Description

Tedizolid Impurity 31 is a designated impurity standard associated with the antibiotic drug substance Tedizolid Phosphate. This compound is critical for pharmaceutical research and development, serving as a key reference marker for analytical method development and validation. It is primarily utilized by quality control laboratories and regulatory affairs departments to ensure the purity, safety, and efficacy of the final drug product. The availability of a well-characterized impurity standard is essential for meeting stringent global regulatory requirements in the pharmaceutical industry.

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: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification stages of Tedizolid Phosphate manufacturing.

Basic Information

Product Name	Tedizolid Impurity 31
CAS No.	1700656-53-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tedizolid Related Compound 31; Tedizolid Impurity 31 (EP); Tedizolid Phosphate Impurity 31; Sivextro Impurity 31; TR-700 Impurity 31; (R)-3-(4-(2-(2-Methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-(hydroxymethyl)oxazolidin-2-one Impurity; Oxazolidinone antibiotic impurity
EINECS	Contact for details

Quality Control

Our Tedizolid Impurity 31 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. 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 principles of current Good Manufacturing Practice (cGMP) for APIs and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

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

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