Bromhexine Impurity NEW

Product Information

Product Number: B008036

English Name: Bromhexine Impurity 36

English Alias: 2,4-dibromo-6-((methylamino)methyl)aniline

CAS Number: 740758-41-2

Molecular Formula: C₈H₁₀Br₂N₂

Molecular Weight: 293.99

Advantages

Well-defined structure and high stability, which can be used to analyze the by-product formation mechanism of bromination and amination reactions in bromhexine synthesis, optimizing processes to control dibromo impurity generation;

As a reference standard containing bromine atoms and amino groups, it provides a standard substance for detecting halogenated aromatic amine impurities in drugs, improving the quantitative accuracy of methods such as HPLC;

Helps study the impact of bromine substituents on drug stability and toxicological properties (halogenated aromatic amines may have potential genotoxicity) to provide a scientific basis for impurity control strategies.

Applications

Drug Development: Used as an impurity reference standard to identify and quantify Impurity 36 in bromhexine preparations, evaluating the purity of APIs and formulations;

Quality Control: Acting as a standard substance to validate the sensitivity of detection methods (e.g., HPLC or LC-MS), ensuring the impurity content meets pharmacopoeia requirements during production;

Toxicological Research: Assisting in evaluating the potential genotoxicity of halogenated aromatic amine impurities to provide data support for drug safety evaluation.

Background Description

Research Status

Synthesis Methods: Developing high-purity synthesis processes for Impurity 36 to solve the purification challenges of halogenated aromatic amines and meet the needs of toxicological research;

Detection Technologies: Establishing trace detection methods (detection limits reach ppb level) for this impurity using ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) technology;

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

Process Control: Analyzing the inducements (such as bromine dosage, reaction temperature)