Description

Tedizolid Impurity 32 is a designated process-related impurity and reference standard used in the pharmaceutical development and quality control of the antibiotic Tedizolid Phosphate. This high-purity chemical is critical for ensuring the safety, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Tedizolid Impurity 32 in Tedizolid Phosphate API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure API batches meet stringent pharmacopeial (e.g., USP, EP) and internal specification limits for impurities.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of the drug substance.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Tedizolid to minimize the formation of this impurity.

Basic Information

Product Name	Tedizolid Impurity 32
CAS No.	856866-79-0
Molecular Formula	C17H15FN6O2
Molecular Weight	354.34 g/mol
Synonyms	(5R)-3-(3-Fluoro-4-{[(5-methyl-1,3-oxazol-2-yl)methyl]amino}phenyl)-5-[(1H-1,2,3-triazol-1-yl)methyl]-1,3-oxazolidin-2-one; Tedizolid Related Compound 32; TR-700 Impurity 32; Torezolid Impurity 32; (R)-3-(3-Fluoro-4-((5-methyloxazol-2-yl)methylamino)phenyl)-5-(1H-1,2,3-triazol-1-yl)methyl)oxazolidin-2-one
EINECS	Contact for details

Quality Control

Every batch of Tedizolid Impurity 32 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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