Description

Linezolid Related Impurity 1 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of the antibiotic Linezolid by enabling the accurate identification and quantification of this specific impurity during pharmaceutical development and manufacturing. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on pharmaceutical impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Linezolid Related Impurity 1 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols.
• Quality Control and Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels and ensure drug substance and product meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed as a marker to track the formation of degradation products in Linezolid formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research and Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and toxicological profiling of Linezolid and its related substances.

Basic Information

Product Name	Linezolid Related Impurity 1
CAS No.	1532560-87-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linezolid Impurity 1; Linezolid Related Compound 1; (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]acetamide (related substance); Oxazolidinone impurity of Linezolid; Zyvox Impurity 1; Linezolid EP Impurity A; Linezolid USP Related Compound A; Linezolid Degradation Product
EINECS	Contact for details

Quality Control

Our Linezolid Related Impurity 1 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including identity confirmation by spectroscopic methods (e.g., NMR, IR, MS) and purity determination by chromatographic techniques (e.g., HPLC). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with relevant standards. Our quality commitment supports compliance with ICH Q3A, Q3B, USP, and EP guidelines.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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