Description

n-[[(5S)-3-[4-[(2-Hydroxyethyl)Amino]Phenyl]-2-Oxo-5-Oxazolidinyl]Methyl]Acetamide (Linezolid Impurity) CAS NO 227200-81-9 is a high-purity chemical reference standard, specifically identified as a known impurity of the antibiotic Linezolid. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry focused on method validation, stability studies, and regulatory compliance for oxazolidinone-class antibiotics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Linezolid and related drug substances.
• Impurity Profiling & Identification: Critical for identifying and characterizing this specific impurity in Linezolid active pharmaceutical ingredient (API) and finished drug products during stability and forced degradation studies.
• Analytical Method Development & Validation: Used as a system suitability and calibration standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Batch Release Testing: Employed in QC laboratories to monitor and control impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring batch-to-batch consistency.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities, which is a mandatory requirement for drug approval.
• Research on Degradation Pathways: Serves as a marker in studies to understand the degradation mechanisms and stability profile of Linezolid under various environmental conditions.

Basic Information

Product Name	n-[[(5S)-3-[4-[(2-Hydroxyethyl)Amino]Phenyl]-2-Oxo-5-Oxazolidinyl]Methyl]Acetamide (Linezolid Impurity)
CAS No.	227200-81-9
Molecular Formula	C15H21N3O4
Molecular Weight	307.35 g/mol
Synonyms	Linezolid Impurity; Linezolid Related Compound; Acetamide, N-[[(5S)-3-[4-[(2-hydroxyethyl)amino]phenyl]-2-oxo-5-oxazolidinyl]methyl]-; (5S)-N-[[3-[4-[(2-Hydroxyethyl)amino]phenyl]-2-oxo-5-oxazolidinyl]methyl]acetamide; Linezolid EP Impurity; Linezolid USP Impurity; Zyvox Impurity; PNU-100766 Impurity
EINECS	Contact for details

Quality Control

Our n-[[(5S)-3-[4-[(2-Hydroxyethyl)Amino]Phenyl]-2-Oxo-5-Oxazolidinyl]Methyl]Acetamide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and control of related substances, to ensure it meets the stringent requirements for a pharmaceutical reference standard. Certificates of Analysis (COA) are provided with each shipment, detailing batch-specific results and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive); ensure containers are sealed tightly after each use to prevent moisture absorption and degradation.

Specification

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

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