普罗布考USP翻译.docVIP

普罗布考 Phenol,4,4‘-[(1-methylethylidene)bis(thio)]bis[2,6-bis(1,1-dimethylethyl)-. Acetone bis(3,5-di-tert-butyl-4-hydroxyphenyl) mercaptole [23288-49-5]. 4，4′-[(1-甲基亚乙基)二]双[2,6-二(1,1-二甲乙基)苯酚。双（35-二叔丁基羟基苯硫）缩丙酮Probucol contains not less than 98.0 percent and not more than 102.0 percent of C31H48O2S2, calculated on the dried basis. 按干燥品计算，普罗布考含C31H48O2S2应为98.0%~102.0%。 Packaging and storage- Preserve in well-closed , light-resistant containers. 包装与贮存：密封，遮光保存。 USP REFERENCE STANDARDS 11 — 美国药典标准品 USP Probucol RS 美国药典普罗布考对照品 USP Probucol Related Compound A RS 2,2,6,6-Tetra-tert-butyldiphenoquinone. C28H40O2 408.63 美国药典普罗布考有关化合物A对照品 2,2’,6,6’-四叔丁基二苯醌 USP Probucol Related Compound B RS 4,4-(Dithio)bis(2,6-di-tert-butylphenol). C28H42O2 474.78 美国药典普罗布考有关化合物B对照品 4,4’-(二硫)双（2,6-二叔丁基苯酚） USP Probucol Related Compound C RS 4-[(3,5-Di-tert-butyl-2-hydroxyphenylthio)isopropylidenethtio]-2,6-di-tert-butylphenol. C31H4802S2 516.86 美国药典普罗布考有关化合物C对照品 4-[(3,5-二叔丁基-2-羟苯硫)亚异丙基硫]-2,6-二叔丁基苯酚 Identification, Infrared Absorption 197K . 鉴别，红外吸收 197K 项下. MELTiNG RANGE, Class / 741 : between 124°and 127°, a dried specimen being used. 熔点范围，按Class / 741项下测定：干燥样品应为124°~ 127°。 LOSS ON DRYING 731 — Dry it in vacuum at 80° for 1 hour: it loses not more than l.0% of its weight. 干燥失重，按731 项下测定，80°减压干燥1小时，减失重量不得过1.0%。 RESIDUE ON IGNITION 281 : 0.1 %. 炽灼残渣，按281 项下测定：0.1 % HEAVY METALS, Method // 231 : 0.002%. 重金属,按 231 项下第Ⅱ法：0.002% Related compounds— 有关化合物. Mobile phase—Prepare a mixture of n-hexane and dehydrated alcohol (4000:1). Make adjustments, if necessary (see Systerm Suitability under chromatography 621) 流动相—正己烷和无水乙醇按4000:1配制。如果有必要，可以适当调整（见色谱法621项下）。 Reference solution 1— Dissolve an accurately weighed quantity of USP Probucol Related Compound A RS in n-hexane, and dilute quantitatively and stepwise with n-hexane to obtain a solution having a known concentration of about 10 μg per mL. 参比溶液1—将精密称定的USP普罗布考有关化合物A对照品溶解于正己烷中，并用正己烷稀释至浓度约为10μg/mL。 Reference solution2-Dissolve an accurat