Description

Linezolid Impurity 48 is a designated chemical reference standard used in 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 by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) for method validation and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Linezolid Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating High-Performance Liquid Chromatography (HPLC) or other chromatographic methods for Linezolid analysis.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish drug shelf life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA and EMA.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and metabolic pathway studies related to Linezolid.

Basic Information

Product Name	Linezolid Impurity 48
CAS No.	78692-88-3
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; Linezolid Related Compound H; Linezolid EP Impurity H; Linezolid USP Impurity H; Zyvox Impurity H; (S)-Acetamide, N-[[3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-; PNU-101603
EINECS	Contact for details

Quality Control

Every batch of Linezolid Impurity 48 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content	≤ 2.0%
Residual Solvents	Complies with ICH Q3C

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