Description

Teriflunomide Impurity 1 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Teriflunomide, a medication used to treat multiple sclerosis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing. The availability of a well-characterized impurity standard is essential for compliance with stringent global pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Teriflunomide Impurity 1 in drug substance and drug product analysis.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Batch Release: Essential for routine quality control testing of Teriflunomide API to ensure impurity levels are within International Council for Harmonisation (ICH) specified limits.
• Stability Studies: Employed to monitor the formation of this impurity over time 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 control strategies.
• Research & Development: Used in R&D laboratories for studying the degradation pathways and chemistry of Teriflunomide.

Basic Information

Product Name	Teriflunomide Impurity 1
CAS No.	1385789-70-7
Molecular Formula	C12H9F3N2O2
Molecular Weight	270.21 g/mol
Synonyms	2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide; Teriflunomide Related Compound A; (2Z)-2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide; A77 1726 Impurity; Leflunomide Metabolite Impurity; Teriflunomide Degradant; Teriflunomide Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Teriflunomide Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (HPLC, NMR, MS) to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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