Description

Linezolid Impurity 53 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) departments, and contract research organizations (CROs) for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Linezolid Impurity 53 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity levels throughout the drug's shelf life.
• Quality Control & Batch Release: Employed in routine QC testing to ensure that Linezolid drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) as part of forced degradation and long-term stability programs.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity characterization and control strategies to health authorities like the FDA and EMA.
• Research & Process Chemistry: Aids in understanding the formation pathway of this impurity during synthesis, enabling process optimization to minimize its generation.

Basic Information

Product Name	Linezolid Impurity 53 Hcl
CAS No.	1236077-63-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linezolid Related Compound 53 Hydrochloride; Linezolid EP Impurity 53 HCl; Linezolid USP Impurity 53 Hydrochloride; (S)-N-({3-[3-Fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl}methyl)acetamide Hydrochloride; Zyvox Impurity 53 HCl; PNU-100766 Impurity 53 Hydrochloride
EINECS	Contact for details

Quality Control

Our Linezolid Impurity 53 Hcl is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, NMR, and MS. Our quality system is designed to support compliance with cGMP and ICH guidelines for pharmaceutical reference standards.

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. The container should be opened only under anhydrous conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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