Description

Linezolid Impurity 51 is a designated impurity of the synthetic oxazolidinone antibiotic, Linezolid. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, stability studies, and quality control. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Linezolid drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Linezolid Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles in compliance with ICH guidelines.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Quality Control & Batch Release: A critical component in the quality control process to ensure that Linezolid batches meet stringent pharmacopeial (USP, EP) specifications for impurity limits.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the impurity profile.
• Research on Degradation Pathways: Used in research to elucidate the degradation pathways and mechanisms of Linezolid, aiding in formulation optimization.

Basic Information

Product Name	Linezolid Impurity 51
CAS No.	39608-52-1
Molecular Formula	C16H20FN3O4
Molecular Weight	337.35 g/mol
Synonyms	(S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]acetamide; Acetamide, N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-; Linezolid Related Compound; Linezolid EP Impurity; Linezolid USP Impurity; Linezolid Degradant; (S)-N-((3-(3-Fluoro-4-morpholinophenyl)-2-oxooxazolidin-5-yl)methyl)acetamide
EINECS	Contact for details

Quality Control

Our Linezolid Impurity 51 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and batch-specific data, supporting compliance with ICH Q3A/B and pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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