Ioversol Impurity 25;1096689-22-3
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E-mail: anna@molcoo.com
Product Code：L066025
English Name：Ioversol Impurity 25
English Alias：5-amino-N1-(1,3-dihydroxypropan-2-yl)-N3-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide
CAS No.：1096689-22-3
Molecular Formula：C₁₄H₁₈I₃N₃O₆
Molecular Weight：705.02
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Ioversol triiodinated impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-acetonitrile mixture within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 25 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 >40% by adjusting iodination temperature (e.g., 30-40℃) and reaction time.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Ioversol, a commonly used non-ionic triiodinated contrast agent, achieves tissue imaging through the high X-ray absorption of iodine atoms, widely applied in cardiovascular and neurological imaging diagnostics. Impurity 25, an iodinated process impurity in Ioversol synthesis, may originate from over-iodination of isophthalamide derivatives or amino alcohol condensation side reactions. Its triiodo substituents, polyhydroxy groups, and amide bonds may affect drug osmotic pressure, hydrophilicity, and stability. Strict impurity control for iodinated contrast agents is critical to imaging quality 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 12 minutes, with LOD of 0.005 ng/mL for high-precision trace triiodinated impurity analysis.
Formation Mechanism：Formed by condensation of 5-aminoisophthalamide with 1,3-diamino-propan-2-ol and 2,3-diamino-1-propanol, followed by iodination in potassium iodate/sulfuric acid systems; optimizing iodine reagent concentration and reaction pH inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 168.3 μM against HUVEC cells (Ioversol IC₅₀=7.5 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 (40℃) and high humidity (75%RH) conditions and its potential impact on the main drug.
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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