PHR1625
卢非酰胺
Pharmaceutical Secondary Standard; Certified Reference Material
别名:
Rufinamide, 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-Triazole-4-carboxamide
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关于此项目
经验公式（希尔记法）:
C10H8F2N4O
化学文摘社编号:
分子量:
238.19
NACRES:
NA.24
PubChem Substance ID:
UNSPSC Code:
41116107
MDL number:
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)
SMILES string
NC(=O)c1cn(Cc2c(F)cccc2F)nn1
InChI key
POGQSBRIGCQNEG-UHFFFAOYSA-N
grade
certified reference material, pharmaceutical secondary standard
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
Quality Level
Gene Information
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General description
Effective therapy for partial seizures in adults and childhood seizures in Lennox-Gastaut syndrome.
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.
Analysis Note
These secondary standards offer multi-traceability to the USP and EP 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.
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.
signalword
Warning
hcodes
Hazard Classifications
Carc. 2 - Repr. 2 - STOT SE 3
target_organs
Central nervous system
存储类别
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
Stability indicating liquid chromatographic method for the quantitative determination of rufinamide in pharmaceutical dosage forms
Annapurna MM, et al.
Journal of Drug Delivery and Therapeutics, 2(4), 66-70 (2012)
Development and validation of a stability indicating RP-HPLC method for the determination of Rufinamide
Kumar PSB, et al.
Journal of Pharmaceutical Analysis, 3(1), 66-70 (2013)
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