Description

Linezolid Impurity 15 is a designated chemical reference standard used in the analytical profiling and quality control of the antibiotic Linezolid. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug purity, safety, and regulatory compliance. It serves as a key marker for identifying and quantifying specific process-related impurities during the development and production of Linezolid API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Linezolid Active Pharmaceutical Ingredient (API).
• Analytical Research & Development: Employed in HPLC, UPLC, and LC-MS studies to establish impurity profiles, degradation pathways, and stability-indicating methods.
• Regulatory Compliance & Filings: Essential for preparing impurity identification and qualification reports required for regulatory submissions (e.g., FDA, EMA, ICH guidelines Q3A(R2) and Q3B(R2)).
• Pharmacopoeial Testing: Used to verify compliance with purity specifications outlined in pharmacopoeias such as USP, EP, or BP monographs for Linezolid.
• Process Chemistry Optimization: Helps in monitoring and controlling impurity formation during the synthesis and scale-up of Linezolid manufacturing processes.
• Stability Studies: Acts as a benchmark in forced degradation and long-term stability studies to assess the shelf-life and storage conditions of Linezolid products.

Basic Information

Product Name	Linezolid Impurity 15
CAS No.	1391062-33-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linezolid Related Compound 15; (S)-N-[[3-[3-Fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl]methyl]acetamide; Linezolid EP Impurity I; Linezolid USP Impurity 15; Linezolid Process Impurity; Zyvox Impurity 15; (5S)-5-(Acetamidomethyl)-3-(3-fluoro-4-morpholinophenyl)-2-oxazolidinone
EINECS	Contact for details

Quality Control

Every batch of Linezolid Impurity 15 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH and cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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