and regulatory filings.

    Industry compliance standards

    • ICH Q7 GMP for APIs
    • USP/NF, EP, JP monographs for amino acid raw materials
    • FDA cGMP 21 CFR Parts 210 & 211
    • EDQM guidelines for pharmaceutical substances

    Typical usage ratio

    • Mono-residue dosing as per sequence requirements, typically 1.0–1.5 molar equivalents per coupling step based on resin loading and amino acid chain length

    Downstream process integration

    • Direct charging into peptide synthesis reactors for stepwise Fmoc/Boc solid-phase synthesis
    • Post-coupling wash and deprotection protocols
    • Incorporation into purification and lyophilization of peptide APIs

    Final product types

    • Therapeutic peptides (injectable, oral lyophilizate, nasal sprays)
    • Peptide-based drug intermediates
    • Diagnostic peptide standards

    2. Parenteral Nutrition Formulations (PN Solutions)

    Clinical nutrition manufacturers utilize this lysine salt as a critical essential amino acid in compounding parenteral nutrition (PN) solutions, ensuring balanced amino acid supply for hospital and homecare infusions. Formulation precisely controls the inclusion based on patient nutrition protocols and adheres closely to validated pharmacopeial guidelines, as well as international standards for infusion admixtures.

    Industry compliance standards

    • USP/NF, EP, JP standards for injectable-grade amino acids
    • WHO Model List of Essential Medicines for Parenteral Nutrition
    • EN ISO 13485 for medical device/infusion bag manufacturing
    • EU and US Pharmacopoeia amino acid solution monographs

    Typical usage ratio

    • AA content adjusted between 0.5–2.5% w/v depending on total formula concentration, patient age, and clinical indication

    Downstream process integration

    • Dissolution into sterile mixing vessels under Class A/B cleanroom conditions
    • Filtration and sterile filling into multi-liter infusion bags or glass flacons
    • Terminal sterilization and in-process control (IPC) checks

    Final product types

    • Ready-to-infuse amino acid solutions for parenteral application
    • Custom-compounded total parenteral nutrition (TPN) admixtures
    • Pediatric and adult amino acid injection formulations

    3. Cell Culture Media Production

    Companies manufacturing high-purity cell culture media for biopharmaceutical fermentation and biotechnology R&D rely on H-Lys-OH·2HCl as a core component to promote cell proliferation, antibody expression, and recombinant protein yield. Use of this raw material adheres to controlled cell culture ingredient specifications, with close alignment to quality and traceability standards that assure lot-to-lot consistency for regulated downstream biological manufacturing.

    Industry compliance standards

    • ISO 13485 for medical/bio process suppliers
    • USP Chapter <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
    • European Medicines Agency (EMA) guidelines for cell therapy ancillary materials
    • Animal origin–free declarations and TSE/BSE certification

    Typical usage ratio

    • Final concentration in basal media typically 0.146–0.366 g/L; concentration finetuned to match the target organism’s growth profile and bioprocess needs

    Downstream process integration

    • Blending into aqueous basal media under controlled temperature and mixing protocols
    • pH adjustment, filtration (0.2 μm sterile filtration), and aseptic filling
    • Lot release through in vitro performance and sterility validation

    Final product types

    • Dry powder and liquid cell culture media
    • Serum-free and chemically defined media kits
    • Customized media for CHO, HEK293, BHK, and hybridoma cell lines
    • Component concentrates for biomanufacturing fermentation

    4. Food and Feed Premix Manufacturing

    Producers of specialty food fortifiers and animal feed supplements incorporate this lysine derivative as a nitrogen source to balance essential amino acid profiles. Human nutritional applications require strict food-grade specifications as defined under international additive standards, while animal feed usage targets maximal conversion efficiency in livestock production, monitored by global feed safety protocols.

    Industry compliance standards

    • FCC, Food Grade Certificates, FDA 21 CFR 172.320 (food additives)
    • EU Commission Regulation (EU) No 231/2012 (food ingredient spec)
    • FAMI-QS and GMP+
    • ISO 22000 and HACCP for food/feed safety

    Typical usage ratio

    • Food fortification: 0.15–0.5% w/w depending on product matrix
    • Animal feed additive: 0.1–0.3% for ruminant and swine formulations, adjusted per total dietary protein requirement

    Downstream process integration

    • Homogeneous mixing into vitamin and amino acid premix blends using ribbon blenders or paddle mixers
    • Integration into spray-drying or extrusion lines for granule and powder production
    • In-line QC for nutrient uniformity and contamination risk management

    Final product types

    • Infant formula and pediatric nutrition powders
    • Protein-fortified food bars and beverages
    • Multi-amino acid feed concentrates for livestock & aquaculture
    • Pet food enrichment premixes

    5. Diagnostic Reagent and Calibration Standard Production

    Diagnostic manufacturers use this reagent-grade lysine salt as a reference material for calibrating amino acid analyzers and quantitative clinical assays. High-purity requirements follow analytical and clinical chemistry norms, with careful batch validation to underpin routine production and quality assurance in laboratories and in vitro diagnosis (IVD) kit assembly.

    Industry compliance standards

    • ISO 13485 and ISO 15189 for IVD manufacturing
    • CLSI (Clinical Laboratory Standards Institute) recommendations for reference materials
    • Traceability to NIST and certified reference materials (CRM) where applicable
    • FDA 21 CFR Part 820 for medical device quality systems

    Typical usage ratio

    • Preparation of reference calibration standards typically at 10–200 μM for analyzer calibration; exact level as per instrument or diagnostic kit protocol

    Downstream process integration

    • Weighing and dissolution in phosphate-buffered saline or assay buffer solutions
    • Aliquoting into glass or polypropylene vials following gravimetric protocol
    • Batch-wise secondary standard preparation and documentation for traceability

    Final product types

    • Amino acid analyzer calibration solutions
    • Reference standards for clinical chemistry controls
    • Quality-control panels for laboratory proficiency testing
    • Diagnostic kit reagent components

    6. Biopolymer and Enzyme Manufacturing

    Specialist enzyme and biopolymer makers use this raw material to supply core nitrogen and carbon in fermentation media, supporting robust microbial growth for targeted biocatalyst production. Careful control of feed concentration and purity impact fermentation efficiency, linked to internationally recognized manufacturing standards for safe and consistent bioprocess output.

    Industry compliance standards

    • ISO 9001 for industrial enzyme/bioproducts
    • GMP for industrial and food enzyme production, as applicable
    • Food Chemical Codex (FCC) for bioprocess enzymes
    • Relevant national environmental & discharge regulations (e.g., REACH, EPA TSCA)

    Typical usage ratio

    • Inoculation media typically contains 0.10–0.25% w/v; adjustment based on target biomass yield, targeted enzyme titers, and strain-specific needs

    Downstream process integration

    • Addition to growth media during microbial and fungal seed fermenter preparation
    • Fed-batch dosing in bioreactor runs to support continued enzyme and biopolymer synthesis
    • QC sampling for amino acid profile stability post-fermentation

    Final product types

    • Industrial enzymes (e.g., proteases, amylases, lipases)
    • Microbially produced amino acid polymers
    • Specialty oligopeptides and biocatalysts
    • Enzyme blends for detergent, textile, and food processing
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    Certification & Compliance
    More Introduction

    H-Lys-OH·2HCl: Precision at the Foundation of Peptide Synthesis

    More Than a Reagent: Our Perspective as an Amino Acid Manufacturer

    In an industry where every variable counts, H-Lys-OH·2HCl—the dihydrochloride salt of lysine—continues to draw the attention of researchers and manufacturers alike. We speak from the floor of our own production lines: few materials reveal their quality or flaws so quickly as this fine white powder. When one batch supports uninterrupted peptide elongation, while another leads to side-reactions or impure products, the root often traces back to the choices made during H-Lys-OH·2HCl production. This is why we keep our own synthesis under tight control, from raw material sourcing to final packaging, ensuring that each shipment meets exacting standards for purity, moisture content, and absence of trace contaminants.

    Understanding H-Lys-OH·2HCl at Its Core

    At its essence, this product is the dihydrochloride salt of L-lysine, an amino acid bearing a side-chain that plays a critical role in peptide and protein chemistry. Unlike the free base of lysine, the dihydrochloride form provides a stable, crystalline, highly soluble powder. This form avoids the unpredictable caking and moisture retention that otherwise threaten both storage and solution preparation. Each year, as peptide synthesis projects grow more complex, the demand for reliable, high-purity H-Lys-OH·2HCl only intensifies.

    Decades on the synthesis line have shown us why this salt outperforms alternatives in solid phase peptide synthesis (SPPS) and related applications. Many would dismiss the impact of residual solvents or trace metals at the parts-per-million level. Our experience says otherwise: even slight contamination disrupts automated peptide assembly, leading to truncated sequences or by-products. H-Lys-OH·2HCl, with its established track record, shields researchers from these setbacks by presenting a clear analytical profile batch after batch.

    Model and Specifications: What Matters Most

    As natural scientists and hands-on technologists, we do not chase the newest label or internal code for marketing appeal. We invest in tight parameter control. Purity sits at the heart of our internal checks, commonly measured by HPLC and titration, with limits surpassing 98 percent on a dry basis as standard. Heavy metals rarely escape our scrutiny, with defined limits far below international thresholds; we see the results echoed in smoother couplings and higher peptide yields. Residual solvents, especially any remaining from hydrochloride addition, routinely stay beneath detection limits thanks to vacuum drying at controlled temperatures.

    Granular details carry consequences. Moisture content above one percent opens the door to unwanted side-reactions, so controlled-atmosphere rooms play a prominent role. Particle size might not seem crucial to every user, but uneven granulation impacts not only solution preparation but also the dosing and feed delivery in automated systems. By optimizing crystallization, we supply a powder that resists clumping and pours freely, even in extended storage periods.

    Packed for Protection, Delivered for Efficiency

    Every kilogram of H-Lys-OH·2HCl leaves our facilities in high-barrier, multi-layer packaging designed to keep out light, moisture, and atmospheric gases. We have tested plenty of alternatives—plastic drums, simple zip-bags, even glass jars for specialty uses—and have settled on this approach after years of monitoring stability samples. Material remains as delivered even after months in a storage warehouse, so customers receive product equal to what we handle in-house.

    We have also responded to requests for custom lot sizes. Labs working on early-stage projects often rely on 100-gram or 250-gram packs, while larger pharmaceutical production lines order by the drum. From our vantage point, "one size fits all" solutions serve no one well, which is why we keep our filling rooms flexible and our batch records tightly managed for traceability.

    Applications Across Industries: From Laboratory Bench to Pilot Plant

    Much of H-Lys-OH·2HCl's output supports the pharmaceutical sector, where it forms the backbone for both research-grade and commercial peptides. Experienced scientists recognize the cost of rework and re-validation: a poorly characterized lysine salt can halt a production run or undermine regulatory submissions. Even when serving academic labs running advanced coupling chemistry, issues like "ghost peaks" in HPLC traces or inconsistent elongation stops can often be tracked to impure amino acid reagents, especially during scale-up.

    Outside direct peptide synthesis, our product finds use in enzyme production, tissue culture feed supplementation, and even certain cosmetic ingredient formulations needing a source of highly pure lysine. Although these users make up a smaller share of demand, their requirements for analytical precision, consistent solubility, and batch-to-batch uniformity never fall below the bar set by pharma giants. Smaller differences in specifications ripple outward: a solubility gap or color variation might be acceptable in food-grade material, but in these high-precision uses, every detail matters.

    Comparing H-Lys-OH·2HCl With Other Lysine Forms

    We field frequent questions about whether the dihydrochloride salt—Lysine dihydrochloride—actually differs in performance from the monohydrochloride salt or the free base. Experience shows that the dihydrochloride offers clear advantages for those building complex peptides. The two chloride ions neutralize both the α- and ε-amino groups, providing a predictable, fully protonated form. Handling the free base or the monohydrochloride salt introduces extra steps for pH control and raises the chance of unwanted side-reactions in manual or automated syntheses.

    The most common competitor, food-grade L-lysine monohydrochloride, enters the market at a lower price point. Yet it comes with substantial compromises: higher moisture content, more variability in particle size, and greater risk of trace contaminants drawn from mass fermentation production methods. For fine chemical applications, especially those demanding lengthy regulatory filings, the consistency and traceability found in pharmaceutical-grade H-Lys-OH·2HCl outweigh any cost difference. Food-grade material works for some feed or fertilizer uses, but stops short of meeting the purity and performance needs of biopharma and diagnostics.

    The difference becomes starker when chromatography comes into play. Our H-Lys-OH·2HCl demonstrates a single sharp peak, low UV absorbance at critical wavelengths, and no sign of interfering by-products. Attempts to substitute technical-grade or food/feed intermediates often lead to headaches in downstream processing. Over the years, we have supplied customers who endured repeated failed syntheses with technical grades and then found their workflow stabilized only after switching to our controlled product.

    Pitfalls in Manufacturing and How We Navigate Them

    Managing a reliable supply of high-grade amino acid salts like H-Lys-OH·2HCl draws on more than just a well-equipped production facility. The greatest threats often begin with the choice of starting materials. Sub-par L-lysine feedstocks, prone to optical impurities or trace fermentation byproducts, create challenges that no downstream purification step can fully resolve. We have invested in direct relationships with select L-lysine producers, arranging for dedicated lots and joint analytical stringency, rather than relying on commodity intermediates.

    During synthesis, reaction temperature control and careful addition of hydrochloric acid define the difference between a uniform crystalline powder and amorphous, sticky masses prone to degradation. Operators need extensive training to spot telltale shifts—slight color changes or unexpected viscosity signals—that indicate a deviation. Automated controls help, but the human eye and years on the bench remain irreplaceable. We have learned not to cut corners on drying, which draws unneeded moisture off the finished salt and locks in both free-flowing powder and long-term stability. Even routine cleaning of our production lines avoids introducing metal ions, which later undermine peptide coupling yields.

    Testing by independent labs complements our own in-house quality checks: samples routinely make their way to third-party facilities for heavy metal and residual solvent screening. We embraced this external oversight willingly, knowing that only robust, transparent data count for customers navigating regulatory filings or troubleshooting challenging reactions. We do not gamble with loose specifications, knowing firsthand the downstream havoc they can create.

    Supporting Complex Synthesis: Partnership With the End User

    Getting an amino acid salt like H-Lys-OH·2HCl right does not end at the loading dock. Many of our customers work on the frontier of peptide API development, needing not just a product but also guidance grounded in manufacturing reality. Over years of direct support, we have answered questions spanning optimal dissolution protocols, recommendations for pre-use drying, and fine-tuning storage conditions. A batch flagged as "off-spec" by a customer doesn't just prompt a refund; it triggers a root-cause analysis reaching deep into our production logs. By closing the feedback loop, we identify both critical process parameters and overlooked risks, sharing those insights with both internal teams and trusted partners.

    Some requests have stretched our process know-how. We have designed extra-filtration steps to meet ultra-low endotoxin specifications for especially sensitive bio-reactor feeds. Other cases demanded a change in packaging after a longtime collaborator reported signs of early clumping after long-haul shipping during monsoon season. We do not see these as exceptional service, but rather as an extension of the collaborative approach that sets manufacturers apart from anonymous traders: our understanding of H-Lys-OH·2HCl is both rooted in chemistry and shaped by daily realities on the ground.

    Long-term projects, such as scale-up of therapeutic peptide APIs or validation batches for diagnostics, demand massive reliability. Our production planning includes reserve stock and redundant equipment to mitigate shortages, drawing on a multi-year record of uninterrupted supply even through periods of increased demand or logistical disruptions. The trust customers place in our material shapes every upstream decision, from which L-lysine supplier we source to the choice of cleaning solvents in our reactors.

    Regulatory Considerations and Industry Trends

    The world rarely stands still: regulatory expectations rise, assay requirements grow stricter, and new supply chain risks emerge at every turn. The last decade has seen a clear trend towards greater transparency, whether in cGMP standards for pharmaceutical intermediates or the demand for detailed impurity profiles from diagnostics companies. Firms relying on mass-market grades increasingly find themselves caught off guard by new regulations. From our vantage, close engagement with both global and local standards agencies serves as insurance: our documentation, lot traceability, and validated methods clear the hurdles so customers won't hit a roadblock months or years down the line.

    Traceability is not just a buzzword. Each container of H-Lys-OH·2HCl carries full batch data accessible for audits or regulatory submission. We maintain the raw data for years, supporting not only our processes but also clients' downstream needs, such as re-certification or recall studies. Over time, this documentation-first approach has become a crucial advantage, shortening the step from product acquisition to final user approval.

    The landscape continues to shift as well. High-throughput peptide synthesis platforms, which drive demand for sharper, cleaner intermediates, have forced older production lines to modernize or exit the space entirely. In response, our plant regularly audits its crystallization, drying, and filling procedures. Sharper scrutiny of allergen, endotoxin, and even microplastic residues drives near-constant review of both sourcing and finished product testing. We have adapted not by inflating costs or restricting supply, but through investment in smarter production controls, better powder handling, and more comprehensive staff training.

    Challenges and Future Directions

    Every manufacturer of H-Lys-OH·2HCl faces ongoing challenges. Volatile availability of top-tier L-lysine raw material, fluctuations in energy costs, and shipping disruptions threaten stability. There is no shortcut here: advanced purchasing, diversified suppliers, and careful buffer inventory are strategies honed through tough experience. In some years, extreme weather or supply chain interruptions pushed us to redesign our delivery logistics entirely, including even the route materials take from fermentation plant to final packaging.

    A significant challenge arises with sustainability, as both customers and regulators want reassurance that process waste streams and downstream emissions have been minimized. Our team has explored lower-impact hydrochloride generation routes, implemented solvent recycling systems, and retrained staff on energy-efficient batch processing. We find the gains worthwhile, with performance and regulatory compliance improving in lockstep. Even routine decisions about packaging—choosing recyclable materials, reusing secondary containers—help preserve trust with environmentally focused clients.

    Technical advances continue to shape our approach. Current research into continuous synthesis platforms, advanced crystallization, and even AI-driven yield prediction offers hope for future cost reduction and quality enhancement. For now, careful batch-by-batch synthesis, anchored by skilled human workers, delivers the product quality our customers expect. We keep a close watch on emerging methods but never transition production until rigorous internal and external validation. This cautious innovation means we consistently supply H-Lys-OH·2HCl that works, not just on the specification sheet, but in the real-world settings where customer expectations and scientific ambitions meet.

    Conclusion: The Value of Experience-Driven Manufacturing

    Beyond every shipment of H-Lys-OH·2HCl stands a set of practices, traditions, and judgments refined through years of chemical manufacturing experience. Our customers trust us because each drum, bottle, or lab pack bears the signature of defined process control and quality assurance, rather than luck or clever branding. The best evidence comes from long-standing clients who have tried alternatives—free base, monohydrochloride, food-grade intermediates—but return for the crystalline, reliable, and thoroughly characterized salt we provide.

    The marketplace may see lysine products as mere commodities, but direct, hard-won knowledge of peptide chemistry, analytical challenges, and downstream process needs shows how much work unfolds before each batch lands in a laboratory or production facility. For researchers and chemists, whether scaling up a life-saving therapy or running the 500th peptide sequence, our commitment to quality means that H-Lys-OH·2HCl supports not only individual projects, but the steady advance of science and medicine.