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Iopromide | CAS No: 73334-07-3 | GMP-certified suppliers
A medication that supports vascular and organ diagnostic imaging by providing reliable contrast enhancement for X‑ray and CT procedures in major clinical applications.
Therapeutic categories
Benzene DerivativesCompounds used in a research, industrial, or household settingContrast MediaDiagnostic Uses of ChemicalsDrugs that are Mainly Renally ExcretedIodinated Contrast Agents
Generic name
Iopromide
Molecule type
small molecule
CAS number
73334-07-3
DrugBank ID
DB09156
Approval status
Approved drug
ATC code
V08AB05
Primary indications
- Iopromide, as the product IOVIST, is approved by the FDA for use as an intra-arterial or intravenous X-ray contrast agent
- For intra-arterial administration, iopromide is indicated for cerebral arteriography, peripheral arteriography, coronary arteriography, left ventriculography, visceral angiography, and aortography in adults and radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older
- For intravenous administration, iopromide is indicated for excretory urography in adults and pediatric patients aged 2 years and older, contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older, and contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound
Product Snapshot
- It is an iodinated, nonionic small‑molecule contrast agent supplied as injectable solutions for intravascular and intracavitary use
- Its primary uses are diagnostic enhancement in CT imaging, angiography, urography, and other radiographic procedures
- It is approved in major regulated markets including the US (FDA) and Canada (Health Canada)
Clinical Overview
Iopromide (CAS 73334-07-3) is a nonionic, low osmolar iodinated X‑ray contrast agent used for intravascular administration. It is classified among 4‑halobenzoic acid derivatives and functions by opacifying blood vessels and extracellular spaces along the flow path, enabling radiographic visualization until dilution reduces contrast intensity.
Clinically, iopromide is approved for intra‑arterial and intravenous use in adults and pediatric patients aged 2 years and older. Intra‑arterial indications include cerebral, peripheral, and coronary arteriography, left ventriculography, visceral angiography, and aortography. Intravenous indications include excretory urography, contrast CT of the head, thorax, abdomen, and retroperitoneum, and contrast mammography in adults. Additional region‑specific approvals include renal arteriography, phlebography, and arthrography at specific concentrations. Marketed under brands such as ULTRAVIST and IOVIST, its applications span diagnostic vascular and organ imaging.
Iopromide acts by delivering iodine atoms that attenuate X‑rays, producing contrast enhancement proportional to the local iodine concentration. After intravenous administration, renal parenchymal opacification typically begins within one minute, with peak visualization of the collecting system between five and fifteen minutes. Elimination is primarily renal, and delayed excretion may occur in nephropathic conditions.
The agent has an established safety profile for intravascular use, though serious adverse reactions have been reported, including hypersensitivity, cardiac events, and thromboembolism. Inadvertent intrathecal administration is associated with severe toxicity. Population differences in adverse event incidence have been observed, with higher rates reported in women and outpatients. Overall adverse event frequency in long‑term observation was approximately 0.7 percent.
For API procurement, sourcing should prioritize quality systems that ensure control of iodine content, osmolarity, impurity levels, and stability, with full documentation to support regulatory submissions and regional pharmacopeial compliance.
Clinically, iopromide is approved for intra‑arterial and intravenous use in adults and pediatric patients aged 2 years and older. Intra‑arterial indications include cerebral, peripheral, and coronary arteriography, left ventriculography, visceral angiography, and aortography. Intravenous indications include excretory urography, contrast CT of the head, thorax, abdomen, and retroperitoneum, and contrast mammography in adults. Additional region‑specific approvals include renal arteriography, phlebography, and arthrography at specific concentrations. Marketed under brands such as ULTRAVIST and IOVIST, its applications span diagnostic vascular and organ imaging.
Iopromide acts by delivering iodine atoms that attenuate X‑rays, producing contrast enhancement proportional to the local iodine concentration. After intravenous administration, renal parenchymal opacification typically begins within one minute, with peak visualization of the collecting system between five and fifteen minutes. Elimination is primarily renal, and delayed excretion may occur in nephropathic conditions.
The agent has an established safety profile for intravascular use, though serious adverse reactions have been reported, including hypersensitivity, cardiac events, and thromboembolism. Inadvertent intrathecal administration is associated with severe toxicity. Population differences in adverse event incidence have been observed, with higher rates reported in women and outpatients. Overall adverse event frequency in long‑term observation was approximately 0.7 percent.
For API procurement, sourcing should prioritize quality systems that ensure control of iodine content, osmolarity, impurity levels, and stability, with full documentation to support regulatory submissions and regional pharmacopeial compliance.
Identification & chemistry
| Generic name | Iopromide |
|---|---|
| Molecule type | Small molecule |
| CAS | 73334-07-3 |
| UNII | 712BAC33MZ |
| DrugBank ID | DB09156 |
Pharmacology
| Summary | Iopromide is a nonionic, iodinated contrast agent that enhances X‑ray and CT visualization by increasing attenuation in the vasculature and extracellular space after intravascular administration. Its pharmacologic effect stems from the high atomic number of iodine, which produces transient radiographic opacification along the agent’s distribution and excretion pathways. Contrast intensity depends on local iodine concentration, with renal opacification and subsequent urinary excretion occurring rapidly under normal physiologic conditions. |
|---|---|
| Mechanism of action | Iopromide is a nonionic iodinated, water-soluble, radiographic contrast medium that is available in two stable, ready-to-use solutions of different concentrations (i.e., 300 mg I/mL and 370 mg I/mL). Following intravascular injection, iopromide provides radiographic opacification of the vasculature and extracellular space in the path of flow of the agent, allowing diagnostic assessment of the limbs and internal organs until significant dilution occurs. |
| Pharmacodynamics | After intravenous injection, opacification of the renal parenchyma begins within 1 minute. Excretion of the contrast agent becomes apparent in 1 to 3 minutes with optimal contrast in the calyces and collecting system occurring between 5 and 15 minutes. In nephropathic conditions, particularly when excretory capacity has been altered, the excretion rate varies unpredictably and opacification may be delayed for several hours after injection.the degree of contrast enhancement is related to the iodine concentration in the tissue of interest. |
ADME / PK
| Absorption | Immediately following intravascular injection, iopromide reaches peak plasma concentrations and is then rapidly distributed throughout the extracellular fluid compartment. It displays little tendency to bind to serum or plasma proteins.Iodinated contrast agents cross a disrupted blood-brain barrier. |
|---|---|
| Half-life | After intravenous administration to healthy adult subjects, the plasma iopromide concentration-time profile shows an initial distribution phase with a half-life of 0.24 hours; a main elimination phase with a half-life of 2 hours; and a terminal elimination phase with a half-life of 6.2 hours. |
| Protein binding | The plasma protein binding of iopromide is 1%. |
| Metabolism | Iopromide does not undergo significant metabolism, deiodination, or biotransformation. |
| Route of elimination | The amounts excreted unchanged in urine represent 97% of the dose in adult healthy subjects. Only 2% of the dose is recovered in the feces. Similar recoveries in urine and feces are observed in middle-aged and elderly patients. This finding suggests that, compared to the renal route, biliary and/or gastrointestinal excretion is not important for iopromide. During the slower terminal phase, only 3% of the dose is eliminated; 97% of the dose is disposed of during the earlier phases, the largest part of which occurs during the main elimination phase. The ratio of the renal clearance of iopromide to the creatinine clearance is 0.82, suggesting that iopromide is mainly excreted by glomerular filtration. Additional tubular reabsorption is possible. |
| Volume of distribution | The total volume of distribution at steady state is about 16 L, suggesting distribution into extracellular space. |
| Clearance | The mean total and renal clearances are 107 mL/min and 104 mL/min, respectively. |
Formulation & handling
- Formulated exclusively as high‑strength aqueous injections for intravascular and intra‑arterial administration, requiring control of viscosity and osmolality typical of iodinated contrast media.
- High hydrophilicity (logP −0.44) and moderate water solubility necessitate use of concentrated sterile solutions rather than solid reconstitution formats.
- Thermal stability supports storage at room temperature, but handling typically avoids excessive cooling to prevent increased viscosity and crystallization risk in concentrated solutions.
Regulatory status
| Lifecycle | I don’t have the patent‑expiry timing for this API, so I can’t characterize its lifecycle stage precisely. If you can share the relevant expiry dates, I can provide a concise, accurate summary tailored to the US and Canadian markets. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Iopromide is supplied primarily by a single originator company, reflected by the repeated Ultravist brand, which remains the standard branded product in the US, Canada, and other major markets. The product has long-past patent protection, indicating that generic competition is technically permitted, although market entry may be limited by the complexity of manufacturing injectable contrast agents. |
|---|
Safety
| Toxicity | There are no data on iopromide use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Iopromide crosses the placenta and reaches fetal tissues in small amounts. In animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to 0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects. The safety and efficacy of iopromide have been established in pediatric patients aged 2 years and older for radiographic evaluation of cardiac chambers and related arteries, excretory urography, and contrast computed tomography of the head and body. The use of iopromide in these age groups for these indications is supported by evidence from adequate and well-controlled studies in adults and additional safety data in pediatric patients aged 2 years and older, including data from published studies. Pediatric patients who are at higher risk of experiencing an adverse reaction during and after the administration of any contrast agent include those with asthma, sensitivity to medication and/or allergens, cyanotic and acyanotic heart disease, congestive heart failure, or serum creatinine greater than 1.5 mg/dL. Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates; Some patients were treated for hypothyroidism. After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates. The clearance of iopromide decreases with increasing degree of renal impairment and results in delayed opacification of the urinary system. In addition, preexisting renal impairment increases the risk of acute kidney injury. Iopromide can be removed by dialysis. Long-term animal studies have not been performed with iopromide to evaluate carcinogenic potential or effects on fertility. Iopromide was not genotoxic in a series of studies including the Ames test, an in vitro human lymphocytes analysis of chromosomal aberrations, an in vivo mouse micronucleus assay, and an in vivo mouse dominant lethal assay. The manifestations of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy. The most common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. |
|---|
High Level Warnings:
- Renal impairment reduces iopromide clearance and increases the risk of acute kidney injury
- Delayed urinary opacification may occur
- Inadvertent intrathecal exposure is associated with severe neurovascular toxicity, including seizures, cerebral hemorrhage, and risk of fatal outcomes
Iopromide is a type of Diagnostic agents
Diagnostic agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used in the field of medical diagnostics. These agents play a vital role in diagnosing various diseases and conditions by aiding in the visualization and identification of specific biomarkers or structures within the body.
Diagnostic agents encompass a wide range of substances, including contrast agents, radiopharmaceuticals, and imaging agents. Contrast agents are commonly used in medical imaging techniques such as X-rays, magnetic resonance imaging (MRI), and computed tomography (CT) scans. They enhance the visibility of certain tissues or organs, allowing healthcare professionals to detect abnormalities more accurately.
Radiopharmaceuticals are another type of diagnostic agent that combines a radioactive component with a pharmaceutical compound. These agents emit radiation that can be detected by specialized imaging equipment, enabling the visualization of metabolic processes and the identification of abnormal cellular activity.
Imaging agents are designed to target specific molecular structures or biomarkers within the body. They can be used to detect and visualize specific proteins, enzymes, or receptors associated with certain diseases or conditions. By targeting these specific biomarkers, imaging agents provide valuable information about the presence, location, and extent of a disease, aiding in diagnosis and treatment planning.
Overall, diagnostic agents are essential tools in modern medicine, facilitating accurate and timely diagnoses. These pharmaceutical APIs enable healthcare professionals to identify and monitor diseases at an early stage, leading to better patient outcomes and improved treatment strategies.
Iopromide API manufacturers & distributors
Compare qualified Iopromide API suppliers worldwide. We currently have 5 companies offering Iopromide API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | CoA, GMP, MSDS, USDMF, WC | 229 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Bayer | Producer | Germany | Unknown | CEP, CoA, GMP, KDMF, USDMF | 42 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 757 products |
When sending a request, specify which Iopromide API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Iopromide API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Iopromide API
Sourcing
What matters most when sourcing GMP-grade Iopromide?
Key considerations include confirming the manufacturer’s GMP compliance for the US and Canadian markets and verifying that the material meets all relevant quality and regulatory documentation requirements. Because Iopromide supply is concentrated with a single established producer, ensuring secure and traceable sourcing is essential. The manufacturing complexity of injectable contrast agents makes supplier qualification and batch-to-batch consistency particularly important.
Which documents are typically required when sourcing Iopromide API?
Request the core API documentation set: CoA (5 companies), GMP (5 companies), USDMF (4 companies), CEP (3 companies), MSDS (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Iopromide API?
Known or reported manufacturers for Iopromide: Aurora Industry Co., Ltd, Apino Pharma Co., Ltd., Global Pharma Tek, Sinoway industrial Co.,Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Iopromide API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Iopromide manufacturers?
Audit reports may be requested for Iopromide: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Iopromide API on Pharmaoffer?
Reported supplier count for Iopromide: 5 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Iopromide API?
Production countries reported for Iopromide: China (3 producers), India (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Iopromide usually hold?
Common certifications for Iopromide suppliers: CoA (5 companies), GMP (5 companies), USDMF (4 companies), CEP (3 companies), MSDS (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Iopromide (CAS 73334-07-3) used for?
Iopromide is a nonionic, low‑osmolar iodinated contrast agent used for intravascular imaging. It is administered intra‑arterially or intravenously to opacify blood vessels and extracellular spaces for procedures such as arteriography, ventriculography, angiography, aortography, excretory urography, contrast CT, and contrast mammography. Region‑specific approvals also include renal arteriography, phlebography, and arthrography at defined concentrations.
Which therapeutic class does Iopromide fall into?
Iopromide belongs to the following therapeutic categories: Benzene Derivatives, Compounds used in a research, industrial, or household setting, Contrast Media, Diagnostic Uses of Chemicals, Drugs that are Mainly Renally Excreted. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Iopromide mainly prescribed for?
The primary indications for Iopromide: Iopromide, as the product IOVIST, is approved by the FDA for use as an intra-arterial or intravenous X-ray contrast agent, For intra-arterial administration, Iopromide is indicated for cerebral arteriography, peripheral arteriography, coronary arteriography, left ventriculography, visceral angiography, and aortography in adults and radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older, For intravenous administration, Iopromide is indicated for excretory urography in adults and pediatric patients aged 2 years and older, contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older, and contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Iopromide work?
Iopromide is a nonionic iodinated, water-soluble, radiographic contrast medium that is available in two stable, ready-to-use solutions of different concentrations (i.e., 300 mg I/mL and 370 mg I/mL). Following intravascular injection, Iopromide provides radiographic opacification of the vasculature and extracellular space in the path of flow of the agent, allowing diagnostic assessment of the limbs and internal organs until significant dilution occurs.
What should someone know about the safety or toxicity profile of Iopromide?
Iopromide has an established safety profile for intravascular use, but serious reactions can occur, including hypersensitivity, cardiac events, and thromboembolism. Renal impairment reduces clearance and increases the risk of acute kidney injury, and delayed urinary opacification may be seen in nephropathic conditions. Inadvertent intrathecal exposure is dangerous and can cause severe neurovascular toxicity, including seizures, cerebral hemorrhage, and potentially fatal outcomes. Population differences in adverse event rates have been reported, with a higher incidence noted in women and outpatients.
What are important formulation and handling considerations for Iopromide as an API?
Iopromide is formulated as high‑strength sterile aqueous injections, so viscosity and osmolality must be tightly controlled to maintain performance typical of iodinated contrast media. Its high hydrophilicity and moderate water solubility require preparation as concentrated solutions rather than reconstitutable solids. Although thermally stable at room temperature, solutions should not be excessively cooled because increased viscosity and potential crystallization can impede handling and administration.
Is Iopromide a small molecule?
Iopromide is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Iopromide?
Iopromide is formulated exclusively as high‑strength aqueous injections and is not developed for oral administration, so oral‑specific stability considerations do not apply. For the approved injectable form, stability is maintained at room temperature, with avoidance of excessive cooling to prevent increased viscosity and crystallization in concentrated solutions.
Regulatory
Where is Iopromide approved or in use globally?
Iopromide is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Iopromide right now?
Available context indicates that Iopromide has regulatory presence in the United States and Canada. No specific details on approval dates, regulatory classifications, or ongoing filings are provided. Patent information is not included in the supplied context, so no patent status can be described.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Iopromide procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Iopromide. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Iopromide included in the PRO Data Insights coverage?
PRO Data Insights coverage for Iopromide: 148 verified transactions across 30 suppliers and 33 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Iopromide?
Market report availability for Iopromide: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
