Description

Oxazolidinone Dimer Impurity is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety profile of active pharmaceutical ingredients (APIs) within the oxazolidinone antibiotic class. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for identifying and quantifying the dimer impurity in Linezolid, Tedizolid, and other oxazolidinone antibiotics.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Essential for in-process testing and release testing of bulk APIs to ensure they meet stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to monitor the formation of degradation products in drug substance and drug product stability programs under various ICH storage conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and demonstrate control strategies.
• Research and Development: Used in synthetic chemistry R&D to study reaction pathways and optimize processes to minimize dimer formation.

Basic Information

Product Name	Oxazolidinone Dimer Impurity
CAS No.	914777-33-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linezolid Dimer Impurity; Tedizolid Dimer Impurity; Oxazolidinone Antibiotic Dimer; (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]acetamide Dimer; 1,3-Oxazolidin-2-one dimer derivative; Zyvox Related Compound Dimer; Sivextro Related Compound Dimer
EINECS	Contact for details

Quality Control

Every batch of our Oxazolidinone Dimer Impurity is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by HPLC, LC-MS, NMR, and IR. A detailed Certificate of Analysis (COA) with batch-specific results is supplied with each shipment, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.