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HPLC DATA :SHEET 了J匕才亏少一儿(米国薬局方記載条件)Aripiprazole (The United States Pharmacopeia) H140204A (A) Standard solution", Sample solution(0.1 mg/mL Aripiprazole) 1 mAU: 350 300 250 200 Systemsuitability requirement Result Relative standard deviation of the peak area(Aripiprazole) ≤1.0% 0.13% H140129A 0 0 5 10 15 20 25 30 min (B) System suitability solution 司公(1.0 pg/mL Aripiprazole, 1.0 pg/mL Aripirazole related compound F)限有 Aripiprazole Aripiprazole related compound F Column :YMC-Pack ODS-A (3 um, 12 nm) 100X4.6 mml.D Eluent :A) acetonitrile/0.05% TFA (10/90) B) acetonitrile/0.05% TFA (90/10) 20%B (0-2 min), 20-35%B (2-10 min),35-90%B (10-20 min), 90%B (20-25 min), 90-20%B (25-26min),20%B (26-35min) Flow rate : 1.2mL/min Temperature :25℃ Detection . : UV at 254 nm Injection :20 pL (The United States Pharmacopeia 36th; Assay, Impurities) .All solutions were prepared from aripiprazole and aripiprazole related compound F :supplied as1aa reagent forlaboratory use. 按美国药典36版规定的液相色谱方法,用YMC-Pack ODS-A色谱柱(规格3μm,4.6×100mm P/N:AA12S03-1046WT)测定阿立哌唑的含量,拖尾因子及相对标准偏差等均符合规定。
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深圳凯米斯科技有限公司为您提供《阿立哌唑中含量/有关物质检测方案(液相色谱柱)》,该方案主要用于原料药中含量测定检测,参考标准《暂无》,《阿立哌唑中含量/有关物质检测方案(液相色谱柱)》用到的仪器有null。
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