0102030405
Iopromide: High-Quality China Suppliers and Factory for Medical Imaging Solutions
Basic Information
Product Description
Chemical Classification & Properties
Iopromide is a non-ionic, monomeric, water-soluble, triiodinated isophthalic acid derivative that belongs to the class of low-osmolar X-ray contrast media. Key properties include:
- Physical state: White to off-white crystalline powder at room temperature
- Solubility: Highly soluble in water, forming clear, colorless to pale yellow solutions
- pH range of solutions: 6.5-7.5 (typical for injections)
- Osmolality: Low osmolar (approximately 600-850 mOsm/kg H₂O for clinical concentrations)
- Stability: Stable under recommended storage conditions
Mechanism of Action
As an iodinated contrast agent, iopromide works by absorbing X-rays due to its high iodine content, which creates radiopacity. When administered intravascularly, it opacifies blood vessels and organs, enhancing their visualization in X-ray, computed tomography (CT), and angiographic procedures. This allows radiologists to distinguish between different tissues and identify abnormalities more clearly.
Therapeutic Uses (as API in Formulations)
Iopromide API is used in the manufacturing of injectable formulations for various diagnostic imaging procedures, including:
- CT scans: Brain, abdominal, thoracic, and pelvic imaging
- Angiography: Aortic arch, coronary, cerebral, and peripheral vessel studies
- Intravenous urography: Visualization of the urinary tract
- Venography: Examination of veins
- Arthrography: Imaging of joints
Quality Standards & Specifications
Iopromide API must meet strict pharmaceutical standards (EP, USP, BP) with key specifications:
- Purity: ≥99.0% (HPLC)
- Related substances: Total impurities ≤1.0%
- Water content: ≤5.0% (Karl Fischer)
- Residual solvents: Meets ICH guidelines
- Heavy metals: ≤10 ppm
Storage & Handling
- Store in a cool, dry place away from light and moisture
- Keep in tightly sealed containers under inert atmosphere (optional)
- Avoid extreme temperatures (recommended 2-8°C for long-term storage)
- Follow good manufacturing practices (GMP) for handling APIs
Product Specification
| Item | Unit | Specification |
|---|---|---|
| Appearance | White to off-white crystalline powder | |
| Solubility | Freely soluble in water, slightly soluble in ethanol, practically insoluble in non-polar organic solvents such as diethyl ether and acetone. | |
| Melting point | ℃ | 154–158 |
| Identification | Infrared spectroscopy + HPLC retention time | |
| Other impurities | % | ≤0.1 |
| Related Substances - Total Impurities | % | ≤1.0 |
| Main peak purity | % | ≥99.0 |
| Loss on drying | % | ≤0.5 |
| Residue on ignition | % | ≤0.1 |
| Heavy metals | ppm | ≤10 |
| Storage | Store in a cool, dry place away from light and moisture |
Frequently Asked Questions (FAQ)
What is Iopromide used for?
Iopromide is primarily used as an active pharmaceutical ingredient (API) in the manufacturing of injectable formulations for diagnostic imaging procedures. These include CT scans, angiography, intravenous urography, venography, and arthrography.
What is the mechanism of action of Iopromide?
As an iodinated contrast agent, Iopromide works by absorbing X-rays due to its high iodine content. This creates radiopacity, allowing blood vessels and organs to be clearly visualized and distinguished during X-ray and CT imaging procedures.
Is Iopromide soluble in water?
Yes, Iopromide is highly soluble in water, forming clear, colorless to pale yellow solutions. It is slightly soluble in ethanol but practically insoluble in non-polar organic solvents like diethyl ether and acetone.
What is the recommended storage temperature for Iopromide API?
Iopromide API should be stored in a cool, dry place away from light and moisture. For long-term storage, it is recommended to keep it at temperatures between 2-8°C in tightly sealed containers.
What are the purity standards for Iopromide API?
Iopromide API must adhere to strict pharmaceutical standards (such as EP, USP, BP). The main peak purity must be ≥99.0% as measured by HPLC, with total related impurities restricted to ≤1.0%.
Is Iopromide a low-osmolar contrast medium?
Yes, Iopromide belongs to the class of low-osmolar X-ray contrast media. Its clinical concentrations typically have an osmolality ranging from approximately 600 to 850 mOsm/kg H₂O.