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Histamine

    • Product Name Histamine
    • Alias 2-(4-imidazolyl)ethylamine
    • Einecs 200-467-2
    • 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
    VTB
    Specifications

    HS Code

    207084

    Name Histamine
    Chemical Formula C5H9N3
    Molecular Weight 111.15 g/mol
    Iupac Name 2-(1H-imidazol-4-yl)ethanamine
    Cas Number 51-45-6
    Appearance Colorless hygroscopic solid
    Melting Point 83–84 °C
    Solubility In Water Highly soluble
    Pka 5.8 (imidazole ring), 9.4 (amino group)
    Biological Role Organic nitrogenous compound involved in local immune responses

    As an accredited Histamine factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing Histamine, 5g amber glass bottle with screw cap; labeled with product name, chemical formula, CAS number, and hazard warnings.
    Shipping Histamine is shipped as a hazardous chemical and must comply with relevant regulatory requirements. It is typically packed in sealed, clearly labeled containers, protected from light and moisture. Transport follows safety protocols for toxic substances, including leak-proof packaging, with documentation indicating UN number 1937 and appropriate hazard classifications for safe handling.
    Storage Histamine should be stored in a tightly closed container, protected from light and moisture, in a cool, dry, and well-ventilated area. It should be kept at room temperature, typically between 2–8°C, away from incompatible substances such as oxidizing agents. Proper labeling and secure storage prevent accidental exposure, degradation, and ensure safety in laboratory or industrial settings.
    Application of Histamine

    Applications of Histamine in Industrial Manufacturing

    As a direct manufacturer of histamine, we supply this specialty chemical to core industrial sectors for controlled, regulatory-compliant processes. Our product goes through strict QC to meet the exacting standards of pharmaceutical, biotechnological, food, and diagnostic test kit production. The following sections detail the principal downstream application routes, separated by segment, with implementation parameters for each context.

    1. Active Pharmaceutical Ingredient (API) Synthesis in Allergy Diagnostics

    Pharmaceutical labs use histamine as a critical positive control agent in skin prick allergy testing formulations. Our manufacturing clients incorporate it under strict batch traceability, with careful concentration regulated to meet medical guidelines. The histamine hydrochloride form is dissolved into sterile diluent and loaded onto commercial skin test kit systems for application in clinical allergology.

    Industry compliance standards

    • USP (United States Pharmacopeia) monographs for Histamine Dihydrochloride
    • European Pharmacopoeia (Ph. Eur.) reference standards
    • 21 CFR Part 211 (GMP for Finished Pharmaceuticals)
    • FDA guidance for biological allergen products (allergy diagnostics)

    Typical usage ratio

    • 0.1 mg/mL final concentration for skin test formulations, with precise dosing for batch uniformity based on validated clinical reference ranges

    Downstream process integration

    • Blending in aqueous solution with pharmaceutical-grade excipients
    • Sterile filtration and aseptic filling into test vials or ampoules
    • QC checkpoints including concentration verification and sterility assurance before final packaging

    Final product types

    • Skin prick allergy test kits
    • Positive control vials for in vitro histamine response
    • Allergen panel production lots for medical use

    2. Biotechnological Research Reagents

    Leading biotech manufacturers purchase histamine for controlled cell signaling and receptor activity assays in preclinical drug discovery platforms. End users require high-purity free base or salt form, which integrates into custom assay kit reagents, animal model feeds, and cell culture protocols within molecular pharmacology R&D. Packaging, labeling, and COA must satisfy academic and commercial laboratory standards.

    Industry compliance standards

    • ISO 9001:2015 (Quality Management for Laboratory Reagents)
    • Certificate of Analysis (COA) documentation with purity >98.0%
    • OECD Good Laboratory Practice (GLP) standards (where applicable)

    Typical usage ratio

    • 0.01–10 μM in receptor binding or activation assays
    • 1–100 mg/kg in vivo dosing for animal research feed, adjusted based on protocol needs and species

    Downstream process integration

    • Direct dissolution into physiological saline for in vitro protocols
    • Homogenization into animal feed or liquid diet preparations
    • Aliquoting for distribution in high-throughput screening formats

    Final product types

    • Biochemical assay kits targeting histamine receptor studies
    • Cell stimulation reagents for receptor pathway analysis
    • In vivo pharmacological test feeds

    3. Food and Beverage Quality Control Standardization

    Industrial processors engaged in seafood, wine, and cheese production laboratories rely on histamine reference standards for residue and spoilage control. Our histamine is used by chemical analysis kit manufacturers and food QC labs who monitor biogenic amine levels according to safety legislation. Certified batches ensure traceability for calibration and validation of test results in regulatory screening.

    Industry compliance standards

    • ISO 17025 for food analysis laboratories
    • CAC/GL 56-2005 (Codex Guidelines for Histamine in Fish and Fishery Products)
    • EU Regulation (EC) No. 2073/2005 (Microbiological food criteria including histamine limits)

    Typical usage ratio

    • Premixed calibration standards at 2–100 mg/L in test kit assembly for seafood and wine

    Downstream process integration

    • Solution blending into certified reference sample sets for commercial test kit production
    • Distribution to QA labs for daily equipment calibration and method validation

    Final product types

    • Food safety histamine detection kits
    • Certified reference materials for chemical analysis
    • Calibration controls for HPLC and rapid test strips

    4. Veterinary Medicine Formulation

    Veterinary preparation labs utilize histamine salts for provocation and diagnostic challenge tests in animal health applications. Production requires GMP compliance, consistent granularity, and precise dissolution. The compound integrates into injectable or oral challenge formulations designed to monitor animal allergenic responses with full batch release testing for veterinary regulators.

    Industry compliance standards

    • European Pharmacopoeia (veterinary substances)
    • VICH GL 9 (Good Clinical Practice for Veterinary Medicinal Products)
    • Local Ministry of Agriculture registration for veterinary active substances

    Typical usage ratio

    • Injection formulations at 0.01–0.1 mg/mL for provocation tests in target species; dosage varies by clinical protocol

    Downstream process integration

    • Weighing and dissolution into sterile saline for injectable dosage form development
    • QC verification through endotoxin and identity testing

    Final product types

    • Veterinary allergy test kits
    • Diagnostic injection solutions

    5. Clinical Diagnostic Enzyme Assays

    Producers of enzyme-based clinical diagnostic kits incorporate histamine as both a substrate and enzyme calibration agent. This application requires high assay-grade purity and stable, quantified packaging for enzyme histaminase or monoamine oxidase testing. Manufacturers formulate the compound to integrate with reagent buffer systems, ensuring accuracy in patient sample measurement protocols for hospital and laboratory use.

    Industry compliance standards

    • IVD (In Vitro Diagnostic Medical Devices Regulation) EU 2017/746
    • ISO 13485:2016 (Medical Device Quality Management Systems)
    • FDA 21 CFR 820 (Quality System Regulation for Diagnostics)

    Typical usage ratio

    • 10–500 μM in calibration or substrate buffer for commercial enzyme assays, adjusted per lot and required dynamic range of detection

    Downstream process integration

    • Dissolution into buffered analytical reagents during diagnostic kit manufacture
    • Aliquoting to multi-well plates or lyophilization for ready-to-use formats
    • In-process and finished kit QC for accuracy and stability

    Final product types

    • Enzyme activity test kits for hospital and research use
    • Calibrators for monoamine oxidase and diamine oxidase diagnostics
    Free Quote

    Competitive Histamine prices that fit your budget—flexible terms and customized quotes for every order.

    For samples, pricing, or more information, please call us at +8615371019725 or mail to admin@sinochem-nanjing.com.

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    Certification & Compliance
    More Introduction

    Histamine: Reliable Quality from the Source

    What Sets Our Histamine Apart

    Producing histamine takes commitment to purity, safety, and consistency. We handle every gram of raw material ourselves at our own facility, which means our team oversees the entire process—right from synthesis through to finished product. Running state-of-the-art reactions and securing strict process controls has given us valuable experience with the quirks and complexities this compound brings. Our chemists have spent years refining our process to minimize known byproducts and maximize reproducibility. The result shows in a clean, fine-grained histamine dihydrochloride that meets the benchmarks scientists look for: clear melting range, tight specification for related substances, and low moisture.

    We maintain a running dialogue with researchers and formulators who depend on histamine. Our chemists listen closely when customers point out batch-to-batch variation or rare, unexpected impurities. Modifying syntheses or tweaking purification steps, we choose reliable starting materials, run in-house HPLC, and trace each lot’s story. You’re sourcing histamine from a manufacturer who knows how subtle shifts in pH or water content can matter. Every kilo that leaves our plant meets traceability and documentation requirements. That’s not a marketing slogan—it’s a matter of science and trust.

    Making Sense of the Details: Our Model, Specs, and Forms

    We offer histamine dihydrochloride for research and pharmaceutical use. Our production follows a batch process, and each batch comes with a Certificate of Analysis listing specific data points: purity by HPLC or titration, residual solvent results, identity by IR and NMR (when requested), and appearance checks. A typical batch falls within 99–101% purity by HPLC and shows a crisp melting point consistent with pharmacopeia monographs.

    The main form we produce is a free-flowing, crystalline powder that dissolves completely in water, leaving no visible residue. Bulk customers often request bags ranging from 500 grams up to 25 kilograms. Smaller bottles for laboratory research receive the same attention. For those scaling up pharmaceutical manufacturing, we can supply lots with tighter impurity specs by adding extra purification steps, though this extends lead time. Offering a standard specification helps with planning; if you ask for enhanced documentation or non-standard forms—such as micronized powder or special blends—our technical team handles these requests internally, which cuts lead times and miscommunication.

    Intended Uses and Your Application—What Matters Most

    Histamine’s uses reflect the breadth of the chemical, medical, and life science fields. Scientists studying allergic reactions, inflammation, or neurotransmission depend on our material for bioassays and preclinical models. Histamine dihydrochloride also finds a place in clinical diagnostics, where quality must be tightly managed due to its known effects at low doses. The pharmaceutical world brings the most scrutiny—every parameter, from particle size to extractable metals, becomes crucial in injectable or oral dosage forms.

    Those working in the laboratory usually look for clean handling, prompt solubility, and tight labeling on every bottle. With bulk manufacturing, differences take on a larger role. For instance, as particle size or powder density changes, suspension or blending behaviors can shift. That’s why we run powder rheology tests on request and maintain data on each production lot’s properties. Pharmaceutical customers also care about elemental impurity risk, environmental controls, and nitrosamine screening—even more so in the wake of recent regulatory moves.

    Histamine vs. Other Suppliers: Direct Relationship Matters

    Many customers step into the histamine market through traders, third-party brokers, or repackagers. This brings risk and uncertainty. Labeling might be inconsistent, lots may not trace back to a true origin, and there’s little feedback loop about process changes or new analytical requirements. We’ve heard about labs receiving histamine that felt sandy, didn’t dissolve well, or gave off-color reactions on chromatography. Each issue erodes trust and complicates science.

    By dealing directly with a manufacturer, you get first-hand answers about batch decisions, storage protocols, and any process changes. If there’s any doubt—say, a changed impurity profile after shipment or possible assay drift—we can pull up in-plant records, retain samples, and resolve it quickly. For pharma or diagnostic use, this is as important as the molecule itself. Our responsibility runs from reaction scale-up all the way to the final drum or bottle that goes into your laboratory or production line.

    In today’s chemicals market, synthetic steps have grown more complex. The move toward green chemistry, the drive to limit genotoxins, and changing expectations from regulators mean you can’t assume two histamine batches are interchangeable. By staying close to our product and keeping synthesis in-house, we react swiftly to new guidance, market needs, or quality expectations. We have navigated supply interruptions and regulatory changes in the past; customers who chose to trust a known source fared better than those left searching after a quality recall.

    Facing Real Problems: Purity, Consistency, and New Needs

    Manufacturing histamine isn’t just about ticking purity boxes. It requires a lot of vigilance. For years, some labs—their results unpredictable—tracked the issue back to trace amines or oxidized byproducts in the raw histamine. We learned to adjust our cycle, tweak solvent quality, and increase control over reaction pH. Moisture, often overlooked, affects both shelf life and reactivity in solution, especially for analytical and pharmaceutical applications. Our storage area holds temperature and humidity stable, and every outgoing batch gets checked for Karl Fischer water content.

    Regulation never stands still, and nor do the needs of our customers. The requirement for ever-lower impurities, particulate control, and safety documentation drove extensive investment in analytical equipment and in-process controls. Several years ago, changes in European pharma guidance forced us to deepen our risk assessment for elemental impurities and nitrosamines. We responded by running side-by-side validations and resolving gaps before regulators came knocking. Rather than chase the bare minimum, we aim to lead, so questions from clients already have clear, reliable answers.

    Some competitors cut corners by outsourcing synthesis or reprocessing leftover mother liquors. These shortcuts might make a sale in the short run but introduce risks—non-conforming residuals, missed identification of related substances, and unreliable documentation. We stick with controlled, fresh production cycles, steadily refining yields and efficiency to offer competitive pricing that doesn’t compromise on quality.

    Product Integrity from Start to Finish

    Trust comes from the continuity between manufacturing and our clients’ end uses. Laboratories need a consistent product so that controls work, baselines stay steady, and statistical noise stays low. For pharmaceuticals, real-world reliability means much tighter parameters, which translates into more rigorous documentation, trace element screening, and process validation.

    Every histamine batch stays under study in our retained sample archive—if an issue arises months or years down the line, we investigate without delay. Some users request micro-sized batches, and others require multi-kilo lots for validation and market release. We have met urgent needs by expediting scheduling, expanding capacity, and working longer shifts—delays in the clinical world affect outcomes far beyond our factory.

    With every order, we provide full batch records and supply chain documentation, so our customers stay compliant and audit-ready. Many auditors have commented on the depth and clarity of our records. Working directly, you can always discuss requirements before ordering, and follow up on technical or regulatory needs later.

    Supporting Progress in Research and Therapy

    Histamine’s role goes beyond fundamental research. Each year, more groups explore its effects in cell lines, animal models, or developing molecules that tweak histamine receptors. Novel drug candidates and diagnostic tests mean increased scrutiny over raw materials. Our technical department stays engaged with these developments, attending conferences and reviewing current literature, helping clients find the ideal form, purity, and documentation support for their work.

    We know timelines matter. Planned studies depend on reliable raw materials. We hold running stocks to minimize downtime, and our logistics staff has weathered supply chain challenges from weather to pandemics. This involves regular, proactive conversations with our logistics partners—enough to avert most disruptions before they happen.

    Pharmaceutical development brings tough audits and demands forensic-level record-keeping. That’s why, as soon as a question or deviation emerges, our QA team investigates thoroughly and shares lessons learned with other clients in similar fields. Ethical manufacturing means placing human health and safety above short-term profits. We have always chosen to invest ahead of regulation: improved isolation areas, barrier controls, and worker training all pay off in product consistency and, ultimately, client trust.

    Continuous Learning: Listening, Improving, Earning Trust

    Manufacturing quality histamine requires two-way communication with the real people using it daily. Our technical service group is staffed by chemists willing to discuss small details: how a certain solvent, used upstream, might affect shelf life; why a particular test reveals solubility changes or particle size variation. Many of our improvements came directly from listening—incorporating customer feedback on physical properties, packaging, and paperwork.

    We visit customer labs, observe handling practices, and watch what happens to our product after it leaves the plant. First-hand observations matter as much as batch analytics. Customers have pointed out issues with static buildup in some types of packaging, clumping in humid climates, or label designs that were too easy to smudge during transit. We took those lessons and updated our materials, providing tamper-evident closures and moisture-proof liners for bulk buyers, along with user-friendly, legible labels for lab-scale users.

    Process changes at our plant rarely happen behind closed doors—clients know when shifts are planned, and we discuss potential impacts together. Our company operates under a culture that prizes transparency over marketing spin. We believe our buyers deserve an honest reckoning with any issues. No chemical process runs perfectly every time. We confront process anomalies directly, document deviations, and deliver nonconforming product reports as soon as possible if they ever arise. Most manufacturers hide mistakes; we see mutual benefit in confronting and correcting problems as a community.

    Comparing Direct and Indirect Sourcing

    Direct relationships cut the risk of supply chain snags. With repackagers or traders, misplaced labels or shifts in storage conditions may escape detection, causing avoidable compliance problems. Reports from the field confirm that missing paperwork can stall shipments or invalidate experimental results. By purchasing directly from a facility like ours, researchers and manufacturers get the transparency and accountability needed to avoid project delays.

    We keep platform-to-platform dialogue with our clients. From the onset of an order, through delivery, to follow-up, our staff remains available for troubleshooting or technical explanation. If you ever face documentation questions during an audit, our technical and quality staff can respond with detailed records, even years after shipping. Most third-party vendors lack this technical context because they aren’t involved in daily production and don’t retain long-term records or technical staff familiar with your use case.

    We ship globally and comply with customs regulations. Our logistics team knows how to handle hazardous materials, and we work closely with regulatory authorities to avoid shipment delays. In practice, that means urgent research or manufacturing won't get held up waiting for noncompliant paperwork or improperly packaged goods.

    A Future-Focused Approach

    Histamine’s place in scientific, medical, and industrial work keeps changing. Trends point to more targeted drugs, tighter impurity requirements, and increased focus on trace contaminants. Our manufacturing responds—adopting cleaner solvents, eco-friendly synthesis steps, and more sensitive analytical techniques. Regular internal reviews keep our approach up to date. Regulatory requirements shift rapidly, and so we monitor proposed changes, read the latest pharmacopeia drafts, and keep close relationships with regulatory and inspection agencies.

    Feedback loops go through everyone—chemist, packager, logistics, and even finance staff. Lessons learned from each batch or incident inform training, equipment upgrades, and often inform research collaborations with academic or pharmaceutical partners. We see ourselves as stewards, responsible not only for product quality but for the science and health advances our histamine supports.

    Every day brings fresh challenges, whether demand spikes, regulatory pressures, or scientific surprises. Our commitment stays rooted in making a product that both researchers and manufacturers can trust—from the first bag opened in a research lab to the final vial delivered for clinical use.