Description

Tedizolid Impurity 27 is a high-purity chemical reference standard used in the analytical profiling and quality control of the antibiotic Tedizolid. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient by identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Tedizolid Phosphate API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data required by ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles and ensure drug product shelf-life.
• Process Chemistry & R&D: Used by synthetic chemists to understand and control impurity formation during the manufacturing process of Tedizolid.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability and calibration standard in routine batch release testing.

Basic Information

Product Name	Tedizolid Impurity 27
CAS No.	2044710-49-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tedizolid Related Compound 27; Tedizolid EP Impurity 27; Tedizolid USP Impurity 27; TR-700 Impurity 27; (3R,5R)-5-[(5-(2,2-Difluoro-1,3-benzodioxol-5-yl)-4H-1,2,4-triazol-3-yl)methyl]-3-(2-fluoro-4-pyridinyl)-2-oxazolidinone Impurity; Tedizolid Phosphate Impurity 27; Sivextro Impurity 27
EINECS	Contact for details

Quality Control

Every batch of Tedizolid Impurity 27 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting cGMP and ISO 9001 requirements for traceability and reliability.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.