Description

Tedizolid Impurity 34 is a designated impurity of the oxazolidinone-class antibiotic, Tedizolid Phosphate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and quality control. It is essential for scientists and quality assurance professionals in the pharmaceutical industry who require high-purity materials to ensure the safety, efficacy, and regulatory compliance of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Tedizolid Phosphate API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure API batches 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 during forced degradation and long-term stability studies of Tedizolid formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify specifications.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Tedizolid to minimize the formation of this impurity.

Basic Information

Product Name	Tedizolid Impurity 34
CAS No.	2095200-69-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tedizolid Related Compound 34; Tedizolid EP Impurity 34; Tedizolid USP Impurity 34; (S)-3-(4-(2-(2-Methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-(hydroxymethyl)oxazolidin-2-one Impurity; TR-700 FA Impurity 34; Oxazolidinone Impurity; Antibiotic Impurity Standard.
EINECS	Contact for details

Quality Control

Our Tedizolid Impurity 34 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

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 should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 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.