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Nafamostat

    • Product Name Nafamostat
    • Alias Futhan
    • Einecs 254-029-4
    • 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

    791606

    chemical_name Nafamostat
    molecular_formula C19H17N5O2
    molecular_weight 347.37 g/mol
    CAS_number 81525-10-2
    drug_class Serine protease inhibitor
    mechanism_of_action Inhibits proteolytic enzymes such as trypsin, thrombin, and plasmin
    route_of_administration Intravenous
    primary_use Anticoagulant in extracorporeal circulation
    half_life Approximately 8 minutes
    appearance White to off-white crystalline powder
    solubility Freely soluble in water
    storage_temperature Store at 2°C to 8°C

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

    Packing & Storage
    Packing Nafamostat is packaged in a sealed amber glass vial, containing 100 mg of sterile lyophilized powder, labeled with product and safety information.
    Shipping Nafamostat is shipped in compliance with international regulations for the transport of hazardous chemicals. It is securely packaged in tightly sealed containers, with appropriate labeling and documentation. Shipments are typically sent at controlled room temperature, or refrigerated if specified, and handled by authorized carriers to ensure product integrity and safety.
    Storage Nafamostat should be stored in a tightly sealed container, protected from moisture and light. Keep it at a temperature between 2°C and 8°C (refrigerated conditions). Avoid freezing. Store in a secure, well-ventilated area away from incompatible materials such as acids or oxidizing agents. Ensure the storage area is marked for chemicals and restrict access to authorized personnel only.
    Application of Nafamostat

    Applications of Nafamostat in Industrial Manufacturing

    Nafamostat is a specialized synthetic serine protease inhibitor with advanced applications across key life science and biochemical manufacturing segments. As the originator, we ensure strict compliance, precision batching, and process control to support global pharmaceutical, cell therapy, diagnostic reagent, extracorporeal therapy, and research industries with consistent industrial-grade Nafamostat integration.

    1. Anticoagulant Reagent Production for Hemodialysis and Extracorporeal Circulation

    Large-scale producers of anticoagulant solutions for use in hemodialysis, hemofiltration, and extracorporeal membrane oxygenation (ECMO) frequently source Nafamostat as a critical active ingredient. Facilities must implement exacting formulation protocols, where sterile GMP-compliant solution blending lines introduce the compound at a late stage under continuous monitoring. Quality teams calibrate the concentration based on treatment modality and patient blood flow rates, strictly controlling impurities and active validation per pharmacopoeial monographs. Batch release hinges on both analytical and biological activity data, as downstream medical device integration requires consistency for patient therapy. Key customers deploy ready-to-use anticoagulant solutions administered in clinical dialysis centers and ICU settings.

    Industry compliance standards

    • Japanese Pharmacopoeia (JP) monograph for Nafamostat Mesylate for injection
    • Good Manufacturing Practice (GMP, PIC/S, ICH Q7)
    • ISO 13485 for medical device-related solutions
    • European Directorate for the Quality of Medicines (EDQM) APIs compliance

    Typical usage ratio

    • 0.01–1 mg/mL in final solution (precise dose based on clinical protocol and dialysis system)
    • Adjusted to total blood volume flow and patient body weight in large-volume manufacturing

    Downstream process integration

    • Introduced post-filtration, sterile compounding with closed-system mixing at controlled temperature
    • In-line sterile filtration with real-time UV/vis quantification before terminal fill
    • Final filling under ISO Class 5 aseptic conditions

    Final product types

    • Ready-to-use anticoagulant infusion bags/cartridges for dialysis machines
    • Sterile injectable ampoules or vials for hospital and clinical use
    • Pre-mixed ECMO-compatible anticoagulant fluid packs

    2. Active Pharmaceutical Ingredient (API) Manufacturing for Injectable Anticoagulant Drugs

    Pharmaceutical companies manufacturing injectable anticoagulant drugs source purified Nafamostat for use as a regulated API. Production units perform multi-step crystallization and purity validation to meet finished product registration requirements in key regulated markets. Process teams operate reactor lines under GMP with precise solvent controls, while QA maintains in-process documentation for regulatory submissions. Batches undergo comprehensive release testing for identification, purity, residual solvents, and microbiological contamination. The API is shipped to global contract manufacturers and brand owners for final drug product compounding and fill-finish, supporting the hospital injectable portfolio for acute thrombosis management.

    Industry compliance standards

    • GMP for APIs (ICH Q7, EudraLex Vol. 4 Part II)
    • Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP)
    • FDA Drug Master File (DMF) referencing for US submissions
    • Relevant country registration dossiers (e.g., NMPA, PMDA)

    Typical usage ratio

    • API batch purity: ≥98.5% by HPLC or titration
    • Blending for finished drug: 2–10 mg/2mL or as specified by dossier formulation

    Downstream process integration

    • Crystallized and milled post-synthesis, transferred under nitrogen blanket to blending suite
    • Weighing and QC sampling pre-blending for injectable formulation
    • Packed in sterile, double-lined drums or glass containers for controlled distribution

    Final product types

    • Single-use injectable anticoagulant vials for hospital formulary supply
    • Bulk solution APIs for compounding pharmacies
    • Combination anticoagulant/fibrinolytic drugs for critical care

    3. Specialty Protease Inhibitor Additive in Cell Therapy and Bioprocessing

    Cell therapy manufacturers and advanced therapy producers incorporat Nafamostat as a functional protease inhibitor in bioreactor cultures, cell expansion, and virus-based vector production. Bioprocess teams add the compound during key steps to prevent proteolytic degradation of critical growth factors or therapeutic proteins. Precision dosing supports both research and late-phase clinical manufacturing under controlled, traceable environmental conditions. Materials are sourced with low endotoxin and animal-free certification, with analytical monitoring throughout the batch. This application supports development and scale-up of novel cellular and gene therapies used in oncology and regenerative medicine.

    Industry compliance standards

    • USP <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
    • 21 CFR 210/211 cGMP for finished biologicals
    • ISO 20399 for bioprocessing materials
    • TSE/BSE-free and low endotoxin specification certificates

    Typical usage ratio

    • 50–500 μM in cell therapy media (final process concentration)
    • Titer adjusted per lot based on cell line protease secretion profile

    Downstream process integration

    • Added at designated media supplementation stage prior to inoculation
    • Sterile filtered into cell culture wave bags or spinner flasks under closed conditions
    • Integrated with in-process analytical testing for protease inhibition monitoring

    Final product types

    • CAR-T and TCR-based cell therapy intermediates and final products
    • AAV and lentiviral vector manufacturing batches
    • Ex vivo gene-edited cellular therapies for clinical trial supply

    4. Component in Diagnostics, Laboratory Reagents, and Coagulation Test Kits

    Diagnostic reagent manufacturers utilize Nafamostat as a high-purity inhibitor in coagulation assay kits, D-dimer test solutions, and laboratory reagents for clinical analysis. Production operations demand controlled micro-dosing to ensure reliable, interference-free results for diagnostic end users. The compound enters the mixing process at microgram to milligram levels, with strict metrology and trace impurity evaluation to satisfy laboratory accreditation and product shelf-life requirements. Material released for this segment meets documented traceability with batch analytics to guarantee downstream compatibility. Bulk customers produce automated and manual diagnostic kits for hospital laboratories and reference testing networks.

    Industry compliance standards

    • ISO 13485 certification for IVD reagent manufacture
    • FDA 21 CFR 820 Quality System Regulation for diagnostic devices
    • CLSI EP05 for precision and reproducibility of lab kits
    • REACH Regulation (EC) No 1907/2006 for chemical safety

    Typical usage ratio

    • 1–50 μg/mL in final test solution (optimized per kit and analyzer protocol)
    • Lab-scale batch adjustment based on substrate sensitivity and detection range

    Downstream process integration

    • Metered into reagent concentrate during primary formulation under inert atmosphere
    • Quality control via spectrophotometric and enzyme inhibition assays pre-packaging
    • Final blending with sample buffer or lyophilized into test kit vials

    Final product types

    • Automated coagulation analyzer reagent cassettes
    • D-dimer and fibrin degradation test kit solutions
    • Clinical laboratory inhibitor cocktails for research and quality control
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    Certification & Compliance
    More Introduction

    Nafamostat: A Closer Look at Our Trusted Protease Inhibitor

    What Drives Us to Make Nafamostat the Right Way

    Our team approaches the manufacture of nafamostat with experience gained from decades working on fine chemicals, reagents, and pharmaceuticals. Developing this compound is never only about reaching a set purity or responding to what's trending. From raw material sourcing to reaction control, everything we do shapes how end users experience this molecule. Whether a partner needs steady intermediates, a clean API solution, or robust technical support, we've come to see that quality starts at the reactor—long before the material arrives at anyone’s laboratory.

    The Story Behind Our Nafamostat Model

    We focus on providing nafamostat mesylate in powder form, usually with purity levels above 99.5%, as determined by HPLC. Over the years, requests for bulk quantities, research-grade lots, or customization led us to refine our setup. This model combines cost-effective scale with flexibility. The synthesis uses protected amidine chemistry and precise times for deprotection and salt formation. Rather than chasing what others have already done, we work with real process data and insights from each batch.

    Our labs analyze not only the final product for common contaminants, but every step of the way. Preservation of crystal structure matters, since even minimal changes in lattice can throw off the solubility in water or saline, which directly impacts downstream work. By applying real-world controls and continuous monitoring, we create a batch-to-batch constancy users can expect from a primary producer.

    Why Consistent Specifications Matter

    For today’s customers, fluctuations in color, texture, or solubility waste hours and often require expensive troubleshooting. Differences may appear minor on paper, but they tarnish trust and slow down time-sensitive research and development projects.

    We commit to a model where specifications remain the same—not just on release paperwork but in every single bag or container. In the last year, none of our clients reported out-of-spec crystalline forms or visible particulates, even on large-volume shipments. That success reflects direct oversight. Laboratory teams respond quickly if they notice even the subtlest deviation in melting point or moisture content.

    Real chemical control isn’t about mere documentation; it has to withstand production scale, storage conditions, and shipping time. Whether labs are dissolving milligrams or scale-up groups are processing kilograms at a time, the small details we manage matter at the practical bench level.

    Application Domains: Why Purity and Integrity Influence Outcomes

    While nafamostat is best known as a serine protease inhibitor and anticoagulant, most customers use it in settings that require reliable activity against trypsin, thrombin, plasmin, or kallikrein. Some developments involve therapeutic applications against viral targets, for example in work with MERS or SARS-CoV-2 proteases. In each situation, researchers need to know their compound doesn’t introduce other biochemical signals due to sloppy synthesis or poor packaging.

    Downstream users test for effects in cell-based systems, pathway studies, or animal models. The confidence in results relates back to our attention to batch homogeneity and trace contaminant control. Impurities—even ones below regulatory reporting level—can cause false leads or require additional purification. We structure everything from choice of mesylate formation to drying technique so the product remains inert, easily weighed, and rapidly soluble.

    Not every industry will require pharmacological grade, but even academic and industrial screening projects benefit from a manufacturer’s discipline. Much of the edge comes down to how we handle raw input stocks, plant cleaning, and packing into controlled atmosphere bags. Those hands-on controls don’t show in a standard spec sheet, yet they remove unexpected bumps for everyone down the line.

    Comparing Nafamostat to Related Protease Inhibitors

    Customers sometimes ask why not simply switch to aprotinin, camostat, or other serine protease inhibitors. In practice, nafamostat’s rapid and potent inhibition profile means it is delivered at far lower working concentrations than many peers. That strength, coupled with rapid clearance in biological systems, minimizes risk for off-target effects. At the warehouse and factory level, we see that the stability of nafamostat mesylate presents fewer logistical headaches than alternatives like camostat, which can degrade unpredictably depending on moisture and temperature swings.

    Among its class, nafamostat dissolves cleanly in both saline and water, creates less foam, and resists surface adsorption. From an operational side, these differences cut down on re-work; in its supplied form, it does not cause blockages in feed lines nor aggregation when blended into analytical mixtures. The compact molecular structure also eases stepwise control in combined inhibitor cocktails, where users try to avoid unintended chemical cross-reactions.

    From our experience, a simple substitution by chemical class rarely suffices. Downstream testing in plasma, enzyme solutions, or even microfluidic arrays confirms that transitions between classes or suppliers can force costly repeat experiments. Our responsibility is to remove as many unknowns as possible before material leaves the plant.

    Supporting Efficient and Safe Usage

    End users want a material that fits into their daily operations without unexpected hurdles. Packing the compound in vacuum-sealed foil allows fast weighing and transfer, shields the powder from light, and blocks ambient moisture—three of the most common causes of changes in reactivity and color. The neutral off-white powder granulates easily, with no dusting or caking even at high humidity, thanks to careful drying and preconditioning.

    Users frequently need solubility in a wide pH range. We design our process to yield small, uniform granules that disperse within seconds in both neutral and mildly acidic buffers. Even scaled-up mixing equipment benefits from easy handling, limiting clean-up times and reducing routine waste.

    Safety always sits beneath every operational change: avoiding cross-contamination not only protects the batch but safeguards laboratory technicians and downstream users. Dedicated lines and validation of our packaging area have cut cross-contact complaints to zero in customer reports for multiple production cycles.

    Sustaining Trust: Raw Material Choices and Verification

    Many labs handle good manufacturing practices by careful sourcing and independent verification. We take this burden on at our own site. Using third-party verification for both starting materials and final product purity, we minimize downstream issues and provide an extra layer of support in audits. Papers can show the right certificates, but the lived result comes from seeing batches test clean day after day.

    We never substitute cheaper input stocks at the first sign of upstream supply fluctuation. During shortages, we maintain critical relationships with core synthetic intermediates providers to avoid a race-to-the-bottom in costs at the expense of quality. That discipline shapes outcomes not only for us, but for every customer project relying on us. Our staff runs regular stability tests, subjecting materials to cycles of hot, cold, and humid storage, simulating the conditions faced by global shipments.

    Real-World Problems and How We Solve Them

    A few years ago, labs began reporting emerging impurities in off-brand nafamostat batches: spectral noise from aromatic contamination led to unexpected signals in NMR and LC-MS. Because of our vertical control and auditing, none of these problems showed up in our material. We helped users trace back the cause to hasty third-party production or uncontrolled recycling of solvents. Instead of deflecting blame, we offered assistance in resolving these headaches—even for those who weren’t yet buying from us.

    Many projects demand custom sizing, pre-mixed buffers, or alternate storage forms. We support this by rerouting packaging lines, establishing clean-room protocols, and maintaining small, made-to-order runs alongside our bulk production lots. Our teams explain the rationale behind every adjustment; if the chemistry won’t allow a shortcut, we say so clearly.

    Looking Toward a More Reliable Future in Chemical Manufacturing

    Global demand for precise reagents pushes us to keep improving our operations, training, and supply chain stability. Process engineers and chemists talk regularly to find better ways to save solvent, lower energy, and keep our environmental footprint smaller with every run. We invest in data monitoring that flags subtle shifts before they grow into big problems—catching even the invisible trouble before customers notice.

    As researchers push nafamostat into new therapeutic or test settings, our feedback channels allow us to refine both product and service. If trials call for extra stability or regulatory documentation, we plan early instead of waiting for a complaint. That approach lets us adapt faster, so customers aren’t left guessing about changes in their critical materials.

    Regulatory compliance may get much of the attention, but it’s everyday reliability that sustains progress. Every sample going out tells a story—not only about our chemical process, but our commitment to every scientist, technologist, and business partner who puts trust in what we make.

    Customer Stories: Real Feedback, Practical Results

    Many of our clients share feedback on their experience with our nafamostat model. An academic group working on complement inhibition needed a single lot delivered across multiple school years. By keeping clear batch records and aligning production windows, we matched supply to teaching schedules, making sure students had uninterrupted access. Clinical trial labs commented that direct-shipping in validated containers cut down on delay-causing stability tests upon arrival.

    Industrial process developers described fewer stoppages and smoother blending than with earlier suppliers. They noted that our product granulate did not form agglomerates or generate fine particulates, which allowed for rapid integration into semi-automated feed lines. Pre-weighed portions meant less exposure risk for technicians and reduced unnecessary waste.

    We keep track of these practical details not as trophy testimonials, but as signals of what truly works at ground level. The difference between a good working day and a week of troubleshooting often rests on details that start with the producer, not the end user.

    The Work Continues: Collective Progress with Nafamostat

    Every year, the bar for purity, reliability, and support rises higher. Our teams meet regularly to compare user challenges, process deviations, and innovations both inside and outside our company. Challenges like emerging contaminants, evolving regulatory demands, or new applications each drive us to keep updating both equipment and knowledge.

    The more we listen to direct customer input and the realities of their laboratories, the stronger our own procedures become. True progress in chemical manufacturing, for both established and novel compounds like nafamostat, depends on this open exchange—not only on published specifications, but on every shared insight.

    As primary producers, we bear responsibility not only for the quality of what we make, but for working honestly with our clients about what’s possible and where the limits lie. Our best improvements have come from these conversations—aimed always at making work on the bench, in the clinic, or in production a little more predictable, a little safer, and a little easier for the next team in line.