Products

Iopamidol

    • Product Name: Iopamidol
    • Chemical Name (IUPAC): 1-N,3-N-bis(2,3-dihydroxypropyl)-5-[(2-hydroxyacetyl)amino]-2,4,6-triiodoisophthalamide
    • CAS No.: 60166-93-0
    • Chemical Formula: C17H22I3N3O8
    • 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

    773399

    Generic Name Iopamidol
    Brand Names Isovue, Iopamiron
    Chemical Formula C17H22I3N3O8
    Drug Class Non-ionic iodinated contrast agent
    Molecular Weight 777.09 g/mol
    Route Of Administration Intravenous, intra-arterial
    Indications Contrast enhancement in imaging procedures (CT, angiography, urography)
    Osmolality Low-osmolar
    Appearance Clear, colorless to pale yellow solution
    Mechanism Of Action Enhances radiographic contrast by absorbing X-rays
    Contraindications Hypersensitivity to iodinated contrast media
    Storage Temperature 20°C to 25°C (68°F to 77°F)
    Pregnancy Category Category B
    Excretion Renal (primarily unchanged)
    Half Life Approximately 2 hours

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

    Packing & Storage
    Packing Iopamidol is supplied in a 100 mL clear glass vial, sealed with a gray rubber stopper and covered by a protective aluminum cap.
    Container Loading (20′ FCL) Iopamidol is shipped in 20′ FCLs, securely packed in sealed drums or cartons, ensuring safe transport and protection from contamination.
    Shipping Iopamidol is shipped as a non-hazardous chemical, typically in sealed, labeled, and protective containers to prevent contamination and degradation. Standard shipping regulations apply; however, it should be stored and transported at controlled room temperature, avoiding extreme heat or freezing. Always consult the manufacturer's SDS and local regulations for specific shipping instructions.
    Storage Iopamidol should be stored at controlled room temperature, typically between 20°C to 25°C (68°F to 77°F). Protect it from light, excessive heat, and freezing. Keep the container tightly closed and store in the original packaging until use. Avoid contamination and ensure the storage area is secure, away from incompatible substances. Follow all relevant guidelines and institutional protocols.
    Shelf Life Iopamidol typically has a shelf life of 24 to 36 months when stored unopened, protected from light, and at recommended temperatures.
    Application of Iopamidol

    Applications of Iopamidol in Industrial Manufacturing

    As an experienced producer of iopamidol, we specialize in ensuring reliable supply and knowledge-driven integration of this non-ionic, water-soluble contrast agent across multiple regulated downstream sectors. The following are the principal fields where iopamidol is industrially formulated, each with its own compliance, formulation, processing, and product specifications.

    1. Medical Contrast Media for Radiological Imaging

    In the medical imaging sector, iopamidol serves as a key raw material for large-scale manufacture of injectable X-ray contrast agents utilized in computed tomography (CT), angiography, digital subtraction angiography, and urography. Downstream formulators integrate iopamidol into sterile solutions that require stringent quality controls under global health authority regulations, supporting accurate diagnostic procedures in hospital and clinical environments.

    Industry compliance standards

    • USP (United States Pharmacopeia) Monograph for Iopamidol Injectable
    • Ph. Eur. (European Pharmacopoeia) Iopamidol Reference
    • China Pharmacopoeia (ChP) for Radiopaque Contrast Agents
    • ICH Q7 GMP Guidelines for Active Pharmaceutical Ingredients
    • US FDA 21 CFR Part 210/211 (cGMP for finished pharmaceuticals)
    • EU Medical Device Regulation (MDR) when formulated as a device

    Typical usage ratio

    • Formulators typically use iopamidol in end-use concentrations ranging from 200 mg I/mL to 370 mg I/mL, with overall iopamidol content adjusted within 30–62% w/v in injectable solutions, based on the target imaging application and contrast strength required.

    Downstream process integration

    • Iopamidol enters sterile manufacturing lines after in-house synthesis or as a cGMP bulk substance. It is dissolved in pyrogen-free water, adjusted for osmolality and pH, filtered through sterilizing-grade membranes, then aseptically filled into pre-sterilized glass vials or ampoules, and terminally autoclaved as required.

    Final product types

    • Non-ionic injectable radiocontrast media (single or multi-dose vials)
    • Pre-filled syringes for contrast injector systems
    • Ready-to-use contrast ampoules for diagnostic radiology

    2. Formulation of Orally Administered Imaging Media

    Iopamidol enables the industrial production of oral gastrointestinal imaging agents, particularly for CT and enterography procedures where gastrointestinal tract delineation is required. Downstream production prioritizes liquid and diluted formulations that are safe for direct patient ingestion, requiring compliance with separate regulatory frameworks from injectables.

    Industry compliance standards

    • Food and Drug Administration (FDA) – New Drug Application (NDA) for oral contrast agents
    • European Directorate for the Quality of Medicines (EDQM) Standards
    • Japanese Ministry of Health, Labour and Welfare (MHLW) standards for oral imaging preparations
    • Good Manufacturing Practice (GMP) for oral pharmaceuticals

    Typical usage ratio

    • Oral formulations typically contain 5–15% w/v iopamidol, tailored to achieve adequate gastrointestinal contrast with reduced overall iodine exposure for the patient demographic.

    Downstream process integration

    • Manufacturers blend iopamidol with purified water, flavor stabilizers, and buffering agents, then process the solution through liquid compounding tanks, followed by sterile filtration and packaging into dosing bottles or sachets under aseptic conditions.

    Final product types

    • Oral gastroenterography contrast suspensions
    • Pre-mixed drinking solutions in single-use bottles
    • Unit dose pouches for pediatric and adult patient imaging

    3. Raw Material for Syringe and Cartridge Filling in Medical Device Manufacturing

    Device manufacturers use iopamidol as a high-purity fill solution for prefilled contrast injector cartridges and syringes commonly deployed in automated imaging systems. Strict batch release and device-related validation are necessary to ensure system compatibility and patient safety, often involving additional leachable/extractable assessments and sterile barrier system evaluations.

    Industry compliance standards

    • ISO 13485 Quality Management for Medical Devices
    • ISO 11607-1/2 Packaging for terminally sterilized medical devices
    • Ph. Eur. and USP standards for sterile injectable solutions
    • Directive 93/42/EEC or MDR (EU Medical Devices Regulation)

    Typical usage ratio

    • Concentration targets for iopamidol fill solutions closely follow injectable radiology standards (200–370 mg I/mL, 30–62% w/v), with batch-specific adjustments based on device fill volumes and clinical application protocols.

    Downstream process integration

    • Iopamidol bulk solution feeds into high-precision liquid filling equipment, ensuring accurate dosing into sterile polymeric or glass cartridges, followed by in-line sealing, device assembly, and packaging under validated environmental controls.

    Final product types

    • Pre-filled single-use injector cartridges for CT and angiography
    • Sterile contrast syringes for automated injection pumps
    • Patient-specific ready-to-administer contrast device units

    4. Reference Standard Production for Analytical Laboratories

    Certified reference standard manufacturers require iopamidol as a raw material for creating traceable calibrators and controls used in analytical quality assurance. These standards ensure accurate instrument performance in pharmaceutical batch release, impurity profiling, and regulatory compliance testing.

    Industry compliance standards

    • ISO 17034 General requirements for the competence of reference material producers
    • ISO/IEC 17025 Laboratory Accreditation for Testing and Calibration
    • USP/NF and Ph. Eur. Reference Standards for contrast media
    • GLP (Good Laboratory Practice) for standard preparation

    Typical usage ratio

    • Iopamidol reference materials are prepared at high purity (≥99.5% by HPLC) and diluted to concentrations most needed for method calibration—ranging from 0.1 mg/mL to 10 mg/mL depending on the analytical technique (HPLC, GC, LC-MS).

    Downstream process integration

    • Reference producers dissolve purified iopamidol in analytical-grade solvents and aliquot into ampoules or vials under nitrogen or inert conditions. Each batch undergoes direct assaying, documentation, and homogeneity testing prior to cold-chain packaging and dispatch.

    Final product types

    • Primary reference standards for instrument calibration
    • Certified calibrators for quality control laboratories
    • System suitability solutions for regulatory analytical workflows

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    Certification & Compliance
    More Introduction

    Iopamidol: A Trusted Choice for Medical Imaging

    What Sets Iopamidol Apart as a Contrast Agent

    Our team at the production facility works daily with Iopamidol, and over the years, we've found that this non-ionic, low-osmolar contrast agent remains highly valued by radiologists and technicians worldwide. The science behind Iopamidol comes down to its molecular design. With a tri-iodinated benzene ring structure, it provides the necessary radiopacity in X-ray and CT imaging without introducing excessive osmolality. Many healthcare professionals prefer it for intravenous and intra-arterial procedures, from routine head and body CT scans to more specialized angiographic studies. By maintaining a lower risk profile for adverse reactions, including reduced discomfort upon injection, Iopamidol continues to earn its place in hospitals and clinics around the globe.

    Models and Specifications: Meeting Clinical Demands

    Daily experience in manufacturing highlights how end users value a range of options. Iopamidol comes in several models distinguished by their concentration levels. Our common formulas include 300 mgI/mL and 370 mgI/mL strengths, each designed for specific imaging protocols. From pediatric radiology to complex cardiovascular diagnosis, users find the right match in this lineup. Quality control at our plant ensures every batch meets international standards for purity and sterility. Packaging sizes range from single-use vials ideal for smaller facilities to larger containers preferred in high-volume diagnostic centers. It’s not just about quantity; it’s about predictability and consistency, both qualities that reduce the pressure on staff and allow them to focus on patient experience.

    Where many generic contrast agents only focus on bulk supply, we have invested in refining particle size distribution, pH stability, and viscosity control. This pursuit translates directly to better shelf life and fewer incidents during administration. Hospital staff share feedback about smooth injections, minimal risk of line clogging, and a straightforward setup, even with more automated delivery systems. These details add up in real-world practice, shaving minutes off procedure times and reducing worries about unexpected slowdowns.

    Iopamidol in the Imaging Suite: Daily Realities

    Clinical staff often describe how patient comfort can make or break their workflow. Nothing disrupts a radiology department like repeated interruptions due to pain or mild allergic responses from a contrast agent. By selecting Iopamidol, facilities report fewer such incidents. Lower osmolality, compared to older ionic agents, leads to less heat sensation or discomfort during injection. Many children and adults tolerate the product well, even in cases involving repeat scans or long-term monitoring schedules.

    Patients with compromised renal function pose challenges for imaging. Doctors repeatedly look for agents that clear rapidly, limiting risk of nephrotoxicity. Our research and feedback confirm that Iopamidol, with its high degree of renal excretion and low lipid solubility, helps meet those needs. Its speed of elimination reduces the burden on the kidneys. In populations with pre-existing conditions, this property becomes critical—especially since alternatives often push up rates of adverse reactions or complicate post-scan recovery.

    What Experience Teaches About Quality Control

    Working on the production line gives unique insights. Maintaining consistency batch after batch tests every facet of our process, from raw chemical sourcing to packaging integrity checks. Ordinary users don’t see the detailed analytics and stress-testing we run. Each vial clears checks for pyrogens, particulate matter, and chemical degradation. The finished product undergoes independent testing for iodine content and osmolality. Failures are rare, but when they happen, flawed lots never reach the shelf.

    Many healthcare systems demand a clear track record of regulatory compliance. Every time standards shift in key markets, our teams update their calibration and oversight. This means our Iopamidol always matches the current regulatory picture, often going above and beyond simply ticking the boxes. In the manufacturing facility, everything from HEPA filtration to airlock procedures supports routine and reliable output. End users, in turn, tell us they rarely encounter recalls or unexplained variations between shipments.

    Iopamidol Compared to Other Contrast Agents

    Hospitals often weigh Iopamidol against alternative products like Iohexol and Iopromide. From a manufacturer’s standpoint, each product offers its own benefits, but users regularly note Iopamidol’s lower viscosity per milligram of iodine. This allows for easier handling through thin intravenous catheters and automated injectors, an edge during quick-paced procedures. Compared to traditional high-osmolality agents, Iopamidol’s non-ionic structure drastically cuts down on vasodilation, tissue swelling, and delayed contrast reactions. Doctors who monitor post-procedural recovery mention shorter observation times, especially useful when tight scheduling is the rule.

    Cost factors enter every purchasing discussion. While Iopamidol sometimes comes at a premium over older generic agents, hospitals point out that lower rates of extra monitoring, fewer emergency interventions for adverse effects, and smoother logistics often offset the difference. For children and the elderly, reduced osmolality matters even more. Oncology teams, with patients needing frequent scans, favor predictable, gentle agents to avoid compounding tissue irritation or cumulative toxicity.

    We regularly measure feedback from buyers and medical staff about viscosity, mixing performance with saline, rates of image artifact, and clarity of diagnostic output. Iopamidol consistently performs well on all these fronts, minimizing streaking and shadow effects in brain and chest imaging. Nurses and radiographers appreciate standard closure systems and labeling, making manual handovers easier and reducing prep errors across shifts. The process of drawing, prepping, and disposing of containers also sees fewer mishaps compared to irregularly shaped competitors.

    Addressing Concerns and Looking Forward

    Discussing adverse reactions remains a priority for us. Though rare with non-ionic agents, we acknowledge that Iopamidol is not risk-free. Our team maintains a vigilant tracking system for field reports on hypersensitivity, extravasation, or unexpected imaging outcomes. These insights inform our next-generation formulas and strengthen user outreach and training. After decades in the field, we have seen overall adverse event rates decrease steadily, yet we remain focused on transparency because patients depend on real-world honesty.

    Supply chain interruptions over recent years have exposed vulnerabilities in contrast agent provision. By investing in local raw material sources, expanding backup power, and cross-training staff, our manufacturing site has maintained continuous delivery even during border closures and transport delays. Hospitals placing standing orders rarely face situations where imaging schedules are disrupted for lack of contrast agent. Efficient inventory management, based on direct conversations with buyers, keeps lead times short and emergency deliveries possible. Working closely with healthcare purchasing departments, we find that a transparent approach builds mutual trust; neither side benefits from last-minute surprises.

    Usage Recommendations from a Manufacturer’s Viewpoint

    Decades of collaboration with hospital pharmacists, technologists, and procurement officers have taught us that successful contrast administration begins long before the patient enters the radiology suite. Proper storage, mixing, and injection technique play a massive role. We supply detailed guidance to staff on storage between 15–30°C, avoiding excessive heat or chilling. This small step keeps product integrity intact and shores up shelf life. Handlers always use strict aseptic technique, minimizing contamination risk. Waste disposal follows local hazardous chemical protocols, preventing cross-contamination and environmental harm.

    Radiologists often review patient allergies, hydration status, and prior imaging records before they schedule Iopamidol-based scans. This approach limits complications. Providers often pre-hydrate at-risk patients and select the lowest possible volume to accomplish diagnostic goals. Our technical support helps troubleshoot rare issues, whether users need quick clarification on mixing different contrast concentrations, managing air bubbles, or training rotating staff on new protocols.

    Across thousands of cases, one trend appears: clear, early communication with departments leads to smoother patient flows. The agents work best in a system that respects both product quality and human variables—timely staff education, regular feedback loops, and honest reporting of unexpected outcomes. This ongoing partnership forms the backbone of reliable contrast-enhanced imaging.

    Safety, Sustainability, and Responsibility

    Manufacturing a medical-grade contrast agent carries far-reaching responsibility. We partner with environmental regulators to manage waste solvents, byproducts, and water usage. In recent years we have cut discharge levels and invested in closed-loop systems, both for ethical reasons and regulatory mandates. Energy-efficient equipment and low-toxicity reagents also shrink our CO2 footprint. Every year, we expand recycling protocols and educate staff about emerging best practices. Hospitals increasingly ask about the environmental impact of their providers, especially in procurement negotiations.

    We follow strict worker safety guidelines, both for the staff who handle active ingredients and for those managing packaging, logistics, and laboratory analysis. Adequate ventilation, regular eye and skin protection, and hazard communication training create a safe workplace. No one should have to risk their health in service of patient care, whether in a clinical or manufacturing role. By sharing these stories openly, we hope to contribute to broader safety improvements across the pharmaceutical supply chain.

    Continuous Improvement: Learning from Every Batch

    Leadership in this industry stems from daily, small improvements. Over time, we added more precise filtration steps, automated packaging, and regular statistical checks on product viscosity and pH. Feedback from radiology nurses, who see plenty of day-to-day mixing and administration challenges, led our engineers to redesign container shapes and injection ports for easier gripping and opening. Small modifications often mean the difference between easy days and stressful ones in busy clinics.

    Sometimes product complaints arrive directly from the field—someone notes a stubborn air bubble or a vial stopper that resists puncturing. We take this input seriously, running it through root-cause analysis and, when needed, adjusting tooling or process steps in the next production cycle. This feedback loop is vital. Unlike high-volume commodity chemical producers, we remain committed to hands-on review and reactive shifts. Customers who know their feedback shapes the product are more likely to report both positive and negative experiences, helping everyone in the chain improve.

    Global Reach, Local Commitment

    The story of Iopamidol extends far beyond the factory gates. In rural health posts, isolated clinics, and major urban trauma centers, our product often serves as the linchpin in rapid diagnosis and treatment of stroke, vascular injuries, or tumors. Standardized labeling, multi-language inserts, and robust packaging all support effectiveness in settings where resources run thin. International partners rely on consistently clear instructions and assurance that each bottle reflects the same high standard. Given the critical nature of diagnostic imaging, reliability cannot be a luxury.

    Across regions, healthcare delivery systems differ, but the need for dependable, safe contrast media remains universal. Scientific conferences, online feedback, and direct field visits all filter back to our research and quality teams. By integrating the lived experiences of caregivers and logisticians, we refine the processes that reduce errors, ease usage, and keep supply lines robust during turbulent periods.

    Looking to the Future

    Manufacturing Iopamidol is about more than producing a clear liquid for hospital use. It reflects a promise to patients and caregivers facing diagnoses that can reshape lives. Technological change continues, with new imaging modalities pushing the demands on contrast agents. Meanwhile, regulatory landscapes shift, and patient populations age or develop new sensitivities.

    Instead of standing still, we update our formulae, modernize manufacturing lines, and keep research lines open to new stabilizers and delivery forms. We partner with academic labs to test emerging applications, such as dual-energy CT or low-volume pediatric scanning. Through these initiatives, we push back against complacency and investigate every route to safer, smoother imaging.

    In the end, each vial of Iopamidol represents years of trial, feedback, and careful oversight. Our commitment rests on real-world outcomes, day-to-day honesty, and open dialogue with healthcare teams. No manufacturer controls every variable, but by listening, adapting, and keeping patients at the center, we strive to support every clinical decision with the most dependable tools possible. Through thick and thin, that motivation underpins every lot that leaves our doors.