Description

Erdosteine Metabolite 1 is a key intermediate and reference standard in the synthesis and analytical profiling of the mucolytic drug Erdosteine. This compound is critical for pharmaceutical research and development, particularly in studies concerning drug metabolism, pharmacokinetics, and impurity characterization. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in API development and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of Erdosteine and its related substances in drug substances and finished products.
• Metabolite Research: Essential for in-vitro and in-vivo studies to understand the metabolic pathways, bioavailability, and excretion profile of Erdosteine.
• Impurity Profiling: Serves as a critical marker for monitoring and controlling process-related impurities and degradation products during API manufacturing.
• Analytical Method Development: Employed in the development and validation of HPLC, LC-MS, and other chromatographic methods for drug analysis.
• Regulatory Submissions: Provides necessary data and materials for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding of drug substance composition.
• Stability Studies: Used as a benchmark in forced degradation and long-term stability studies to assess drug product shelf-life.

Basic Information

Product Name	Erdosteine Metabolite 1
CAS No.	121213-21-6
Molecular Formula	C8H11NO4S2
Molecular Weight	249.31 g/mol
Synonyms	N-(2-Oxo-2-((2-oxotetrahydrothiophen-3-yl)thio)ethyl)acetamide; (R)-2-((2-Oxotetrahydrothiophen-3-yl)thio)-N-acetylglycine; Erdosteine Metabolite I; Metabolite I of Erdosteine; S-Carboxymethylcysteine; S-Carboxymethyl-L-cysteine derivative; Acetylcysteine analog; N-Acetyl-S-carboxymethylcysteine
EINECS	Contact for details

Quality Control

Our Erdosteine Metabolite 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assessment by HPLC, and control of specific impurities. A Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment to ensure traceability and compliance with your research and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to maintain optimal stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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