Product Information

Product Number: N020013

English Name: Nicardipine EP Impurity A

English Alias: 3-(2-(benzyl(methyl)amino)ethyl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate

CAS Number: 59875-58-0

Molecular Formula: C??H??N?O?

Molecular Weight: 477.51

Serving as an EP-compliant reference standard for direct use in quality testing of nicardipine APIs and formulations, ensuring consistency with international pharmacopoeia requirements;

Helping to analyze the by-product formation mechanism of amino substitution reactions in nicardipine synthesis to optimize processes and reduce the formation of benzylmethylamine impurities;

Assisting in evaluating the impact of nitro and amino structures on drug stability and safety to provide a basis for establishing storage conditions and quality standards.

Applications

Quality Control: Used as an EP standard impurity reference for system suitability tests in HPLC and other detection methods to verify whether the content of this impurity in nicardipine meets EP limits;

Drug Development: In generic drug research, used to compare the impurity profile of the original drug to ensure quality consistency between the generic and original drug;

Process Optimization: Guiding the optimization of amination and pyridine ring condensation reaction conditions in the synthesis route to reduce the generation of this impurity through impurity content analysis.

Background Description

Research Status

Detection Method Optimization: Using EP-recommended HPLC-UV methods or LC-MS combined techniques to improve the detection sensitivity and specificity of this impurity;

Synthesis Process Improvement: Reducing the generation of benzylmethylamine derivatives by adjusting the reagent ratio and temperature of amination reactions;

Stability Studies: Investigating the degradation behavior of this impurity under light, high temperature, and high humidity conditions to evaluate its impact on nicardipine formulation stability;

Toxicological Evaluation: Studying the potential genotoxicity of nitro and amino structures through in vitro cell experiments to provide data support for establishing safe limits.