Description

Leflunomide Ep Impurity F is a high-purity reference standard specifically identified as a process-related impurity of the active pharmaceutical ingredient Leflunomide. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is an essential material for research and development scientists, quality assurance laboratories, and regulatory affairs professionals within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Leflunomide Ep Impurity F in active pharmaceutical ingredient (API) batches.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and accurately measure this specific impurity.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles and ensure Leflunomide API complies with stringent pharmacopeial specifications (e.g., EP, USP, ICH Q3A/B guidelines).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed as an analytical marker to track impurity formation in Leflunomide drug substances and products under various stability conditions.
• Research on Degradation Pathways: Facilitates studies to understand the formation, fate, and control of this impurity during API synthesis and storage.

Basic Information

Product Name	Leflunomide Ep Impurity F
CAS No.	1403564-06-6
Molecular Formula	C12H9F3N2O2
Molecular Weight	270.21 g/mol
Synonyms	5-Methyl-N-[4-(trifluoromethyl)phenyl]-4-isoxazolecarboxamide; Leflunomide Impurity F; Leflunomide Related Compound F; A77 1726 Impurity; UNII-9K4869I0BH; Teriflunomide Impurity; 4-Isoxazolecarboxamide, 5-methyl-N-[4-(trifluoromethyl)phenyl]-
EINECS	Contact for details

Quality Control

Every batch of Leflunomide Ep Impurity F is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) containing batch-specific data 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 under inert atmosphere to maintain stability.

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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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