Product Number: P059051
English Name: Pomalidomide Impurity 51
English Alias: 2-(1,3-dioxoisoindolin-2-yl)pentanedioic acid
CAS Number: 6349-98-0
Molecular Formula: C₁₃H₁₁NO₆
Molecular Weight: 277.23
As an impurity reference standard for pomalidomide, this compound has the following advantages:
Well-defined structure and high stability, enabling precise analysis of by-product formation mechanisms during pomalidomide synthesis, such as phthalimide ring introduction and glutaric acid condensation reactions, to optimize processes and reduce imide impurity generation;
As a polar reference standard containing imide rings and carboxyl groups, it provides a standard substance for detecting impurities with multiple functional groups in drugs, improving the quantitative accuracy of methods like HPLC and LC-MS;
Helps study the impact of imide structures on drug stability and toxicological properties (imide compounds may affect drug activity or produce toxic metabolites), providing a scientific basis for impurity control strategies.
Drug Development: Used as an impurity reference standard to identify and quantify Impurity 51 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.
Pomalidomide is an immunomodulatory agent used in the treatment of hematological diseases such as multiple myeloma. During its synthesis, if the reaction conditions of phthalic anhydride and glutaric acid are out of control or raw materials remain, impurities containing imide rings such as 2-(1,3-dioxoisoindolin-2-yl)pentanedioic acid are easily generated. Since such impurities may affect drug safety and effectiveness, research on them is a key part of pomalidomide quality control and safety assessment.
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 catalyst types, reaction temperature, and raw material ratios to reduce 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 to improve the pomalidomide quality control system.
China
