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High-Capacity Purification Technology for Iohexol
High-Capacity Purification Technology for Iohexol
High-Capacity Purification Technology for Iohexol: Enhancing Quality, Efficiency, and Scalability in API Manufacturing
Background: Iohexol as a High-Value Contrast Agent
Iohexol is a widely used non-ionic, water-soluble X-Ray and CT contrast agent. Known for its low osmolality, excellent patient tolerance, and clear imaging performance, it is commonly applied in vascular angiography, spinal imaging, and CT enhancement scans.
To ensure product safety, global pharmacopeias set strict limits on related impurities in Iohexol. However, during industrial production, small amounts of acidic impurities and ionizable by-products can remain in the process stream. These impurities not only impact product quality but may also increase the risk of adverse reactions during clinical use.
Challenges in Traditional Purification Processes
Conventional purification technologies for Iohexol often face several limitations:
- High-temperature operations and long purification cycles, creating barriers to industrial scale-up
- Low adsorption capacity of traditional resins, resulting in limited throughput
- High operating costs and energy consumption, especially in large-volume production
As the demand for high-purity contrast agents continues to grow, the pharmaceutical industry requires a high-capacity, high-efficiency, and more economical purification solution.
Sunresin’s Solution: High-Capacity Purification Method for Iohexol
Sunresin has developed a new purification technology specifically optimized for the unique characteristics of Iohexol. This approach enhances adsorption capacity, improves purification efficiency, and significantly reduces production costs.
Key Technical Advantages:
1. High Capacity and Increased Throughput
The process uses ultra-high cross-linked macroporous styrene–divinylbenzene polymer beads as chromatographic packing material.
These materials feature:
- Large pore size
- High specific surface area
- Strong affinity for Iohexol
This results in significantly improved loading capacity and an increase in single-batch production output.
2. Excellent Alkaline Stability for Longer Media Lifespan
The styrene–DVB polymer matrix is highly resistant to alkaline conditions.
This allows the packing material to be washed with high-pH solutions, extending its usable lifetime and lowering long-term operating costs.
3. One-Step Purification Meeting Pharmacopeia Standards
With this improved adsorption and separation mechanism, Iohexol can be purified to pharmacopeia-compliant quality in a single chromatographic step, achieving:
- ≥ 90% recovery rate
- Excellent batch-to-batch consistency
- Reduced downstream processing workload
4. Mild Operating Conditions for Industrial Scale Production
The process uses deionized water as the mobile phase, offering:
- Safe and mild operating conditions
- Full compatibility with continuous or large-scale industrial processes
- Improved environmental sustainability
5. Cost-Effective Regeneration and Reusability
The packing material can be regenerated using an ethanol–water solution, which can be recovered and reused.
This further reduces:
- Chemical consumption
- Operational costs
- Environmental impact
Driving Pharmaceutical Purification Forward
Sunresin has built comprehensive expertise across the entire purification chain—from specialty adsorbent materials to process development, equipment integration, and industrial-scale implementation.
This high-capacity Iohexol purification solution empowers pharmaceutical manufacturers to:
- Achieve higher product purity and safety
- Increase production efficiency
- Extend the service life of separation media
- Reduce overall manufacturing costs
It also supports the global contrast agent supply chain in meeting the rapidly rising demand for high-quality medical imaging products.
Sunresin: Enabling High-Quality and Sustainable API Manufacturing
With deep technical foundations in separation materials and process engineering, Sunresin will continue advancing innovative purification technologies for Iohexol, APIs, intermediates, and other pharmaceutical products—contributing to safer, more efficient, and more sustainable pharmaceutical production worldwide.
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