Suzetrigine Impurity 7
Product Code: S054007
English Name: Suzetrigine Impurity 7
English Alias: methyl 4-aminopicolinate
CAS No.：71469-93-7
Molecular Formula: C₇H₈N₂O₂
Molecular Weight: 152.15
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.
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.
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.
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
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