药品检验报告中的一些词语的英文翻译

检验报告常用术语中英文对照序号 English Chinese 序号 English Chinese 1bend 弯曲 102shrink mark收缩纹2broken 破烂 103stress mark顶白印3broken label标贴烂 104thin spray喷油过薄4broken screw缧丝断 105uneven coation涂色不圴5burn mark烧痕 106uneven spray喷油不均匀6burr 毛边 107uneven surface高低落差过大 7carton broken外箱烂108untrimmed thread线头过长8color deviatiion色差过大 109water mark水渍9damage 损坏 110wrinkle 皱纹10deform 变形 111wrong assortment错混装11foreign tape纸屑 112wrong color错颜色12dent mark凹陷 113wrong labelling错标贴13dirt mark污渍 114wrong packing错包装14flash 披锋 115wrong products错货品15flow mark胶料注塑纹 116wrong sewing label错缝合标贴16foreign material外物(就是脏东西 117foreign stuffing线头17gate mark水口修不好 118missing letter缺字18glue mark胶水渍 119missing segment缺字划19hole misalignment孔位不正 120part detach配件甩掉20illegible letter字型模糊不清 121part loose配件松21label peel off标贴脱落 122screw not tight缧丝未收紧22label peel up标贴浮起/分离 123uneven table surface台面不平23large gap间隙过大 124wrong letter错字24missing glue漏胶水 125wrong parts错配件25missing label漏标贴 126bent insert纸卡变形26mould 发霉 127air leakage漏气27no glue无胶水 128cannot assembly组装不成功28oil mark油渍 129dim light灯光过暗29oxidization 氧化 130distortion 失真30paint mark补油不良 131intermittent function间断没功能31paint mark喷油渍 132missing parts漏配件32poor coating露底色 133missing products漏货品33poor fitting接合不良 134narrow goal socket袋口过窄34poor glue黏合不良 135no light无灯光35poor hot stamp烫金不良 136no sound无声音36poor parting line接合边位修不好 137noise 噪声37poor printing印刷不良 138non function无功能38poor seal封合位不良 139poor packing包装不良39poor sewing缝合不良 140poor soldering焊接不良40poor silk screen printing丝印不良 141water leakage漏水41poor spray喷油不良 142weak soung声音过弱42poor stitching缝合孔位过大 143wire damage电线烂43poor tampo printing移印不良 144wire exposed电线外露44poor trimmimg修剪不良 145wrong function错功能45poor trimmimg胶边位修不好 146wrong soung错声音46base 底座 147cracking 裂纹47rough edge边位粗糙 148blood mark血渍48rough surface表面粗糙 149high pole test failure电气高压测试失败 49rust mark生锈 150insect 昆虫50scratch mark花痕 151sharp edge利边 , 毛刺51screw slip缧丝滑牙 152sharp point尖点52instruction sheet came off缺少说明书 153sharp point利角53hard to assembly装配困难 154short circuit漏电 / 短路 54poorfunction功能不良 155damaged window sheet彩盒损坏55too loose太松 156label misalinged标贴贴倒56scratch mark刮花 157dislocated 移位57color deviation颜色有差别,色差 158poor label sticking贴纸不良58electro-plating yellownish电镀变黄 159poor molding注塑不良59electro-plating peel off电镀脱落 160poor packing包装不良60electro-plating abrase电镀擦花 161poor electro-plating电镀不良61tempo incomplete移印不完整 162missing Part缺少附件62tempo off position移印移位 163oversize 尺寸过大63paint abrase喷油擦花 164packing damaged包装损坏64electro-plating rainbow电镀彩虹印 165poor bewing车缝不良65electro-plating shadow电镀阴阳色 166poor soldering焊接不良66electro-plating black mark电镀发黑 167poor shrink wrap收缩包装不良67oxidatton 氧化 168poor tampo移印不良68inner carton内盒 169seam open车缝开口69gift box彩盒 170seam torn车缝穿洞70ejector mark顶针位 171stripping screw螺丝打滑71flow mark流水痕 172wrong instruction sheet 说明书错误Defect name72flow line流水纹 173blister 吸塑73fold mark折痕 174FOLD MARK ON GIFT彩盒折痕74white mark发白 175GIFT BOX DEFORM彩盒压变形 75poor transparency透明度不良 176BLISTER DEFORM吸塑变形76sink mark凹痕 177BLISTER CRACK吸塑裂77poor contact接触不良 178BLISTER POOR HEAT SEALING吸塑不良78loosen 脱落 179gift box unseal彩盒无封口贴 79air-bubble on painting漆上有气泡180poor silk sckeen prining印刷不良 80painting scratched油漆刮花 181over plating电镀过多 81painting peeled off油漆脱落 182under plating电镀不足82pough surface painting油漆面粗糙 183color mismatch颜色不配对83rivet 铆钉 184color misalignment颜色不配对 84blister 泡盒 185color deviation颜色有差别,色差 85rust mark锈迹 186electro-plating yellownish电镀变黄86flow mark流水痕 187electro-plating peel off电镀脱落87flow line流水纹 188electro-plating abrase电镀擦花88fold mark折痕 189tempo incomplete移印不完整 89white mark发白 190tempo off position移印移位90poor transparency透明度不良 191paint abrase喷油擦花91sink mark凹痕 192electro-plating rainbow电镀彩虹印 92poorcontact接触不良 193electro-plating shadow电镀阴阳色 93loosen 脱落194electro-plating black mark电镀发黑94air-bubble on painting漆上有气泡 195oxidatton 氧化95painting scratched油漆刮花 196inner carton内盒96painting peeled off油漆脱落 197gift box彩盒97pough surface painting油漆面粗糙 198ejector mark顶针位98rivet 铆钉 199rust mark锈迹99blister 泡盒 200fixed sleeve 固定套100spring 弹簧 201Cover Plate面板101Lining 内衬 202Slide tube伸缩管203Stem Extension延长杆。

药品检验报告中的一些词语的英文翻译检验报告Certificate of analysis化工chemical CO. , LTD制药(药业) Pharmaceutical co. ,Ltd.化工厂CHEMICAL PLANT精细化工FINE CHEMICAL CO., LTD品名PRODUCT //title批号batch NO.生产日期manufacturing date // manu. Date检验日期Analysis date有效期Exp date // expiry date检验标准quality standard //inspecting basis //Specification数量QUANTITY 报告日期report date 包装规格package企业标准Company Standard//enterprise standard检查项目test items//analytical items性状appearance // characteristics//description//Character分子式molecular formula 分子量molecular wt化学式Chemical formula鉴别identification溶液外观appearance of solution澄清度&颜色clarity & color白色或类白色结晶粉末white or almost white crystalline powder味微苦 a little bitter taste无色无味odorless,smelless酸碱度acidity and alkalinity铅盐Plumbum salts 砷盐Arsonium salts有关物质related substances 分为：individual impurity substance NMT….；total impurity substance NMT。

药品检验报告中的一些词语的英文翻译检验报告Certificate of analysis化工有限公司chemical CO. , LTD制药(药业)有限公司Pharmaceutical co. ,Ltd.化工厂CHEMICAL PLANT精细化工有限公司FINE CHEMICAL CO., LTD品名PRODUCT //title批号batch NO.生产日期manufacturing date // manu. Date检验日期Analysis date有效期Exp date // expiry date检验标准quality standard //inspecting basis //Specification数量QUANTITY 报告日期report date 包装规格package企业标准Company Standard//enterprise standard检查项目test items//analytical items性状appearance // characteristics//description//Character分子式molecular formula 分子量molecular wt化学式Chemical formula鉴别identification溶液外观appearance of solution澄清度&颜色clarity & color白色或类白色结晶粉末white or almost white crystalline powder味微苦 a little bitter taste无色无味odorless,smelless酸碱度acidity and alkalinity铅盐Plumbum salts 砷盐Arsonium salts有关物质related substances 分为：individual impurity substance NMT….；total impurity substance NMT。

SFDA Glossary：GCP，GLP，TRIAL Accuracy 准确度Active control，AC 阳性对照，活性对照Adverse drug reaction，ADR 药物不良反应Adverse event，AE 不良事件Adverse medical events 不良医学事件Adverse reaction 药物不良反应Alb 白蛋白ALD（Approximate Lethal Dose）近似致死剂量ALP 碱性磷酸酶Alpha spending function 消耗函数ALT 丙氨酸氨基转换酶Analysis sets 统计分析的数据集Approval 批准Assistant investigator 助理研究者AST 天门冬酸氨基转换酶ATR 衰减全反射法AUCss 稳态血药浓度－时间曲线下面积Audit 稽查Audit or inspection 稽查／视察Audit report 稽查报告Auditor 稽查员Bias 偏性，偏倚Bioequivalence 生物等效应Blank control 空白对照Blind codes 编制盲底Blind review 盲态审核Blind review 盲态检查Blinding method 盲法Blinding/ masking 盲法，设盲Block 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form，CRF 病例报告表，病例记录表Categorical variable 分类变量Cav 平均浓度CD 圆二色谱CL 清除率Clinical equivalence 临床等效应Crossover design 交叉设计Cross-over study 交叉研究Css 稳浓度Cure 痊愈Data management 数据管理Database 建立数据库Descriptive statistical analysis 描述性统计分析DF 波动系统Dichotomies 二分类Diviation 偏差Documentation 记录／文件Dose-reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲Drop out 脱落DSC 差示扫描热量计Effectiveness 疗效Electronic data capture，EDC 电子数据采集系统Electronic data processing，EDP 电子数据处理系统Emergency envelope 应急信件End point 终点Endpoint criteria/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件Ethics committee 伦理委员会Excellent 显效Exclusion criteria 排除标准Factorial design 析因设计Failure 无效，失败Final point 终点Fixed-dose procedure 固定剂量法Forced titration 强制滴定Full analysis set 全分析集GC－FTIR 气相色谱－傅利叶红外联用GC－MS 气相色谱－质谱联用Generic drug 通用名药Global assessment variable 全局评价变量GLU 血糖Good clinical practice，GCP 药物临床试验质量管理规范Good manufacture practice，GMP 药品生产质量管理规范Good non-clinical laboratory practice，GLP 药物非临床研究质量管理规范Group sequential design 成组序贯设计Health economic evaluation，HEV 健康经济学评价Hypothesis test 假设检验Hypothesis testing 假设检验International Conference of Harmonization，ICH 人用药品注册技术要求国际技术协调会，国际协调会议Improvement 好转Inclusion criteria 入选标准Independent ethics committee，IEC 独立伦理委员会Information consent form，ICF 知情同意书Information gathering 信息收集Informed consent，IC 知情同意Initial meeting 启动会议Inspection 视察／检查Institution inspection 机构检查Institution review board，IBR 机构审查委员会Intention to treat 意向治疗（——临床领域）Intention-to –treat，ITT 意向性分析（－统计学）Interactive voice response system，IVRS 互动式语音应答系统Interim analysis 期中分析Investigator 研究者Investigator's brochure，IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward，LOCF 最接近一次观察的结转LC－MS 液相色谱－质谱联用LD50 板数致死剂量Logic check 逻辑检查LOQ （Limit of Quantitation）定量限LOCF，Last observation carry forward 最近一次观察的结转Lost of follow up 失访Marketing approval/ authorization 上市许可证Matched pair 匹配配对Missing value 缺失值Mixed effect model 混合效应模式Monitor 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS－MS 质谱－质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multicenter trial 多中心试验Multi-center trial 多中心试验New chemical entity，NCE 新化学实体New drug application，NDA 新药申请NMR 核磁共振谱Non-clinical study 非临床研究Non-inferiority 非劣效性Non-parametric statistics 非参数统计方法Obedience 依从性ODR 旋光光谱Open-blinding 非盲Open-label 非盲Optional titration 随意滴定Original medical record 原始医疗记录Outcome 结果Outcome assessment 结果指标评价Outcome measurement 结果指标Outlier 离群值Parallel group design 平行组设计Parameter estimation 参数估计Parametric statistics 参数统计方法Patient file 病人档案Patient history 病历Per protocol，PP 符合方案集Placebo 安慰剂Placebo control 安慰剂对照Polytomies 多分类Power 检验效能Precision 精密度Preclinical study 临床前研究Primary endpoint 主要终点Primary variable 主要变量Principal investigator 主要研究者Principle investigator，PI 主要研究者Product license，PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit，QAU 质量保证部门Quality assurance，QA 质量保证Quality control，QC 质量控制Query list，query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities，RA 监督管理部门Replication 可重复RSD 日内和日间相对标准差Run in 准备期Safety evaluation 安全性评价Safety set 安全性评价的数据集Sample size 样本含量Sample size 样本量，样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Serious adverse event，SAE 严重不良事件Serious adverse reaction，SAR 严重不良反应Seriousness 严重性Severity 严重程度Significant level 检验水准Simple randomization 简单随机Single blinding 单盲Single-blinding 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source data verification，SDV 原始数据核准Source data，SD 原始数据Source document，SD 原始文件Specificity 特异性Sponsor 申办者Sponsor-investigator 申办研究者Standard curve 标准曲线Standard operating procedure，SOP 标准操作规程Statistic 统计量Statistical analysis plan 统计分析计划Statistical analysis plan 统计参数计划书Statistical analysis plan，SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者Subject 受试者Subject diary 受试者日记Subject enrollment 受试者入选Subject enrollment log 受试者入选表Subject identification code，SIC 受试者识别代码Subject recruitment 受试者招募Subject screening log 受试者筛选表Superiority 检验Survival analysis 生存分析SXRD 单晶X－射线衍射System audit 系统稽查T1/2 消除半衰期Target variable 目标变量T－BIL 总胆红素T－CHO 总胆固醇TG 热重分析TLC、HPLC 制备色谱Tmax 峰时间TP 总蛋白Transformation 变量变换Treatment group 试验组Trial error 试验误差Trial master file 试验总档案Trial objective 试验目的Trial site 试验场所Triple blinding 三盲Two one-side test 双单侧检验Unblinding 揭盲Unblinding 破盲Unexpected adverse event，UAE 预料外不良事件UV－VIS 紫外－可见吸收光谱Variability 变异Variable 变量Visual analogy scale 直观类比打分法Visual check 人工检查Vulnerable subject 弱势受试者Wash-out 清洗期Washout period 洗脱期Well-being 福利，健康。

【分享】药品检验报告中的一些词语的英文翻译检验报告Certificate of analysis化工有限公司chemical CO. , LTD制药(药业)有限公司Pharmaceutical co. ,Ltd.化工厂CHEMICAL PLANT精细化工有限公司FINE CHEMICAL CO., LTD品名PRODUCT //title批号batch NO.生产日期manufacturing date // manu. Date检验日期Analysis date有效期Exp date // expiry date检验标准quality standard //inspecting basis //Specification数量QUANTITY 报告日期report date 包装规格package企业标准Company Standard//enterprise standard检查项目test items//analytical items性状appearance // characteristics//description//Character分子式molecular formula 分子量molecular wt化学式Chemical formula鉴别identification溶液外观appearance of solution澄清度&颜色clarity & color白色或类白色结晶粉末white or almost white crystalline powder味微苦 a little bitter taste无色无味odorless,smelless酸碱度acidity and alkalinity铅盐Plumbum salts 砷盐Arsonium salts有关物质related substances 分为：individual impurity substance NMT….；total impurity substance NMT。

药品检验报告中的一些词语的英文翻译检验报告Certificate of analysis化工有限公司chemical CO. , LTD制药(药业)有限公司Pharmaceutical co. ,Ltd.化工厂CHEMICAL PLANT精细化工有限公司FINE CHEMICAL CO., LTD品名PRODUCT //title批号batch NO.生产日期manufacturing date // manu. Date检验日期Analysis date有效期Exp date // expiry date检验标准quality standard //inspecting basis //Specification数量QUANTITY 报告日期report date 包装规格package企业标准Company Standard//enterprise standard检查项目test items//analytical items性状appearance // characteristics//description//Character分子式molecular formula 分子量molecular wt化学式Chemical formula鉴别identification溶液外观appearance of solution澄清度&颜色clarity & color白色或类白色结晶粉末white or almost white crystalline powder味微苦 a little bitter taste无色无味odorless,smelless酸碱度acidity and alkalinity铅盐Plumbum salts 砷盐Arsonium salts有关物质related substances 分为：individual impurity substance NMT….；total impurity substance NMT。

序号 English Chinese 序号 English Chinese 1bend 弯曲 102shrink mark 收缩纹2broken 破烂 103stress mark顶白印3broken label标贴烂 104thin spray喷油过薄4broken screw缧丝断 105uneven coation涂色不圴5burn mark烧痕 106uneven spray喷油不均匀6burr 毛边 107uneven surface高低落差过大 7carton broken外箱烂108untrimmed thread线头过长8color deviatiion色差过大 109water mark水渍9damage 损坏 110wrinkle 皱纹10deform 变形 111wrong assortment错混装11foreign tape纸屑 112wrong color错颜色12dent mark凹陷 113wrong labelling错标贴13dirt mark污渍 114wrong packing错包装14flash 披锋 115wrong products错货品15flow mark胶料注塑纹 116wrong sewing label错缝合标贴16foreign material外物(就是脏东西 117foreign stuffing线头17gate mark水口修不好 118missing letter缺字18glue mark胶水渍 119missing segment缺字划19hole misalignment孔位不正 120part detach配件甩掉20illegible letter字型模糊不清 121part loose配件松21label peel off标贴脱落 122screw not tight缧丝未收紧22label peel up标贴浮起/分离 123uneven table surface台面不平23large gap间隙过大 124wrong letter错字24missing glue漏胶水 125wrong parts错配件25missing label漏标贴 126bent insert纸卡变形26mould 发霉 127air leakage漏气27no glue无胶水 128cannot assembly组装不成功28oil mark油渍 129dim light灯光过暗29oxidization 氧化 130distortion 失真30paint mark补油不良 131intermittent function间断没功能31paint mark喷油渍 132missing parts漏配件32poor coating露底色 133missing products漏货品33poor fitting接合不良 134narrow goal socket袋口过窄34poor glue黏合不良 135no light无灯光35poor hot stamp烫金不良 136no sound无声音36poor parting line接合边位修不好 137noise 噪声37poor printing印刷不良 138non function无功能38poor seal封合位不良 139poor packing包装不良39poor sewing缝合不良 140poor soldering焊接不良40poor silk screen printing丝印不良 141water leakage漏水41poor spray喷油不良 142weak soung声音过弱42poor stitching缝合孔位过大 143wire damage电线烂43poor tampo printing移印不良 144wire exposed电线外露44poor trimmimg修剪不良 145wrong function错功能45poor trimmimg胶边位修不好 146wrong soung错声音46base 底座 147cracking 裂纹47rough edge边位粗糙 148blood mark血渍48rough surface表面粗糙 149high pole test failure电气高压测试失败49rust mark生锈 150insect 昆虫50scratch mark花痕 151sharp edge利边 , 毛刺51screw slip缧丝滑牙 152sharp point尖点52instruction sheet came off缺少说明书 153sharp point利角53hard to assembly装配困难 154short circuit漏电 / 短路 54poor function功能不良 155damaged window sheet彩盒损坏55too loose太松 156label misalinged标贴贴倒56scratch mark刮花 157dislocated 移位57color deviation颜色有差别,色差 158poor label sticking贴纸不良58electro-plating yellownish电镀变黄 159poor molding注塑不良59electro-plating peel off电镀脱落 160poor packing包装不良60electro-plating abrase电镀擦花 161poor electro-plating电镀不良61tempo incomplete移印不完整 162missing Part缺少附件62tempo off position移印移位 163oversize 尺寸过大63paint abrase喷油擦花 164packing damaged包装损坏64electro-plating rainbow电镀彩虹印 165poor bewing车缝不良65electro-plating shadow电镀阴阳色 166poor soldering焊接不良66electro-plating black mark电镀发黑 167poor shrink wrap收缩包装不良 67oxidatton 氧化 168poor tampo移印不良68inner carton内盒 169seam open车缝开口69gift box彩盒 170seam torn车缝穿洞70ejector mark顶针位 171stripping screw螺丝打滑71flow mark流水痕 172wrong instruction sheet 说明书错误Defect name72flow line流水纹 173blister 吸塑73fold mark折痕 174FOLD MARK ON GIFT彩盒折痕74white mark发白 175GIFT BOX DEFORM彩盒压变形 75poor transparency 透明度不良 176BLISTER DEFORM吸塑变形76sink mark凹痕 177BLISTER CRACK吸塑裂77poor contact接触不良 178BLISTER POOR HEAT SEALING吸塑不良78loosen 脱落 179gift box unseal彩盒无封口贴 79air-bubble on painting漆上有气泡 180poor silk sckeen prining印刷不良 80painting scratched油漆刮花 181over plating电镀过多 81painting peeled off油漆脱落 182under plating电镀不足82pough surface painting油漆面粗糙 183color mismatch颜色不配对83rivet 铆钉 184color misalignment颜色不配对 84blister 泡盒185color deviation颜色有差别,色差 85rust mark锈迹 186electro-plating yellownish电镀变黄86flow mark流水痕 187electro-plating peel off电镀脱落87flow line流水纹 188electro-plating abrase电镀擦花88fold mark折痕 189tempo incomplete移印不完整 89white mark发白190tempo off position移印移位90poor transparency透明度不良 191paint abrase喷油擦花91sink mark凹痕 192electro-plating rainbow电镀彩虹印 92poor contact 接触不良 193electro-plating shadow电镀阴阳色 93loosen 脱落 194electro-plating black mark电镀发黑94air-bubble on painting漆上有气泡 195oxidatton 氧化95painting scratched油漆刮花 196inner carton内盒96painting peeled off油漆脱落 197gift box彩盒97pough surface painting油漆面粗糙 198ejector mark顶针位98rivet 铆钉 199rust mark锈迹99blister 泡盒 200fixed sleeve 固定套100spring 弹簧 201Cover Plate面板101Lining 内衬 202Slide tube伸缩管203Stem Extension延长杆。

药物分析专业英语词汇表Aabsorbance 吸收度 absorbance ratio 吸收度比值absorption 吸收 absorption curve 吸收曲线absorption coefficient 吸收系数 accurate value 准确值Acid—dye colormcty 酸性染料比色法 acidimcty 酸量法acidity 酸度 activity 活度adjusted retention time 调整保留时间 absorbent 吸收剂absorption吸附 alkalinity 碱度alumina 氧化铝，矾土 ambient temperature 室温ammonium thiocyanate 硫氰酸铵 analytical quality control 分析质量控制 anhydrous substance 干燥品antioxidant 抗氧剂 application of sample 点样area normalization method 面积归一法 arsenic 砷arsenic sport 砷斑 assay 含量测定assay tolerance 含量限度 attenuation 衰减acid burette 酸式滴定管 alkali burette 碱式滴定管a mortar 研钵Bback extraction 反萃取 band absorption 谱带吸收batch 批 batch number 批号Benttendorlf method 白田道夫法 between day precision 日间密度精biotransformation 生物转化 blank test 空白试验boiling range 沸程 British Pharmacopeia 英国药典bromate titration 溴酸盐滴定法 bromine method 溴量法bromothymol blue 溴麝香酚蓝bulk drug 原料药by—product 副产物breaker 烧杯burette glass bead nozzle 滴定管 brown acid burette 棕色酸式滴定管Ccalibration curve 校正曲线 calomel electrode 甘汞电极calorimetry 量热分析 capacity factor 容量因子capillary gas chromatography 毛细管气相色谱法carrier gas 载气characteristics description 性状chelate compound 螯合物 chemical equivalent 化学当量Chinese pharmacopeia 中国药典 Chinese material medicine 中成药Chinese material midical preparation 中药制剂 chiral 手性的chiral carbon atom 手性碳原子 chromatogram 色谱图chromatography 色谱法 chromatographic column 色谱柱chromatographic condition 色谱条件 clarity 澄清度coefficient of distribution 分配系数 coefficient of variation 变异系数color change interval 变色范围 color reaction 显色反应colormetry 比色法 column efficiency 柱效column temperature 柱温 comparative test 比较试验completeness of solution 溶液的澄清度 conjugate 缀合物concentration—time curve 浓度时间曲线 confidence interval 置信区间confidence level 置信水平 controlled trial 对照试验correlation coefficient 相关系数 contrast test 对照试验congealing point 凝点 content unifarmity装量差异controlled trial 对照试验 correlation coefficient 相关系数contrast test 对照试验 counter ion 反离子cresal red 甲酚红 cuvette cell 比色池cyanide氰化物 casserole small 勺皿Ddead—stop titration 永定滴定法 dead time 死时间deflection 偏差 deflection point 拐点degassing 脱气 deionized water 去离子水deliquescence 潮解 depressor substances test 降压物质检查法 desiccant 干燥剂detection 检查 developing reagent 展开剂developing chamber 展开室 deviation 偏差dextrose 右旋糖 diastereoisomer 非对映异构体diazotization 重氮化 differential thermal analysis 差示热分析法 differential scanning calorimetry 差示扫描热法Gutzeit 古蔡 day to day precision 日间精密度dissolution 溶出度direct injection 直接进样 2,6-dichlorindophenol titration 2,6-二氯靛酚滴定法 digestion 消化diphastic titration 双向滴定 disintegration test 崩解试验dispersion 分散度 dissolubility 溶解度dissolution test 溶解度检查 distilling range 滴程distribution chromatography 分配色谱 dose 剂量drug quality control 药品质量控制 drying to constant weight 干燥至恒重duplicate test 重复试验disk method water method 压片法Eeffective constituent 有效成分 effective plate number 有效板数 effective of column 柱效electrophoresis 电泳 elimination消除eluate 洗脱液 elution 洗脱enamtiomer 对映体 end absorption 末端吸收endogenous substances 内源性物质 enzyme drug 酶类药物enzyme induction 酶诱导 enzyme inhibition 酶抑制epimer 差向异构体 equilibrium constant 平衡常数error in volumetric analysis 容量分析误差exclusion chromatography 排阻色谱法 expiration date 失效期external standard method 外标法 extract 提取物extration gravimetry 提取重量法 extraction titration 提取容量法 extrapolated method外插法Erlenmeyer flask 锥形瓶 evaporating dish small 蒸发皿elongated bulb 胖肚 electronic balance MettlerAL204 MettlerAL204电子天平Ffactor 系数 fehling’s reaction 斐林实验filter 过滤 fineness of the particles 颗粒细度flow rate 流速fluorescent agent 荧光剂 fluorescence spectrophotometry 荧光分光光度法fluorescence detection 荧光检测器fluorescence analysis 荧光分析法foreign pigment 有色杂质formulary 处方集 free 游离freezing test 冻结试验 fused silica 熔融石英filter paper 滤纸Ggas chromatography 气相色谱法 gas-liquid chromatography 气液色谱法 gas purifier 气体净化器General identification test 一般鉴别试验 general notices凡例General requirements (药典) 通则 good clinical practices 药品临床管理规范 good laboratory practices 药品实验室管理规范 good manufacturing practices(GMP) 药品生产质量管理规范good supply practices(GSP) 药品供应管理规范 gradient elution 梯度洗脱grating 光栅 gravimetric method 重量法Gutzeit test 古蔡(检砷)法 glass funnel long stem 玻璃漏斗grad cylinder 量筒 glass rod 玻棒graduated pipettes 刻度吸管 GC 气相色谱Hheavy metal 重金属 half peak width 平峰宽heat conductivity 热导率height equivalent to atheoretical plate 理论塔板高度 height of an effective plate有效塔板高度high-performance liquid chromatography (HPLC)高效液相色谱法high-performance thin-layer chromatography (HPTLC)高效薄层色谱法hydrate 水合物 hydrolysis 水解hydrophilicity 亲水性 hydrophobicity 疏水性hydroxyl value 羟值 hyperchromic effect 浓色效应hypochromic effect 淡色效应 HHS-type constant temperature waterbath HHS型恒温水锅 HPLC 高效液相色谱法Iidentification 鉴别 ignition to constant weight 灼烧至恒重 immobile phase 固定相immunoassay 免疫测定 impurity 杂质inactivation 失活 index 索引indicator electrode 指示电极 indicator 指示剂inhibitor 抑制剂 injecting septum 进样隔膜胶垫instrumental analysis 仪器分析 injection value 进样阀insulin assay 胰岛素生物检测法 integrator 积分仪intercept 截距 interface 接口internal standard substance 内标物质 International unit 国际单位in vitro 体外 in vivo 体内iodide 碘化物 iodoform reation 碘仿反应iodometry 碘量法ion pair chromatography 离子对色谱 ion suppression 离子抑制ion suppression 离子抑制 ionic strength 离子强度ion-pairing agent 离子对试剂 ionization 电离isoabsorptive point 等吸收点 isocratic elution 等溶剂组成洗脱 isoelectric point 等电点isoosmotic solution 等渗溶液irreversible indicator 不可逆指示剂irreversible potential 不可逆电位KKarl Fischer titration 卡尔-费舍尔滴定Kjeldahl method for nitrogen 凯氏定氮法 Kober reagent 科伯试剂Kovats retention index 科瓦茨保留指数Llabelled amount 标示量 leading peak 前延峰leveling effect 均化效应 licensed pharmacist 执业药师 limit control 限量控制limit of detection 检测限 limit of quantitation 定量限 limit test 杂质限度试验loss on drying 干燥失重 low pressure gradient pump 氧压梯度泵 linearity and range 线性及范围linearity scanning 线性扫描 luminescence 发光litmus paper 石蕊试纸 lyophilization 冷冻干燥Mmain constituent 主成分 make-up gas 尾吹气maltol reaction 麦芽酚试验 Marquis test 马奎斯试验mass analyzer detector 质量分析检测器 mass spectrometric analysis 质谱分析 mass spectrum 质谱图mean deviation 平均偏差 melting point 熔点melting range 熔距 metabolite 代谢物metastable ion 亚稳离子 micellar chromatography 胶束色谱法 microanalysis 微量分析microcrystal 微晶 microdialysis 微透析migration time 迁移时间 Millipore filtration 微孔过滤 mobile phase 流动相molecular formula 分子式 monitor 检测monochromator 单色器 monographs 正文Nnatural product 天然产物 Nessler’s reagent 碱性碘化汞试液 neutralization 中和nitrogen content 总氮量nonaqueous acid-base titration 非水酸碱滴定 nonprescription drug ,over the counter drugs 非处方药 nonspecific impurity 一般杂质non-volatile matter 不挥发物 normal phase 正相normalization 归一化法 Nessler color comparison tube 纳氏比色管Onotice 凡例 octadecyl silane bonded silicagel 十八烷基硅烷键合硅胶 odorless 辛基硅烷odorless 无臭 official name 法定名official test 法定试验 on-column detector 柱上检测器on-column injection 柱头进样 on the dried basis 按干燥品计opalescence 乳浊 optical activity 光学活性optical isomerism 旋光异构 optical purity 光学纯度organic volatile impurities 有机挥发性杂质 orthogonal test 正交试验orthophenanthroline 邻二氮菲 outlier 可疑数据overtones 倍频封 oxidation-reduction titration 氧化还原滴定oxygen flask combustion 氧瓶燃烧Ppacked column 填充柱 packing material 色谱柱填料palladium ion colorimetry 钯离子比色法 parent ion 母离子particulate matter 不溶性微粒 partition coefficient 分配系数pattern recognition(ppm)百万分之几 peak symmetry 峰不对称性peak valley 峰谷 peak width at half height 半峰宽percent transmittance 透光百分率pH indicator absorbance ratio method pH指示剂吸光度比值法pharmaceutical analysis 药物分析 pharmacopeia 药典pharmacy 药学 photometer 光度计polarimetry 旋光测定法 polarity 极性polydextran gel 葡聚糖凝胶 potentiometer 电位计potentiometric titration 电位滴定法 precipitation form 沉淀形式precision 精密度 preparation 制剂prescription drug 处方药 pretreatment 预处理primary standard 基准物质 principal component analysis 主成分分析prototype drug 原型药物 purification 纯化purity 纯度 pyrogen 热原pycnometer method 比重瓶法 plastic wash bottle 洗瓶platform balance 天平 pipette 移液管pyknowmeter flasks 容量瓶Qquality control 质量控制 quality evaluation 质量评价quality standard 质量标准 quantitative determination 定量测定quantitative analysis 定量分析 quasi-molecular ion 准分子离子Rracemization 消旋化 random sampling 随机抽样rational use of drug 合理用药 readily carbonizable substance 易炭化物质 reagent sprayer 试剂喷雾剂recovery 回收率 reference electrode 参比电极related substance 相关物质 relative density 相对密度relative intensity 相对强度 repeatability 重复性replicate determination 平行测定 reproducibility 重现性residual basic hydrolysis method 剩余碱水解法residual liquid junction potential 残余液接电位residual titration 剩余滴定 residuce on ignition 炽灼残渣resolution 分辨率 response time 响应时间retention 保留 reversed phase chromatography 反相色谱法reverse osmosis 反渗透 rinse 淋洗robustness 可靠性 round 修约reagent bottles 试剂瓶 round bottom flask 圆底烧瓶rubber suction bulb 洗耳球Ssafety 安全性 Sakaguchi test 坂口试验salt bridge 盐桥 salting out 盐析sample applicator 点样器 sample application 点样sampling 取样 saponification value 皂化值saturated calomel electrode 饱和甘汞电极 selectivity 选择性significant difference 显著性水平 significant testing 显著性检验silica get 硅胶 silver chloride electrode 氯化银电极similarity 相似性 sodium dodecylsulfate 十二基酸钠solid-phase extraction 固相萃取 solubility 溶解度specific absorbance 吸收系数 specification 规格specificity 专属性 specific rotation 比旋度specific weight 比重 spiked 加入标准的split injection 分流进样 spray reagent 显色剂stability 稳定性 standard color solution 标准比色液standard deviation 标准差 standardization 标定standard substance 标准品 statistical error 统计误差sterility test 无菌试验 stock solution 储备液stoichiometric point 化学计量点 storage 贮藏stray light 杂散光 substrate 底物substituent 取代基 sulfate 硫酸盐sulphated ash 硫酸盐灰分 support 载体suspension 旋浊度 swelling degree 膨胀度symmetry factor 对称因子 systematic error 系统误差separating funnel 分液漏斗 stopcock 玻璃活塞scissors 剪刀 spirit lamp 酒精灯silica gel G thin layer 硅胶G薄层板Ttable 片剂 tailing factor 拖尾因子tailing peak 拖尾峰 test solution 试液thermal analysis 热分析法 thermal conductivity detector 热导检测器thermogravimetric analysis 热重分析法The United States Pharmacopoeia 美国药典The Pharmacopoeia of Japan 日本药局方thin layer chromatography 薄层色谱thiochrome reaction 硫色素反应thymol 百里酚 thymolphthalein 百里酚酞实用标准文案titer 滴定度 three-dimensional chromatogram 三维色谱图titrant 滴定剂 titration error 滴定误差titrimetric analysis 滴定分析法 tolerance 容许限total ash 总灰分 total quality control 全面质量控制traditional drugs 传统药 traditional Chinese medicine 中药turbidance 浑浊 turbidimetric assay 浊度测定法turbidimetry 比浊度 turbidity 浊度Uultracentrifugation 超速离心 ultraviolet irradiation 紫外线照射undue toxicity 异常毒性 uniform design 均匀设计uniformity of dosage units 含量均匀度 uniformity of volume 装量均匀性uniformity of weight 重量均匀性Vvalidity 可靠性 variance 方差viscosity 粘度 volatile oil determination apparatus 挥发油测定器 volatilization 挥发性volumetric analysis 容量分析 volumetric solution 滴定液volumetric flasks 比重瓶Wwave length 波长 wave number 波数weighing bottle 称量瓶 weighing form 称量形式well-closed container 密闭容器 white board 白瓷板Xxylene cyanol blue FF 二甲苯蓝FF xylenol orange 二甲酚橙ZZigzag scanning 锯齿扫描 zwitterions 两性离子Zymolysis 酶解作用 zone electrophoresis 区带电泳文档大全。

药品检验报告英语检验报告 Certificate of analysis化工有限公司chemical CO. , LTD制药(药业)有限公司Pharmaceutical co. ,Ltd.化工厂CHEMICAL PLANT精细化工有限公司FINE CHEMICAL CO., LTD品名PRODUCT //title批号batch NO.生产日期manufacturing date // manu. Date检验日期Analysis date有效期Exp date // expiry date检验标准quality standard //inspecting basis //Specification 数量QUANTITY 报告日期report date 包装规格package企业标准Company Standard//enterprise standard检查项目test items//analytical items性状appearance // characteristics//description//Character 分子式molecular formula 分子量molecular wt化学式Chemical formula鉴别identification溶液外观appearance of solution澄清度&颜色clarity & color白色或类白色结晶粉末white or almost white crystalline powder味微苦 a little bitter taste无色无味odorless,smelless酸碱度acidity and alkalinity铅盐Plumbum salts 砷盐Arsonium salts有关物质related substances 分为：individual impurity substance NMT….；total impurity substance NMT。

药品生产常用词汇中英文对照表环境，健康，安全environment，health, safety，E H S质量风险管理quality risk management, Q R M风险评估risk assessment风险控制risk control事先危害分析preliminary hazard analysis, P H A失败模式效果分析failure mode effects analysis，F M E A危害分析及主要控制点hazard analysis and critical control points, H A C C P 过失树分析fault tree analysis, FTA两次失败之间的平均时间mean time between failure, M T B F主题事务专家subject matter expert, S M E缎带式混合机ribbon blender在线清洗clean in place，CIP锥型混合机conical screw blender辊压制粒roller compaction压片能力compressibility导流管wurster column中间过程控制in process control, IPC物料桶intermediary bulk containers, IBCs关键工艺参数critical process parameters, CPP工艺验证process validation前验证/前瞻性验证prospective validation同步验证concurrent validation回顾性验证retrospective validation个人防护设备personal protective equipment, PPE职业暴露限值occupational exposure limit, O E L职业暴露等级occupational exposure bands, O E B口服固体制剂oral solid dosage, OSD人流/物流person flow / material flow药物活性成分active pharmaceutical ingredients，API中间体intermediate products需氧细菌aerobic bacteria安瓿瓶ampoule厌氧细菌anaerobic bacteria空态洁净区as - bulit clean room无菌生产aseptic processing静态at - rest灭菌釜‘ autoclave微生物污染水平bioburden生物指示剂biological indicators吹灌封blow/fill/seal玻璃瓶bottle轧盖capping洁净区clean area洁净级别cleanliness level在线清洗clean in place, CIP洁净室clean room菌落数colony forming unit, C F U组分component压缩气体compressed gas污染contaminant关键区域critical areas关键表面critical surfaces菌种保藏culture preservation脱水培养基dehydrated media隧道烘箱depyrogenating tunnel消毒disinfection直接接种法direct inoculation method干热灭菌法dry heat sterilization染色浴dye bath混悬剂emulsion内毒素endotoxin环氧乙烷ethylene oxide面罩face mask灌装filling硫乙醇酸盐流体培养基fluid thioglycollate medium词汇表脆碎性friability真菌fungi着装gowning热分布heat distribution热穿透heat penetration供热通风与空气调节heating, ventilation and air conditioning, H V A C 高效空气过滤器high efficiency particulate air filter, H E P A高压电检漏high frequency crack test高风险操作high risk operations疏水性hydrophobic behaviour卫生hygiene完整性integrity干预intervention辐射irradiation隔离器isolator层流laminar flow缓冲容器level vessel培养基灌装media filling微生物学microbiology微生物microorganism含多种溶剂的混合溶剂mixtures of various solvents改良马丁培养基modified Martin medium监测计划monitoring program阴性对照negative control软膏剂ointments眼用制剂ophthalmic preparation参数放行parametric release未完全密封状态partially closed state微粒particulate悬浮粒子particle增塑剂plasticizer日允许接触剂量permitted daily exposure, PDE极化过滤器polarisation filter阳性对照positive control内包装材料primary package materials非无菌单元的概率probability of non - sterile unit, PNSU 无菌工艺模拟试验process stimulation test保护性眼罩protective goggle热原pyrogen无菌药品Aseptic drug快速传递口rapid transfer ports, RTPs即灭菌胶塞ready for sterilization stoppers，RFS即用胶塞ready for use stoppers, R F U回收测试recovery test冗余过滤redundant filtration储料罐reservoir限制进出隔离系统restricted access barrier system, R A RS 清洁sanitization沉降碟法settle plates区域隔离sit - over大豆胰蛋白胨培养基soybean - casein digest medium质量标准specifications孢子spore杀孢子剂sporicidal标准操作规程standard operation procedure, SOP无菌保证水平sterility assurance level, SAL无菌检査sterility test无菌药品sterile pharmaceutical products灭菌sterilization在线灭菌sterilization in place, SIP储液罐storage vessel表面取样法surface sampling最终灭菌terminal sterilization总有机碳total organic carbon, T O C透明度transparency紊流turbulence单向流unidirectional airflow用户需求标准user requirement specifications，URS西林瓶vial目检visual inspection定量空气法volumetric air称量箱weighing boxes最差条件worst case基本设计basic design按批次生产batch - based production混合blending混批blending batches阶段性生产campaign - based production清场cleanance or site cleaning在线清洗clean in place, CIP概念设计concept design连续生产continuous production委托生产contract manufacture委托检验contract analysis关键偏差critical deviation关键工艺参数critical process parameter, CPP关键操作步骤critical processing step交叉污染cross contamination设计确认design qualification，DQ详细设计detailed design设备使用日志equipment logbook预期收率expected yield有效期expiry date良好工程实践good engineering practice, GEPC 存期holding time杂质档案impurity profile过程控制in _ process control过程取样in _ process sampling安装确认installation qualification, IQ中间体intermediate维护基本实践maintenance basic practice维护最佳实践maintenance best practice,维护良好实践maintenance good practice维护计划maintenance plan维护管理程序maintenance program主细胞库master cell b a n k ，MCB主生产和控制记录master production and control record, MP&CR 不合格non - conformance运行确认operation qualification, OQ原料药续表超标out of specification , OOS性能确认performance qualification, PQ原始细胞库preliminary cell b a n k ，PCB质量协.quality agreement质量审核quality review快速传递接口rapid transfer port，RTP物料平衡reconciliation拒收reject复验期retest date环境、健康及安全safety, environment, health, EHS 半连续生产semi - continuous production质量标准。