Lercanidipin Impurity NEW

Lercanidipin Impurity;3030749-28-8

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E-mail: anna@molcoo.com.

• Product Information

• Product Number: L023016A

• English Name: Lercanidipin Impurity 16(Hydrochloride)

• English Alias: 3-(1-((3,3-diphenylpropyl)(methyl)amino)-2-methylpropan-2-yl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate hydrochloride

• CAS Number: 3030749-28-8

• Molecular Formula: C₃₆H₃₉N₃O₆·HCl

• Molecular Weight: 646.17（609.71 + 36.46）

• Advantages

• As a hydrochloride impurity reference standard for lercanidipin, this compound has the following advantages:
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• Well-defined structure and stable salt form: Precise chemical structure and stability of the hydrochloride form, enabling analysis of by-product formation mechanisms during lercanidipin synthesis, such as pyridine ring construction, amination, and salification reactions, to optimize processes for impurity control;

• Multifunctional standard substance: Contains complex structures like nitrophenyl, pyridine carboxylate, and diphenylpropylamine, providing an accurate standard for HPLC, LC-MS, and other detection methods to improve separation and quantification accuracy of lercanidipin-related impurities;

• Water solubility advantage: The hydrochloride form enhances the compound's water solubility, facilitating simulation of impurity behavior in physiological environments during formulation stability studies and impurity detection.

• Applications

• Drug Development: Used as an impurity reference standard to identify and quantify Impurity 16 in lercanidipin 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 impurity content meets pharmacopoeia and regulatory 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 lercanidipin formulation stability and assist in determining storage conditions.

• Background Description

• Lercanidipin is a dihydropyridine calcium channel blocker used for treating hypertension. During its synthesis, incomplete pyridine ring substitution reactions or improper control of amination reaction conditions easily generate impurities containing diphenylpropylamine structures. As a key quality attribute controlled impurity of lercanidipin, research on this hydrochloride impurity is an important part of ensuring drug safety and effectiveness.

• Research Status

• Current research focuses on:
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• Detection method optimization: Establishing trace detection methods (detection limits reach ppb level) using UPLC-MS/MS technology, leveraging the ionization characteristics of hydrochloride to enhance mass spectrometry response;

• Synthesis process improvement: Reducing by-product generation by optimizing the catalyst and reaction temperature of nitration reactions;

• Salt form stability: Studying the hygroscopicity and degradation pathways of hydrochloride under high temperature and humidity conditions to provide data for storage conditions;

• Toxicological evaluation: Evaluating the potential impact of this impurity on vascular smooth muscle cells through in vitro cytotoxicity experiments to assist in setting safe limits

This product is intended for laboratory use only!

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