Product Information

Product Number: R006055A

English Name: Ropivacaine EP Impurity H(Hydrochloride)

English Alias: 2,6-dimethylaniline hydrochloride

CAS Number: 21436-98-6

Molecular Formula: C?H??N·HCl

Molecular Weight: 157.64

Analyzing the residual aniline raw materials or dealkylation side reaction mechanisms during ropivacaine synthesis to optimize processes for controlling aromatic amine impurity generation;

Serving as a hydrochloride-form reference standard to precisely match the actual state of drugs, improving the accuracy of impurity quantification;

Helping study the impact of aromatic amine structures on drug stability and toxicological properties (aromatic amines may have potential genotoxicity) to provide a scientific basis for impurity control.

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 2,6-dimethylaniline hydrochloride in ropivacaine 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 amination or deprotection reaction conditions in the synthesis route to reduce aromatic amine 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 of this impurity (detection limit reaches ppm level);

Synthesis Process Improvement: Reducing the residue of 2,6-dimethylaniline or by-product generation by optimizing raw material ratios, reaction temperature, and other parameters;

Toxicological Evaluation: Studying the potential mutagenicity of this impurity through in vitro Ames tests and animal models;

Stability Studies: Investigating the degradation behavior of this impurity under light and high-temperature conditions to evaluate its impact on ropivacaine formulation stability