Product Information

Product Number: P059056

English Name: Pomalidomide Impurity 56

English Alias: methyl 5-amino-2-(1,3-dioxoisoindolin-2-yl)-5-oxopentanoate

CAS Number: 64552-20-1

Molecular Formula: C??H??N?O?

Molecular Weight: 290.27

Advantages

With a well-defined structure and high stability, it can accurately analyze the side reaction mechanisms of esterification, amino group introduction, and isoindoline ring formation during pomalidomide synthesis, helping to optimize the production process and reduce impurity generation.

Its structure containing ester, amino, and isoindolinedione groups can serve as a standard substance, significantly enhancing the separation and quantification capabilities of detection methods such as HPLC and LC-MS for complex-structured impurities.

It helps to deeply study the impact of functional groups such as ester and amino groups on drug stability and toxicological properties, providing a strong scientific basis for impurity control strategies.

Applications

Drug Development: During the research and development of pomalidomide and its formulations, it is used as an impurity reference standard to identify and quantitatively analyze Impurity 56, thereby accurately 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, strictly 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 such as light, high temperature, and high humidity, evaluating its impact on the stability of pomalidomide formulations, and providing data support for formulating reasonable storage conditions and shelf life.

Background Description

Research Status

Detection Method Optimization: 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 Process Improvement: Deeply studying the formation pathway of this impurity, and developing synthesis processes that reduce impurity generation by optimizing reaction temperature, catalyst type, reaction time, and raw material ratio.

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

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