Ioversol Impurity 23;267881-77-6
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
Product Code：L066023
English Name：Ioversol Impurity 23
English Alias：5-amino-N1-(1,3-dihydroxypropan-2-yl)-N3-(2,3-dihydroxypropyl)isophthalamide
CAS No.：267881-77-6
Molecular Formula：C₁₄H₂₁N₃O₆
Molecular Weight：327.33
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Ioversol 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 23 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 >30% by adjusting amination temperature (e.g., 50-60℃) 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 non-ionic iodine contrast agent, is commonly used in medical imaging such as CT angiography and urography to assist in diagnosis by enhancing tissue contrast. Impurity 23, a process-related impurity in Ioversol synthesis, may originate from amination side reactions of isophthalamide with polyol amines or incomplete nitro reduction. Its amino, amide, and hydroxyl groups may affect drug water solubility, osmotic pressure, and stability. With stricter safety requirements for medical imaging contrast agents, studying this impurity is crucial 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 8 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by nucleophilic substitution of 5-nitroisophthalamide with 1,3-diamino-propan-2-ol and 2,3-diamino-1-propanol during palladium-carbon-catalyzed reduction; optimizing reducing agent dosage and reaction pH inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 195.4 μM against HUVEC cells (Ioversol IC₅₀=10.2 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under high temperature and humidity 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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