Nimodipine EP Impurity A NEW

Product Information

Product Number: N030001

English Name: Nimodipine EP Impurity A

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

CAS Number: 85677-93-6

Molecular Formula: C₂₁H₂₄N₂O₇

Molecular Weight: 416.42

Advantages

Applications

Quality Control: Used as an EP standard impurity reference for system suitability tests in HPLC, LC-MS, and other detection methods, verifying whether the content of this impurity in nimodipine meets the limit requirements specified by the EP;

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

Process Optimization: Guiding the optimization of key reaction conditions such as nitration and esterification in the synthesis route by analyzing the content of this impurity, reducing impurity generation.

Background Description

Research Status

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

Synthesis Process Improvement: Reducing impurity generation by adjusting parameters such as reaction temperature and catalyst type, and developing high-purity impurity synthesis routes to meet quality research needs;

Stability Studies: Investigating the degradation behavior of this impurity under conditions of light, high temperature, high humidity, etc., evaluating its impact on the stability of nimodipine formulations;

Toxicological Evaluation: Studying the potential toxicity of this impurity through in vitro cell experiments and animal models, providing data support for establishing safe limits.