Hubei Moxin Biotechnology Co., Ltd
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CAS NO.3041980-36-0
1(10.0-10000)Milligram
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.
Suzetrigine Impurity
Product Information
Product Code: S054005
English Name: Suzetrigine Impurity 5
English Alias: (2S,3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-ol
CAS No.：3041980-36-0
Molecular Formula: C??H??F?O?
Molecular Weight: 326.26
Advantages
High Purity Assurance: With a purity of ≥99.0% detected by HPLC, its structure is confirmed by techniques such as NMR and HRMS, ensuring the accuracy and reliability of impurity analysis and providing a precise reference for drug quality research.
Good Stability: Under sealed storage at 2 - 8°C away from light, it has a shelf life of up to 24 months, and the degradation rate in solution (such as methanol) is less than 0.3% within 1 month, ensuring the stability and reproducibility of experimental data.
Compliance with Regulatory Requirements: Meets the quality standards of international pharmaceutical regulatory agencies such as ICH and FDA, helping pharmaceutical companies comply with regulations during drug research, development, production, and application processes.
Applications
Pharmaceutical Quality Testing: Used for the detection and analysis of Impurity 5 in Suzetrigine active pharmaceutical ingredients and formulations by HPLC, LC - MS, etc., strictly controlling the impurity content to ensure that drug quality complies with pharmacopoeia regulations.
Process Optimization Research: Monitor the generation of Impurity 5 during the synthesis of Suzetrigine. Optimize the production process by adjusting reaction conditions (such as temperature, reaction time, catalyst dosage) and raw material ratios to reduce the amount of impurities generated.
Analytical Method Validation: Serves as a reference standard for developing and validating the detection methods of Suzetrigine impurities, evaluating the specificity, sensitivity, and linear range of the methods, and providing reliable analytical means for quality control.
Stability Investigation: Track the content changes of Impurity 5 in drug stability tests (accelerated tests, long-term tests), analyze its impact on drug stability, and provide data support for determining the storage conditions and shelf life of drugs.
Background Description
Suzetrigine is a novel drug. During its research, development, and production processes, the presence of impurities may affect the safety, efficacy, and quality controllability of the drug. As a specific impurity of Suzetrigine, Impurity 5 may originate from side reactions, residual raw materials, or degradation processes during synthesis. With the continuous improvement of global requirements for drug quality, pharmaceutical regulatory agencies around the world (such as FDA, EMA, NMPA) have become increasingly strict in controlling impurities in drugs, requiring comprehensive research and strict limit regulations for impurities. Therefore, the research and control of Suzetrigine Impurity 5 have become a crucial part of ensuring drug quality and patient medication safety.
Research Status
Detection Technology: Currently, UPLC - MS/MS technology is mainly used to detect Impurity 5. By optimizing the chromatographic column (such as C18 column, 1.7μm particle size), the mobile phase system (acetonitrile - water gradient elution with ammonium formate buffer), and mass spectrometry parameters (electrospray ionization source, multiple reaction monitoring mode), highly sensitive detection of impurities can be achieved, with a detection limit as low as 0.002 ng/mL, enabling accurate detection of trace impurities.
Formation Mechanism: Research shows that Impurity 5 may be generated during the synthesis of Suzetrigine due to incomplete protection or abnormal deprotection of hydroxyl groups, resulting in incomplete or excessive reaction of the 2-position hydroxyl group on the tetrahydrofuran ring. By improving reaction conditions, such as selecting appropriate protecting groups and optimizing the deprotection steps, the generation of Impurity 5 can be effectively reduced.
Safety Evaluation: The safety research on Impurity 5 is in the preliminary stage. In vitro cell experiments show that at high concentrations, Impurity 5 has a certain impact on the growth of some cell lines, but the specific toxic mechanism is still unclear. In the future, more in vivo and in vitro experiments, including animal toxicology experiments and pre-clinical studies, are needed to deeply explore its toxic characteristics and provide a scientific basis for formulating reasonable impurity limits.
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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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