Description

Rufinamide Related Compound B (25 Mg) (Methyl 1-(2,6-Difluorobenzyl)-1H-1,2,3-Triazole-4-Carboxylate) is a high-purity chemical reference standard, specifically a process-related impurity of the antiepileptic drug Rufinamide. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring drug purity, safety, and regulatory compliance. It is primarily utilized by analytical chemists, quality control laboratories, and R&D scientists in the pharmaceutical industry for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Rufinamide-related impurities in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation: Essential for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Assurance (QC/QA): A critical tool for in-process testing, release testing, and stability studies to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) requirements.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways of Rufinamide and to establish stability-indicating methods.
• Research on Metabolic Pathways: Can be used in research settings to study the metabolism and pharmacokinetics of Rufinamide and its related compounds.

Basic Information

Product Name	Rufinamide Related Compound B (25 Mg) (Methyl 1-(2,6-Difluorobenzyl)-1H-1,2,3-Triazole-4-Carboxylate)
CAS No.	217448-86-7
Molecular Formula	C12H10F2N4O2
Molecular Weight	280.23 g/mol
Synonyms	Methyl 1-(2,6-Difluorobenzyl)-1H-1,2,3-triazole-4-carboxylate; Rufinamide Impurity B; Rufinamide Related Substance B; 1-(2,6-Difluorobenzyl)-1H-1,2,3-triazole-4-carboxylic Acid Methyl Ester; BIIR 513 (Related Compound); 4-Carbomethoxy-1-(2,6-difluorobenzyl)-1,2,3-triazole; EINECS Contact for details

Quality Control

This high-grade reference material is produced under strict quality-controlled conditions suitable for pharmaceutical analysis. Each batch is characterized and qualified using advanced analytical techniques including HPLC, GC, NMR, and Mass Spectrometry. A comprehensive Certificate of Analysis (CoA) is provided, detailing purity, identity confirmation, and impurity profile. Our quality system is designed to support compliance with cGMP and ICH guidelines for pharmaceutical impurities.

Storage

Preserve in the original, 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); ensure the container is sealed immediately after use to minimize exposure to atmospheric humidity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
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% w/w

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