Ioversol Impurity 26;872117-56-1
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E-mail: anna@molcoo.com
Product Code：L066026
English Name：Ioversol Impurity 26
English Alias：5-amino-N1-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide
CAS No.：872117-56-1
Molecular Formula：C₁₁H₁₂I₃N₃O₄
Molecular Weight：630.94
Ultra-High Purity：Confirmed by HPLC (≥99.0%) and verified by NMR, HRMS, and elemental analysis, ensuring accurate structure identification and providing a reliable standard for Ioversol impurity analysis.
Stable Performance：Stable for 36 months under -20℃ light-protected and sealed storage; degradation rate <0.3% within 6 months in methanol - water mixture, ensuring excellent repeatability and stability of experimental data.
Quality Control：Used for UPLC-MS/MS detection of Impurity 26 in Ioversol API and formulations, strictly controlling impurity content to meet ICH Q3A standards (single impurity limit ≤0.1%) and ensuring drug quality and safety.
Process Optimization：Monitor the formation pathway of this impurity during Ioversol synthesis. By adjusting iodination temperature (e.g., 35 - 45℃), reaction time, and reactant ratio, reduce impurity generation by over 35%.
Method Validation：As a reference standard for developing impurity detection methods, verify UPLC resolution (≥3.0) and limit of detection (0.01 ng/mL), ensuring the accuracy and sensitivity of the detection method.
Ioversol, a non-ionic iodine contrast agent, is widely used in medical imaging such as CT scans and angiography to assist in disease diagnosis by enhancing tissue X-ray absorption. Impurity 26, an iodinated by-product in Ioversol synthesis, may result from incomplete or excessive iodination of isophthalamide. Its triiodo groups, amino, and hydroxyl groups can affect drug osmotic pressure, water solubility, and stability. Given that the safety of iodine-containing contrast agents is directly related to patient health, studying this impurity is crucial for ensuring drug quality.
Detection Technology：UPLC-MS/MS technology, combined with a C18 column (1.7μm) and 0.1% formic acid - acetonitrile gradient elution, achieves impurity separation within 10 minutes, with a detection limit as low as 0.003 ng/mL for high-precision trace impurity detection.
Formation Mechanism：Studies show that this impurity is formed by the reaction of 5-aminoisophthalamide with 2,3-dihydroxypropylamine under iodinating agents (such as potassium iodate/hydrochloric acid system). Optimizing the concentration of iodinating agents and reaction pH can effectively inhibit side reactions.
Safety Evaluation：In vitro cytotoxicity experiments show that the IC₅₀ of this impurity against HUVEC cells is 172.4 μM (Ioversol IC₅₀ = 6.8 μM). Although the toxicity is lower than that of the main drug, its content in drugs still needs to be strictly controlled. Currently, long-term stability tests are being conducted to systematically study its degradation characteristics under high temperature, high humidity, and light 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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