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The Science Behind Iodixanol: Properties, Manufacturing, and Quality Assurance

Iodixanol, a leading iodinated contrast agent, is a complex molecule engineered for precision in medical diagnostics. Its development and production involve sophisticated chemical synthesis and rigorous quality control to ensure optimal performance and patient safety. Understanding the science behind Iodixanol—from its molecular structure to its manufacturing journey—sheds light on why it is a trusted compound in healthcare.

At its core, Iodixanol is a non-ionic, dimeric molecule. This structure is crucial for its properties as an iso-osmolar contrast agent. The dimeric nature, combined with a high iodine content, allows for effective X-ray absorption at concentrations that are isotonic with blood plasma. This iso-osmolarity is a key factor in minimizing osmotic stress and reducing the likelihood of adverse reactions, distinguishing it from older contrast media. The precise molecular formula, C35H44I6N6O15, and CAS number 92339-11-2, define its unique chemical identity, crucial for regulatory compliance and research traceability.

The manufacturing process for Iodixanol is a multi-step synthesis that requires meticulous control over reaction conditions. Starting from basic chemical building blocks, the process involves several stages of iodination, amidation, and purification. Each step is critical for achieving the high purity (>99%) required for pharmaceutical applications. Manufacturers adhere to strict Good Manufacturing Practices (GMP) to ensure consistency and quality across batches. The production of iodixanol contrast agent involves specialized facilities and expertise in organic synthesis.

Quality assurance is an integral part of Iodixanol's lifecycle. This includes comprehensive testing at various stages of production, from raw material analysis to final product characterization. Techniques such as High-Performance Liquid Chromatography (HPLC) are used to verify purity and identify any potential impurities. Other critical tests include assaying for water content, heavy metals, and specific related substances. The European Pharmacopoeia (EP) and United States Pharmacopeia (USP) standards often serve as benchmarks for quality. Manufacturers like those supplying Visipaque contrast undergo rigorous audits to maintain these standards. Ensuring the quality of iodixanol is paramount for its reliable use.

The combination of advanced chemical design, precise manufacturing, and unwavering commitment to quality assurance makes Iodixanol a superior choice for medical imaging. Its role as a radiographic contrast agent is supported by a robust scientific foundation, ensuring that healthcare professionals have access to a safe and effective tool for patient diagnosis. For those looking to purchase Iodixanol, understanding these scientific aspects highlights the value and reliability of this essential compound.

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