Description

Teriflunomide Impurity 3 is a designated reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Teriflunomide. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Teriflunomide Impurity 3 in API and finished drug products.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Research & Development: Facilitates process chemistry research to understand impurity formation pathways and optimize synthesis routes for Teriflunomide.

Basic Information

Product Name	Teriflunomide Impurity 3
CAS No.	62004-05-1
Molecular Formula	C12H9F3N2O2
Molecular Weight	270.21 g/mol
Synonyms	2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide; (Z)-2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide; Teriflunomide Impurity C; Teriflunomide Related Compound C; A77 1726 Impurity; Leflunomide Impurity; ZK-118182 Impurity
EINECS	Contact for details

Quality Control

Every batch of Teriflunomide Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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