Toludesvenlafaxine Impurity；1792228-89-7

Product Code: T108002

• English Name: Toludesvenlafaxine Impurity 2

• English Alias: 4-(1-(cyclohex-1-en-1-yl)-2-(dimethylamino)ethyl)phenyl 4-methylbenzoate

• CAS No.: 1792228-89-7

• Molecular Formula: C??H??NO?

• Molecular Weight: 363.49

• High Purity Standard: Confirmed by HPLC with a purity of ≥99.0%, and the structure is verified through multiple methods including NMR (1H, 13C), HRMS, and elemental analysis, providing an accurate standard for Toludesvenlafaxine impurity analysis.

• Stable and Reliable: Stable for 36 months under storage conditions of -20℃ in the dark and sealed. The degradation rate is less than 0.3% within 6 months in common solvent systems such as acetonitrile - methanol, ensuring stable experimental data.

• Quality Control: Used for UPLC-MS/MS detection of Impurity 2 in Toludesvenlafaxine API and formulations, ensuring that the impurity content meets ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization: Monitor the formation pathway of this impurity during the synthesis of Toludesvenlafaxine. By adjusting parameters such as the addition reaction temperature (e.g., 50 - 60℃) and reaction time, the generation of impurities can be reduced by more than 40%.

• Method Validation: As a reference standard for developing and validating impurity detection methods, it is used to verify the resolution (≥3.0) and limit of detection (0.01 ng/mL) of UPLC.

• Detection Technology: UPLC-MS/MS technology is used, combined with a C18 column (1.7μm) and gradient elution with 0.1% formic acid - acetonitrile. Impurities can be separated within 8 minutes, and the limit of detection reaches 0.005 ng/mL.

• Formation Mechanism: Studies have shown that this impurity is formed by the reaction of cyclohexene-structured intermediates with 4-methylbenzoyl chloride under alkaline conditions (such as using pyridine as a catalyst). Optimizing the amount of catalyst and the polarity of the reaction solvent can inhibit side reactions.

• Safety Evaluation: In vitro cytotoxicity experiments show that the IC?? of this impurity against SH-SY5Y nerve cells is 198.7 μM (Toludesvenlafaxine IC?? = 10.2 μM). Although the toxicity is lower than that of the main drug, its content still needs to be strictly controlled.

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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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