Description

Linezolid Impurity 15 is a designated impurity of the synthetic antibiotic Linezolid, used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a reference standard for analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in quality control and method validation. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Linezolid API and finished drug products.
• Analytical Method Development and Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation and levels of this specific degradation product during forced degradation and long-term stability testing of Linezolid formulations.
• Regulatory Compliance and Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity profiles and justify specification limits.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this impurity during the manufacturing of Linezolid.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard in routine batch release testing to ensure analytical procedures are performing as intended.

Basic Information

Product Name	Linezolid Impurity 15
CAS No.	333753-69-8
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 C; Linezolid EP Impurity C; (S)-Acetamide, N-[[3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-; UNII-6W1F3708Q5; Zyvox Impurity C; Morpholine, 4-[2-fluoro-4-[[(5S)-2-oxo-3-[(acetylamino)methyl]-5-oxazolidinyl]methyl]phenyl]-
EINECS	Contact for details

Quality Control

Our Linezolid Impurity 15 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination, identity confirmation by spectroscopic methods (IR, NMR, MS), and residual solvent analysis to ensure compliance with pharmaceutical impurity reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 nature, the container should be kept in a desiccator or under an inert atmosphere after opening to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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