Description

Tedizolid Impurity 48 is a designated chemical reference standard used in the analytical profiling and quality control of the antibiotic Tedizolid Phosphate. This impurity is critical for pharmaceutical development and manufacturing, enabling precise identification, quantification, and control of related substances to ensure drug safety and efficacy. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and production, supporting compliance with stringent regulatory requirements for impurity characterization.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Tedizolid Phosphate active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation: Crucial for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Quality Control and Batch Release: Used in routine QC testing to monitor impurity levels against established specifications, ensuring batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) during drug substance and product stability testing.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary data on impurity identity, qualification, and control strategies.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during API synthesis, helping to refine manufacturing processes to minimize its generation.

Basic Information

Product Name	Tedizolid Impurity 48
CAS No.	859538-84-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tedizolid Related Compound 48; Tedizolid Phosphate Impurity 48; TR-700 Impurity 48; (R)-3-(4-(2-(2-Methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-(hydroxymethyl)oxazolidin-2-one Impurity; Oxazolidinone antibiotic impurity; TOZ-48; TZD Imp-48
EINECS	Contact for details

Quality Control

Every batch of Tedizolid Impurity 48 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

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.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.