Description

Tedizolid Phosphate Impurity CAS NO 1239662-43-1 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) involved in method development and validation.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Tedizolid Phosphate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to meet ICH guidelines.
• Quality Control & Assurance: Employed in routine QC testing to monitor batch-to-batch consistency and ensure impurity levels remain within specified regulatory limits.
• Stability Studies: Used to track the formation and growth of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Chemical Research & Synthesis: Acts as a key intermediate or reference compound for synthetic chemists working on the synthesis or structural modification of oxazolidinone antibiotics.

Basic Information

Product Name	Tedizolid Phosphate Impurity
CAS No.	1239662-43-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3R)-3-[4-[2-(2-Methyltetrazol-5-yl)pyridin-5-yl]-3-fluorophenyl]-5-[(phosphonooxy)methyl]-1,3-oxazolidin-2-one; Tedizolid Phosphate Related Compound; Tedizolid Phosphate Specified Impurity; TR-700 FA Impurity; Sivextro Impurity; Oxazolidinone antibiotic impurity; (R)-Tedizolid Phosphate Impurity
EINECS	Contact for details

Quality Control

Our Tedizolid Phosphate Impurity is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for pharmaceutical analysis. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that includes data from multiple orthogonal analytical techniques, such as HPLC, NMR, and MS, for full characterization. We adhere to relevant industry standards and can support compliance with ICH Q3A/B, USP, and EP guidelines for impurity identification and qualification.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (typically 15-25°C) in a dry environment. For long-term storage, consider storing desiccated at -20°C. Handle the material under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets requirement
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 5.0%

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