Products

Iohexol

    • Product Name: Iohexol
    • Chemical Name (IUPAC): 5-[acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide
    • CAS No.: 66108-95-0
    • Chemical Formula: C19H26I3N3O9
    • 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.
    • CONTACT NOW
    Specifications

    HS Code

    139002

    Generic Name Iohexol
    Brand Names Omnipaque
    Chemical Formula C19H26I3N3O9
    Molecular Weight 821.14 g/mol
    Drug Class Non-ionic iodinated contrast agent
    Route Of Administration Intravenous, intrathecal, oral
    Indications Diagnostic imaging (CT, angiography, myelography)
    Osmolality Low-osmolar contrast media (LOCM)
    Clearance Renal excretion
    Appearance Clear, colorless to pale yellow solution
    Contraindications Hypersensitivity to iohexol or iodinated contrast agents
    Storage Temperature 15°C to 30°C (59°F to 86°F)

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

    Packing & Storage
    Packing Iohexol is packaged in a sealed 100 mL glass vial, labeled with concentration, lot number, and expiration date, and protective outer box.
    Container Loading (20′ FCL) Container Loading (20′ FCL) for Iohexol: 80-100 drums (25kg each) or 16-20 pallets, securely packed, with safety compliance.
    Shipping Iohexol should be shipped in well-sealed, original containers, protected from light and moisture. Temperature should be maintained between 15–30°C (59–86°F). Handle with care, following relevant chemical regulations and safety guidelines. Shipping documents must comply with applicable international and local transport regulations for pharmaceutical or chemical substances.
    Storage Iohexol should be stored at controlled room temperature, typically between 20°C to 25°C (68°F to 77°F), and protected from light. The container should be tightly closed to avoid contamination. Storage areas should be secure, away from incompatible substances, and accessible only to authorized personnel. Do not freeze, and avoid excessive heat or direct sunlight to maintain stability and efficacy.
    Shelf Life Iohexol has a shelf life of about 3 years when stored in tightly closed containers at controlled room temperature, away from light.
    Application of Iohexol

    Applications of Iohexol in Industrial Manufacturing

    As a specialized manufacturer of Iohexol, we focus on its critical roles across select medical and life science production sectors. Below, we outline the primary downstream industrial applications and integration routes for Iohexol, presenting practical formulation details, precise regulatory adherence, typical process localization, and end-product outputs. Each segment reflects in-depth industry knowledge rooted in direct manufacturer experience.

    1. Non-Ionic Contrast Media for Radiology Pharmaceuticals

    Within the pharmaceutical sector, our primary downstream integration for Iohexol is the formulation of injectable non-ionic contrast agents for medical diagnostic imaging, such as X-ray computed tomography (CT) and angiography. Manufacturing involves rigorous batch control to ensure consistent iodine concentration and low osmolality, as required for safe human administration. Formulators balance solubility, viscosity, and biocompatibility with excipient selection to meet local and international compliance. Final filling occurs under Grade A cleanroom conditions, followed by sterility assurance and particulate monitoring before secondary packaging.

    Industry compliance standards

    • Chinese Pharmacopoeia (ChP) IV, V Editions
    • United States Pharmacopeia (USP 43-NF38)
    • European Pharmacopoeia (Ph. Eur. 10.0)
    • Current Good Manufacturing Practice (cGMP) – ICH Q7

    Typical usage ratio

    • 240–350 mg iodine/mL (adjusted for diagnostic intent and patient safety; varies per formulation)

    Downstream process integration

    • Iohexol dissolved and filtered in aqueous phase, compounded in mixing vessels after bulk sterilization
    • Formulation blending with saline and stabilizers, then filtration through 0.22 μm for aseptic filling

    Final product types

    • Injectable contrast agent ampoules and vials for CT scans
    • Single-use prefilled syringes for cardiovascular angiography
    • Bulk containers for hospital radiology supply chains

    2. Oral Gastrointestinal Radiographic Agents

    Iohexol is incorporated into water-soluble oral radiographic preparations used for gastrointestinal tract imaging, including esophagograms and enterography. Oral agents require careful pH adjustment to enhance gastrointestinal mucosal coating while minimizing patient risk. Dosing concentration depends on imaging target (esophagus, stomach, small bowel) and patient age, with production demanding exacting control of solution clarity and osmolarity. Downstream, bottling and labeling comply with medical device and active pharmaceutical ingredient traceability requirements.

    Industry compliance standards

    • Ph. Eur. 10.0 – Monograph 1507 “Iohexol” for oral contrast agents
    • FDA 21 CFR Part 210/211 (for US-bound finished products)
    • ISO 13485:2016 in relevant finished medical devices
    • WHO Prequalification Standard for Essential Medicines – Imaging

    Typical usage ratio

    • 140–350 mg iodine/mL per product label; adjusted according to radiologist protocol and route (oral vs. rectal)

    Downstream process integration

    • Iohexol solution prepared in sterilized stainless steel reactors; filtered and filled into oral-grade bottles
    • Stabilizer addition and pH balancing immediately prior to aseptic bottling

    Final product types

    • Oral radiographic drink solutions for fluoroscopic intestinal examinations
    • Pre-prepared bottles for mobile imaging units
    • Pediatric oral contrast kits with calibrated dosing cups

    3. Quality Control Standards and Reference Reagents for Analytical Labs

    Certified analytical laboratories utilize high-purity Iohexol as a calibration standard for validating iodine content quantification in pharmaceutical dosing and stability testing. Manufacture for this route emphasizes ultra-low impurity profiles, traceable lot numbers, and batch analytical documentation to support downstream labs’ ISO/IEC 17025 accreditation and regular audits. Iohexol functions as a critical, matrix-matched standard in HPLC and ICP-MS assay development for in-process QC of commercial contrast media.

    Industry compliance standards

    • ISO 17034:2016 – General requirements for reference material producers
    • ICH Q6A/B – Specifications for impurities and identity
    • USP General Chapters <1225> and <621> (validation of compendial procedures)
    • Traceability to NIST SRMs for laboratory calibrators

    Typical usage ratio

    • 0.5–5 mg/mL in analytical standard stock solutions; actual use depends on method calibration requirements

    Downstream process integration

    • Iohexol precisely weighed and dissolved using Class A glassware for calibration standard preparation
    • Aliquoting into ampoules with vacuum-sealing for distribution to analytical labs

    Final product types

    • Certified HPLC/GC calibration standards
    • Reference solutions for iodine assay validation in pharmaceutical QC
    • Proficiency test kits for hospital diagnostic lab commissioning

    4. Active Pharmaceutical Ingredient for Contract Manufacturing Organizations (CDMO/CMO)

    CDMO and CMO clients source high-grade Iohexol as an API for secondary formulation or filling operations tailored to hospital and commercial packaging requirements. Stringent incoming quality control, including heavy metal analysis and microbial limit tests, is enforced before Iohexol release for downstream blending. Contract manufacturers integrate it at the compounding phase along with site-specific diluents and excipients, and may scale volumes for national tenders, requiring full compliance with both exporting and importing country pharmacopoeias.

    Industry compliance standards

    • EU GMP (Part II – Active Substances)
    • US FDA DMF Type II submission (for NDA/ANDA support)
    • Japan Pharmacopoeia 18th Edition
    • Health Canada API Registration Guidance

    Typical usage ratio

    • Active ingredient concentration typically standardized to 300 mg Iodine/mL for downstream batch consistency; can be modified for end-client specifications

    Downstream process integration

    • Bulk Iohexol powder or solution received under GDP conditions, sampled for ID and purity before tank unloading
    • API addition during batch compounding phase, monitored by in-line UV or titration analysis

    Final product types

    • Hospital contract-labeled injectable CT contrast media
    • Branded and generic radiology products for national health procurement
    • Custom-filled syringes, vials, and bulk packs for hospital chains and diagnostic service providers

    Free Quote

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

    For samples, pricing, or more information, please contact us at +8615371019725 or mail to sales7@bouling-chem.com.

    We will respond to you as soon as possible.

    Tel: +8615371019725

    Email: sales7@bouling-chem.com

    Get Free Quote of Jiangxi Brother Pharmaceutical Co., Ltd.

    Flexible payment, competitive price, premium service - Inquire now!

    Certification & Compliance
    More Introduction

    Introducing Iohexol: Quality and Reliability Meet Precision Chemistry

    Iohexol and Our Role in Its Development

    As chemists and manufacturers dedicated to advancing medical imaging materials, we rely on experience and attention to detail throughout each stage of Iohexol production. Decades in the field have taught us that nothing matches the pressure of working with contrast media where safety and clarity are central concerns. Our Iohexol, produced with uncompromising consistency and a deep respect for patient well-being, stands at the crossroads of scientific rigor and daily clinical needs.

    Iohexol remains a mainstay among non-ionic, water-soluble contrast agents. Healthcare teams select Iohexol for its performance during computed tomography (CT), angiography, and a range of radiographic procedures. Behind each vial, a system of raw material sourcing, inert processing, and refined purification supports those moments when contrast enhancement can reshape a diagnosis or help a physician make a critical decision.

    Model and Specification Pathways

    We produce Iohexol under strict batch controls, and our quality assurance extends into routine details. Iohexol presents in several concentrations—often 240, 300, and 350 mg iodine per milliliter—since diagnostic demands differ by patient and clinical context. Each batch passes regular identity, purity, and sterility tests before it reaches packaging. The colorless, slightly viscous solution offers consistent characteristics. Chemists on our floor aim for each lot to match published monographs for impurity profiles, osmolality, and pH—factors that affect both comfort during administration and the clarity of the resulting images. Quality teams track water content, endotoxin levels, and individual container inspection to guarantee a trustworthy finished product.

    Unlike theoretical descriptions, the tangible challenge of Iohexol manufacturing reveals itself in quality control rather than marketing claims. Wizards in R&D direct process optimization, but technicians and QC staff face the reality of meeting regulatory and pharmacopoeial standards daily. We keep recall risk in view throughout production, making sterility and container integrity more than paperwork issues.

    Usage and Real-World Workflow

    In practice, radiologists depend on Iohexol after considering patient hydration status and pre-existing health conditions. The agent enters intravenously for CT angiography, excretory urography, and pediatric diagnostics. Medical teams rely on predictable viscosity—Iohexol’s particular physical characteristics let clinicians prepare syringes and catheters without frantic adjustments, even under time pressure.

    As a team producing this compound, we often field technical questions about dilution or compatibility. Iohexol remains miscible in normal saline and fits with current injector and tubing systems, qualities that minimize procedural delays or unpredictable interactions.

    Daily, we field requests from hospitals with tighter control requirements—from single-use vials to bulk containers for procedural suites. These nuances push us to maintain flexibility on the filling line, always mindful that every dose connects to a patient and a practitioner who trusts our craftsmanship against the backdrop of strict regulatory oversight.

    Differences, Decisions, and Evidence from Manufacturing Experience

    Iohexol entered routine medical use because it bridges patient comfort and diagnostic clarity. As a non-ionic, low-osmolar agent, it creates less sensation on injection than traditional high-osmolar ionic options. Our feedback loops highlight that fewer reported adverse events, such as nausea or heat sensation, motivate care teams to favor Iohexol. We trace these patient-centric outcomes back to our process: controls on ionic residue, close water purification, high-grade starting materials, and real-time stability monitoring.

    Comparisons with similar low-osmolar agents—like iopamidol or iomeprol—reveal subtleties. Iohexol’s slightly higher viscosity in concentrated forms affects injector settings. We document differences in osmolality and iodine distribution; clinicians often rely on these technical parameters when determining which product to stock for specialized diagnostic suites versus general imaging.

    On our end, feedback from radiology departments guides our priorities. Major orders from trauma centers and teaching hospitals require absolute lot-to-lot reliability. This pressure does not exist in a vacuum. Over time, hands-on feedback exposed points where some alternatives may outperform on certain imaging clarity or application-specific ease, but Iohexol consistently delivers a risk-reducing formula—especially for pediatric and geriatric imaging units.

    Here, the contrast between non-ionic and ionic radiographic materials becomes more than theoretical. Ionic agents, still present in some markets for their lower cost, cause more circulating reactions. Our process focuses on minimizing risk of even minor complications, including extravasation or transient nephrotoxicity—issues monitored closely in busy urban hospitals where outcome studies influence purchasing.

    Why Consistent Quality in Iohexol Matters: Experience from the Plant and the Clinic

    Our manufacturing team’s regular involvement in customer complaint handling brings a practical perspective often missing from cut-and-paste product descriptions. On rare occasions, a shipment falls short of expectations—sometimes linked to transit conditions, sometimes to crystallization or trace particulate issues. We react fast, drawing on our histories as chemists and operators, and involve distribution partners early. Regular monitoring and standardized pre-shipment checks sparked improvements in vial stability, case packaging, and even temperature monitoring through the chain.

    Imaging staff in hospitals do not work in ideal conditions. They juggle patient volume, equipment wear, and institutional protocols. They depend on predictable contrast delivery to maintain throughput—especially during periods of high demand, such as seasonal surges or system-wide protocol changes. A contrast medium’s production methods affect outbreak risk. One learning curve—repeated heater-cool cycles—taught us that batch-to-batch stability tests give only part of the picture. Shelf life and physical compatibility in real-world storage often matter more. Each recall incident—though rare—shapes our future controls and batch improvement plans.

    Quality’s importance extends to our own staff, too: producing Iohexol draws on occupational safety measures designed for chemicals with both acute and chronic exposure risks. Careful containment, environmental monitoring, and stepwise traceability for every reagent serve as building blocks not only for finished product safety but also for factory-wide health and sustainability.

    The Question of Environmental Impact

    Chemical manufacturing does not exist separate from environmental responsibility. The synthesis and purification of Iohexol—rooted in chlorinated hydrocarbon chemistry and advanced purification—produce wastewater and solid waste. Long before sustainability became an industry catchphrase, we dealt with solvents, byproducts, and difficult-to-degrade intermediates. Upgrading our water treatment and reclaim systems remains a constant concern.

    Trace amounts of non-ionic contrast agents, including Iohexol, enter municipal water supplies after patient excretion. Our production process attempts to minimize trace contamination by optimizing yields, reducing unnecessary discharges, and switching to closed-reactor systems for some synthesis steps. We work with regulatory teams to monitor local discharge, balancing safety and community health. Efforts toward greener syntheses and solvent recycling are ongoing, with each pound of waste reduced representing a win for both profitability and long-term public health.

    Transparency with our hospital partners about environmental impact opens dialogue for end-of-life solutions—like improved hospital effluent filtration or local wastewater support. These actions amplify our sense of stewardship as a manufacturer, reinforcing the idea that even high-value medical compounds benefit from a cleaner lifecycle.

    Iohexol in Global Context

    Markets vary in their regulatory rigor and purchasing power, shaping how we approach approvals and distribution. In places with advanced pharmacovigilance systems, clinical data on Iohexol guides hospital evaluation committees. We respond with frequent post-market surveillance and regular submissions to regulatory bodies. This means investing in lot release data, supporting clinical research, and maintaining traceability, from synthesis reactors through sterile filling to the final user.

    In developing regions, price matters, but medical teams still seek assurance of safety and reliability. Our own commercial relationships facilitate technology transfer and local staff training. By working alongside overseas partners, we can guarantee both production know-how and supply stability, particularly during periods when global shortages threaten routine medical care.

    Pandemic disruptions underscored vulnerabilities in chemical supply chains. By investing in dual-source raw materials and in-house reagent production, we shield downstream partners from the bulk of global supply shocks. Our team’s longevity—not just our laboratories—engrains tools and principles for risk management, so that end-users see little difference between lean times and business as usual.

    Improving Safety and Supporting Higher-Standard Healthcare

    Iohexol’s low rate of adverse reactions—compared to legacy ionic agents—drives hospital preference. Our past technical troubleshooting pointed out that patient age, dehydration, or certain comorbidities may increase the risk of complications after use. In response, we tightened our batch uniformity, refined stability protocols, and documented results in regular user feedback reviews. Medical staff expect prompt answers to technical queries—including off-label imaging uses—and our on-site pharma support teams meet that demand.

    We invest in continuous professional development, training new chemists and operators to recognize risks before products ever reach a hospital. Our concern for occupational exposure—where acute skin or inhalation hazards exist during certain steps—translates to improved controls and regular staff rotations.

    Users need clear handling guidelines, practical dilution advice, and support in case of suspected reaction. Our responsibility does not end at the factory gate. We maintain monitoring networks for post-market feedback, and we collect data on adverse events to help inform patient safety research. This feedback returns in the form of refined production controls and, where possible, updates to labeling and user documentation.

    Iohexol for Today and Tomorrow: The Manufacturer’s Perspective

    The path from chemical synthesis to a confidently administered dose crosses many disciplines and daily challenges. Manufacturing Iohexol demands more than attention to technical standards—it draws on a willingness to adapt, learn from every incident, and listen to end-users. Through direct engagement with clinicians and sustained investment in process improvement, we keep quality—not just compliance—alive in every shipment.

    Our entire approach to contrast agent manufacturing is rooted in the principle that every step at the reactor, filling, and inspection stage affects a patient. Iohexol’s continued adoption globally owes as much to manufacturing transparency, reliability, and disciplined oversight as to its technical strengths in imaging science. For each lot produced, our teams gauge not just product specs but the total journey from raw ingredient purchase through to imaging outcome in hospitals across continents.

    Challenges and Continuous Improvement in Iohexol Production

    True quality emerges over time, not just from successful batches but also in how manufacturers manage setbacks. Each deviation, whether detected internally or reported by a healthcare professional, sparks inquiry and process review. Our system, honed over years, cultivates the skills needed for immediate response—be it tracing a rogue impurity or revisiting source documentation for a critical intermediate.

    As demand for Iohexol escalates, mainly with growth in cross-sectional imaging, we continuously challenge our teams to keep bottlenecks out of the process. Upgrading reactor automation, integrating real-time QC testing, and investing in personal development for our operators all contribute to predictable, high-quality lots. COVID-19 disruptions emphasized the need for supply chain resilience, including stock material audits and advanced shipment tracking.

    We believe proactive engagement with both upstream and downstream partners shapes Iohexol’s standing in the imaging world. The future of non-ionic contrast agents—including Iohexol—depends on this willingness to improve under pressure, share knowledge with users, and maintain transparency when problems arise.

    Trust, Partnership, and the Way Forward

    Healthcare providers worldwide place profound trust in the supply of diagnostic materials. For us, trust builds stepwise. Years of technical troubleshooting, clinical collaboration, and listening to direct feedback shape our outlook. Iohexol is advanced chemistry in service of rapid, accurate diagnosis—but, more than that, it represents the collective experience of the chemists, engineers, and quality teams who bring each batch safely to market.

    Ethics, transparency, and continuous training underpin every container we ship. Our job does not end when product changes hands. Through ongoing process review, traceability work, and hands-on problem-solving, we support every dose—from the factory floor to the patient bedside. This commitment drives the day-to-day reality of Iohexol production, defining both our success and our sense of responsibility as a chemical manufacturer serving patients and healthcare professionals worldwide.