ASTM E1298-2006 测定生物药品中纯净度、杂质和污染物标准指南

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【英文标准名称】:StandardGuideforDeterminationofPurity,Impurities,andContaminantsinBiologicalDrugProducts
【原文标准名称】:测定生物药品中纯净度、杂质和污染物标准指南
【标准号】:ASTME1298-2006
【标准状态】:现行
【国别】:
【发布日期】:2006
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E48.02
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:分析;污染;药物;指南;杂质;实验室医学
【英文主题词】:
【摘要】:Thisguidesuggestsanalyticalmethodsgenerallyappliedwithinthepharmaceuticalindustrytoidentifyandquantitatethelevelofimpuritiesandcontaminantspresentinthepreparationofabiologicaldrugproduct.Thesemethodsarenotintendedtobeall-inclusive.Themethodsusedbyanindividualmanufacturermustbespecifictotheproductandprocessofproduction.1.1Thisguidecoverstheconceptsofpurity,impurity,andcontaminationinbiologicaldrugproducts.1.2Thisguidesuggestsmethodsfordeterminationofimpuritiesandcontaminantsinsuchproducts.1.3Thisguideisarrangedasfollows:1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C10
【国际标准分类号】:11_120_10
【页数】:4P.;A4
【正文语种】: