Description

Linezolid Impurity CAS NO 496031-56-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Linezolid during its development and manufacturing. It serves as an essential tool for pharmaceutical quality control laboratories and R&D departments focused on impurity profiling, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Linezolid Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to ensure that Linezolid batches meet stringent pharmacopeial specifications (USP, EP, BP) for impurity limits.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthetic routes for Linezolid.

Basic Information

Product Name	Linezolid Impurity
CAS No.	496031-56-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linezolid Related Compound; Linezolid Degradant; Linezolid Process Impurity; (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]acetamide Impurity; Zyvox Impurity; PNU-100766 Impurity; Oxazolidinone Antibiotic Impurity
EINECS	Contact for details

Quality Control

Our Linezolid Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, results, and chromatograms. Our quality standards align with the requirements for pharmaceutical reference standards, supporting compliance with cGMP and ICH guidelines.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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