Keywords

• Suzetrigine Impurity
• 2649470-87-9
• C15H15F5O4

Quick Details

• ProName: Suzetrigine Impurity；2649470-87-9
• CasNo: 2649470-87-9
• Molecular Formula: C15H15F5O4
• Appearance: White to off white powder
• Application: experiment research
• DeliveryTime: prompt delivery
• PackAge: Food bags, aluminum foil bags
• Port: Shenzhen/hongkong
• ProductionCapacity: 5000 Gram/Year
• Purity: 99%+ HPLC
• Storage: cool and dry
• Transportation: DHL,EMS,TNT,UPS,EMS,by air,by sea;
• LimitNum: 10 Milligram
• Moisture Content: 0.1%
• Impurity: 0.1%

Superiority

We supply over 20000 types of spot impurity reference materials, with sufficient supply and same day delivery to meet customers' urgent needs for replenishment at any time. The company has its own research and development center and laboratory, and the team members have over ten years of experience in developing drug impurity reference standards. Our website www.molcoo.com covers over 98% of cutting-edge generic drug projects, with complete structural formulas that greatly save customers time in impurity structure analysis and inference. All products undergo strict quality control testing and provide relevant information such as COA, H-NMR, C-NMR, MS/GC-MS, HPLC/GC purity, QNMR quantification, TGA thermogravimetric analysis, IR infrared, UV ultraviolet, two-dimensional (COSY, NOESY, HMBC, HMQC), etc. These structural confirmation spectra ensure quality and reliability. Our products have a wide range of categories, fast delivery time, good quality, and low prices, which can quickly solve various customer needs such as replenishment and consistency evaluation.

Details

Suzetrigine Impurity 

Product Information

• Product Code: S054002

• English Name: Suzetrigine Impurity 2

• English Alias: (2R,3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-carboxylic acid

• CAS No.：2649470-87-9

• Molecular Formula: C??H??F?O?

• Molecular Weight: 354.27

Advantages

• High-Purity Reference Standard: As a reference standard for Suzetrigine Impurity 2, its structure is confirmed by NMR and HRMS with ≥99.0% purity (HPLC), suitable for qualitative and quantitative analysis of drug impurities.

• Strong Stability: Stored at 2-8℃ in a sealed, light-protected environment, it has a shelf life of 24 months with batch-to-batch variation <0.5%, ensuring reliable detection data.

Applications

• Quality Control: Used for HPLC and LC-MS detection of Impurity 2 in Suzetrigine API and formulations, controlling impurity content ≤0.1% according to ICH Q3A and other standards.

• Process Optimization: Monitor the generation of Impurity 2 during Suzetrigine synthesis. Adjust esterification reaction temperature (e.g., controlled at 40-50℃) and catalyst dosage (e.g., triethylamine ratio) to reduce impurity generation to below 0.05%.

• Stability Studies: Track changes in Impurity 2 content during accelerated stability tests (60℃/RH75%), evaluate its impact on drug stability, and provide data support for storage conditions and shelf life.

Background Description

As a novel sodium channel inhibitor, Suzetrigine requires strict impurity control during R&D and production to ensure efficacy and safety. Impurity 2, a potential degradation or process impurity in its synthesis, contains a carboxylic acid group that may affect the drug's physicochemical properties and biological activity. With the improvement of international pharmaceutical regulatory standards (e.g., FDA, EMA), research on this impurity has become an important part of Suzetrigine's quality system.

Research Status

• 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 2.8 minutes with a detection limit of 0.008 ng/mL, 3 times more sensitive than traditional HPLC.

• Formation Mechanism: Studies show that Impurity 2 may originate from the hydrolysis of the tetrahydrofuran ring during Suzetrigine synthesis or incomplete conversion of residual carboxylic acid intermediates in raw materials. Optimizing the purification process (e.g., using silica gel column chromatography) can reduce impurity content by over 60%.

• Safety Evaluation: Preliminary cytotoxicity tests show an IC?? of 25μM for Impurity 2 in HEK293 cells, lower than that of Suzetrigine (IC?? 120μM), indicating low potential toxicity, but long-term exposure risks still need further evaluation through animal experiments.

WhatsAPP: +86 17320513646
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!