Description

Leflunomide Ep Impurity G is a high-purity reference standard specifically identified for the quality control and analytical profiling of the active pharmaceutical ingredient (API) Leflunomide. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is primarily used in research and development, method validation, and routine quality testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Leflunomide Ep Impurity G in Leflunomide API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Leflunomide meets stringent pharmacopoeial specifications (e.g., EP, USP, ICH guidelines).
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to determine drug product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research on Degradation Pathways: Aids in studying the chemical degradation mechanisms of Leflunomide to improve formulation stability.

Basic Information

Product Name	Leflunomide Ep Impurity G
CAS No.	724429-16-7
Molecular Formula	C12H9F3N2O2
Molecular Weight	270.21 g/mol
Synonyms	5-Methyl-N-[4-(trifluoromethyl)phenyl]-4-isoxazolecarboxamide; Leflunomide Impurity G (EP); Leflunomide Related Compound G; 4-Methyl-5-[4-(trifluoromethyl)phenylcarbamoyl]isoxazole; A77 1726 Impurity; Teriflunomide Impurity; UNII-7C5JWH2T7U; 5-Methyl-4-isoxazolecarboxylic acid [4-(trifluoromethyl)phenyl]amide
EINECS	Contact for details

Quality Control

Every batch of Leflunomide Ep Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopoeial standards and customer specifications. 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 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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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