Description

Linezolid Impurity 32 is a designated chemical reference standard used in the pharmaceutical development and quality control of the antibiotic Linezolid. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on antibiotic development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Linezolid and its related substances.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly HPLC and LC-MS, for impurity detection.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Linezolid Active Pharmaceutical Ingredient (API) and finished drug products to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed to identify and track degradation products formed in Linezolid formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this specific impurity.

Basic Information

Product Name	Linezolid Impurity 32
CAS No.	589489-13-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(S)-N-({3-[3-Fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl}methyl)acetamide; Linezolid Related Compound 32; Linezolid EP Impurity I; Linezolid USP Related Compound; Zyvox Impurity 32
EINECS	Contact for details

Quality Control

Our Linezolid Impurity 32 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods, 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 (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with specified limits
Water Content (KF)	≤ 5.0%

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