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等级
certified reference material
pharmaceutical secondary standard
质量水平
Agency
traceable to USP 1606401
API类
rufinamide
CofA
current certificate can be downloaded
包装
pkg of 500 mg
技术
HPLC: suitable
gas chromatography (GC): suitable
应用
pharmaceutical (small molecule)
包装形式
neat
储存温度
2-30°C
SMILES字符串
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
基因信息
human ... SCN10A(6336) , SCN11A(11280) , SCN1A(6323) , SCN2A(6326) , SCN3A(6328) , SCN4A(6329) , SCN5A(6331) , SCN7A(6332) , SCN8A(6334) , SCN9A(6335)
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一般描述
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.
应用
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.
生化/生理作用
Broad-spectrum anticonvulsant.
诊断含义
Effective therapy for partial seizures in adults and childhood seizures in Lennox-Gastaut syndrome.
分析说明
These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.
其他说明
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.
附注
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.
警示用语：
Warning
危险声明
危险分类
Carc. 2 - Repr. 2 - STOT SE 3
靶器官
Central nervous system
储存分类代码
11 - Combustible Solids
WGK
WGK 3
闪点(°F)
Not applicable
闪点(°C)
Not applicable
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)
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)
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