Description

Tedizolid Phosphate Impurity CAS NO 1239662-42-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Tedizolid Phosphate during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for identifying and quantifying this specific impurity in Tedizolid Phosphate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for accurate impurity detection.
• Quality Control and Batch Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batches meet stringent purity specifications and ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this impurity under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity limits and justify the control strategy.
• Research and Development: Used in synthetic chemistry research to study degradation pathways and to support the development of robust synthetic processes.

Basic Information

Item	Detail
Product Name	Tedizolid Phosphate Impurity
CAS No.	1239662-42-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tedizolid Phosphate Related Compound; Tedizolid Impurity; (R)-3-(4-(2-(2-Methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-(hydroxymethyl)oxazolidin-2-one Phosphate; Oxazolidinone derivative impurity; Sivextro Impurity; TR-700 FA Impurity; Pharmaceutical Intermediate; Chemical Reference Standard
EINECS	Contact for details

Quality Control

Our Tedizolid Phosphate Impurity is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption.

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)	Individual unspecified 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.