Methionine EP Impurity D is a methionine-derived degradation species displaying altered oxidation state or side-chain rearrangement. These changes modify polarity, reactivity, and retention behavior. Researchers use it to understand oxidative pathways and confirm analytical robustness. Applications include impurity profiling, stability testing, and redox-mechanism studies.
CAT No: Z10-101-189
Synonyms/Alias:(2R)-2-[[(2RS)-2-(acetylamino)-4-(methylsulfanyl)butanoyl]amino]-4-(methylsulfanyl)butanoic acid; Ac-DL-Met-D-Met-OH; CY109S16ZI; METHIONINE IMPURITY D [EP IMPURITY]; (2R)-2-(((2RS)-2-(ACETYLAMINO)-4-(METHYLSULFANYL)BUTANOYL)AMINO)-4-(METHYLSULFANYL)BUTANOIC ACID
Methionine EP Impurity D is a chemically defined amino acid derivative recognized as a specific impurity standard associated with methionine, a sulfur-containing essential amino acid. As a structurally related compound, it is of significant analytical and research interest, particularly in the context of pharmaceutical quality control and metabolic studies. Its presence and quantification are critical for ensuring the integrity and safety of methionine-containing formulations, as well as for elucidating the pathways of amino acid degradation and transformation. The availability of Methionine EP Impurity D as a reference material enables researchers and analysts to accurately detect, identify, and quantify this impurity in a variety of biochemical and pharmaceutical matrices, supporting both regulatory compliance and scientific investigation.
Analytical method development: Methionine EP Impurity D is widely used as a reference standard in the development and validation of analytical methods for the detection of methionine impurities. Researchers employ this compound to optimize chromatographic separation techniques such as HPLC and UPLC, ensuring reliable resolution and quantification of related substances in bulk drug substances and finished pharmaceutical products. Its well-characterized properties facilitate the establishment of method specificity, linearity, and sensitivity, which are essential for robust impurity profiling.
Pharmaceutical quality control: In the pharmaceutical industry, the accurate quantification of related impurities is a regulatory requirement for the release and stability testing of amino acid-based formulations. The use of Methionine EP Impurity D as a system suitability and calibration standard allows quality control laboratories to monitor impurity levels with precision, ensuring that products meet stringent safety and efficacy criteria. Its inclusion in impurity panels supports comprehensive batch release testing and ongoing stability studies, thereby safeguarding product quality throughout the manufacturing lifecycle.
Metabolic pathway elucidation: Methionine EP Impurity D serves as a valuable tool in biochemical research focused on amino acid metabolism and degradation pathways. By tracing its formation and transformation in biological samples, scientists gain insight into the enzymatic processes that govern methionine catabolism and the generation of specific byproducts. Such studies contribute to a deeper understanding of metabolic flux, enzyme specificity, and the physiological relevance of minor metabolites in cellular systems.
Reference material in impurity identification: During the characterization of unknown peaks in chromatographic analyses, the availability of Methionine EP Impurity D as a reference standard enables unambiguous identification of specific impurity profiles. By comparing retention times and spectral data, analysts can confirm the presence of this impurity in complex samples, facilitating accurate impurity mapping and supporting the development of regulatory submissions for new drug substances.
Process optimization and synthesis monitoring: In chemical synthesis and process development settings, monitoring the formation and clearance of methionine-related impurities is essential for optimizing reaction conditions and improving product yield. Methionine EP Impurity D can be employed to track impurity profiles during process scale-up, allowing chemists to refine purification strategies and ensure the consistent production of high-quality methionine derivatives. Its use in process analytical technology (PAT) supports real-time decision-making and enhances overall process control in industrial environments.
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