rac-Domperidone EP Impurity C NEW

Product Number: D028005

English Name: rac-Domperidone EP Impurity C

English Alias: Domperidone N-Oxide; 4-(5-chloro-2-oxo-2,3-dihydro-1H-benzo[d]imidazol-1-yl)-1-(3-(2-oxo-2,3-dihydro-1H-benzo[d]imidazol-1-yl)propyl)piperidine 1-oxide

CAS Number: 118435-03-3

Molecular Formula: C₂₂H₂₄ClN₅O₃

Molecular Weight: 441.91

Advantages

Well-defined structure compliant with EP standards, directly applicable to quality testing of domperidone APIs and formulations to ensure consistency with international pharmacopoeia requirements;

As an N-oxide impurity, it can be used to analyze the by-product formation mechanism of oxidation reactions during domperidone synthesis or storage, optimizing processes to control N-oxide impurity generation;

Helps study the impact of N-oxide structures on drug stability and safety (N-oxides may have different pharmacological activities or toxicities) to provide a scientific basis for impurity control strategies.

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 domperidone 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;

Stability Studies: Investigating the formation rate of this impurity under light and high-temperature conditions to evaluate its impact on domperidone formulation stability and assist in establishing storage conditions.

Background Description

Research Status

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

Synthesis Process Improvement: Reducing N-oxide by-product generation by adjusting antioxidant conditions in the reaction system (such as inert gas protection, antioxidant addition);

Toxicological Evaluation: Studying the potential toxicity of N-oxide structures through in vitro cell experiments to provide data support for establishing safe limits;

Stability Prediction: Establishing a formation kinetics model for this impurity based on accelerated test data to predict the shelf life of domperidone formulations.