ASTM E2363-2006a 关于制药业过程技术分析的标准术语

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【英文标准名称】:StandardTerminologyRelatingtoProcessAnalyticalTechnologyinthePharmaceuticalIndustry
【原文标准名称】:关于制药业过程技术分析的标准术语
【标准号】:ASTME2363-2006a
【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】:E55.91
【标准类型】:(Terminology)
【标准水平】:()
【中文主题词】:分析的;定义;工业;药品;工艺学;术语
【英文主题词】:processanalyticaltechnology;pharmaceutical;terminology
【摘要】:1.1Thisterminologycoversprocessanalyticaltechnologyinthepharmaceuticalindustry.TermsaredefinedastheyareusedrelativetothePATframeworkinthepharmaceuticalindustry.Termsthataregenerallyunderstoodandincommonusageoradequatelydefinedinotherreadilyavailablereferencesarenotincludedexceptwhereparticulardelineationtoprocessanalyticaltechnologymaybemoreclearlystated.1.2Thisterminologyisthereforeintendedtobeselectiveoftermsusedgenerallyinprocessanalyticaltechnologyasitisappliedinthepharmaceuticalindustryandpublishedinanumberofdocuments,suchasthoselistedinthesucceedingsections.ThelistingisalsointendedtodefinetermsthatappearprominentlywithinotherrelatedASTMstandardsanddonotappearelsewhere.1.3ThedefinitionsaresubstantiallyidenticaltothosepublishedbytheU.S.FoodandDrugAdministrationandotherauthoritativebodies,suchasISO,IEC,ITU,andnationalstandardsorganizations.1.4Thisterminologysupplementscurrentdocumentsonterminologythatconcentrateonprocessanalyticaltechnologyasitisappliedinthepharmaceuticalindustry.1.5Anincreasingnumberofproductdesignationsanddesignationsforchemical,physical,mechanical,analytical,andstatisticaltestsandstandardsarecomingintocommonusageintheliterature,regulatoryenvironment,andcommerceassociatedwithprocessanalyticaltechnologyinthepharmaceuticalindustry.Sectionliststhosedocumentsreferencedinthisterminology.
【中国标准分类号】:C10
【国际标准分类号】:01_040_11;11_120_01
【页数】:3P.;A4
【正文语种】: