Pomalidomide Impurity 54 NEW

Product Information

Product Number: P059054

English Name: Pomalidomide Impurity 54

English Alias: 5-amino-2-(1,3-dioxoisoindolin-2-yl)-5-oxopentanoic acid

CAS Number: 7607-72-9

Molecular Formula: C₁₃H₁₂N₂O₅

Molecular Weight: 276.24

Advantages

With a clear structure and strong stability, it can be used to deeply study the side reaction mechanisms of reactions such as isoindoline ring connection and amino group introduction during pomalidomide synthesis, optimize the production process, and reduce impurity generation.

As an impurity standard with amino, carboxyl, and isoindolinedione structures, it can provide an accurate reference for the detection of similar complex - structured impurities in drugs, significantly improving the quantitative accuracy of analytical methods such as HPLC and LC - MS.

It helps to explore the impact of the impurity structure on the stability and toxicological properties of drugs, providing an important basis for the scientific formulation of impurity control strategies.

Applications

Drug Development: During the research and development of pomalidomide and its formulations, it is used as an impurity reference standard for identification and quantitative analysis, determining the impurity profile of drugs and evaluating the purity of APIs and formulations.

Quality Control: As a standard substance, it is used to verify the sensitivity and specificity of detection methods such as HPLC and LC - MS, ensuring that the content of this impurity during production meets pharmacopoeia and relevant regulatory requirements.

Stability Studies: Investigating the degradation behavior of this impurity under different environmental conditions (light, high temperature, high humidity), evaluating its impact on the stability of pomalidomide formulations, and providing data support for determining drug storage conditions and shelf life.

Background Description

Research Status

Detection Technologies: Using advanced technologies such as ultra - high - performance liquid chromatography - tandem mass spectrometry (UPLC - MS/MS) and high - resolution mass spectrometry (HRMS) to develop highly sensitive and selective detection methods for trace detection of this impurity.

Synthesis Processes: Deeply studying the formation pathway of this impurity, and developing synthesis processes that reduce impurity generation by optimizing reaction conditions (such as reaction temperature, time, solvent selection) and raw material ratios.

Toxicological Evaluation: Evaluating the potential toxicity of this impurity through in vitro cytotoxicity experiments and animal models to provide data for formulating reasonable impurity limit standards.

Stability Studies: Systematically studying the stability of this impurity under different environmental factors, analyzing its impact on the quality of pomalidomide formulations, and improving the drug quality control system.