Description

Rufinamide 2,6-Didesfluoro Impurity is a critical pharmaceutical reference standard used for the quality control and regulatory compliance of the antiepileptic drug Rufinamide. This compound is essential for analytical method development, validation, and impurity profiling to ensure drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of Rufinamide-based medications.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of the 2,6-didesfluoro impurity in Rufinamide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity levels.
• Stability Studies: Employed in forced degradation and long-term stability studies of Rufinamide to understand impurity formation pathways.
• Quality Control (QC) Testing: A vital component in routine QC release testing of Rufinamide batches to ensure compliance with pharmacopeial limits (e.g., ICH, USP, EP).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over potential impurities.
• Research & Development: Used in synthetic chemistry research to study the metabolism and degradation pathways of Rufinamide.

Basic Information

Product Name	Rufinamide 2,6-Didesfluoro Impurity
CAS No.	80819-65-4
Molecular Formula	C10H8F2N4O2
Molecular Weight	254.20 g/mol
Synonyms	1-[(2,6-Difluorophenyl)methyl]-1H-1,2,3-triazole-4-carboxamide; 2,6-Difluorobenzyl-1H-1,2,3-triazole-4-carboxamide; Rufinamide Desfluoro Impurity; Rufinamide Related Compound A; Rufinamide Impurity A; 1-[(2,6-Difluorophenyl)methyl]-1,2,3-triazole-4-carboxamide; BIA 2-024 Impurity
EINECS	Contact for details

Quality Control

Our Rufinamide 2,6-Didesfluoro Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data, ensuring traceability and compliance with ICH Q3A(R2) and Q3B(R2) guidelines for impurities. The material is suitable for use in GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH limits

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