药品行业词汇表.docx

药品行业词汇表
英文中文翻译英文中文翻译Acceleratedtesting加速试验Reproducibility重复性Climaticzones气候带Detectionlimit检测限Commitmentbatches承诺批次Quantitationlimit定量限Containerclosuresystem包装容器Linearity线性Drugsubstance原料药Range范围Excipient赋型剂Robustness耐用性Expirationdate有效日期Chemicaldevelopmentstudies化学开发研究Formalstabilitystudies正式稳定性研究Enantiomericimpurity异构体杂质Intermediatetesting中间试验Extraneouscontaminant外源性污染Longtermtesting长期试验Identifiedimpurity鉴定的杂质Newmolecularentity新分子实体Identifiedthreshold鉴定阙值（鉴定限）Primarybatch申报批次Impurity杂质Productionbatch大生产批次Impurityprofile杂质概况Re-testdate复检日期Intermediate中间体Re-testperiod复检期Newdrugsubstance新原料药Specification质量标准Precision精密度Stresstesting(drugsubstance)强降解试验Repeatability重复性Analyticalprocedure分析方法Intermediateprecision中间精密度Accuracy准确度Polymorphicform多晶型Potentialimpurity潜在杂质Combinationproduct复方制剂Qualificationthreshold界定阙值（界定限）Chiral手性Reagent试剂Degradationproduct降解产物Reportingthreshold报告阙值（报告限）Enantiomer异构体Solvent溶剂Identifiedimpurity鉴定杂质Specifiedimpurity特定杂质In-processtests过程中检测Startingmaterial起始物料Polymorphism多晶型Unidentifiedimpurity未鉴定杂质Newdrugsubstance新原料药Acceptancecriteria可接受标准Racemate外消旋体Permitteddailyexposure每日可接受药物中残留溶剂的最大摄入量Quality质量Universaltest常规检测Specification质量标准Acceptancecriteria可接受标准Solvent溶剂Activepharmaceuticalingredient药物活性组分（原料药）Specifictest专属性试验APIstartingmaterialAPI起始物料Specifiedimpurity特定杂质Batch批Unidentifiedimpurity未鉴定杂质Batchnumber批号Contractmanufacturer合同制造商Calibration校验Critical关键Computersystem计算机系统Cross-contamination交叉污染Computerizedsystem计算机化系统Deviation偏差Contamination污染Expirydate失效日期Lot批In-processcontrol生产过程控制Lotnumber批号Motherliquor母液Packagingmaterial包装材料Reprocessing再处理Material物料Retestdate复测期Procedure规程Reworking返工Processaids工艺辅助材料Signature(signed)签名Processcontrol工艺控制Validation验证Qualification确认Validationprotocol验证方案Qualityassurance质量保证Yield,Expected预期产量Qualitycontrol质量控制Yield,Theoretical理论产量Qualityunit质量部Designspace设计空间Production生产Formalexperimentaldesign正式实验设计Referencestandard,primary一级标准品Quarantine待验Referencestandard,secondary二级标准品Rawmaterial原辅料Risk风险Correctiveac