Flupentixol Impurity
Product Code：F058020
English Name：Flupentixol Impurity 20
English Alias：(Z)-2-(4-(3-(2-(trifluoromethyl)-9H-thioxanthen-9-ylidene)propyl)piperazin-1-yl)ethanol
CAS No.：[Not Available]
Molecular Formula：C₂₃H₂₅F₃N₂OS
Molecular Weight：434.52
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, compliant with Flupentixol quality control and impurity analysis requirements.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in aqueous solution (pH 4-6) within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 20 in Flupentixol API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors impurity formation during Flupentixol synthesis, reducing generation by >50% by adjusting condensation temperature (e.g., 70-80℃) and reaction time.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥2.5) and LOD (0.01 ng/mL).
Flupentixol, a thioxanthene antipsychotic, is used for treating schizophrenia and depression. Impurity 20, a process-related impurity, may originate from alkylation side reactions of the thioxanthene ring or piperazine ring substitution during synthesis. Its trifluoromethyl and thioxanthene system may affect drug stability and efficacy. With stricter EMA enforcement of EP standards, studying such impurities is crucial for drug registration and manufacturing.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 4 minutes, with LOD of 0.003 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by reaction of 2-trifluoromethylthioxanthenone with piperazine ethanol derivatives under alkaline conditions (e.g., potassium carbonate catalysis); optimizing catalyst dosage and solvent polarity (e.g., DMF-water system) inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 176.5 μM against SH-SY5Y cells (Flupentixol IC₅₀=11.2 μM), with low toxicity but requiring ≤0.1% limit. Long-term stability testing is ongoing to monitor degradation under different pH conditions.
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!
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