Description

Teriflunomide Impurity 2 is a high-purity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient, Teriflunomide. This compound is critical for ensuring the safety and efficacy of pharmaceutical products by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control of Teriflunomide API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity data for stability and characterization studies.
• Stability Indicating Studies: Helps assess the degradation profile of Teriflunomide under various stress conditions.
• Research & Development: Utilized in R&D for studying the synthesis pathways, metabolism, and pharmacokinetics of Teriflunomide.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability and calibration standard in routine pharmaceutical analysis.

Basic Information

Product Name	Teriflunomide Impurity 2
CAS No.	220512-86-7
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 B; Teriflunomide Related Compound B; A77 1726 Impurity; Leflunomide Impurity; ZK-118182 Impurity
EINECS	Contact for details

Quality Control

Every batch of Teriflunomide Impurity 2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure compliance with ICH guidelines and meets the stringent requirements for pharmaceutical reference standards. Comprehensive characterization includes identity confirmation, purity assay, and impurity profiling. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the analytical results and confirming specification compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a cool, dry place. This material is hygroscopic (moisture-sensitive) and must be kept under anhydrous conditions 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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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