Cilnidipine Impurity; 5349-99-5
Product Code：C050009
English Name：Cilnidipine Impurity 9
English Alias：triethyl prop-1-ene-1,2,3-tricarboxylate
CAS No.：5349-99-5
Molecular Formula：C₁₂H₁₈O₆
Molecular Weight：258.27
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Cilnidipine impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in common organic solvents (such as methanol, acetonitrile) within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 9 in Cilnidipine API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors Impurity 9 formation during Cilnidipine synthesis, reducing generation by >40% by adjusting esterification temperature (e.g., 60-70℃) and catalyst dosage.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Cilnidipine, a dihydropyridine calcium channel blocker, is used for treating hypertension. Impurity 9, as a process-related impurity of Cilnidipine, may originate from side products of olefinic carboxylic acid esterification with ethanol during synthesis. Its ester and double bond may affect drug stability and efficacy. With stricter requirements from global regulatory agencies for cardiovascular drug impurities, studying Impurity 9 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 5 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by esterification of prop-1-ene-1,2,3-tricarboxylic acid with ethanol under acidic catalysts (e.g., sulfuric acid); optimizing catalyst type (e.g., p-toluenesulfonic acid) and reaction time inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 210.8 μM against H9c2 cardiac muscle cells (Cilnidipine IC₅₀=12.5 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under different humidity, light, and temperature conditions.
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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 17320513646
E-mail: anna@molcoo.com
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