Description

Tedizolid Impurity 29 is a designated impurity of the antibiotic Tedizolid Phosphate, a critical oxazolidinone-class agent. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of Tedizolid-based drug products.

Application

• Pharmaceutical Reference Standard: Used 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 chromatographic methods (e.g., HPLC, UPLC) to ensure specificity, accuracy, and precision in impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring product safety and efficacy.
• Stability Studies: Used to track the formation and behavior of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing protocols.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during API synthesis, enabling process optimization and impurity minimization.

Basic Information

Item	Details
Product Name	Tedizolid Impurity 29
CAS No.	1551262-90-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tedizolid Related Compound 29; Tedizolid EP Impurity 29; Tedizolid USP Impurity 29; (S)-3-(4-(2-(2-Methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-(hydroxymethyl)oxazolidin-2-one Impurity; A potential degradation product or process-related impurity of Tedizolid.
EINECS	Contact for details

Quality Control

Our Tedizolid Impurity 29 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances. Our quality commitment aligns with the needs of cGMP-compliant pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (typically 15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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