Description

Tedizolid Impurity 39 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 pharmaceutical development and manufacturing, ensuring product safety and regulatory compliance by accurately identifying and quantifying related substances. It is essential for research laboratories, quality control units, and regulatory affairs departments within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Tedizolid Phosphate Active Pharmaceutical Ingredient (API) and finished drug products.
• Method Development & Validation: Used in developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Tedizolid.
• Stability Studies: Employed to monitor the formation of degradation products during forced degradation and long-term stability studies of Tedizolid formulations.
• Quality Control (QC) Testing: A critical component in routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Tedizolid by identifying process-related impurities.

Basic Information

Product Name	Tedizolid Impurity 39
CAS No.	171018-17-0
Molecular Formula	C17H15FN6O2
Molecular Weight	354.34 g/mol
Synonyms	(5R)-3-(3-Fluoro-4-(6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl)phenyl)-5-(hydroxymethyl)oxazolidin-2-one; Tedizolid Related Compound 39; TRIS Impurity 39; Sivextro Impurity 39; (R)-3-(3-Fluoro-4-(6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl)phenyl)-5-(hydroxymethyl)oxazolidin-2-one; Oxazolidinone impurity of Tedizolid
EINECS	Contact for details

Quality Control

Every batch of Tedizolid Impurity 39 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing using validated chromatographic (HPLC/LC-MS) and spectroscopic methods to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing the results against stringent in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment supports compliance in cGMP environments.

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. For long-term storage, consider desiccated conditions.

Specification

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

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