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Iodixanol | CAS No: 92339-11-2 | GMP-certified suppliers
A medication that serves as a low-osmolar iodinated contrast agent for enhanced vascular imaging during coronary angiography, with reduced nephrotoxicity risk in renally impaired patients.
Therapeutic categories
Primary indications
- Iodixanol is a contrast agent during coronary angiography
Product Snapshot
- Iodixanol is an injectable iodinated contrast agent formulated as an aqueous solution for parenteral administration
- It is primarily used in diagnostic imaging procedures such as coronary angiography to enhance vascular visualization
- Iodixanol is approved for use in key regulatory markets including the US and Canada
Clinical Overview
Pharmacologically, iodixanol functions as a radiopaque medium that enhances the visualization of vascular and other internal structures during X-ray imaging procedures. Structurally classified within acylaminobenzoic acid derivatives, iodixanol’s iodine atoms absorb X-rays, producing contrast by increasing opacity in vessels and tissues where it is present. Its osmolality closely matches that of human blood plasma (approximately 290 mOsm/kg H2O), which reduces the risk of osmotic endothelial damage and adverse reactions commonly associated with higher osmolar contrast media.
The mechanism of action is based on the attenuation of X-rays; the degree of radiopacity correlates directly with the concentration and volume of iodixanol administered. Following intravenous injection, iodixanol transiently highlights the vascular lumen and surrounding structures until it undergoes hemodilution and renal elimination.
Pharmacokinetic data indicate that iodixanol is predominantly excreted via the kidneys with minimal metabolic transformation. This renal clearance pathway necessitates consideration in patients with renal impairment, although iodixanol is preferred in such populations due to its low osmolarity and reduced nephrotoxic potential.
Safety considerations include monitoring for hypersensitivity reactions and renal function, especially in at-risk groups. Iodixanol’s formulation is intended to minimize adverse events compared with earlier high-osmolality agents.
Notable commercial formulations include branded contrast media such as Visipaque. These products are widely approved and used in diagnostic radiography globally.
From an API sourcing perspective, ensuring high purity, consistent iodine content, and regulatory compliance are critical for iodixanol manufacture. Control of residual solvents and impurities, as well as adherence to pharmacopoeial standards, is essential to guarantee the safety and efficacy of finished contrast media products.
Identification & chemistry
| Generic name | Iodixanol |
|---|---|
| Molecule type | Small molecule |
| CAS | 92339-11-2 |
| UNII | HW8W27HTXX |
| DrugBank ID | DB01249 |
Pharmacology
| Summary | Iodixanol is an iodinated contrast agent used primarily for enhancing vascular imaging during coronary angiography. It attenuates x-rays proportionally to its concentration, enabling differentiation of iodinated structures from surrounding tissues. Its iso-osmolar formulation reduces renal toxicity risk, making it suitable for patients with compromised kidney function. |
|---|---|
| Mechanism of action | Organic iodine compounds attenuate x-rays as they pass through the body, thereby allowing the body structures containing iodine to be delineated in contrast to those structures that do not contain iodine. The degree of opacity produced by these compounds is directly proportional to the total amount (concentration and volume) of the iodinated contrast agent in the path of the x-rays. After intravascular administration, iodixanol makes opaque those internal structures in its path of flow, allowing their visualization until significant hemodilution and elimination occur. |
| Pharmacodynamics | Iodixanol is a contrast agent commonly used during coronary angiography, particularly in individuals with renal dysfunction, as it is believed to be less toxic to the kidneys than most other intravascular contrast agents. It is an imaging contrast agent with the same osmolality as blood (290mOsm/kg H20). |
ADME / PK
| Half-life | 2.1 hours. In patients with significantly impaired renal function (mean creatinine clearance rate, 9.91 [± 3.58] mL per minute), the plasma half-life is increased to 23 hours. |
|---|---|
| Protein binding | Negligible |
| Metabolism | Excreted unchanged |
| Route of elimination | In adults, approximately 97% of the injected dose of iodixanol is excreted unchanged in urine within 24 hours, with less than 2% excreted in feces within five days post-injection. |
| Volume of distribution | * 0.26 L/kg |
Formulation & handling
- Iodixanol is formulated for parenteral administration with injectable solutions suitable for intravenous, intra-arterial, and intrathecal routes.
- It is a small molecule with low lipophilicity and limited water solubility requiring careful handling to ensure proper dissolution and stability in injectable formulations.
- Due to its administration routes, aseptic processing and sterile packaging are critical to maintain product integrity and patient safety.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's key patents in the United States expired in 2011, indicating market exclusivity has ended. The API is currently marketed in mature markets including the US and Canada. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Iodixanol is primarily supplied by originator companies such as GE Healthcare Inc., with branded products available mainly in the US and Canadian markets. Multiple branded formulations, including Visipaque, indicate a well-established presence in these regions. Patent expirations in the early 2010s suggest that generic competition may currently exist or could be forthcoming. |
|---|
Safety
| Toxicity | Non-ionic radiocontrast agents like iodixanol are cytotoxic to renal cells. The toxic effects include apoptosis, cellular energy failure, disruption of calcium homeostasis, and disturbance of tubular cell polarity, and are thought to be linked to oxidative stress. |
|---|
- Exhibits cytotoxicity to renal tubular cells, potentially inducing apoptosis and cellular energy depletion
- May disrupt intracellular calcium balance and tubular cell polarity, contributing to nephrotoxic effects
- Toxicity mechanisms are associated with oxidative stress pathways
Iodixanol 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.
Iodixanol API manufacturers & distributors
Compare qualified Iodixanol API suppliers worldwide. We currently have 5 companies offering Iodixanol 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 | BSE/TSE, CoA, GMP, MSDS, USDMF | 229 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF, WC | 757 products |
When sending a request, specify which Iodixanol 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 Iodixanol 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.
