很显然这种方法已经过于简陋,准误差较大,同时也不能对其中的金属元素进行准确定量。因此<232>、<233>诞生了。 USP<232>的标题是Elemental impurities-Limits,该章节规定了药物(包括原料药、辅料)中需要检测的重金属种类以及限值。USP<233>的标题是Elemental impurities-Procedures,该章节则对药物中重金属检测的方法流程...
提出的新通则USP<232>(限度)和 <233>(方法)将于2013年起执行。 监测药物样品中有机污染物的现行方法是有着100年历史 的比色法,USP通则<231>中有明确规定。该方法被称为 “重金属限度检测法”,其原理是10种元素(Ag、As、 Bi、Cd、Cu、Hg、Mo、Pb、Sb和Sn)与硫代乙酰胺反 应生成硫化物沉淀。产生的有色...
USP232-233重金属检测方法-中文 系统标签: 重金属检测方法usp分析物pde限量 --- USP232-233重金属检测方法-中文 作者 AmirLiba和EdMcCurdy 安捷伦科技公司 美国元素杂质的USP新通则<232>和<233>:ICP-MS在药物分析中的应用白皮书 摘要 美国药典(USP)正在开发药品及其成分中有机杂质的新检测方法。人们普遍认为目前...
The current United States Pharmacopeia (USP) General Chapter <231> "heavy metals limit test" will be replaced by new instrumental methods, USP <232> (Limits) and <233> (Procedures), in 2013.Validating ICPMS for the Analysis of Elemental Impurities According to Draft USP General Chapters and ...
(ICH), is developing newmethods for inorganic impurities in pharmaceuticals and their ingredients.The current USP method, <231> "heavy metals limit test", is acknowledged to be inadequate and is due to be replaced with new General ChaptersUSP<232> (Limits) and <233> (Procedures) in December...
四环素2274aminophenolacetaminophencontainingdrugproducts对乙酰氨酚药物产品中氨基酚228ethyleneoxidedioxane环氧乙烷和二氧六环231heavymetals重金属删除232elementalimpuritieslimits元素杂质限度233elementalimpuritiesprocedures元素杂质规程241ironmercuryintrusion水银孔隙仪268porositynitrogenadsorptiondesorption氮吸附解吸测定孔隙率271...
(GC) with a reference procedure to be used in many monographs. One example impacting the modernization of more than 1000 monographs is development of General Chapter <232>Elemental Impurities-Limitsand General Chapter <233>Elemental Impurities-Proceduresto replace General Chapter <231>Heavy Metals. ...
<231>HEAVY METALS重金属(删除) <232>ELEMENTAL IMPURITIES—LIMITS元素杂质-限度 <233>ELEMENTAL IMPURITIES—PROCEDURES元素杂质-规程 <241>IRON铁 <251>LEAD铅 <261>MERCURY汞 <267>POROSIMETRY BY MERCURY INTRUSION水银孔隙仪 <268>POROSITY BY NITROGEN ADSORPTION–DESORPTION氮吸附-解吸测定孔隙率 <271>READILY CA...
<231>HEAVY METALS重金属(删除) <232>ELEMENTAL IMPURITIES—LIMITS元素杂质-限度 <233>ELEMENTAL IMPURITIES—PROCEDURES元素杂质-规程 <241>IRON铁 <251>LEAD铅 <261>MERCURY汞 <267>POROSIMETRY BY MERCURY INTRUSION水银孔隙仪 <268>POROSITY BY NITROGEN ADSORPTION–DESORPTION氮吸附-解吸测定孔隙率 <271>READILY CA...
分析的一般要求 <1>INJECTIONSANDIMPLANTEDDRUGPRODUCTS (PARENTERALS)—PRODUCTQUALITYTESTS注射和植入药物产 品(注射用)—产品质量测试 <1>INJECTIONS注射剂 <2>ORALDRUGPRODUCTS—PRODUCTQUALITYTESTS口服药 物产品质量测试 <3>TOPICALANDTRANSDERMALDRUGPRODUCTS—PRODUC ...