Product Number: P059053
English Name: Pomalidomide Impurity 53
English Alias: 5-amino-4-(1,3-dioxoisoindolin-2-yl)-5-oxopentanoic acid
CAS Number: 4292-56-2
Molecular Formula: C₁₃H₁₂N₂O₅
Molecular Weight: 276.24
As an impurity reference standard for pomalidomide, this compound has significant advantages:
Well-defined structure and good stability, enabling precise analysis of side reaction mechanisms during pomalidomide synthesis, such as amino group introduction and isoindoline ring construction, to optimize processes and reduce the generation of such impurities;
As a reference standard containing amino, carboxyl, and isoindolinedione structures, it provides a standard substance for detecting complex impurities with multiple functional groups in drugs, improving the quantitative accuracy of methods like HPLC and LC-MS;
Helps study the impact of amino and isoindoline structures on drug stability and toxicological properties, providing a scientific basis for impurity control strategies.
Drug Development: Used as an impurity reference standard to identify and quantify Impurity 53 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 and shelf life.
Pomalidomide is an immunomodulatory drug used for treating hematological diseases such as multiple myeloma. During its synthesis, if the raw material ratio is improper, the reaction temperature is out of control, or intermediate reactions are incomplete, impurities such as 5-amino-4-(1,3-dioxoisoindolin-2-yl)-5-oxopentanoic acid are likely to be generated. Since such impurities may affect the safety, effectiveness, and bioavailability of the drug, research on them is a crucial part of the pomalidomide quality control system.
Current research focuses on:
Detection Method Optimization: Establishing trace detection methods for this impurity using techniques such as ultra-high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) and high-resolution mass spectrometry (HRMS), achieving precise analysis with sensitivity reaching the ppb level;
Synthesis Process Improvement: Optimizing the synthesis route by adjusting reaction solvents, catalyst types, and reaction time, reducing impurity generation, and developing high-purity impurity synthesis processes;
Toxicological Evaluation: Studying the potential toxicity of this impurity through in vitro cytotoxicity experiments and animal models to provide data support for formulating reasonable impurity limit standards;
Crystal Form and Physicochemical Properties: Investigating the crystal form characteristics of this impurity and its impact on the physical stability of drug formulations, improving the pomalidomide quality control and formulation development system.
China
