仪器确认-附件-质谱仪确认-中英文————————————————————————————————作者:————————————————————————————————日期: workoftheCouncilofEuropeQUALITYMANAGEMENTDOCUMENT质量管理文件PA/PH/OMCL(10)862RQUALIFICATIONOFEQUIPMENT仪器确认ANNEX7:QUALIFICATIONOFMASSSPECTROMETERS附件7:质谱仪的确认Fulldocumenttitleandreference文件全名和索引号QualificationofEquipmentAnnex7:QualificationofmassspectrometersPA/PH/OMCL(10)862RDocumenttype文件类型GuidelineLegislativebasis立法基础-Dateoffirstadoption首次发行日期25thMay2011Dateoforiginalentryintoforce首次执行日期1stJuly2011Dateofentryintoforceofreviseddocument修订后执行日期-Previoustitles/otherreferences原文件名/其它索引号-work/WORKGUIDELINE“QUALIFICATIONOFEQUIPMENT”OMCL网络指南“仪器确认”:QUALIFICATIONOFGASCHROMATOGRAPHY-MASSSPECTROMETERSWITHELECTRONIMPACTIONIZATION(GC-EI-MS)装备电子碰撞电离的气相色谱-质谱仪的确认Introduction介绍Thepresentdocumentisthefirstpartofthe7thAnnexofthecoredocument“QualificationofEquipment”,binationwithitwhenplanning,performinganddocumentingthequalificationprocessofGC-EI-“仪器确认”的第7个附件,在计实施和记录GC-EI-MS的确认过程中,应与核心文件结合使用。ThecoredocumentcontainstheIntroductionandgeneralformsforLevelIandIIofqualification,。Thepresentannexcontainsinstrument-eptancelimits,,以及在实施这些检查时可以采用的方法学实例。-EI-MS(examples)GC-EI-MS最低要求(举例)uracy质量准确性PFTBA(FC-43)*Orinternalcalibrationgas或内部校正气体m/z=69±=219±=502±±±**线性r2≥**系统/仪器精密度≤%*)PFTBA(FC-43):Perfluoro-tributyl-amine(CASNO.:311-89-7)PFTBA(FC-43):全氟三丁胺(CAS号311-89-7)**)Incaseofquantificationpurposes,,这些参数必须要检查。-C-EI-MSGC-EI-()如特定分析方法定义,或根据欧洲药典或MAH档案(见第四级附件2的举例)
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