Iodixanol Powder Cas No.92339-11-2

Iodixanol Powder Cas No.92339-11-2

Product Name: Iodixanol
Product Source: Synthetic
Product Specification: ≥98%
CAS No.: 92339-11-2
Molecular Formula: C₃₅H₄₄I₆N₆O₁₅
Molecular Weight: 1550.18
Test Method: HPLC
Active Ingredient: Iodixanol
Product Characteristics: White to off-white amorphous powder, odorless, hygroscopic
Product Packaging: 1kg/bag; 25kg/drum
Storage Conditions: Keep sealed, protected from light and moisture. May be stored at room temperature or refrigerated.
Shelf Life: 24 months Declaration of Use: This product is intended for industrial use or scientific research only.
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Products Description

Iodixanol API Powder CAS 92339-11-2

High-Purity Iodixanol API | CAS 92339-11-2

Iodixanol (CAS No. 92339-11-2) is a non-ionic, dimeric, water-soluble X-ray contrast medium. As a premier Active Pharmaceutical Ingredient (API), it is uniquely characterized by its isotonicity relative to human blood (approx. 290 mOsm/kg H2O), which fundamentally distinguishes it from traditional monomeric contrast agents. Manufactured under rigorous cGMP-compliant protocols, Xi'an Tihealth provides pharmaceutical-grade Iodixanol powder with an HPLC-validated purity of ≥98.0%. Specifically engineered for high-acuity diagnostic imaging, our API offers a superior safety profile, significantly minimizing the risk of Contrast-Induced Nephropathy (CIN) and vascular irritation. It is the optimal choice for manufacturers of premium cardiovascular and cerebral angiographic injectables.

Technical Data Sheet (TDS) & Core Specifications

To ensure the extreme safety required for systemic intravenous administration, our Iodixanol undergoes exhaustive analytical profiling for impurity and osmolality control:

Testing Item Specification (USP/EP/ChP)
Chemical Name 5,5'-[(2-hydroxy-1,3-propanediyl)bis(acetylamino)]bis[N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide]
Assay (HPLC, Anhydrous) 98.0% - 102.0%
Iodine Content 48.2% - 49.1%
Free Inorganic Iodide ≤ 10 ppm (Strictly controlled for safety)
Heavy Metals ≤ 10 ppm
Bacterial Endotoxins ≤ 0.5 EU/mg (Injection Grade)

Pharmacological Mechanism & Imaging Efficacy

Iodixanol facilitates high-resolution diagnostic imaging through its optimized molecular architecture:

  • X-ray Attenuation: By carrying six iodine atoms per molecule, it provides high radiopacity, effectively enhancing the contrast between blood vessels, organ parenchymas, and surrounding soft tissues during X-ray, CT, and fluoroscopic procedures.
  • The Isotonic Advantage: Unlike monomeric agents that are hyperosmolar, the dimeric structure of Iodixanol achieves the target iodine concentration while remaining isotonic to plasma. This minimizes osmotic-induced damage to the renal tubular cells and reduces fluid shifts across the vascular endothelium.
  • Non-Ionic Stability: The absence of dissociated ions reduces electrical interference with excitable tissues, significantly decreasing the incidence of arrhythmias and neurological adverse events during cerebral and cardiac angiography.

Applications in Imaging & Research

  • Clinical Contrast Agents: The definitive API for formulating Visipaque™ type injectables used in coronary angiography, peripheral arteriography, and contrast-enhanced CT.
  • Density Gradient Centrifugation: Widely utilized in molecular biology for the purification of viruses (Adenovirus, AAV), the separation of fragile cells, and the isolation of exosomes due to its low toxicity and adjustable density.
  • Urographic Imaging: Ideal for intravenous urography in patients with pre-existing renal impairment where low-osmolar agents are mandatory.

Regulatory Compliance Notice: Iodixanol API is supplied strictly for B2B industrial formulation, GMP manufacturing, and laboratory R&D. Downstream manufacturers must ensure sterile processing and adhere to clinical guidelines regarding iodine-sensitive patients.

Frequently Asked Questions (FAQ)

Why is Iodixanol considered safer than Iohexol for renal patients?

Iodixanol is an isotonic dimer, meaning its osmolality matches that of human blood. In contrast, Iohexol is a monomeric, low-osmolar agent that is still hypertonic compared to plasma. Iodixanol's isotonicity significantly reduces osmotic stress on the renal tubules, leading to a lower incidence of Contrast-Induced Acute Kidney Injury (CI-AKI).

 

What is the shelf life and storage protocol for Iodixanol powder?

Our Iodixanol API has a standard shelf life of 36 months when stored in original, unopened pharmaceutical-grade containers. It should be kept at room temperature (15-30°C), protected from direct light and moisture to prevent secondary degradation of the iodine-carbon bonds.

 

Can this API be used as a density gradient medium for viral purification?

Yes. Our high-purity Iodixanol is ideal for biological separation. Its non-ionic nature and low toxicity preserve the biological activity of viruses (like AAV) and delicate cell types better than sucrose or cesium chloride gradients.

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