Alverine EP Impurity E NEW

Alverine EP Impurity E; 408309-07-9

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E-mail: anna@molcoo.com.

• Product Information

• Product Number: A076005

• English Name: Alverine EP Impurity E

• English Alias: tris(3-phenylpropyl)amine

• CAS Number: 408309-07-9

• Molecular Formula: C₂₇H₃₃N

• Molecular Weight: 371.56

• Advantages

• As an EP impurity reference standard for alverine, this compound has significant advantages:
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• Well-defined structure and good stability, enabling precise analysis of by-product formation mechanisms during alverine synthesis, such as amination reactions, to optimize the production process and reduce impurity generation;

• As a reference standard with a multi-phenylpropyl structure, it provides a standard substance for detection methods like HPLC and LC-MS, improving the separation and quantification accuracy of complex-structured impurities;

• Helps study the impact of multi-alkyl substituted amine structures on drug stability and toxicological properties to provide a scientific basis for impurity control strategies.

• Applications

• Drug Development: Used as an impurity reference standard to identify and quantify Impurity E in alverine and its formulations, evaluating the purity of APIs and formulations;

• Quality Control: Acting as a standard substance to validate the sensitivity and specificity of detection methods (e.g., HPLC, LC-MS), ensuring the impurity content meets European Pharmacopoeia (EP) requirements during production;

• Stability Studies: Investigating the degradation behavior of this impurity under light, high temperature, and high humidity conditions to evaluate its impact on alverine formulation stability and assist in determining storage conditions.

• Background Description

• Alverine is a smooth muscle relaxant used to relieve gastrointestinal spasms. During its synthesis, if amination reaction conditions are not properly controlled or raw materials remain, impurities such as tris(3-phenylpropyl)amine are likely to be generated. Since such impurities may affect drug safety, effectiveness, and bioavailability, and the European Pharmacopoeia has strict control standards for drug impurities, research and control of alverine impurities are key to ensuring drug quality and compliance with regulatory requirements.

• Research Status

• Current research focuses on:
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• Detection Method Optimization: Establishing trace detection methods for this impurity using techniques such as ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) and high-resolution mass spectrometry (HRMS), achieving precise analysis with sensitivity reaching the ppb level;

• Synthesis Process Improvement: Optimizing the synthesis route by adjusting reaction temperature, catalyst types, and raw material ratios to reduce impurity generation;

• Toxicological Evaluation: Studying the potential toxicity of this impurity through in vitro cytotoxicity experiments and animal models to provide data support for formulating reasonable impurity limit standards;

• Crystal Form and Physicochemical Properties: Investigating the crystal form characteristics of this impurity and its impact on the physical stability of drug formulations to improve the alverine quality control system

This product is intended for laboratory use only!

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com