Description

Tedizolid Impurity 36 is a designated process-related impurity and reference standard used in the analytical profiling of the antibiotic Tedizolid Phosphate. This high-purity chemical is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this specific impurity during drug substance manufacturing. It is an essential tool for quality assurance professionals and analytical chemists working to ensure the safety, efficacy, and regulatory compliance of Tedizolid API and finished pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for method development, validation, and routine quality control testing of Tedizolid Phosphate Active Pharmaceutical Ingredient (API).
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate, identify, and quantify this specific impurity.
• Impurity Profiling and Characterization: Used in stability studies and forced degradation studies to understand the degradation pathways of Tedizolid and establish appropriate specification limits.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity identification and supporting toxicological assessments.
• Process Chemistry Research: Aids chemists in optimizing synthesis and purification processes to minimize the formation of this impurity, improving overall API yield and purity.
• Quality Control Laboratories: Serves as a system suitability standard and for preparing calibration curves to ensure the accuracy and precision of impurity assays in QC release testing.

Basic Information

Product Name	Tedizolid Impurity 36
CAS No.	143835-97-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tedizolid Related Compound 36; Tedizolid EP Impurity G; Tedizolid USP Impurity; (S)-3-Fluoro-4-(6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl)phenyl 5-(1,2,3-triazol-1-ylmethyl)oxazolidin-2-one; TR-700 FA Impurity 36; Oxazolidinone impurity of Tedizolid; Sivextro Impurity 36
EINECS	Contact for details

Quality Control

Every batch of Tedizolid Impurity 36 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, GC, MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere.

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 unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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