Alverine EP Impurity D NEW

Alverine EP Impurity D;2732347-30-5

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

• Product Information

• Product Number: A076004

• English Name: Alverine EP Impurity D

• English Alias: 3-cyclohexyl-N-ethyl-N-(3-phenylpropyl)propan-1-amine

• CAS Number: 2732347-30-5

• Molecular Formula: C₂₀H₃₃N

• Molecular Weight: 287.48

• Advantages

• As an EP impurity reference standard for Alverine, this compound has the following advantages:
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• With a well-defined structure and good stability, it can be precisely used to analyze the by-product formation mechanism of amination and alkylation reactions during Alverine synthesis, providing a basis for optimizing the production process and reducing impurity generation.

• Its structure containing cyclohexyl, ethyl, and phenylpropyl groups can serve as a standard substance, significantly improving the separation and quantification accuracy of detection methods such as HPLC and LC-MS for impurities related to Alverine.

• It helps to deeply explore the influence of different alkyl substituents on impurity properties, thus providing scientific support for impurity control strategies and ensuring drug quality stability.

• Applications

• Drug Development: During the research and development of Alverine and its formulations, it is used as an impurity reference standard to identify and quantitatively analyze Alverine EP Impurity D, accurately evaluating the purity of APIs and formulations.

• Quality Control: As a standard substance, it is used to verify the sensitivity and specificity of detection methods such as HPLC and LC-MS, strictly ensuring that the content of this impurity during production meets the requirements of the European Pharmacopoeia (EP) and relevant regulations.

• Stability Studies: Investigating the degradation behavior of this impurity under different environmental conditions such as light, high temperature, and high humidity, evaluating its impact on the stability of Alverine formulations, and providing data support for formulating reasonable storage conditions and shelf life.

• Background Description

• Alverine is a smooth muscle relaxant used to relieve gastrointestinal spasms. During its synthesis, due to the complex reaction steps and strict condition requirements, if there are raw material residues, improper reaction temperature, or catalyst use, impurities such as 3-cyclohexyl-N-ethyl-N-(3-phenylpropyl)propan-1-amine are likely to be generated. The presence of such impurities may affect the safety, effectiveness, and bioavailability of the drug. The European Pharmacopoeia (EP) has strict control standards for drug impurities. Therefore, the research and control of Alverine impurities are key links to ensure drug quality and compliance with pharmacopoeia specifications.

• Research Status

• Currently, research on Alverine EP Impurity D mainly focuses on the following aspects:
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• Detection Method Optimization: Using advanced technologies such as ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) and high-resolution mass spectrometry (HRMS) to develop highly sensitive and selective detection methods for trace detection of this impurity.

• Synthesis Process Improvement: Deeply studying the formation pathway of this impurity, and developing synthesis processes that reduce impurity generation by optimizing reaction conditions (such as reaction temperature, time, solvent selection) and raw material ratios.

• Toxicological Evaluation: Evaluating the potential toxicity of this impurity through in vitro cytotoxicity experiments and animal models, providing data support for scientifically formulating reasonable impurity limit standards.

• Stability Studies: Systematically studying the stability of this impurity under the influence of different environmental factors, analyzing its impact on the quality of Alverine formulations, and further improving the drug quality control system.

This product is intended for laboratory use only!

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