Keywords

• Suzetrigine Impurity
• 2875066-38-7
• C14H13F5O3

Quick Details

• ProName: Suzetrigine Impurity；2875066-38-7
• CasNo: 2875066-38-7
• Molecular Formula: C14H13F5O3
• 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: S054001

• English Name: Suzetrigine Impurity 1

• English Alias: (3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)dihydrofuran-2(3H)-one

• CAS No.：2875066-38-7

• Molecular Formula: C??H??F?O?

• Molecular Weight: 324.24

Advantages

• High-Purity Reference Standard: As a reference standard for Suzetrigine Impurity 1, its structure is confirmed by multiple techniques including NMR and HRMS, with a purity of ≥99.0% (HPLC), ensuring accurate and reliable impurity analysis.

• Good Stability: Stored at 2-8°C in a dark, dry environment, it has a shelf life of 24 months, with batch-to-batch variation <0.3%, suitable for long-term quality control and methodology validation.

Applications

• Pharmaceutical Quality Testing: Used for the detection of Impurity 1 in Suzetrigine API and formulations by HPLC and LC-MS, strictly controlling impurity content to meet regulatory standards of ICH, FDA, etc.

• Process Optimization: Monitor the generation of Impurity 1 during Suzetrigine synthesis. Optimize the process by adjusting parameters such as reaction temperature, raw material ratio, and catalyst dosage to reduce impurity levels.

• Stability Studies: Track the change trend of Impurity 1 in accelerated stability tests (e.g., 60℃/RH75%) and long-term stability tests, providing data support for drug storage conditions and shelf life.

Background Description

Suzetrigine is a novel sodium channel inhibitor used in the treatment of neuropathic pain and other conditions. During its R&D and production, various impurities may be generated due to residual raw materials, reaction by-products, or degradation. As a specific impurity of Suzetrigine, Impurity 1 may affect the safety and efficacy of the drug. With the increasingly strict global regulatory requirements for impurity control, the research and control of Suzetrigine Impurity 1 have become crucial for ensuring drug quality and patient medication safety.

Research Status

• Detection Technology: UPLC-MS/MS is the mainstream technology. By optimizing the chromatographic column (C18 column, 1.7μm particle size), mobile phase system (acetonitrile-water gradient elution), and mass spectrometry parameters, highly sensitive detection of Impurity 1 can be achieved, with a detection limit as low as 0.005 ng/mL.

• Formation Mechanism: Research shows that Impurity 1 may originate from cyclization side reactions of key intermediates during Suzetrigine synthesis or the residual transformation of similar-structured impurities in raw materials. Improving reaction conditions and purification processes can reduce the content of Impurity 1 by over 70%.

• Safety Evaluation: Preliminary toxicological studies indicate that high concentrations of Impurity 1 may have potential toxic effects on hepatocytes. Currently, strict limits (e.g., ≤0.1%) have been set for it in drug quality standards. Further in-depth research on its toxic mechanism is needed to improve impurity control strategies.

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!