Description

Linezolid Impurity 24 CAS NO 1138458-15-7 is a designated chemical reference standard used for the analytical profiling and quality control of the antibiotic Linezolid. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug purity, safety, and regulatory compliance. It is primarily utilized in method development, stability studies, and batch release testing within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of specific impurities in Linezolid Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research and Development (R&D): Used in synthetic chemistry research to study the degradation pathways and metabolism of Linezolid.
• Pharmacopoeial Testing: Supports testing to meet the specifications outlined in pharmacopoeias such as USP, EP, or BP for Linezolid.

Basic Information

Product Name	Linezolid Impurity 24
CAS No.	1138458-15-7
Molecular Formula	C16H20FN3O4
Molecular Weight	337.35 g/mol
Synonyms	Linezolid Related Compound 24; (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; Zyvox Impurity 24; (5S)-3-[3-Fluoro-4-(4-morpholinyl)phenyl]-5-[(acetylaminomethyl)-2-oxazolidinone]; 2-Oxazolidinone, 3-[3-fluoro-4-(4-morpholinyl)phenyl]-5-[(acetylamino)methyl]-, (5S)-
EINECS	Contact for details

Quality Control

Every batch of Linezolid Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopoeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, cool place. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
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.