Description

Linezolid Impurity 11 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 product purity, safety, and regulatory compliance. It serves as a key marker for identifying and quantifying specific process-related impurities during drug development and production. The primary users are professionals in pharmaceutical R&D, quality assurance, and regulatory affairs who require high-purity reference materials.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Linezolid Impurity 11 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Assurance: A critical component in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of Linezolid API.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data and specifications for drug master files (DMFs).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Research and Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes for Linezolid.

Basic Information

Product Name	Linezolid Impurity 11
CAS No.	1394245-06-7
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 EP Impurity J; Linezolid Related Compound J; (S)-Acetamide, N-[[3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-; Zyvox Impurity J; UNII-8V3Y1K2T6F; Linezolid Process Impurity; Oxazolidinone Impurity.
EINECS	Contact for details

Quality Control

Every batch of Linezolid Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting its use in GMP and regulatory environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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