Description

Tedizolid Phosphate Impurity CAS NO 856867-56-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antibiotic Tedizolid Phosphate by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on method development, validation, and compliance. The availability of this well-characterized impurity supports robust analytical procedures and helps manufacturers meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Tedizolid Phosphate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of Tedizolid Phosphate, supporting specifications per USP/EP monographs.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track the formation of degradation products under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy in Drug Master Files (DMFs) and New Drug Applications (NDAs).
• Research on Degradation Pathways: Facilitates research into the chemical stability and metabolic pathways of Tedizolid Phosphate.

Basic Information

Product Name	Tedizolid Phosphate Impurity
CAS No.	856867-56-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3R)-3-[3-Fluoro-4-(6-methyl-1,2,4-triazolo[4,3-a]pyridin-3-yl)phenyl]-5-[(phosphonooxy)methyl]-1,3-oxazolidin-2-one; Tedizolid Phosphate Related Compound; Tedizolid Phosphate Process Impurity; TR-700 FA Impurity; Sivextro Impurity
EINECS	Contact for details

Quality Control

Every batch of Tedizolid Phosphate Impurity (CAS 856867-56-6) 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 industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability. We support compliance with cGMP, ICH Q3A/B, and relevant pharmacopeial guidelines (USP, EP).

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	98.0% - 102.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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