Description

Tedizolid Impurity 3 is a specified impurity of the oxazolidinone-class antibiotic, Tedizolid Phosphate. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of the final drug product. The accurate identification and quantification of this impurity are essential for meeting stringent regulatory standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Tedizolid Phosphate active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development and Validation: Used in the development, optimization, and validation of analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Aids in the identification of degradation products formed 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 thresholds and justify specifications.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity during API manufacturing.

Basic Information

Product Name	Tedizolid Impurity 3
CAS No.	1835340-19-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tedizolid Related Compound 3; Tedizolid EP Impurity C; Tedizolid USP Impurity; (R)-3-Fluoro-4-(6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl)phenyl 2-(2-methyltetrazol-5-yl)acetate; Tedizolid Process Impurity; TR-700 Impurity 3; Sivextro Impurity
EINECS	Contact for details

Quality Control

Our Tedizolid Impurity 3 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 to support your regulatory and quality requirements.

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 must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric humidity.

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%
Related Substances (HPLC)	Single 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.