Description

Tedizolid Impurity 36 is a designated impurity reference standard used in the analytical profiling and quality control of the antibiotic drug substance Tedizolid Phosphate. This compound is critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Tedizolid-based formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Tedizolid Phosphate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on 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 necessary data for regulatory filings (e.g., ANDA, NDA) to establish impurity limits and control strategies.
• Research & Development: Aids in process chemistry research to understand and minimize impurity formation during the synthesis of Tedizolid.

Basic Information

Product Name	Tedizolid Impurity 36
CAS No.	1239662-45-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tedizolid Related Compound 36; Tedizolid EP Impurity 36; Tedizolid USP Impurity 36; (S)-3-Fluoro-4-(6-(2-methyl-2H-tetrazol-5-yl)pyridin-3-yl)phenyl 2-(2-methyl-2H-tetrazol-5-yl)acetate; TRIS salt of Tedizolid Impurity; Tedizolid Phosphate Impurity 36; Oxazolidinone Impurity
EINECS	Contact for details

Quality Control

Every batch of Tedizolid Impurity 36 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC purity determination and structural confirmation (NMR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.