Product Information

Product Number: N011004

English Name: Nitrendipine EP Impurity A

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

CAS Number: 89267-41-4

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

Molecular Weight: 358.35

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

Helping to analyze the regioselective side reaction mechanism during pyridine ring construction in nitrendipine synthesis to optimize processes and reduce the formation of meta-nitrophenyl-substituted impurities;

Assisting in evaluating the impact of meta-nitro structures on drug stability and activity 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 nitrendipine 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 nitration and pyridine ring condensation reaction conditions in the synthesis route to reduce meta-nitro impurity generation 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 meta-nitrophenyl derivatives by adjusting the reagent ratio and temperature of the nitration reaction;

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

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