Suzetrigine Impurity 3 NEW

Suzetrigine Impurity 

Product Information

• Product Code: S054003

• English Name: Suzetrigine Impurity 3

• English Alias: 2-(4-fluoro-2-methoxyphenyl)acetic acid

• CAS No.：886498-61-9

• Molecular Formula: C₉H₉FO₃

• Molecular Weight: 184.16

Advantages

• High Purity and Structure Confirmation: Structure confirmed by multiple techniques including NMR and HRMS, with ≥99.0% purity (HPLC), enabling precise impurity analysis of Suzetrigine.

• Excellent Stability: Shelf life of 24 months under 2-8℃ in a dark, dry environment; degradation rate <1% within 1 month in solution (e.g., methanol), ensuring reliable detection data.

Applications

• Pharmaceutical Quality Control: Used for HPLC and LC-MS detection of Impurity 3 in Suzetrigine API and formulations, controlling impurity content ≤0.1% according to ICH Q3A standards.

• Process Traceability Analysis: Monitor the content of Impurity 3 during Suzetrigine synthesis to trace the purity of raw materials (e.g., 4-fluoro-2-methoxybenzaldehyde) or the formation pathway of by-products, optimizing the synthesis process.

• Methodology Validation: Serves as a reference standard for developing Suzetrigine impurity detection methods, validating method specificity, sensitivity, and repeatability.

Background Description

Research Status

• Detection Technology: UPLC-MS/MS is employed with a C18 column (1.7μm, 2.1×100mm) and 0.1% formic acid water-acetonitrile gradient elution, completing separation within 1.5 minutes with a detection limit of 0.003 ng/mL, 4 times more efficient than traditional HPLC.

• Formation Mechanism: Studies indicate that Impurity 3 may result from incomplete reaction of starting materials or side reactions like defluorination and oxidation during intermediate condensation. Optimizing reaction temperature (controlled at 30-40℃) and prolonging reaction time can reduce impurity content by over 75%.

• Safety Evaluation: Preliminary toxicological studies show low toxicity of Impurity 3 to in vitro cells (e.g., HepG2), but further animal experiments are needed to assess long-term exposure risks. Current drug quality standards set its limit at ≤0.1%.

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E-mail: anna@molcoo.com

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

NEW IN STOCK!

The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!