Suzetrigine Impurity
Product Code: S054004
English Name: Suzetrigine Impurity 4
English Alias: (R)-4,4,4-trifluoro-3-hydroxy-3-methylbutan-2-one
CAS No.：2875067-31-3
Molecular Formula: C₅H₇F₃O₂
Molecular Weight: 156.10
High-Purity Reference Standard: As a reference standard for Suzetrigine Impurity 4, its structure is confirmed by NMR and HRMS with ≥99.0% purity (HPLC), suitable for qualitative and quantitative analysis of drug impurities.
Good Stability: Stored at 2-8℃ in a sealed, light-protected environment, it has a shelf life of 24 months with <0.5% degradation in solution (e.g., acetonitrile) within 1 month, ensuring reliable detection data.
Quality Control: Used for HPLC and LC-MS detection of Impurity 4 in Suzetrigine API and formulations, controlling impurity content ≤0.1% according to ICH Q3A standards.
Process Optimization: Monitor the generation of Impurity 4 during Suzetrigine synthesis. Adjust fluorination reaction temperature (e.g., controlled at -10~0℃) and raw material ratio to reduce impurity generation to below 0.05%.
Methodology Validation: Serves as a reference standard for developing Suzetrigine impurity detection methods, validating the specificity and sensitivity of analytical methods.
As a novel sodium channel inhibitor, Suzetrigine requires strict impurity control during R&D and production to ensure safety and efficacy. Impurity 4, a potential by-product of fluorination reactions or residual raw material impurity in its synthesis, contains trifluoromethyl and hydroxyl groups that may affect the drug's physicochemical properties and biological activity. With the improvement of international pharmaceutical regulatory standards for impurity control, research on this impurity has become an important part of Suzetrigine's quality system.
Detection Technology: UPLC-MS/MS is used with a C18 column (1.7μm, 2.1×100mm) and 0.1% formic acid water-acetonitrile gradient elution, completing separation within 1.2 minutes with a detection limit of 0.005 ng/mL, 3 times more sensitive than traditional HPLC.
Formation Mechanism: Studies show that Impurity 4 may originate from excessive reaction of trifluoromethylating reagents during Suzetrigine synthesis or fluorination side reactions of raw material (R)-3-hydroxy-3-methylbutan-2-one. Optimizing reaction time and purification processes (such as vacuum distillation) can reduce impurity content by over 60%.
Safety Evaluation: Preliminary toxicological experiments show low toxicity of Impurity 4 to in vitro cells (e.g., A549), but long-term exposure risks still need further evaluation through animal experiments. Current drug quality standards set its limit at ≤0.1%.
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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!
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E-mail: anna@molcoo.com
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