Ioversol Impurity 24;111453-32-8

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E-mail: anna@molcoo.com
Product Code:L066024
English Name:Ioversol Impurity 24
English Alias:3-amino-5-((2,3-dihydroxypropyl)carbamoyl)-2,4,6-triiodobenzoic acid
CAS No.:111453-32-8
Molecular Formula:C₁₁H₁₁I₃N₂O₅
Molecular Weight:631.93
High-Purity Reference Standard:Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Ioversol iodinated impurity analysis and quality control.
Stability Assurance:Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-water mixture within 6 months.
Quality Control Testing:Used for UPLC-MS/MS detection of Impurity 24 in Ioversol API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research:Monitors impurity formation during Ioversol synthesis, reducing generation by >35% by adjusting iodination temperature (e.g., 40-50℃) and pH.
Method Validation:Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Ioversol, a non-ionic triiodinated contrast agent, enhances X-ray absorption through iodine atoms and is widely used in medical imaging such as CT and angiography. Impurity 24, an iodinated by-product in Ioversol synthesis, may originate from over-iodination of benzoic acid derivatives or incomplete carbamoylation. Its triiodo substituents, amino, and hydroxyl groups may affect drug osmotic pressure, water solubility, and stability. Strict impurity control for iodinated contrast agents is critical to imaging efficacy and patient safety, making research on this impurity essential for ensuring drug quality.
Detection Technology:UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 10 minutes, with LOD of 0.005 ng/mL for trace iodinated impurity analysis.
Formation Mechanism:Formed by iodination of 3-amino-5-carbamoylbenzoic acid in potassium iodate/hydrochloric acid systems; optimizing iodine reagent dosage and reaction time inhibits side reactions.
Safety Evaluation:In vitro cytotoxicity shows IC₅₀ of 178.6 μM against HUVEC cells (Ioversol IC₅₀=8.7 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor deiodination degradation under high temperature and humidity conditions
NOTE!
We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
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