Description

Linezolid Impurity 21 is a designated impurity of the synthetic antibiotic Linezolid, used for quality control and analytical reference 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 utilized in research and development, method validation, and as a certified reference standard in quality assurance processes for the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Quality Control & Assurance (QC/QA): Essential for monitoring and controlling the levels of this specific impurity in Linezolid Active Pharmaceutical Ingredient (API) and finished drug formulations.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing necessary impurity profiling data.
• Stability Studies: Employed to identify and quantify degradation products that may form during the stability testing of Linezolid under various conditions.
• Method Development: Serves as a key analyte in the development and optimization of chromatographic methods, such as HPLC and UPLC.
• Pharmacopoeial Testing: Used to comply with impurity limits specified in pharmacopoeial monographs (e.g., USP, EP, BP) for Linezolid.

Basic Information

Product Name	Linezolid Impurity 21
CAS No.	212325-40-1
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; Acetamide, N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-; Linezolid Related Compound; Linezolid EP Impurity; Linezolid USP Impurity; PNU-100766 Impurity; (5S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]acetamide
EINECS	Contact for details

Quality Control

Our Linezolid Impurity 21 is manufactured under strict quality control protocols to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile as determined by advanced analytical techniques including HPLC, MS, and NMR. We support compliance with ICH guidelines and major pharmacopoeial standards (USP, EP).

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
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: ≤ 5.0%
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.