Description

Linezolid n-Oxide is a key pharmaceutical intermediate and impurity standard in the synthesis and quality control of the potent antibiotic Linezolid. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a reference marker for oxidative degradation products. It is primarily utilized by pharmaceutical manufacturers and contract research organizations (CROs) engaged in antibiotic development, analytical method validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for HPLC, LC-MS, and other analytical methods to quantify and control related substances in Linezolid API and finished drug products.
• Process Research & Development (R&D): Employed in route scouting and optimization studies to understand and mitigate oxidation pathways during the synthesis of Linezolid.
• Quality Control & Assurance (QC/QA): Essential for establishing specification limits, validating analytical procedures, and preparing regulatory submission documents (e.g., ICH guidelines).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability testing to profile the degradation behavior of Linezolid under various stress conditions.
• Academic & Biomedical Research: Serves as a tool in microbiological and pharmacological research to study the structure-activity relationships and metabolic pathways of oxazolidinone antibiotics.

Basic Information

Product Name	Linezolid n-Oxide
CAS No.	189038-36-6
Molecular Formula	C16H20FN3O5
Molecular Weight	353.35 g/mol
Synonyms	Linezolid N-Oxide; Linezolid Impurity F (EP); Linezolid Related Compound F; (S)-N-({3-[3-Fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl}methyl)acetamide N-Oxide; Zyvox N-Oxide; PNU-100766 N-Oxide; Linezolid Oxidative Degradant; Oxazolidinone N-Oxide Derivative
EINECS	Contact for details

Quality Control

Our Linezolid n-Oxide is manufactured under strict quality systems to meet the exacting standards of pharmaceutical impurity analysis. Each batch is characterized and tested using advanced spectroscopic and chromatographic techniques to ensure high purity and correct identity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and identification tests performed in compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards.

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 minimize further oxidative degradation.

Specification

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

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