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 |
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