Suzetrigine Impurity 1 NEW

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: C₁₄H₁₃F₅O₃

• 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

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!