Suzetrigine Impurity 6
Product Code: S054006
English Name: Suzetrigine Impurity 6
English Alias: (2R,3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-carbonitrile
CAS No.：2875067-17-5
Molecular Formula: C₁₅H₁₄F₅NO₂
Molecular Weight: 335.27
High Purity and Precise Structure: Structure confirmed by NMR and HRMS, with ≥99.0% purity (HPLC), providing a reliable standard for Suzetrigine impurity analysis.
Excellent 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 stable detection data.
Strong Regulatory Compliance: Meets international pharmaceutical regulatory standards of ICH, FDA, etc., helping pharmaceutical companies meet impurity control requirements and ensure drug quality.
Quality Control Testing: Used for HPLC and LC-MS detection of Impurity 6 in Suzetrigine API and formulations, strictly controlling impurity content to meet pharmacopoeia and regulatory standards.
Process Optimization Research: Monitor the generation of Impurity 6 during Suzetrigine synthesis. Optimize the process by adjusting parameters such as reaction temperature, raw material ratio, and reaction time to reduce impurity generation.
Analytical Method Validation: Serves as a reference standard for developing and validating Suzetrigine impurity detection methods, evaluating method specificity, sensitivity, and repeatability to ensure reliable analytical results.
Stability Studies: Track changes in Impurity 6 content during accelerated stability tests (e.g., 60℃/RH75%) and long-term stability tests, evaluate its impact on drug stability, and provide data support for determining drug shelf life and storage conditions.
As a novel drug, Suzetrigine requires strict impurity control during R&D and production to ensure safety and efficacy. Impurity 6, a potential by-product or residual raw material impurity in Suzetrigine synthesis, contains a nitrile group that may affect the drug's physicochemical properties and pharmacological activity. With the increasingly strict global pharmaceutical regulatory requirements, research and control of Suzetrigine impurities have become crucial for building a drug quality system. Studying Impurity 6 helps improve drug quality standards and ensure patient safety.
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 1.8 minutes with a detection limit of 0.003 ng/mL, significantly enhancing impurity detection sensitivity and efficiency.
Formation Mechanism: Research shows that Impurity 6 may originate from the cyanidation step in Suzetrigine synthesis, resulting from side reactions between unreacted halogenated substances and cyanide in raw materials. Optimizing the dosage of cyanidation reagents and controlling the reaction pH at weakly alkaline levels (pH 8-9) can reduce impurity content by over 70%.
Safety Evaluation: Preliminary toxicological experiments indicate that Impurity 6 has certain toxicity to in vitro cells (e.g., HEK293) at high concentrations, but the specific mechanism remains unclear. Current drug quality standards set its limit at ≤0.1%, and further animal experiments are needed to evaluate its long-term toxicity and potential risks.
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!
China
