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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 | 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. |
Applications of Ioversol in Industrial ManufacturingIoversol, 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 ProductionMedical 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
Typical usage ratio
Downstream process integration
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2. API Intermediate for Pharmaceutical SynthesisPharmaceutical 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
Typical usage ratio
Downstream process integration
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3. Preclinical Diagnostic Reagent ManufacturingPreclinical 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
Typical usage ratio
Downstream process integration
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4. Radiology Consumables Contract ManufacturingContract 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
Typical usage ratio
Downstream process integration
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.