PHR1625

Rufinamide

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Rufinamide, 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-Triazole-4-carboxamide
• Empirical Formula (Hill Notation): C₁₀H₈F₂N₄O
• CAS Number: 106308-44-5
• Molecular Weight: 238.19
• MDL number: MFCD00865314
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823517
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to USP 1606401
• API family: rufinamide
• CofA: current certificate can be downloaded
• packaging: pkg of 500 mg
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: 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)
• InChI key: POGQSBRIGCQNEG-UHFFFAOYSA-N
• Gene Information: human ... SCN10A(6336) , SCN11A(11280) , SCN1A(6323) , SCN2A(6326) , SCN3A(6328) , SCN4A(6329) , SCN5A(6331) , SCN7A(6332) , SCN8A(6334) , SCN9A(6335)

Description

General description

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.

Biochem/physiol Actions

Broad-spectrum anticonvulsant.

Diagnostic Implications

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

Analysis Note

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

Other Notes

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.

Footnote

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.

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Warning
• Hazard Statements: H336,H351,H361fd
• Precautionary Statements: P202 - P261 - P271 - P280 - P304 + P340 + P312 - P308 + P313
• Hazard Classifications: Carc. 2 - Repr. 2 - STOT SE 3
• Target Organs: Central nervous system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable