Description

Leflunomide Impurity 1 CAS NO 202057-74-7 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Leflunomide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Leflunomide API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine batch release testing to ensure product purity meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of Leflunomide-related impurities.

Basic Information

Product Name	Leflunomide Impurity 1
CAS No.	202057-74-7
Molecular Formula	C12H9F3N2O2
Molecular Weight	270.21 g/mol
Synonyms	5-Methyl-N-[4-(trifluoromethyl)phenyl]-4-isoxazolecarboxamide; Leflunomide Related Compound A; Leflunomide Impurity A; 5-Methyl-4-isoxazolecarboxylic acid [4-(trifluoromethyl)phenyl]amide; UNII-4K5P5WY9QJ; 4-Isoxazolecarboxamide, 5-methyl-N-[4-(trifluoromethyl)phenyl]-; A77 1726 Impurity
EINECS	Contact for details

Quality Control

Our Leflunomide Impurity 1 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, chromatograms, and traceability information. The material is suitable for use as a reference standard in compliance with ICH Q3A/B guidelines.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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