Description

Linezolid Impurity 104 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of process-related impurities during the manufacturing of the antibiotic Linezolid. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the quantitative and qualitative analysis of Linezolid and its related substances.
• Analytical Method Development & Validation: Used in developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for batch release testing, ensuring drug substance and drug product purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation impurities under various stress conditions (heat, light, humidity) for shelf-life determination.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Linezolid Impurity 104
CAS No.	1373348-82-3
Molecular Formula	C₁₆H₂₀FN₃O₄
Molecular Weight	337.35 g/mol
Synonyms	(S)-N-[[3-[3-Fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl]methyl]acetamide; Linezolid Related Compound 104; Linezolid EP Impurity H; Linezolid USP Related Compound C; Zyvox Impurity 104; (5S)-5-(Acetamidomethyl)-3-(3-fluoro-4-morpholinophenyl)-2-oxazolidinone; UNII-4F8VJX2K9R
EINECS	Contact for details

Quality Control

Every batch of Linezolid Impurity 104 is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results from advanced analytical techniques including HPLC, NMR, and MS. Our quality commitment supports compliance with cGMP and relevant pharmacopeial guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
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.