Products

Iodixanol

    • Product Name: Iodixanol
    • Chemical Name (IUPAC): 5,5'-[(2-Hydroxy-1,3-propanediyl)bis(acetylamino)]bis[N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide]
    • CAS No.: 92339-11-2
    • Chemical Formula: C35H44I6N6O15
    • Form/Physical State: Liquid
    • Factroy Site: No. 1 Xuelin Street, Haining, Zhejiang, China
    • Price Inquiry: sales7@bouling-chem.com
    • Manufacturer: Jiangxi Brother Pharmaceutical Co., Ltd.
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    Specifications

    HS Code

    498194

    Chemical Name Iodixanol
    Cas Number 92339-11-2
    Molecular Formula C35H44I6N6O15
    Molecular Weight 1550.2 g/mol
    Appearance White to off-white powder
    Solubility Highly soluble in water
    Melting Point 162-165°C
    Storage Temperature 2-8°C
    Ph Aqueous Solution 6.8-7.6
    Application Density gradient centrifugation
    Purity ≥99%
    Synonyms Visipaque, Nycodenz II
    Stability Stable under recommended storage conditions
    Iodine Content 49% (w/w)
    Logp -2.59

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

    Packing & Storage
    Packing Iodixanol is supplied in a sealed 500 mL amber glass bottle with a secure screw cap, labeled with product and safety information.
    Container Loading (20′ FCL) Container Loading (20′ FCL) for Iodixanol typically accommodates around 12–14 metric tons, securely packed in drums or intermediate bulk containers.
    Shipping Iodixanol is shipped in tightly sealed, leak-proof containers, protected from light and moisture. It is typically transported at controlled room temperature or as specified by the manufacturer. Shipping complies with safety and regulatory guidelines for non-hazardous chemicals. Always refer to the Safety Data Sheet (SDS) for detailed handling and transport instructions.
    Storage Iodixanol should be stored at 2°C to 25°C (36°F to 77°F), away from light and moisture, in a tightly closed container. Protect from freezing and excessive heat. Store the chemical in a cool, dry, and well-ventilated area, clearly labeled and separated from incompatible materials. Follow all safety and regulatory guidelines for storage and handling.
    Shelf Life Iodixanol typically has a shelf life of 2-3 years when stored unopened at 15–30°C, protected from light and moisture.
    Application of Iodixanol

    Applications of Iodixanol in Industrial Manufacturing

    Iodixanol serves essential roles in several advanced manufacturing processes. As an original producer, we support clients operating in regulated high-tech sectors that require high-purity and consistency. Below we detail real-world downstream applications, compliance considerations, formulation practices, process flows, and typical end products.

    1. Formulation of Non-Ionic Contrast Media for Medical Imaging

    Medical device and pharmaceutical companies incorporate iodixanol for the production of non-ionic iodine-based contrast agents. This application demands careful attention to regulatory filing and batch quality. Our direct supply allows clients strict batch-to-batch traceability required for human health uses. Manufacturers hydrate and blend the raw material under GMP guidelines, often adjusting the dilution to reach patient-dosed contrast agent concentrations. Plants use sterilizable mixing vessels, incoming QC on iodine content, and continuous-process documentation. Final agents offer excellent osmolality properties and are widely applied in CT and angiography diagnostics.

    Industry compliance standards

    • Pharmacopoeia: USP, Ph. Eur., JP requirements for Iodixanol APIs
    • GMP (Current Good Manufacturing Practice) certification
    • FDA and EMA regulations for injectable products
    • ISO 13485 for medical device manufacturing quality

    Typical usage ratio

    • Raw material adjusted for 270–320 mg iodine/mL—a typical range of 40–65% w/v in finishing solution
    • Formulation varies based on diagnostic imaging requirements and human dose safety

    Downstream process integration

    • Metered as primary API during pharmaceutical agent blending and solution preparation
    • Subjected to sterile filtration and aseptic filling processes
    • Pre-packaged for end-use human injection or intravenous infusion

    Final product types

    • Intravenous non-ionic iodinated contrast media vials
    • Single-dose syringes for angiography or radiology
    • Pre-filled dual-chamber injectors for multi-phase CT scans

    2. Density Gradient Media for Cell Separation in Bioprocessing

    Biopharmaceutical and clinical laboratory sectors use iodixanol as a key component for isosmotic density gradient media. Manufacturers require the material’s precise density characteristics and high chemical purity for reproducible separation of organelles, viruses, cells, or exosomes. The product integrates into ready-to-use media through controlled hydration and filtration, supporting process-standardized cell isolation workflows. QC laboratories validate every batch against ISO and regional standards before use in downstream centrifugation systems. Applications include gene therapy vector purification and advanced cell therapy preparation.

    Industry compliance standards

    • ISO 9001/ISO 13485 for documentation and lot traceability
    • Ph. Eur. and USP reference quality for research and clinical grade reagents
    • Internal bioprocessing SOPs for raw material validation
    • GMP guidelines for clinical grade media (as applicable)

    Typical usage ratio

    • 10%–60% (w/v) gradient media prepared using concentrated working solutions
    • Concentrations tailored to specific gravity targets (1.06 to 1.32 g/mL)

    Downstream process integration

    • Incorporated during media preparation for centrifugation separation steps
    • Handled in sterile and endotoxin-free conditions to protect biological samples
    • Often used with automated cell separation and gene vector purification platforms

    Final product types

    • Ready-to-use density gradient tubes and bottles
    • Separation kits for laboratory and GMP cell therapy facilities
    • Purified viral vectors and cell fractions for medical research or therapeutic use

    3. Ingredient in Optical Lens Coating Solutions

    Optical manufacturing leaders integrate iodixanol into high-refractive index coating solutions for specialty glass and polymer lenses. The compound’s unique iodine density enables precise tuning of optical properties for anti-reflective, UV-blocking, or contrast-enhancing coatings. Engineers formulate dispersions using accurate weighing and solvent protocols, then apply via automated dip, spin, or spray systems. All raw material must meet ISO quality checks for transparency, solubility, and contamination. Batch records support downstream compliance with glass lens safety and performance standards. The resulting layers contribute to improving clarity, contrast, and safety performance in optics.

    Industry compliance standards

    • ISO 8980-4: Spectacle lenses—transmittance and optical properties
    • ISO 10110: Optics and photonics—preparation of drawings for optical elements and systems
    • RoHS Directive (EU) for restriction of hazardous substances in electronics
    • OEM-specific incoming goods optical QC protocols

    Typical usage ratio

    • Coating dispersions formulated with 1–5% iodixanol (w/w), depending on refractive index requirements
    • Formulation dependent on lens composition and thickness

    Downstream process integration

    • Mixed with solvents and other additives in precision-controlled batches
    • Applied to lens substrates after shaping and primer pre-treatments
    • Cured by UV or thermal processes to form adherent coatings

    Final product types

    • Anti-reflective laboratory and industrial eyewear lenses
    • UV-protective camera or optical instrument optics
    • High-contrast or filter lenses for scientific equipment

    4. Additive for Microfluidic and Diagnostic Device Manufacturing

    Microfluidics and lab-on-a-chip device producers select iodixanol for tuning phase densities in biological sample handling systems. Its low osmolality and biocompatibility are critical for handling live biological materials and protein samples. Technicians prepare microfluidic assay formulations by incorporating iodixanol as a density modifier to create stable sample streams and controlled partitioning within device channels. In this context, traceability and clean-room production batch control are mandatory to ensure integration with sensitive bioassay workflows. Devices built with these solutions enable direct sample separation, analyte detection, and rapid diagnostics at the point of care, meeting strict LDT and device safety criteria.

    Industry compliance standards

    • ISO 13485 for quality management in medical device manufacture
    • FDA 21 CFR 820 QSR (Quality System Regulation) for device production
    • CE Marking (where required) for in vitro diagnostics
    • Lot release testing for endotoxin and trace metals

    Typical usage ratio

    • 0.5–15% w/v in diagnostic chip or assay buffer formulations, precisely matched to target liquid phase requirements
    • Concentration tailored to each device’s fluid dynamics needs

    Downstream process integration

    • Added to polymeric or glass cartridge filling lines during device assembly
    • Assay channel rinsing and pre-loads made under aseptic, monitored conditions
    • Supported by continuous in-process quality inspection for device uniformity

    Final product types

    • Microfluidic lab-on-a-chip diagnostic cartridges
    • Disposable sample preparation units for clinical labs
    • Integrated sample separation and detection platforms for point-of-care analysis

    Free Quote

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    Certification & Compliance
    More Introduction

    Iodixanol: Enhancing Medical Diagnostics from the Perspective of the Producer

    Real Progress in Contrast Imaging

    Making Iodixanol isn’t just a matter of following a recipe. From the moment the raw materials reach our doors, every stage gets special attention. Each batch starts with a molecular structure designed for stable, non-ionic contrast. We work in cleanroom conditions, double-checking all critical temperature and pressure points during synthesis. The end goal always stays the same – a finished product that physicians and radiologists can trust, because even a small deviation can muddy scan results or trigger side effects. Iodixanol isn’t just another contrast agent—its low osmolality and high hydrophilicity came out of decades of chemical ingenuity. This isn’t an ingredient pieced together in someone else’s warehouse. Every vial represents years of in-house innovation, backed up by an experienced team that knows both the production lines and the clinical needs driving demand.

    Practical Benefits for Healthcare Workers

    Drawing on feedback from diagnostic centers, our R&D labs looked for ways to reduce patient discomfort and support clearer imaging. This led us to focus on the 320 and 270 mg Iodine/mL models, the concentration ranges most requested by clinics performing CT or angiographic studies. We keep the iodine content consistent, allowing for sharper image contrast without increasing viscosity or introducing risky contaminants. Iodixanol’s unique balance reduces the sting patients sometimes experience during injection. Technicians report fewer adverse events compared to earlier generations of contrast agents. Doctors rely on consistent enhancement between organs and tissue structures, even in patients with renal vulnerabilities.

    Hands-On Experience Guides Every Batch

    Manufacturing isn’t something we leave to automation alone. Each tank, mixer, and filtration system benefits from operators who understand the quirks of every run—ambient humidity, hidden batch-to-batch variable, subtle pH drift. Over years of producing contrast agents, we’ve identified pinch points others often miss during scale-up. By building continuous feedback loops from our QC team to production, we keep impurities at bay and maintain stability in each lot released.

    Differentiation Starts on the Factory Floor

    Some products on the market flaunt high purity or upgraded filtration. Our Iodixanol starts with pharmaceutical-grade raw materials. We monitor solvent levels, test for residuals, and invest in stainless-steel reactor upkeep, not just final inspection. Instead of relying on a distributor to enforce cold chain, we developed packaging and logistics protocols that preserve thermal stability during shipment. This comes from hard-won experience moving product across continents and through a range of climates—losing potency in transit isn’t something we’re willing to risk.

    The Patient Impact: Unpacking Real-World Outcomes

    Features mean little unless they support patient health. Experience tells us one of the biggest challenges involves reducing the risk of nephrotoxicity during contrast imaging. Iodixanol’s iso-osmolar formulation, matched more closely to blood plasma than the older hyperosmolar types, delivers a lower risk profile in patients with impaired kidney function. Early-stage research and clinical use pointed out this advantage, but it takes continued attention on the factory side to keep impurities, ionic residue, and preservatives within strict bounds. End users—mostly radiology departments—report smoother post-procedural recoveries when using Iodixanol compared with legacy agents.

    Supporting Diagnostic Versatility in Hospitals

    Facilities often run into constraints, whether in budget or supply. By offering Iodixanol in multiple concentrations and volumes, we help hospitals streamline inventory without maintaining separate lines for each diagnostic application. MRI, CT angiography, cardiovascular imaging—different studies call for different protocols, but having a flexible and predictable contrast agent simplifies planning. Production runs match observed usage patterns, not just forecasts or broad estimates. This lowers wastage, ensures fresher product turnover, and eases the pressure on busy procurement departments.

    Meeting Regulatory Challenges through Internal Controls

    Navigating international regulations imposes a web of GMP and pharmacopoeia compliance. We don’t simply follow the book; production, retention, and transport records get reconciled against ever-evolving standards. After seeing how batch recall events cripple hospital operations, our QA department invested in granular lot traceability and digital reporting at every transfer point. Testing covers not only purity and sterility, but also real-world attributes like shelf-life under fluctuating conditions; solutions used in the field haven’t always enjoyed stable storage. Consistent production controls at scale form the backbone of a trustworthy Iodixanol supply.

    What Sets Our Iodixanol Apart from Other Contrast Agents?

    Through years of customer interaction and on-site evaluations, we’ve documented some recurring challenges with other iodinated contrast media: unpredictable viscosity, spikes in allergic reactions, supply interruptions, and confounding impurities. Iodixanol’s unique architecture—six iodine atoms on a dimeric, non-ionic backbone—lets doctors deliver a high contrast load using lower volumes. Its viscosity rivals the best in class, while the osmolality hugs physiological norms, minimizing cellular and vascular disruptions. Our engineers push for incremental improvements after every major feedback round, especially when a clinical site encounters an unexpected variable. For example, in remote locations where cold-chain enforcement remains spotty, our modified packaging reduces degradation, giving hospitals wider margins for safe storage.

    Why Manufacturing Oversight Matters More Than Ever

    Each time a new contrast agent launches, skepticism follows—will it perform the same as the last product? What happens if a supplier gets acquired or outsources their lines? We’ve held firm on keeping all Iodixanol contracts in-house. Personnel training goes beyond SOP manuals; production staff undergo scenario-based drills, including emergency deviation response. Years of running validation studies taught us how easy it is to introduce micro-contamination or lose batch consistency if oversight lapses, especially during maintenance or shutdown turnovers. Upgrading a single valve might seem routine, but in pharmaceutical manufacturing that decision ripples throughout the supply chain. Real accountability sits inside the plant itself.

    Addressing Compatibility and Application Questions

    Pharmacies and radiology staff often ask about mixing protocols and storage windows. Our technical support team runs laboratory checks on reagent compatibility for every new hospital instrument or delivery system on the market. Iodixanol’s low viscosity profile lets it flow easily through catheters, reducing procedural delays and mechanical stress on pumps. We provide real measurements for pH, osmolality, and temperature sensitivity, so users can calibrate dosing or adjust protocols fast. Live feedback from radiologists and pharmacists loops back into our formulation process; sometimes a field report on unexpected residue leads to updated filter materials or line cleaning procedures within weeks.

    Continuous Improvement Based on End-User Feedback

    We don’t treat Iodixanol as a finished story. Every delivery, every lot, every returned vial points toward possible refinements. In one recent year, multiple sites reported minor foaming upon injection—a subtle effect that could interfere with certain imaging procedures. After collecting detailed field notes, we re-assessed our degassing step, ramped up gas purging efficiency, and trimmed air exposure from fill to seal. Smaller production tweaks like this cut the foam problem down. It costs more to run additional controls, but precision pays: repeat business and long-term partnerships depend on visible, tested improvements, not just promises.

    Transparency and Partnership with Health Professionals

    It’s easy to promise quality, but much harder to provide evidence during supply interruptions or crowded regulatory cycles. Since we run our own plants, we open our processes to regular audits; representatives from major hospitals and procurement consortia visit the floor, review documentation, and watch production runs in person. While not every detail can be disclosed for proprietary reasons, our willingness to engage in direct conversation builds trust on both sides. If a product recall hits the market, our lot traceability covers root causes in days, letting downstream clients plan or substitute before major disruption hits.

    Looking at Clinical Outcomes Beyond the Factory Gates

    Few tasks bring as much satisfaction as seeing research trials or case studies reflect the composition and handling choices we lock in at the plant. In pediatric settings, lower hypersensitivity risk and kidney-friendly profiles make a visible difference in post-procedure recovery rates. In elderly patients, stable viscosity lets physicians run smoother infusion rates and avoid flow problems common with older agents. Our dialogue with imaging specialists led to targeted improvements: more transparent labeling, improved color contrast for quick visual checks, and tamper-evident caps for every unit. These tweaks sound small but came directly from hospital workflow observations.

    Manufacturing Sustainably and Safely

    Sustainability doesn’t mean sacrificing control. All Iodixanol waste streams pass through solvent recovery and advanced wastewater treatments. Hazardous byproducts don’t disappear—they get neutralized before exiting the facility. Our plant safety protocols serve a dual role. They protect employees and keep local communities safe. Rather than outsourcing hazardous steps overseas or cutting corners to save costs, we reinvest in automation for the highest-risk steps and routinely cross-train staff on process safety. Reviewing near-misses as a team yields changes that protect both people and product integrity.

    Working Through Tough Logistics and Variable Global Demand

    Seasonal or regional spikes in demand can empty storerooms faster than projections predict. We keep a buffer of finished stock and critical precursors in climate-controlled storage to handle emergencies without sacrificing quality. Shipping containers use insulation and modular cold packs. While these add expense, the payoff comes during a heatwave or customs hold. Because we’ve seen what happens when poorly handled contrast agents arrive at distant clinics—cloudy vials, unstable color, lost potency—we prioritize direct shipping by known carriers and refuse to chase fleeting bulk contracts that compromise oversight. Our logistics team phones ahead to make sure on-site staff know what to check and how to store each shipment, especially in rural sites dealing with outdated infrastructure.

    Supporting Clinical Education Beyond the Label

    Doctors and nurses don’t learn everything they need from datasheets. We invest heavily in outreach, sending chemical engineers or product specialists to major hospitals for in-person or online seminars. Direct interaction matters more than glossy brochures; it builds familiarity with the product and surfaces real-world puzzles. How does Iodixanol perform in combined-modality scans? What do you do if a patient’s allergy status is unclear? Our team answers, documents, and brings back recurring questions to inform manufacturing changes or future batch testing requirements.

    Facing Pricing Pressures Without Cutting Corners

    Healthcare budgets grow tighter each season. Generic competition and “good enough” alternatives keep chipping at margins. Instead of trimming production safeguards or sourcing questionable ingredient lots, our answer remains technical excellence and relationship depth. Hospitals buying direct know what to expect and can spot corners cut elsewhere. The decision to run extra stability tests or extend lot holds before market release costs short-term revenue but pays off through consistent performance, fewer recalls, and tighter trust between buyer and supplier.

    Maintaining Access and Affordability for Underserved Regions

    One overlooked challenge involves balancing technical sophistication with affordability for smaller hospitals and low-income regions. We stagger releases to ensure every customer, whether in a capital city or rural outpost, gets regular access to fresh Iodixanol. Our technical support hotline doesn’t require a service contract; even facilities with a handful of annual scans get equal access to troubleshooting or application advice. Over time, this approach reduces hoarding, helps avoid expired stock, and keeps overall utilization efficient—a difference felt most acutely in networks running on slim budgets.

    Traceability and Documentation: Learning from Each Batch

    Chemical manufacturing always walks a tightrope between efficiency and oversight. Every Iodixanol lot gets tracked through digital systems, with electronic documentation kept permanently on-site and encrypted off-site. Auditors, clients, and regulatory inspectors can check source records in real time. Field issues—an unusual particulate, a break in temperature control, a mislabel—get flagged immediately and tied back to both process adjustments and supplier follow-up. Mistakes and near-misses don’t disappear; they drive next-generation quality improvements and tighter root cause analyses. Lessons from one recall cycle become embedded in the next run well before market re-entry.

    A Large Team, Not Just a Brand

    Launching and sustaining a product like Iodixanol takes more than a few scientists and operators. Years of concerted effort from procurement, maintenance, environmental technicians, IT, and dispatch drivers feed into every successful shipment. Prepping the plant for a major run covers equipment inspection, supplier vetting, and hands-on batch supervision. Our staff schedules and retains a full shift backup during critical campaign windows: this ensures problems don’t wait for a single person to get back from leave, a detail too often neglected in remote manufacturing. New hires get trained by senior staff who lived through previous bottlenecks and incidents, handing down knowledge that no SOP can fully capture.

    The Daily Reality of Listening and Responding

    Feedback never gets ignored. Pharmacy managers, radiologists, and technicians—everyone using our Iodixanol in the field—point out performance gaps, unexpected interactions, or minor frustrations. Our management team reads these reports daily. Sometimes a request sparks significant process changes; more often, small tweaks accumulate, gradually making the product more robust. There’s no faceless algorithm or distant plant manager “approving improvements.” Everything comes back to the shared belief that reliable contrast agents save time, reduce pain, and lead to faster, more accurate diagnoses for real people.

    Addressing the Broader Scientific Landscape

    The diagnostic imaging field pushes forward, with new procedures and hybrid scan technologies launching every year. Iodixanol manufacturers can’t stand still. We attend international symposia, exchange notes with university research teams, and keep tabs on the latest peer-reviewed findings. If next-generation detectors demand a tighter viscosity control or a special additive, our development pipeline responds rapidly. The core composition gets protected, but we stay open to format variations—multi-dose vials, sterile ampoules, or tailored packs for high-volume emergency departments—whenever actual use cases demand them. Listening to both science and workflow needs sets our team apart from mass-market commodity suppliers.

    Returning to the Real Meaning of Reliability

    At the plant, reliability means more than hitting specs on a test certificate. It means weathering a staffing shortfall or an equipment breakdown without letting quality slip. It means having operators who can spot a pH drift before a sensor flags it or who know how to recalibrate a pump after a power surge. We invest in the people and tools that can keep operations steady. That way, every vial or bottle of Iodixanol we ship can be used by a doctor or nurse with confidence that it will perform to the same standard as the one before. That’s the difference production expertise brings—and why physicians and patients trust products coming straight from our line.