Description

Tedizolid Impurity 26 is a designated impurity standard used in the analytical profiling and quality control of the antibiotic Tedizolid Phosphate. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity identification for Tedizolid-based formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Tedizolid Phosphate API and finished drug products.
• Method Development & Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and LC-MS, to monitor impurity levels.
• Quality Control & Batch Release: Used in routine QC testing to ensure Tedizolid batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Employed to identify and quantify degradation products that may form during the shelf-life studies of Tedizolid formulations.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., with FDA, EMA) to support drug approval.
• Research & Development: Used in synthetic chemistry R&D to understand and control impurity formation during the manufacturing process of Tedizolid.

Basic Information

Product Name	Tedizolid Impurity 26
CAS No.	883230-75-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tedizolid Related Compound 26; Tedizolid EP Impurity 26; Tedizolid USP Impurity 26; (S)-3-Fluoro-4-(6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl)phenyl 2-(2-methyl-1,3-thiazol-4-yl)acetate; TR-700 Impurity 26; Torezolid Impurity 26
EINECS	Contact for details

Quality Control

Our Tedizolid Impurity 26 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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