Finerenone Impurity;1230021-28-9
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
Product Code：F044118
English Name：Finerenone Impurity 118
English Alias：2-formyl-3-methoxybenzonitrile
CAS No.：21962-44-7
Molecular Formula：C₉H₇NO₂
Molecular Weight：161.16
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Finerenone 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.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 118 in Finerenone API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors impurity formation during Finerenone synthesis, reducing generation by >30% by adjusting formylation temperature (e.g., 0-5℃) 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).
Finerenone, a selective mineralocorticoid receptor antagonist, is used for treating renal and cardiovascular complications in patients with chronic kidney disease and type 2 diabetes. Impurity 118, as a process-related impurity in Finerenone synthesis, may originate from formylation side reactions of methoxybenzonitrile. Its formyl and methoxy groups may affect drug stability and receptor binding. With stricter requirements for kidney disease drug impurities, 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 5 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by Vilsmeier-Haack reaction of 3-methoxybenzonitrile with phosphorus oxychloride and N,N-dimethylformamide (DMF); optimizing DMF dosage and reaction temperature inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 186.5 μM against HK-2 renal tubular epithelial cells (Finerenone IC₅₀=8.7 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
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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