Ioversol Impurity 25 NEW

Ioversol Impurity 25;1096689-22-3

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

Product Information

• 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

Advantages

• 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.

Applications

• 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).

Background Description

Research Status

• 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

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!