Nifedipine EP Impurity A NEW

Product Information

• Product Number: N003001

• English Name: Nifedipine EP Impurity A

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

• CAS Number: 67035-22-7

• Molecular Formula: C₁₇H₁₆N₂O₆

• Molecular Weight: 344.32

Advantages

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

• Helping to analyze the side reaction mechanism of pyridine ring construction in nifedipine synthesis to optimize processes and reduce the formation of ortho-nitrophenyl-substituted impurities;

• Assisting in evaluating the impact of ortho-nitro structures on drug stability to provide a basis for establishing storage conditions and shelf life.

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 nifedipine meets EP standards;

• 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 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 ortho-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 nifedipine formulation stability;

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