Description

Methionine Ep Impurity D(Racemic Mixture)/(2S)-2-(2-Acetamido-4-(Methylthio)Butanamido)-4-(Methylthio)Butanoic Acid CAS NO 1879009-96-7 is a high-purity reference standard and a critical process-related impurity in the synthesis of methionine and its derivatives. This compound is essential for pharmaceutical quality control and analytical method development, enabling precise identification and quantification of impurities to ensure product safety and regulatory compliance. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and manufacturers of amino acid-based APIs and nutritional supplements.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in the analysis of methionine active pharmaceutical ingredients (APIs).
• Method Development and Validation: Critical for developing, validating, and transferring analytical procedures in compliance with ICH Q2(R1) and pharmacopeial guidelines (USP, EP).
• Process Chemistry Research: Employed to study and optimize synthesis pathways, helping to identify and minimize the formation of this specific impurity during methionine production.
• Quality Control & Assurance: Essential for routine batch release testing to confirm that methionine products meet stringent purity specifications for pharmaceutical and high-grade applications.
• Regulatory Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing impurity characterization data.
• Academic and Industrial Research: Serves as a research chemical in studies related to amino acid chemistry, metabolism, and stability testing.

Basic Information

Product Name	Methionine Ep Impurity D(Racemic Mixture)/(2S)-2-(2-Acetamido-4-(Methylthio)Butanamido)-4-(Methylthio)Butanoic Acid
CAS No.	1879009-96-7
Molecular Formula	C12H22N2O4S2
Molecular Weight	322.44 g/mol
Synonyms	(2S)-2-[(2-Acetamido-4-(methylthio)butanoyl)amino]-4-(methylthio)butanoic Acid; Methionine EP Impurity D; Methionine Related Compound D; N-Acetyl-L-methionyl-L-methionine; L-Methionine, N-acetyl-, L-methionine ester; N-Acetyl-L-methionine-L-methionine; Ac-Met-Met-OH; 2-Acetamido-4-(methylthio)butanoic acid (2S)-2-[[2-acetamido-4-(methylthio)butanoyl]amino]-4-(methylthio)butanoate
EINECS	Contact for details

Quality Control

Every batch of our Methionine EP Impurity D is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity assay, identification by IR and MS, and control of related substances, to ensure it meets the exacting standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results. Our quality commitment aligns with the expectations of GMP and ISO-guided environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants and inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.