Ioversol Impurity 26 NEW

Ioversol Impurity 26;872117-56-1

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

Product Information

• 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

Advantages

• 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.

Applications

• 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.

Background Description

Research Status

• 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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