Products

Ioversol

    • Product Name: Ioversol
    • Chemical Name (IUPAC): N,N'-Bis(2,3-dihydroxypropyl)-5-[N-(2-hydroxyethyl)glycolamido]-2,4,6-triiodoisophthalamide
    • CAS No.: 87771-40-2
    • Chemical Formula: C18H24I3N3O9
    • 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

    491227

    Generic Name Ioversol
    Brand Names Optiray
    Chemical Formula C18H24I3N3O9
    Molecular Weight 807.12 g/mol
    Classification Non-ionic, iodinated contrast agent
    Appearance Clear, colorless to pale yellow solution
    Osmolality 630–792 mOsm/kg (depending on concentration)
    Iodine Content 31% by weight
    Route Of Administration Intravenous, intra-arterial
    Indications Diagnostic imaging (CT, angiography, urography, etc.)
    Storage Temperature 20°C to 25°C (68°F to 77°F)
    Viscosity 4.2–13.9 mPa·s at 37°C (varies by concentration)

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

    Packing & Storage
    Packing Ioversol is supplied in a 100 mL clear glass vial, sealed with a gray rubber stopper and protected by an aluminum cap.
    Container Loading (20′ FCL) Container Loading (20′ FCL) for Ioversol: Standard load is 80 drums, each 200 kg, total net weight approximately 16,000 kg.
    Shipping Ioversol should be shipped as a non-hazardous chemical under ambient conditions, in tightly sealed containers to prevent contamination. Avoid extreme temperatures and direct sunlight during transport. Ensure compliance with local and international regulations for chemical shipping. Proper labeling and documentation should accompany the shipment for safe and secure handling.
    Storage Ioversol should be stored at controlled room temperature, typically between 20°C and 25°C (68°F and 77°F). Protect it from light and freezing. Keep the container tightly closed when not in use and store it in a dry, well-ventilated area designated for chemicals. Follow all applicable regulations for the storage of pharmaceuticals and radiographic contrast agents.
    Shelf Life Ioversol typically has a shelf life of 24 to 36 months when stored in its original, unopened container at recommended conditions.
    Application of Ioversol

    Applications of Ioversol in Industrial Manufacturing

    Ioversol, a non-ionic, water-soluble contrast agent, has secured key roles in industrial-scale medical diagnostics, pharmaceutical manufacturing, and chemical process sectors through stringent quality control, regulatory alignment, and dedicated application engineering. The following sections highlight real-world downstream use cases, detailed compliance mandates, and specific production requirements.

    1. X-ray and CT Contrast Media Production

    Medical imaging manufacturers use Ioversol as a core ingredient for X-ray and computed tomography (CT) injectable contrast agents. The material’s high hydrophilicity and negligible protein binding facilitate patient safety and image clarity in diagnostic procedures. Downstream blending operates under strict aseptic techniques, integrating Ioversol solutions with isotonic excipients and sterilizing filters. Formulators must calibrate iodine concentration according to diagnostic demand and patient safety requirements, supporting single-dose and multi-dose final product lines for global hospitals and clinics.

    Industry compliance standards

    • USP (United States Pharmacopeia) Monographs for Iohexol & Omnipaque analogs, applicable for Ioversol
    • European Pharmacopoeia 10.0 – Monograph 1045/04.2
    • Good Manufacturing Practice (GMP) EU Directive 2017/1572
    • FDA 21 CFR 210/211 for finished pharmaceuticals

    Typical usage ratio

    • Dosage range: 240–350 mg iodine/mL in final injectable solutions, adjusted by radiologist protocol
    • Ioversol ≥90% concentration preformulation, with reduced excipient loads as regulated

    Downstream process integration

    • Direct addition in sterile water to create bulk solution post-filtration
    • Inline mixing with stabilizers and pH adjusters; terminal sterilization via autoclave or filtration
    • Bottling and laminar flow filling into vials or syringes under cleanroom conditions
    • Packaging for clinical distribution post-QC release

    Final product types

    • Injectable iodinated contrast media for CT and angiography
    • Ready-to-use prefilled syringes for radiology labs
    • Multi-dose vials for hospitals
    • Pediatric imaging solutions

    2. API Intermediate for Pharmaceutical Synthesis

    Pharmaceutical manufacturers leverage Ioversol as a reference API intermediate in the synthesis and scale-up of related non-ionic iodinated contrast agents. Its high-purity, well-characterized impurity profile, and regulated supply facilitate qualification as a reference standard in GMP-compliant facilities worldwide. Downstream processing uses controlled crystallization and solvent exchange systems, with batch records linked to regulatory submissions and DMF support.

    Industry compliance standards

    • ICH Q7 – API cGMP for intermediates and final substances
    • FDA DMF (Drug Master File) Type II references
    • China Pharmacopoeia (ChP) for injectable and research-grade APIs
    • WHO GMP for active pharmaceutical ingredient plants

    Typical usage ratio

    • Direct intermediate: ≥98% purity, 45–80% process yield depending on route
    • As a standard: 1–5% standard solution for HPLC or NMR reference

    Downstream process integration

    • Chemical synthesis of analog iodinated APIs via direct amidation, halogenation, or sulfonation
    • Reference standard solution blending for method validation
    • Purification by preparative chromatography or crystallization in pharmaceutical plants
    • Lot-specific GMP documentation for regulatory filings and batch release

    Final product types

    • Active pharmaceutical ingredients (APIs) for contrast agent families
    • Reference standards for in-house or contract analytical testing
    • Bulk intermediates for downstream formulation houses
    • Validation materials for method development in R&D

    3. Preclinical Diagnostic Reagent Manufacturing

    Preclinical research reagent suppliers deploy Ioversol in the formulation of diagnostic calibrators and imaging research kits used in toxicology or pharmacokinetics studies. These specialized kits must meet laboratory-grade standards for reproducibility and analyte response. Ioversol-based reagent solutions undergo small-batch blending, microfiltration, and lyophilization, aligning with animal study protocols and GLP compliance for distribution to CROs and research hospitals.

    Industry compliance standards

    • OECD Good Laboratory Practice (GLP)
    • ISO 13485 for diagnostic reagent manufacturers
    • US FDA 21 CFR Part 58 for nonclinical laboratory studies
    • REACH guidelines for chemical safety data in Europe

    Typical usage ratio

    • Working solutions: 80–300 mg/mL for imaging calibration, scaled to study design
    • Kits formulated to match 50–100 animal doses per pack

    Downstream process integration

    • Solution preparation by gravimetric dosing and filtration
    • Portion packaging into vials with inert atmospheres
    • Freeze-drying or stabilizing formulation as required
    • Final QC for pH, sterility, and imaging efficacy

    Final product types

    • Preclinical imaging diagnostic kits
    • Animal model calibrators for CT studies
    • Quality control reference standards for life science laboratories
    • Lyophilized diagnostic reagents

    4. Radiology Consumables Contract Manufacturing

    Contract manufacturing organizations (CMOs) in the radiology sector use Ioversol for third-party production of customer-branded contrast media, requiring robust supply chain traceability and controlled environment batch operations. These facilities must document every phase – solution compounding, sterile filtration, and unit filling – per contract terms and customer audit requirements. Customization of iodine concentration and ampoule volume occurs during master batch preparation to support unique private label and specialty medical projects.

    Industry compliance standards

    • PIC/S GMP guidelines for contract medicinal product manufacturing
    • FDA 21 CFR 820 for radiological device components
    • ISO 9001:2015 for quality management systems in medical manufacturing
    • Local NMPA regulations (China) for contrast agent CMOs

    Typical usage ratio

    • Final fill: 240–320 mg iodine/mL, tailored by customer’s product dossier
    • Ioversol bulk solution 92–99% pre-mixing, limited by excipient choices and fill volume

    Downstream process integration

    • Batched solution preparation and filtration in segregated cleanroom suites
    • Metered filling into ampoules, bottles, or dual-chamber injectors
    • Final sterilization cycles per validated protocol (autoclave or 0.22 μm filtration)
    • Batch release documentation meeting CMO-client agreements and regulatory bodies

    Final product types

    • Contract-branded radiology contrast media
    • Private label injectable imaging solutions
    • Single-use diagnostic kits for hospital systems
    • Ready-fill glass ampoules for export markets

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    Certification & Compliance
    More Introduction

    Ioversol: A Modern Contrast Agent Backed by Proven Manufacturing

    From Formula to Practice: The Story of Ioversol

    Over decades in the chemical business, we've seen demand for precision, safety, and reliability grow in parallel with medical technology. Ioversol stands out among non-ionic, low-osmolar contrast agents. By leaning on years of direct experience with synthesis and strict purification, we’ve witnessed first-hand its steadfast performance under pressure. Ioversol isn’t just another option on a long list—it’s the culmination of real-world improvements, guided by the constant feedback loop with physicians, radiologists, and supply chain partners.

    A Closer Look at Our Ioversol

    We produce Ioversol with a sharp focus on clinical results. Its core structure, based on a tri-iodinated benzene ring, balances high X-ray attenuation with low toxicity. The solubility and stability of Ioversol under physiological conditions allow for consistent image enhancement, reducing the risk of unpredictable outcomes. It flows through syringes and catheters with minimal resistance, meeting the direct demands of fast-paced imaging environments.

    Our batches undergo rigorous particle-size and pH testing. This careful approach eliminates the risk of microcrystal formation, which we’ve learned can hinder imaging and patient comfort. Every lot features actual-use trials before shipping—an approach shaped by long years spent troubleshooting small flaws overlooked in the theoretical lab setting.

    Molecular Characteristics and Model Range

    Among non-ionic iodinated agents, Ioversol brings a unique balance: strong iodine content, modest viscosity, and tailored osmolality. Its molecular formula and hydrophilic side chains are the result of targeted chemical design, not a template copied from earlier agents. We offer Ioversol in strengths ranging from 240 mg I/mL to 350 mg I/mL. These concentrations address the varied requirements for angiography, urography, and contrast CT. Higher strengths provide deep contrast suitable for cardiac and neuroimaging. Lower versions suit vascular studies where patient fragility demands lower osmolar load. Each model draws from feedback not just from clinicians, but from our own manufacturing logs and transport stability studies.

    Early generations of contrast media brought more side effects due to hyper-osmolarity and poor clearance. The Ioversol series, by comparison, offers reduced chemotoxicity. By holding osmolality close to that of blood, we’ve seen lower rates of adverse reactions across wide patient populations, from adults to pediatric cases. It’s these ground-level safety gains that really cement Ioversol as a go-to solution.

    Performance in Clinical Settings

    Large-scale hospitals and regional imaging clinics face different daily realities, but both demand reliability. Across thousands of administered doses, Ioversol has delivered crisp, reliable imaging with less patient discomfort. We know from direct feedback that technicians appreciate its viscosity—less likelihood of clogging or manual force during injection. Patients report fewer sensations of heat and lower incidents of nausea. These details matter more than any abstract promise.

    During mass screenings, workflow interruptions can lead to significant delays and expense. Ioversol’s stability in pre-filled syringes and bulk dispensers saves precious minutes for busy staff. Its consistent chemical profile has proven, in our case studies, to cut down on equipment cleaning cycles, and reduces wear and tear on injection pumps.

    More Than A Standard Product

    Many off-the-shelf contrast agents claim similar uses, but our Ioversol benefits from manufacturing control from raw iodine sourcing to final vial fill. We audit our iodine sources for trace contaminant risk and log every change in the purification process. Shortcuts in hydrolysis or poor control over the drying stage, which we’ve seen from less careful producers, often cause unwanted byproducts. Such shortcuts have no place in manufacturing for healthcare.

    Our real-world handling audits push product resilience beyond standard lab tests. We simulate transit from our plant to field clinics, testing for precipitation, sediment, and microbial risks under a range of ambient temperatures and humidity. This commitment goes beyond compliance; it comes from years spent tracing avoidable errors in other contrast media that led to stock recalls or missed diagnosis.

    Ioversol vs. Conventional Agents—What’s the Practical Difference?

    Comparing Ioversol to older ionic contrast agents, we keep running into the same themes: patient safety, speed through workflow, and imaging reliability. Ionic agents, once common due to ease of synthesis, have higher hyperosmolarity. This means greater fluid shifts in vulnerable patients, translating to real complications like pain, renal stress, and allergic responses. Ioversol brings a modern answer, lowering osmotic impact while maintaining visualization power.

    In our data, non-ionic alternatives like Ioversol cut adverse reaction rates by more than half compared with legacy compounds. As every practitioner knows, even rare side effects feel significant in high-volume settings or with immunocompromised patients. The careful chemical structure of Ioversol doesn’t just bring textbook benefits—it drives a measurable drop in re-dosing, complications, and emergency deviations from procedure.

    The viscosity of Ioversol, often overlooked by marketers, plays a key role in practical daily use. Some competitors still ship agents with higher resistance at cold temperatures, slowing down the workflow. Our formulation has been optimized to stay injectable and predictable across standard storage conditions, as shown in distributor and field technician reports. Less time spent heating, agitating, or swapping out stuck syringes means more time for diagnosis and care.

    Responsible Use and Future-Proofing

    Contrast media, despite their routine use, always carry risk for a fraction of patients. Over the years, our close work with clinical partners has shaped our formulation guidelines. For example, patients with reduced renal function benefit from lower osmolality and improved clearance kinetics; we have tailored our manufacturing to hit these marks batch after batch. We are also quick to adapt when new best practices emerge, updating our documentation and labeling with input from our hospital users—not just on paper, but in active technical roundtables and workshops.

    No product lasts through the long haul without ongoing validation. We regularly test Ioversol stability well past standard shelf life, not just at ideal temperatures but at the temperatures encountered in field clinics or remote transport. This attention to real-life handling, born out of our own frustrations with returns and storage failures, keeps clinics running without interruption.

    What Nurtures Confidence in Ioversol?

    We control every aspect of production, from initial material procurement through multi-stage purification to automation of fill-finish under aseptic conditions. Each shipment passes residue analysis and is trackable via internal codes—not just for our records, but to give physicians traceability they can count on if product queries arise.

    We listen when end users call—in the rare case of field complaints, our internal batch review process brings all parties to the table, from chemists to shipping managers. This culture of responsibility has given us years of evidence that continuous improvement, rather than shortcuts or surface-level compliance, drives confidence both in the product and among our partners.

    Manufacturing Insights: Experience-Driven Improvements

    Ioversol production involves several steps where experience pays off. Over time, we improved yield not by automatically scaling up, but by monitoring those small variables that have large impacts in bulk settings—mixer speed, reaction timing, solvent purity, batch temperature curves. Not every variable shows up in a patent or specification sheet, but we see the difference in finished product clarity and shelf-life stability.

    Temperature logs and real-time analytics have shown us that batching under too-rapid heating pulses can affect final chromatographic purity. Years spent logging every deviation mean we continuously adjust, shortening impurity removal times or stretching filter washes to avoid buildup and extended maintenance downtime. Efficiency and safety grow together—we adjust our own standards faster than outside regulations update, because our customers depend on us to spot issues before a regulator or clinical user does.

    Why Ioversol Matters: A Manufacturer’s Perspective

    Contrast agents remain a core tool in diagnostic imaging, and while new modalities arise, there’s no replacement for reliable, injectable iodine media. Our experience on the manufacturing floor, paired with ongoing partner clinics and field support, brings out the true strengths of Ioversol: consistent clarity, minimized complications, fast throughput, and respect for the real conditions under which healthcare teams operate. We know every decision—from raw material lot testing through to cap crimps and label adhesion—has downstream effects, and this drives our up-close involvement at every stage.

    For healthcare professionals, dependability often beats theoretical performance. With Ioversol, every customer gains not just documentation but a background of long-term validation in the hands of real users facing real patients. That’s why, despite periodic claims of new breakthroughs in contrast media, the feedback we receive relies on practical results: doctors continue to choose Ioversol for challenging vascular studies or vulnerable patient groups because their results back up what the data says.

    Continuous Learning and Product Evolution

    Industry standards have shifted again and again—new research on radiocontrast nephropathy, ongoing questions about bioaccumulation, more scrutiny on byproducts. Each new concern sends us back to our own records, checking real batch histories and post-market feedback to adapt faster than the market demands. This cycle has given us deep insights into what really counts in hospital workflows: a product that consistently delivers, even in tough logistical settings or after lengthy storage.

    We invest in training and technical partnerships, not just for our own employees but for the downstream users who rely on our product stability. From the first chain-of-custody to the final injection, we track, learn, and adjust. If a hospital flags an outlier—rising coloration, slight odor shift, or other minor concern—it triggers real investigation, not just a checkmark on a complaint log. That’s the value of keeping R&D, quality, and batch history under one roof.

    Supporting Diagnostic Progress By Listening to the End User

    The best chemical solutions grow out of listening to the people using them—not just in focus groups, but through long-term support relationships. Ioversol has evolved because radiologists, nurses, and even maintenance staff have flagged details nobody in product marketing considered. Whether it’s improve open time on multi-patient dispensers, reducing bubble formation under fast draw, or ensuring label readability in low-light imaging suites, it’s the sum of these small improvements over years that sets our product apart.

    Our facility teams maintain open lines with radiology departments. Every field test, returned vial, or procedural comment feeds back directly to our formulation teams. Product evolution, in our hands, isn’t about ticking boxes—it’s an ongoing conversation between manufacturer and user, grounded in trust and shared goals for safe, effective diagnosis.

    Addressing Global Challenges: Cost, Supply, and Stewardship

    In today’s supply climate, cost pressures and logistics cannot be ignored. We maintain redundant material sourcing, maintain live inventory dashboards, and build buffer stocks not to meet a quarterly goal, but to keep hospitals from canceled scans when shipments encounter delays. This close control, built from years spent watching what can go wrong, makes the difference when regions face supply chain shocks or urgent spikes in demand.

    Environmental stewardship comes with its own challenges. We control effluent discharge points, reclaim solvents wherever feasible, and audit byproduct streams. Not every operation can claim this, but over years of running a multi-stage synthesis for Ioversol, we’ve learned that responsible production pays off in fewer regulatory headaches and better community relations.

    Looking Ahead: Keeping Ioversol Relevant in an Evolving Field

    Diagnostic technology moves fast—more detailed scanners, combined PET/CT, and ongoing shifts towards minimally invasive imaging. We know that Ioversol’s role is not static. We pilot modifications in collaboration with imaging innovators, adding real-world-use data from product launches in new regions or populations. As we see new needs emerge—from improved pediatric dosing to faster delivery formats—we update not with a broad-strokes change, but pinpointed shifts in formulation and packaging.

    As we look toward the future, we stand by the relationship built across manufacturing, regulatory, and medical communities. Ioversol’s success rests not just on the molecule, but on the ongoing coordination from raw substance to patient injection. This hands-on cycle of control, adaptation, and transparency forms the core of how we manufacture and deliver Ioversol, day in and day out.