Description

Linezolid Impurity D Hcl CAS NO 1391068-25-9 is a high-purity chemical reference standard specifically identified as a degradation product or process-related impurity of the antibiotic Linezolid. This compound is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of impurities to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly for method validation, stability studies, and regulatory compliance filings.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Linezolid and its related substances.
• Method Development and Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in Linezolid Active Pharmaceutical Ingredient (API) and finished drug products.
• Stability Studies: Employed in forced degradation and long-term stability testing to understand the degradation pathways of Linezolid and establish appropriate shelf-life specifications.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research and Development: Used in academic and industrial R&D to study the chemical behavior, synthesis pathways, and metabolic fate of Linezolid-related compounds.

Basic Information

Product Name	Linezolid Impurity D Hcl
CAS No.	1391068-25-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(S)-N-({3-[3-Fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl}methyl)acetamide Hydrochloride; Linezolid Related Compound D HCl; Linezolid EP Impurity D HCl; Linezolid USP Impurity D HCl; (S)-Acetamide, N-[[3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl]methyl]-, hydrochloride; Zyvox Impurity D Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Linezolid Impurity D HCl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic data, and traceability information.

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 light-sensitive; therefore, containers must be kept tightly sealed and desiccated to maintain stability and purity. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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