Keywords

• Suzetrigine Impurity
• 71469-93-7
• C7H8N2O2

Quick Details

• ProName: Suzetrigine Impurity；71469-93-7
• CasNo: 71469-93-7
• Molecular Formula: C7H8N2O2
• 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 7

Product Information

• Product Code: S054007

• English Name: Suzetrigine Impurity 7

• English Alias: methyl 4-aminopicolinate

• CAS No.：71469-93-7

• Molecular Formula: C?H?N?O?

• Molecular Weight: 152.15

Advantages

• High Purity Assurance: With a purity of ≥99.0% detected by HPLC, its structure is confirmed by NMR and HRMS, ensuring accurate impurity analysis and providing a reliable standard for Suzetrigine quality research.

• 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., methanol) within 1 month, ensuring stable and reproducible experimental data.

• Strong Regulatory Compliance: Meets the requirements of international pharmaceutical regulatory agencies such as ICH and FDA, helping pharmaceutical companies meet regulatory standards during drug R&D, production, and application.

Applications

• Quality Control: Used for HPLC and LC-MS detection of Impurity 7 in Suzetrigine API and formulations, controlling impurity content ≤0.1% according to ICH Q3A and other standards to ensure drug quality compliance.

• Process Optimization: Monitor the generation of Impurity 7 during Suzetrigine synthesis. Optimize the process by adjusting reaction temperature, raw material ratio, and other parameters to reduce impurity generation and improve product purity.

• Methodology Validation: Serves as a reference standard for developing and validating Suzetrigine impurity detection methods, evaluating method specificity, sensitivity, and linear range to provide reliable analytical means for quality control.

• Stability Studies: Track changes in Impurity 7 content during accelerated stability tests (e.g., 60℃/RH75%) and long-term stability tests, analyze its impact on drug stability, and provide data support for determining shelf life and storage conditions.

Background Description

As a novel drug, Suzetrigine requires strict impurity control during R&D and production to ensure safety and efficacy. Impurity 7, a potential residual raw material or by-product impurity in Suzetrigine synthesis, has a simple structure but may affect drug quality. With the continuous improvement of global pharmaceutical regulatory requirements, research and control of Suzetrigine impurities have become crucial for building a drug quality system. Studying Impurity 7 helps improve drug quality standards and ensure patient safety.

Research Status

• Detection Technology: UPLC-MS/MS is the mainstream technology, using a C18 column (1.7μm, 2.1×100mm) and 0.1% formic acid water-acetonitrile gradient elution to complete separation within 1.3 minutes, with a detection limit as low as 0.002 ng/mL, significantly more sensitive than traditional HPLC.

• Formation Mechanism: Research shows that Impurity 7 may originate from side reactions during pyridine ring construction or amino protection/deprotection steps in Suzetrigine synthesis, or incomplete reaction of methyl 4-aminopicolinate in raw materials. Optimizing reaction conditions (such as controlling reaction time and selecting suitable catalysts) and purification processes (such as column chromatography) can reduce impurity content by over 80%.

• Safety Evaluation: Preliminary toxicological experiments show low toxicity of Impurity 7 to in vitro cells (e.g., A549 cells), but long-term exposure risks still need further evaluation through animal experiments. Current drug quality standards set its limit at ≤0.1%, and further 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!