Pomalidomide Impurity 52 NEW

Product Information

Product Number: P059052

English Name: Pomalidomide Impurity 52

English Alias: 2-((2,6-dioxopiperidin-3-yl)carbamoyl)benzoic acid

CAS Number: 6139-18-0

Molecular Formula: C₁₃H₁₂N₂O₅

Molecular Weight: 276.24

Advantages

Well-defined structure and high stability, enabling analysis of side reaction mechanisms during pomalidomide synthesis, such as piperidinedione ring and benzoyl group linkage, to optimize processes and reduce amide impurity generation;

As a bicyclic reference standard containing piperidinedione and benzoyl groups, it provides a standard substance for detecting polycyclic impurities in drugs, improving the quantitative accuracy of methods like HPLC and LC-MS;

Helps study the impact of piperidinedione structures on drug stability and toxicological properties (piperidinediones may participate in in vivo amide bond hydrolysis reactions) to provide a scientific basis for impurity control strategies.

Applications

Drug Development: Used as an impurity reference standard to identify and quantify Impurity 52 in pomalidomide preparations, evaluating the purity of APIs and formulations;

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

Stability Studies: Investigating the degradation behavior of this impurity under light, high temperature, and high humidity conditions to evaluate its impact on pomalidomide formulation stability, assisting in determining storage conditions.

Background Description

Research Status

Detection Method Optimization: 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 to enhance impurity separation in complex matrices;

Synthesis Process Improvement: Reducing by-product generation by optimizing the construction conditions (such as reaction temperature, solvent polarity) of piperidinedione rings, and developing high-purity impurity synthesis routes;

Toxicological Evaluation: Studying the potential mutagenicity of piperidinedione structures through in vitro Ames tests and animal models to provide data support for establishing safe limits;

Crystallization Behavior Research: Analyzing the cocrystallization characteristics of this impurity with pomalidomide to evaluate its impact on drug formulation crystal form stability and improve the quality control system.