Description

Linezolid Impurity 22 is a designated impurity of the synthetic antibacterial agent Linezolid, used for analytical reference and quality control purposes. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily used in the development and validation of analytical methods, stability studies, and as a certified reference material for quantitative analysis.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Linezolid Impurity 22 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Linezolid batches.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Linezolid API and formulations meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability testing of Linezolid.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Linezolid under various conditions.

Basic Information

Product Name	Linezolid Impurity 22
CAS No.	264601-17-4
Molecular Formula	C16H20FN3O4
Molecular Weight	337.35 g/mol
Synonyms	(S)-N-({3-[3-Fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl}methyl)acetamide; Linezolid Related Compound 22; Linezolid EP Impurity H; Linezolid USP Related Compound H; (S)-Acetamide, N-[[3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-; Zyvox Impurity 22
EINECS	Contact for details

Quality Control

Our Linezolid Impurity 22 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and accurate identification. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity confirmation (by IR, NMR, MS), and impurity profile by HPLC. We support compliance with pharmacopeial standards (USP, EP) and regulatory requirements for pharmaceutical impurities.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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