Description

Linezolid Impurity 34 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of the antibiotic Linezolid, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Linezolid drug substance and finished products.
• Method Development and Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor and control impurity levels during manufacturing.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, ICH, and EMA guidelines.
• Quality Control (QC) Testing: Serves as a system suitability and identification marker in routine QC testing of active pharmaceutical ingredients (APIs).
• Research and Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Item	Details
Product Name	Linezolid Impurity 34
CAS No.	1233093-70-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linezolid Related Compound 34; Linezolid EP Impurity I; Linezolid USP Impurity; (S)-N-({3-[3-Fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl}methyl)acetamide Impurity; Oxazolidinone Impurity; Zyvox Impurity; Antibiotic Impurity Standard
EINECS	Contact for details

Quality Control

Our Linezolid Impurity 34 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic identification (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment 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)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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