ASTM E2503-2007 篮式和搅拌溶解器具合格的标准实施规范

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【英文标准名称】:StandardPracticeforQualificationofBasketandPaddleDissolutionApparatus
【原文标准名称】:篮式和搅拌溶解器具合格的标准实施规范
【标准号】:ASTME2503-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:E55.03
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:器具;溶解;制药技术;医药品;药剂学;合格
【英文主题词】:basketdissolutionapparatus;calibration;paddledissolutionapparatus
【摘要】:Thispracticeoutlinesaprocedureforthemechanicalcalibrationofpaddleandbasketdissolutionunitstoensurereproducibilityofresults.Onceaunitmeetsallofthemechanicalspecificationsincludedinthispractice,itisconsideredcalibratedandfurthercalibrationwithdissolutioncalibratortabletsisnotrequired.1.1Thispracticecoverstheset-upandcalibrationofthepaddleandbasketdissolutionapparatus.1.2Useofthispracticemaybeappliedtoapparatusthathavebeenmodifiedtoenableautomaticdissolutiontesting(thatis,avalveinthebottomofthevesselorsamplingthroughtheshaft).1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C30
【国际标准分类号】:11_120_99
【页数】:4P.;A4
【正文语种】: