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: C₁₈H₁₈N₂O₆
Molecular Weight: 358.35
As a European Pharmacopoeia (EP) standard impurity of nitrendipine, the research advantages of this compound include:
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.
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.
Nitrendipine is a commonly used dihydropyridine calcium channel blocker in clinical practice for the treatment of hypertension. If the nitro substitution position or pyridine ring condensation reaction is not properly controlled during its synthesis, meta-nitrophenyl-substituted impurities (such as Impurity A) are easily generated. The European Pharmacopoeia (EP) has clear limits for this impurity, making research on it a necessary part of international quality control for nitrendipine.
Current research focuses on:
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.
China
