Description

Linezolid Impurity 33 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antibiotic Linezolid. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions focused on antibiotic development and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analytical method development and validation of Linezolid API and finished dosage forms.
• Quality Control & Assurance: Essential for routine batch testing in QC laboratories to monitor and control impurity levels, ensuring product meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed in forced degradation and long-term stability studies to identify and track the formation of this specific degradation product.
• Research & Development: Serves as a key material in synthetic chemistry R&D for studying the degradation pathways and impurity formation mechanisms of Linezolid.

Basic Information

Product Name	Linezolid Impurity 33
CAS No.	1997296-64-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Linezolid Related Compound 33; Linezolid Degradant 33; (S)-N-[[3-[3-Fluoro-4-(morpholin-4-yl)phenyl]-2-oxo-1,3-oxazolidin-5-yl]methyl]acetamide Impurity; Zyvox Impurity 33; PNU-100766 Impurity 33; Oxazolidinone Impurity
EINECS	Contact for details

Quality Control

Our Linezolid Impurity 33 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept under inert atmosphere or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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