Flupentixol Impurity

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• Product Information

• Product Code：F058019A

• English Name：Flupentixol Impurity 19(Dihydrochloride)

• English Alias：(E)-2-(4-(3-(2-(trifluoromethyl)-9H-thioxanthen-9-ylidene)propyl)piperazin-1-yl)ethanol dihydrochloride

• CAS No.：[Not Available]

• Molecular Formula：C??H??F?N?OS·2HCl

• Molecular Weight：507.44（434.52 + 2×36.46）

• Advantages

• Ultra-High Purity：Confirmed by HPLC (≥99.5%), combined with multiple techniques such as NMR (1H, 13C), HRMS, and elemental analysis, accurately verifying the structure and providing a reliable standard for Flupentixol impurity analysis.

• Excellent Stability：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.1% in acetonitrile - water (1:1) solution within 6 months, ensuring the stability and reproducibility of experimental data.

• Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 19 (dihydrochloride) in Flupentixol API and formulations, strictly controlling impurity content to meet ICH Q3A and Q3B standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitor the formation pathway of this impurity during Flupentixol synthesis. Reduce impurity generation by over 60% by adjusting reaction temperature (e.g., 60 - 70℃), reaction time, and acid-base conditions.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.5) and LOD (0.003 ng/mL) to meet the strict requirements of regulatory authorities for detection methods.

• Background Description

• Flupentixol is a commonly used thioxanthene antipsychotic drug in clinical practice, used for treating mental disorders such as schizophrenia and depression. Impurity 19 (dihydrochloride), as a specific process-related impurity of Flupentixol, may arise from incomplete intermediate reactions, side reactions, or raw material residues during multi-step synthesis. Its trifluoromethyl, thioxanthene structure, and hydrochloride form may affect the drug's stability, safety, and efficacy. With the increasing strict requirements of global regulatory agencies (such as FDA and EMA) for drug impurities, the study of this impurity has become a crucial part of ensuring the quality of Flupentixol drugs and patient safety.

• Research Status

• Detection Technology：UPLC-MS/MS with a C18 column (1.7μm) and 0.1% formic acid - acetonitrile gradient elution achieves separation within 5 minutes, with an LOD as low as 0.001 ng/mL, enabling highly sensitive detection of trace impurities.

• Formation Mechanism：Studies indicate that this impurity mainly forms during the condensation reaction of thioxanthene rings and piperazine ethanol derivatives, as well as subsequent hydrochlorination steps. It can be effectively inhibited by optimizing the reaction solvent system (e.g., using DMF instead of methanol), precisely controlling the amount of hydrochloric acid, and adjusting the reaction pH.

• Safety Evaluation：In vitro cytotoxicity tests show that the IC?? of this impurity against PC12 cells is 145.6 μM (Flupentixol IC?? = 9.8 μM). Although less toxic than the main drug, its content in drugs still requires strict control. Currently, long-term stability tests are being carried out to systematically monitor its degradation behavior under different humidity, light, and temperature 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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E-mail: anna@molcoo.com




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