Iohexol Powder Cas No.66108-95-0

Iohexol Powder Cas No.66108-95-0

Product Name: Iohexol Powder
Product Source: Synthetic
Product Specification: ≥98%
CAS No.: 66108-95-0
Molecular Formula: C₁₉H₂₆I₃N₃O₉
Molecular Weight: 821.14 g/mol
Testing Method: HPLC
Active Ingredient: Iohexol
Product Characteristics: White or off-white powder or crystalline powder
Product Packaging: 1kg/bag; 25kg/drum
Storage Conditions: Moisture-proof, light-protected, sealed storage
Shelf Life: 24 months

Declaration of Use: This product is intended for industrial use or scientific research only.
Send Inquiry

High-Purity Iohexol API Powder

Low-Osmolar Contrast Medium (LOCM) | Pharmaceutical Grade for Diagnostic Radiology

CAS Number 66108-95-0
Molecular Formula C19H26I3N3O9
Molecular Weight 821.14 g/mol
Quality Standard USP / EP / ChP

1. Product Characterization & Value Proposition

Iohexol (CAS No. 66108-95-0) is a globally recognized non-ionic, water-soluble, low-osmolar contrast medium (LOCM). As a pivotal Active Pharmaceutical Ingredient (API) for diagnostic radiology, it provides a superior safety profile with significantly lower neurotoxicity and systemic adverse events compared to legacy ionic precursors.

Manufactured under stringent cGMP-compliant protocols, Xi'an Tihealth supplies pharmaceutical-grade Iohexol powder with an HPLC-validated purity of ≥98.5%. Our product is optimized for high-concentration injectables, ensuring excellent batch-to-batch consistency and ultra-low levels of free inorganic iodide. It remains the preferred choice for the industrial formulation of intravascular contrast agents used in CT scans, angiography, and diagnostic urography.

2. Technical Data Sheet (TDS) & Quality Standards

Our Iohexol API undergoes rigorous analytical verification to ensure its suitability for high-acuity sterile injectable formulations:

Testing Item Specification (USP / EP / ChP)
Chemical Name 5-[acetyl(2,3-dihydroxypropyl)amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
Assay (HPLC, Anhydrous) 98.5% - 101.0%
Iodine Content 46.0% - 46.8%
Free Inorganic Iodide ≤ 10 ppm (Critical for injection safety)
Bacterial Endotoxins ≤ 0.5 EU/mg (Compliant with Injection Grade)

3. Pharmacological Mechanism & Imaging Efficacy

Iohexol facilitates precision diagnostic imaging by selectively altering the X-ray attenuation coefficient in targeted vascular and tissue beds:

Radiopaque Visualization

The organically bound iodine atoms in Iohexol absorb X-rays in direct proportion to local concentration, enabling high-contrast visualization of arteries, veins, and internal organ structures during CT and fluoroscopy.

Non-Ionic LOCM Advantage

As a non-ionic monomer, Iohexol exhibits significantly lower osmolality than ionic contrast agents. This leads to improved patient tolerability, reduced osmotic stress on renal tubules, and a lower incidence of severe adverse reactions.

Glomerular Filtration Kinetics

Iohexol is minimally protein-bound and undergoes virtually no metabolic transformation. It is excreted almost entirely unchanged via the kidneys, providing excellent visualization of the urinary system during urography.

4. Core Pharmaceutical Applications

  • Angiography & CT Enhancement: The primary API for manufacturing sterile intravenous solutions used in cardiovascular and cerebral imaging.
  • Myelography & Intrathecal Use: Specifically refined for subarachnoid administration due to its exceptionally low neurotoxicity profile.
  • Diagnostic Urography: Exploiting its rapid renal clearance for imaging the kidneys, ureters, and bladder.
B2B REGULATORY & HANDLING PROTOCOLS

Regulatory Notice: Iohexol API is supplied strictly for B2B industrial formulation, GMP manufacturing, and laboratory R&D. It is not a finished drug product and is strictly not for direct human injection. Downstream manufacturers must ensure sterile processing and strictly monitor renal function implications in final dosage forms.

5. Frequently Asked Questions (FAQ)

What is the clinical difference between Iohexol and Iodixanol?
Iohexol (CAS 66108-95-0) is a non-ionic monomer and is classified as a low-osmolar contrast medium (LOCM). Iodixanol is a non-ionic dimer and is isotonic to blood. Iohexol is highly versatile and cost-effective for general angiography, while Iodixanol is typically reserved for high-risk patients with severe pre-existing renal impairment.
How do you ensure the stability of the organically bound iodine?
Our advanced synthesis process ensures the absolute stability of the iodine-carbon bonds. We strictly control free inorganic iodide levels below 10 ppm to minimize potential allergic/thyrotoxic reactions and to guarantee the API's long-term crystalline stability during global transport and warehousing.
Can Xi'an Tihealth support the regulatory audit process for DMF filings?
Yes. We provide complete technical dossiers including Batch Chromatograms, Method of Analysis (MOA), MSDS, and comprehensive stability data. We are fully committed to supporting our pharmaceutical partners through factory audits and assisting with generic drug registration filings (e.g., DMF support).

Hot Tags: iohexol powder cas no.66108-95-0, China iohexol powder cas no.66108-95-0 manufacturers, suppliers, factory, hialuronato de sodio hialuronato sodico sodium hyaluronate, , , sodium hyaluronate dan hyaluronic acid, sodium retinoyl hyaluronate

Send Inquiry