Description

Linezolid Impurity 23 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Linezolid during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) involved in impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Linezolid Impurity 23 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor this specific impurity.
• Quality Control & Batch Release: Serves as a system suitability standard in routine QC testing to ensure analytical procedures are performing as intended for impurity detection.
• Stability Studies: Employed in forced degradation and long-term stability studies of Linezolid to track the formation and levels of Impurity 23 over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research on Degradation Pathways: Used in academic and industrial research to study the degradation mechanisms and metabolism of Linezolid.

Basic Information

Product Name	Linezolid Impurity 23 Hcl
CAS No.	1429334-07-5
Molecular Formula	C16H20FN3O4 • HCl
Molecular Weight	373.81 g/mol (Free base: 337.35 g/mol)
Synonyms	Linezolid Related Compound 23 Hydrochloride; (S)-N-({3-[3-Fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl}methyl)acetamide Hydrochloride; Linezolid EP Impurity C HCl; Linezolid USP Related Compound C Hydrochloride; Zyvox Impurity 23 HCl; PNU-100766 Impurity 23 Hydrochloride; (5S)-3-[3-Fluoro-4-(4-morpholinyl)phenyl]-5-[(acetylaminomethyl)-2-oxazolidinone Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Linezolid Impurity 23 Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
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.