Methionine EP Impurity E represents a further oxidized or rearranged variant that shifts thiol reactivity and chromatographic behavior. Researchers study its formation under oxidative stress to refine impurity specifications. Applications include method validation, redox-profiling, and degradation-pathway elucidation.
CAT No: Z10-101-190
Synonyms/Alias:(2S)-2-[[(2RS)-2-(acetylamino)-4-(methylsulfanyl)butanoyl]amino]-4-(methylsulfanyl)butanoic acid; 5-(acetylamino)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-2,4,6-triiodobenzene-1,3-dicarboxamide; Ac-DL-Met-L-Met-OH; 51XHX4G94E; METHIONINE IMPURITY E [EP IMPURITY]; (2S)-2-(((2RS)-2-(ACETYLAMINO)-4-(METHYLSULFANYL)BUTANOYL)AMINO)-4-(METHYLSULFANYL)BUTANOIC ACID
Methionine EP Impurity E is a structurally distinct impurity associated with methionine, an essential sulfur-containing amino acid. As a defined reference standard, this compound is significant in pharmaceutical and biochemical research, particularly within the context of quality control, analytical method development, and impurity profiling. Its unique molecular characteristics provide valuable insight into the chemical landscape encountered during methionine synthesis and storage, supporting rigorous investigation into the stability and purity of amino acid preparations. Methionine EP Impurity E is not intended for therapeutic use but is indispensable for researchers and analysts seeking to ensure the integrity and compliance of methionine-based products.
Analytical method development: Methionine EP Impurity E serves as a critical reference material in the validation and optimization of chromatographic and spectrometric methods. By providing a well-characterized impurity standard, it enables analytical chemists to establish robust methods for the detection, quantification, and separation of related substances in methionine samples. This function is essential for laboratories developing high-performance liquid chromatography (HPLC) or mass spectrometry (MS) protocols, where accurate identification of minor constituents ensures reliable assessment of sample composition.
Pharmaceutical quality control: In the context of pharmaceutical manufacturing and quality assurance, the presence and quantification of methionine-related impurities must be rigorously monitored. Utilizing Methionine EP Impurity E as a reference substance allows for precise calibration of analytical instruments and verification of impurity limits in active pharmaceutical ingredients (APIs) and finished dosage forms. This application is fundamental to meeting regulatory expectations for impurity profiling and maintaining product safety and efficacy during production and batch release.
Stability studies: Investigation of methionine degradation pathways and product shelf-life relies on the availability of authentic impurity standards. Methionine EP Impurity E is instrumental in forced degradation and stability-indicating studies, where it facilitates the identification and quantification of degradation products over time or under stress conditions. By enabling detailed tracking of impurity formation, researchers can elucidate the mechanisms underlying methionine instability and optimize formulation strategies to enhance product longevity.
Process development and optimization: During the synthesis and purification of methionine, the formation of related substances such as Impurity E can inform process efficiency and robustness. Inclusion of this impurity in process development workflows allows chemists and engineers to monitor reaction byproducts, evaluate purification steps, and refine manufacturing conditions to minimize unwanted contaminants. As a result, the use of defined impurity standards contributes to higher yields, improved reproducibility, and greater overall process control.
Research in amino acid chemistry: Methionine EP Impurity E also supports broader scientific investigations into amino acid reactivity, side reactions, and impurity formation mechanisms. Its availability enables academic and industrial researchers to probe the chemical behavior of methionine under various conditions, advancing the understanding of sulfur-containing amino acid stability and transformation. Insights gained from such studies can inform future improvements in amino acid synthesis, storage, and analytical characterization across multiple fields of biochemical research.
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