Description

Rufinamide Related Compound A (25 Mg) (1-(2-Fluorobenzyl)-1H-1,2,3-Triazole-4-Carboxamide) is a high-purity reference standard critical for the analytical profiling and quality control of the antiepileptic drug Rufinamide. This compound serves as a key impurity marker, enabling pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance. It is essential for professionals engaged in method development, stability studies, and batch release testing within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Rufinamide Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC methods for Rufinamide analysis.
• Quality Control & Assurance (QC/QA): Employed in routine quality control laboratories to monitor impurity levels against ICH Q3A/B guidelines, ensuring batch-to-batch consistency.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of drug stability-indicating assays.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and marketing authorization applications.
• Research & Development: Utilized in pharmaceutical R&D for studying the metabolism, degradation pathways, and synthesis-related impurities of Rufinamide.

Basic Information

Product Name	Rufinamide Related Compound A (25 Mg) (1-(2-Fluorobenzyl)-1H-1,2,3-Triazole-4-Carboxamide)
CAS No.	106308-41-2
Molecular Formula	C11H10FN5O
Molecular Weight	247.23 g/mol
Synonyms	1-(2-Fluorobenzyl)-1H-1,2,3-triazole-4-carboxamide; Rufinamide Impurity A; Rufinamide Related Substance A; BIIR 513 Related Compound A; 4-Carbamoyl-1-(2-fluorobenzyl)-1H-1,2,3-triazole; CGP 33101 Related Compound A; E 2080 Related Compound A; Xilep Related Compound A
EINECS	Contact for details

Quality Control

Our Rufinamide Related Compound A is manufactured under strict quality systems to meet the exacting standards of pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening, to ensure compliance with pharmacopeial guidelines. A detailed Certificate of Analysis (COA) is provided, documenting the exact purity, impurity profile, and analytical results for full traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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