PHR1625

Rufinamide

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Rufinamide, 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-Triazole-4-carboxamide
• Formule empirique (notation de Hill): C₁₀H₈F₂N₄O
• Numéro CAS: 106308-44-5
• Poids moléculaire : 238.19
• Numéro MDL: MFCD00865314
• Code UNSPSC : 41116107
• ID de substance PubChem : 329823517
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• Agence: traceable to USP 1606401
• Famille d'API: rufinamide
• CofA (certificat d'analyse): current certificate can be downloaded
• Conditionnement: pkg of 500 mg
• Technique(s): HPLC: suitable; gas chromatography (GC): suitable
• Application(s): pharmaceutical (small molecule)
• Format: neat
• Température de stockage: 2-30°C
• Chaîne SMILES: NC(=O)c1cn(Cc2c(F)cccc2F)nn1
• InChI: 1S/C10H8F2N4O/c11-7-2-1-3-8(12)6(7)4-16-5-9(10(13)17)14-15-16/h1-3,5H,4H2,(H2,13,17)
• Clé InChI: POGQSBRIGCQNEG-UHFFFAOYSA-N
• Informations sur le gène: human ... SCN10A(6336) , SCN11A(11280) , SCN1A(6323) , SCN2A(6326) , SCN3A(6328) , SCN4A(6329) , SCN5A(6331) , SCN7A(6332) , SCN8A(6334) , SCN9A(6335)

Description

Description générale

Rufinamide is an antiepileptic drug, used as an adjunctive for the treatment of seizures associated with Lennox−Gastaut syndrome. Its mode of action involves prolonging the refractory period of voltage-dependent sodium channels via stabilization of the sodium channel inactive state, thus effectively keeping the ion channels closed.

Application

Rufinamide may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using reversed-phase high-performance liquid chromatography technique.

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Actions biochimiques/physiologiques

Broad-spectrum anticonvulsant.

Implications diagnostiques

Effective therapy for partial seizures in adults and childhood seizures in Lennox-Gastaut syndrome.

Remarque sur l'analyse

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Autres remarques

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Note de bas de page

To see an example of a Certificate of Analysis for this material enter LRAA5294 in the slot below. This is an example certificate only and may not be the lot that you receive.

Informations sur la sécurité

• Pictogrammes: GHS08,GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H336,H351,H361fd
• Conseils de prudence: P202 - P261 - P271 - P280 - P304 + P340 + P312 - P308 + P313
• Classification des risques: Carc. 2 - Repr. 2 - STOT SE 3
• Organes cibles: Central nervous system
• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 3
• Point d'éclair (°F): Not applicable
• Point d'éclair (°C): Not applicable