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Diatrizoate Sodium

    • Product Name Diatrizoate Sodium
    • Alias Hypaque
    • Einecs 211-072-2
    • 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

    890783

    Generic Name Diatrizoate Sodium
    Drug Class Radiographic Contrast Agent
    Chemical Formula C11H8I3N2NaO4
    Molecular Weight 635.89 g/mol
    Appearance White to off-white crystalline powder
    Solubility Highly soluble in water
    Route Of Administration Oral, Intravenous
    Indications Imaging of gastrointestinal tract, urography, angiography
    Contraindications Hypersensitivity to iodine compounds
    Storage Temperature Store at 20° to 25°C (68° to 77°F)
    Osmolarity High osmolar contrast medium
    Mechanism Of Action Increases radiographic contrast by absorbing X-rays

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

    Packing & Storage
    Packing The packaging for Diatrizoate Sodium includes a 500 mL amber glass bottle, securely sealed with a tamper-evident cap and labeled appropriately.
    Shipping Diatrizoate Sodium is shipped in tightly sealed, leak-proof containers, protected from moisture and light. Packaging complies with regulations for hazardous chemicals, labeled with appropriate hazard warnings. Transport is conducted under ambient conditions, avoiding extreme temperatures. Documentation includes safety data sheets to ensure safe handling and compliance with international shipping standards.
    Storage Diatrizoate sodium should be stored at controlled room temperature, typically between 20°C and 25°C (68°F and 77°F). Protect the container from light and moisture, and keep it tightly closed when not in use. Store away from incompatible substances and out of reach of unauthorized personnel. Follow all labeled storage instructions and local regulations for safe chemical storage.
    Application of Diatrizoate Sodium

    Applications of Diatrizoate Sodium in Industrial Manufacturing

    As a core iodinated compound, Diatrizoate Sodium serves key imaging, diagnostic, and purification functions across several regulated industrial markets. Our experience in precision synthesis delivers consistent quality for sophisticated applications requiring reliable performance, adherence to strict industry standards, and integration into high-value production lines. Below, we detail main downstream application areas with technical use-cases, relevant regulations, and real production flows.

    1. X-ray and CT Diagnostic Contrast Media Production

    Diatrizoate Sodium is a critical ingredient in formulating radiographic contrast agents used for X-ray and CT imaging within medical settings. Our material supports injectable solutions where clarity, non-toxicity, and rapid systemic elimination are required. The pharmaceutical processing often leverages its high iodine content for superior radiopacity. Formulators blend this raw material under sterile conditions to achieve batch reliability and meet stringent patient safety expectations in end-use clinical diagnostics.

    Industry compliance standards

    • USP (United States Pharmacopeia)
    • EP (European Pharmacopoeia)
    • Chinese Pharmacopoeia (ChP)
    • GMP guidelines for parenteral solutions
    • ISO 13485 for medical device ingredients

    Typical usage ratio

    • 60–80% w/v as the main solute, adjusted based on required contrast density for targeted imaging type and patient dosage.

    Downstream process integration

    • Material enters the compounding stage within aqueous injectable contrast preparations and is sterilized prior to filtration, filling, and vialing.

    Final product types

    • Injectable contrast media for angiography, urography, computed tomography, and gastrointestinal tract imaging.

    2. Diagnostic Cavity Lavage and Retrograde Studies

    Manufacturers of diagnostic lavages use Diatrizoate Sodium to formulate solutions for biliary, gastrointestinal, and urologic retrograde examinations. Its solubility and low viscosity allow operators to introduce the solution directly into body cavities where sharp contrast outlining is needed for radiology. The raw material's iodine concentration is critical in achieving clear cavity segmentation without excessive tissue irritation. Production lines blend standardized solution strengths, then aseptically package for hospital and clinic delivery.

    Industry compliance standards

    • USP and EP monograph requirements for contrast agents
    • FDA 21 CFR part 211 for finished pharmaceuticals
    • National Formulary (NF) guides for large volume parenterals

    Typical usage ratio

    • 30–60% w/v, tailored by organ system and examination purpose, with dilution or concentration applied based on protocol requirements.

    Downstream process integration

    • Solution compounding lines dose in the iodine salt after water preparation and pH correction, followed by sterile filtration and filling into delivery bottles or bags.

    Final product types

    • Biliary tract diagnostic lavages
    • Retrograde pyelography solutions
    • Gastrointestinal imaging washes

    3. Radiopaque Fillers for Pharmaceutical Tablet and Capsule Applications

    Tableting and hard capsule production in pharmaceuticals utilize the dense atomic mass of Diatrizoate Sodium to impart radiopacity in oral dosage forms. This allows for precise localization during in vivo tracking studies. We support applications that require a non-reactive additive maintaining chemical stability throughout granulation, blending, and compression, without altering API release characteristics. Stringent quality controls are necessary at all handling stages to eliminate cross-contamination and ensure accurate dose uniformity in finished lots.

    Industry compliance standards

    • USP/NF for excipient quality
    • ICH Q7 for API and excipient handling
    • FDA 21 CFR 210/211 (CGMP regulations for finished pharma)

    Typical usage ratio

    • 1–10% w/w, adjusted per dosage size and required imaging contrast intensity, with levels validated by in vitro dissolution and imaging correlation studies.

    Downstream process integration

    • Integrated into dry granulation or direct blending stage before tablet compression or capsule filling, with mixing homogeneity verified through batch sampling.

    Final product types

    • Radiopaque oral tablets for gastrointestinal transit studies
    • Marker capsules for clinical imaging research

    4. Laboratory and Calibration Standards for Imaging Equipment

    Producers of radiographic imaging reference materials incorporate Diatrizoate Sodium in standard calibration solutions or phantoms. These highly controlled applications demand batch reproducibility and documented purity, as test results underpin equipment certification, regulatory audits, and operator training. The raw material’s high iodine content acts as a traceable radiodensity marker for equipment linearity checks and dose calibration. Laboratories prepare calibration blocks or solutions in standardized formats for routine instrument QA.

    Industry compliance standards

    • ISO 9001 for reference material manufacturing
    • IEC 61223 for X-ray equipment performance
    • Good Laboratory Practice (GLP) for analytical chemistry

    Typical usage ratio

    • Concentration ranges from 5–75% w/v depending on equipment type and attenuation targets, with specific calibration points defined by the client’s QA protocol.

    Downstream process integration

    • Weighing and dissolution into reference matrix, followed by homogenization, filtration, quality analysis, and packaging into calibration ampoules or resin blocks.

    Final product types

    • Radiopaque calibration solutions
    • Phantom materials for imaging QA
    • Reference tablets for device validation
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    Certification & Compliance
    More Introduction

    Introducing Diatrizoate Sodium: Experience, Quality, and Practical Application

    From Factory Floor to Finished Product: Our Commitment to Reliable Chemistry

    Working long hours in a chemical plant, surrounded by the dynamic world of synthesis and purification, you learn which products truly stand the test of time. In our line of work, Diatrizoate Sodium often comes up as an example. Chemists across diagnostic imaging trust this compound not because advertising tells them to, but because its reliability has been proven batch after batch, year after year. Our production lines have handled the challenges of scale-up, purification, and quality assurance, ensuring every shipment matches the standards demanded by our partners in healthcare and research.

    What Sets Our Diatrizoate Sodium Apart

    Building Diatrizoate Sodium begins far upstream, starting with careful sourcing of raw materials and attention to every purification step. In our experience, the difference shows in the finished product’s clarity, solubility, and compatibility in demanding medical applications. Our model Diatrizoate Sodium offers high-purity, consistently achieving a sodium content that aligns with pharmacopeial requirements for radiopaque contrast agents.

    One of the practical lessons we learned is that impurities impact both clinical performance and storage stability. Clients have seen that not every batch from every source dissolves easily, especially when compounded for large-volume hospital use. We invest in repeated filtration and drying cycles, removing even the finest particulate matter. The resulting white, free-flowing powder handles well during formulation and resists clumping during long-term storage. Chemists and pharmacists regularly share feedback that they notice less sedimentation and improved clarity in solution compared with some other grades on the market.

    Production Approach: Why Process Matters

    Some producers try to cut corners, relying on basic filtration or less rigorous drying methods to save time. Working daily with both quality control teams and bulk customers, we have refined our approach, insisting on controlled temperature drying and strict monitoring of residual moisture. The result stands up to real-world conditions, whether stored in a humid hospital storeroom or shipped halfway across the world. Less moisture means less risk of caking, which makes weighing, dissolving, and portioning easier for pharmacy technicians in busy settings.

    Process validation isn’t just a regulatory hurdle—it’s the backbone of what our clients expect. Every reactor run goes through checks: sampling for heavy metals, looking for organic residuals, and testing for loss on drying. By defending every step with evidence and documentation, we maintain a reputation for uniform output, which is why hospitals and pharmaceutical companies return with repeat orders.

    Uses of Diatrizoate Sodium—From Diagnostics to Research

    Diatrizoate Sodium owes its importance to its role as a contrast medium for X-ray imaging and computed tomography. Hospitals and clinics depend on its ability to increase the opacity of blood vessels, urinary tract, and digestive system during imaging procedures. Our conversations with clinicians have highlighted that dose reliability matters most—each solution must deliver the expected radiopacity, or images risk becoming useless for diagnosis.

    Laboratory researchers also reach out to us for Diatrizoate Sodium, especially those focused on density gradient centrifugation, cell separation, or studies requiring non-toxic, water-soluble density media. Over the years, our feedback channels have become a two-way street—by listening to the changing needs of the scientific community, we adjust packaging sizes and improve lot-to-lot consistency, making sure researchers get results they can trust.

    Specifications That Matter in the Real World

    Specifications on paper mean less than performance in use. From the start, our process development team worked hand-in-hand with application chemists. Together, we focused on purity, as measured by chromatographic tests—the fewer the unidentified peaks, the safer the product. Sodium content remains tightly controlled, avoiding batch variations that could impact clinical outcomes. Microbial limits and endotoxin levels face regular scrutiny, especially after lessons learned from past product recalls in the industry at large. Nobody wants a supply chain disrupted because a batch couldn’t meet sterile filtration or pyrogen testing.

    Our facility uses closed-system handling, ensuring the powder moves directly from the dryer into sterile packaging. This attention has prevented environmental contamination during especially dry winter months, when static can attract airborne dust into open containers. The difference between a consistently dry, well-packaged batch and a leaky or inconsistent shipment stands at the core of dependable clinical supply.

    Understanding Differences from Other Contrast Media

    In daily production and in consultation with healthcare professionals, we often get asked how Diatrizoate Sodium stacks up against alternatives like Iohexol, Iopamidol, or Iodixanol. Diatrizoate Sodium has a long track record because of its rapid excretion and ease of formulation in water. Though newer nonionic agents offer some advantages in reduced patient discomfort or allergenic risk, our customers value the cost effectiveness, long shelf life, and proven image quality achieved with Diatrizoate Sodium. Many teaching hospitals continue to prefer it for certain procedures, especially in gastrointestinal imaging, due to its reliable density and radiodensity.

    We have produced both ionic and nonionic media, so we see firsthand the tradeoffs in synthesis complexity, raw material availability, and final product cost. Where budgets matter and staff have experience handling ionic agents, Diatrizoate Sodium remains a dependable tool. Our technical team sees the difference most clearly in logistics—larger batch sizes, established regulatory pathways, and straightforward documentation simplify procurement.

    Ongoing Challenges and Solutions

    Global demand for medical contrast media keeps growing, stretching supply chains and raising concerns about raw material reliability. We face shipping delays, changes in regulatory reporting, and increasingly stringent quality audits. To keep pace, our supply team vets every upstream supplier and runs reserve inventories of critical inputs, including iodine sources and solvents. Direct relationships with raw material producers give us transparency and leverage in negotiations, preventing shortages during surges in hospital demand.

    Occasionally, a regulatory body updates allowable impurity profiles or imposes new environmental rules for disposal and waste management. By maintaining an adaptable, process-driven manufacturing floor, we absorb those changes rather than scrambling in response. Engineers on our team work with environmental officers to install advanced waste capture and filtration, ensuring compliance and reducing environmental burden. Our ability to solve these operational puzzles—grounded in experience and collaboration with field experts—means hospital buyers and pharmacy heads sleep better at night, knowing their supply is secure.

    Supporting Safe and Effective Use

    Our technical service line shares a steady stream of inquiries from formulation chemists and hospital pharmacists. Concerns often revolve around solution clarity, reconstitution times, and compatibility with other injectable agents. By conducting in-house mixing trials and stress testing under real-world conditions, we provide practical troubleshooting for field questions. When asked about altered shelf life due to recycling or repeated vial access, we share published results along with our own stability test data, empowering clinicians to make safe, informed decisions.

    Education doesn’t stop at shipment. We engage with clinical partners to develop protocols for storage, handling, and dissolution, presenting clear information about solubility and shelf life based on our own validation. These practices reduce medication errors and streamline patient workflows. Over the years, our product has helped reduce unnecessary waste by minimizing returns and discards—an outcome tied directly to process quality and predictable batch performance.

    Meeting the Needs of Hospitals, Clinics, and Labs

    Our bulk packaging reflects an understanding of how Diatrizoate Sodium moves through real-world supply chains. Product available in multi-kilogram drums and sealed, tamper-evident pails makes restocking fast for central pharmacies and purchasing departments. Smaller, laboratory-sized containers mean students and researchers don’t pay for more than they need, avoiding expiration and underuse. We receive feedback from shipping departments about broken seals and package damages experienced with some brands. In response, we improved our container design with reinforced lids and double-layered linings, preventing spillage and contamination.

    Customers appreciate access to technical documentation. Rather than burying users in paperwork, we offer tailored, easy-to-understand details regarding handling, stability, and compatibility. This transparency supports regulatory submissions and smooths communication between purchasing agents, clinicians, and product support staff.

    Building Trust—Year by Year

    Trust in a chemical supplier grows with every successful batch. Customers stick with us not just for a competitive price, but because incoming shipments arrive on time, meet agreed specifications, and deliver reliable results in the field. Diatrizoate Sodium has become an essential part of the diagnostic toolkit, but it’s the day-to-day connection between our production crew, our quality assurance experts, and frontline healthcare workers that cements lasting relationships.

    Colleagues in the industry sometimes mention the temptation to switch suppliers in search of lower costs or flashy marketing claims. The feedback we hear from seasoned purchasing managers at major hospitals tells a different story. After experiencing inconsistent powder granulation, unpredictable reconstitution times, or impurities that trigger instrument alarms, many return to the stability of our Diatrizoate Sodium supply.

    Years spent on the production floor developed our perspective—that every gram must earn its place in a healthcare setting. Observing nurses and pharmacists at work, managing a rush of imaging procedures and patient turnover, gave us firsthand insight into the challenges they face. We hear about the problems that crop up when a contrast agent fails to dissolve or presents with unexpected particulates. Our production changes reflect these realities, aiming to prevent costly and stressful interruptions in care.

    Pushing for Continual Improvement

    Quality isn’t static. Advancements in analytical technology let us screen for impurities at lower levels, confirming purity in ways impossible just a decade ago. Our chemists work closely with instrument manufacturers to stay ahead of regulatory updates and clinical expectations. This work takes more than a technical manual—it takes hands-on experience, a willingness to learn from customer feedback, and a commitment to corrective action when the product doesn’t perform as promised.

    Improvement doesn’t only come from the laboratory. Listening to end users—hospital imaging techs, laboratory directors, logistics coordinators—shaped our approach to everything from lot labeling to drum size. We refine our instructions to match the real flow of pharmaceuticals from receiving dock through to point-of-care mixing, helping prevent waste and error.

    Industry Outlook and Looking Ahead

    Diatrizoate Sodium continues to hold an essential place in the diagnostic world, even as innovation introduces alternatives. Budget constraints, changing reimbursement models, and a renewed focus on value make its established reliability and robustness hard to beat. By investing in process improvement and ongoing technical training, we aim to keep this compound ready for whatever tomorrow’s clinic or laboratory demands.

    The world of chemical manufacturing remains anything but routine. From coping with the volatility in raw material pricing to managing evolving global transport regulations, experience and resilience drive success. Attention to detail, honest communication with customers, and a willingness to adapt keep us steady in the face of fluctuating demand. Through every change, Diatrizoate Sodium remains a cornerstone product—a testament to the daily work of our production team and the trust built over years of real-world collaboration.

    Conclusion

    Diatrizoate Sodium production is not simply chemistry; it is a marriage between technique, customer insight, and genuine care for the needs of hospitals, clinics, and research facilities. From raw ingredient selection to batch release and shipment, experience shapes every decision. Facing new challenges each year, our resolve grows. Our teams stand behind each batch, knowing that their daily work makes a difference for patients, practitioners, and scientists alike. That commitment will always drive our standards, setting Diatrizoate Sodium apart in an ever-changing world.