Description

Tedizolid Impurity CAS NO 1256966-04-7 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 drug Tedizolid Phosphate. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard to identify, quantify, and monitor this specific impurity during the development and manufacturing of Tedizolid Phosphate API.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to ensure accurate detection and quantification limits.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to confirm the performance of analytical procedures and ensure batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity standards necessary for establishing specifications and shelf-life studies.
• Stability Studies: Employed in forced degradation and long-term stability studies of Tedizolid to understand degradation pathways and establish appropriate storage conditions.
• Research & Development: Used in pharmaceutical R&D for studying the chemical and metabolic pathways of Tedizolid and related compounds.

Basic Information

Product Name	Tedizolid Impurity
CAS No.	1256966-04-7
Molecular Formula	C₁₇H₁₅F₂N₅O₃
Molecular Weight	375.33 g/mol
Synonyms	(5R)-3-[3-Fluoro-4-(6-methyl-1,2,4-triazolo[4,3-a]pyridin-3-yl)phenyl]-5-[(1-methyl-1H-1,2,3-triazol-4-yl)methyl]-1,3-oxazolidin-2-one; Tedizolid Related Compound; Tedizolid Phosphate Impurity; TR-700 Impurity; (R)-3-(3-Fluoro-4-(6-methyl-[1,2,4]triazolo[4,3-a]pyridin-3-yl)phenyl)-5-((1-methyl-1H-1,2,3-triazol-4-yl)methyl)oxazolidin-2-one; Sivextro Impurity; Oxazolidinone Impurity.
EINECS	Contact for details

Quality Control

Every batch of Tedizolid Impurity (CAS 1256966-04-7) is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality protocols are designed to meet the stringent requirements of pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including identification (IR, NMR), assay (HPLC), and impurity profile analysis.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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