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药物分析知识要点绪论：药物（drugs/medicines/pharmaceutical substances）：是指用于预防、治疗、诊断人的疾病，有目的的调节人的生理机能并规定适应证或者功能主治、用法和用量的物质。
药品（medicinal products）：通常是指由药物经一定的处方和工艺制备而成的制剂产品，是可供临床使用的商品。
药物分析（Pharmaceutical analysis）：是利用分析测定手段，发展药物的分析方法，研究药物的质量规律，对药物进行全面检查与控制的科学。
药物分析的性质：1、药品具有与人的性命相关性；2、药品具有严格的质量要求性；3、药品具有社会公共福利性药物分析的任务：就是对药进行全面的分析研究，确立药物的质量规律，建立合理有效的药物质量控制方法和标准，保证药品的质量稳定与可控，保障药品使用的安全、有效和合理。
国务院药品监督管理部门（国家食品药品监督管理局，CFDA）依据《中华人民共和国药品管理法》制定了相关的管理规范。
1、《药物非临床研究质量管理规范》（Good Laboratory Practice，GLP）；2、《药物临床试验质量管理规范》（Good Clinical Practice，GCP）；3《药品生产质量管理规范》（Good Manufacture Practice，GMP）；4、《药品经营质量管理规范》（Good Supply Practice，GSP）人用药品注册技术要求国际协调会（ICH）ICH有有关药品质量的技术要求（以代码Q标识）ICH有有关药品安全性的技术要求（以代码S标识）ICH有有关药品有效性的技术要求（以代码E标识）ICH有有关药品综合技术要求（以代码M标识）第一章药品质量研究的内容与药典概况药品标准（药品质量标准）：系根据药物自身的理化与生物学特性，按照批准的来源、处方、生产工艺、储藏运输条件等所制定的，用以检测药品质量是否达到用药要求并衡量其质量是否稳定均一的技术规定。
《分析化学》中常见词汇中英对照《分析化学》中常见词汇中英对照《分析化学》中常见词汇的中英对照第一章绪论分析化学：analytical chemistry 定性分析：qualitative analysis 定量分析：quantitative analysis 物理分析：physical analysis 物理化学分析：physico-chemical analysis 仪器分析法：instrumental analysis 流动注射分析法：flow injection analysis；FIA顺序注射分析法：sequentical injection analysis；SIA 化学计量学：chemometrics第二章误差的分析数据处理绝对误差：absolute error 相对误差：relative error 系统误差：systematic error 可定误差：determinate error随机误差：accidental error 不可定误差：indeterminate error 准确度：accuracy 精确度：precision偏差：debiation，d 平均偏差：average debiation 相对平均偏差：relative average debiation标准偏差(标准差)：standerd deviation；S 相对平均偏差：relatibe standard deviation；RSD变异系数：coefficient of variation 误差传递：propagation of error有效数字：significant figure 置信水平：confidence level显著性水平：level of significance 合并标准偏差(组合标准差)：pooled standard debiation舍弃商：rejection quotient；Q化学定量分析第三章滴定分析概论滴定分析法：titrametric analysis 滴定：titration 容量分析法：volumetric analysis化学计量点：stoichiometric point 等当点：equivalent point 电荷平衡：charge balance电荷平衡式：charge balance equation 质量平衡：mass balance 物料平衡：material balance 质量平衡式：mass balance equation第四章酸碱滴定法酸碱滴定法：acid-base titrations 质子自递反应：autoprotolysis reaction 质子自递常数：autoprotolysis constant 质子条件式：proton balance equation 酸碱指示剂：acid-base indicator 指示剂常数：indicator constant变色范围：colour change interval 混合指示剂：mixed indicator 双指示剂滴定法：double indicator titration第五章非水滴定法非水滴定法：nonaqueous titrations 质子溶剂：protonic solvent 酸性溶剂：acid solvent碱性溶剂：basic solvent 两性溶剂：amphototeric solvent 无质子溶剂：aprotic solvent均化效应：differentiating effect 区分性溶剂：differentiating solvent 离子化：ionization离解：dissociation 结晶紫：crystal violet 萘酚苯甲醇：-naphthalphenol benzyl alcohol奎哪啶红：quinadinered 百里酚蓝：thymol blue 偶氮紫：azo violet溴酚蓝：bromophenol blue第六章配位滴定法配位滴定法：compleximetry 乙二胺四乙酸：ethylenediamine tetraacetic acid,EDTA螯合物：chelate compound 金属指示剂：metal lochrome indcato r第七章氧化还原滴定法氧化还原滴定法：oxidation-reduction titration碘量法：iodimetry 溴量法：bromimetry]溴量法：bromine method 铈量法：cerimetry高锰酸钾法：potassium permanganate method 条件电位：conditional potential 溴酸钾法：potassium bromate method 硫酸铈法：cerium sulphate method 偏高碘酸：metaperiodic acid 高碘酸盐：periodate亚硝酸钠法：sodium nitrite method 重氮化反应：diazotization reaction重氮化滴定法：diazotization titration 亚硝基化反应：nitrozation reaction亚硝基化滴定法：nitrozation titration 外指示剂：external indicator外指示剂：outside indicator 重铬酸钾法：potassium dichromate method第八章沉淀滴定法沉淀滴定法：precipitation titration 容量滴定法：volumetric precipitation method 银量法：argentometric method 第九章重量分析法重量分析法：gravimetric analysis 挥发法：volatilization method引湿水(湿存水)：water of hydroscopicity 包埋(藏)水：occluded water吸入水：water of imbibition 结晶水：water of crystallization 组成水：water of composition 液-液萃取法：liquid-liquid extration溶剂萃取法：solvent extration 反萃取：counter extraction 分配系数：partition coefficient 分配比：distribution ratio 离子对(离子缔合物)：ion pair 沉淀形式：precipitation forms称量形式：weighing forms《分析化学》下册仪器分析概述物理分析：physical analysis 物理化学分析：physicochemical analysis 仪器分析：instrumental analysis第十章电位法及永停滴定法电化学分析：electrochemical analysis 电解法：electrolytic analysis method 电重量法：electtogravimetry库仑法：coulometry 库仑滴定法：coulometric titration 电导法：conductometry电导分析法：conductometric analysis 电导滴定法：conductometric titration 电位法：potentiometry直接电位法：dirext potentiometry 电位滴定法：potentiometric titration 伏安法：voltammetry极谱法：polarography 溶出法：stripping method电流滴定法：amperometric titration 化学双电层：chemical double layer相界电位：phase boundary potential 金属电极电位：electrode potential化学电池：chemical cell 液接界面：liquid junction boundary 原电池：galvanic cell电解池：electrolytic cell 银-氯化银电极：silver silver-chloride electrode液接界面：liquid junction boun 不对称电位：asymmetry potential表观PH 值：apparent PH 复合PH 电极：combination PH electrode离子选择电极：ion selective electrode 敏感器：sensor晶体电极：crystalline electrodes 均相膜电极：homogeneous membrance electrodes非均相膜电极：heterog eneous membrance electrodes非晶体电极：non-crystalline electrodes 刚性基质电极：rigid matrix electr ode负极：cathrode 正极：anode 电池电动势：eletromotive force 指示电极：indicator electrode 参比电极：reference electroade 标准氢电极：standard hydrogen electrode 一级参比电极：primary reference electrode饱和甘汞电极：standard calomel electrode 银-氯化银电极：silver silver-chloride electrode液接界面：liquid junction boundary 不对称电位：asymmetry potential表观PH 值：apparent PH 复合PH 电极：combination PH electrode离子选择电极：ion selective electrode 敏感器：sensor 晶体电极：crystalline electrodes均相膜电极：homogeneous membrance electrodes 非均相膜电极：heterog eneous membrance electrodes非晶体电极：non-crystalline electrodes 刚性基质电极：rigid matrix electrode流流体载动电极：electrode with amobile carrier 气敏电极：gas sensing electrodes酶电极：enzyme electrodes 金属氧化物半导体场效应晶体管：MOSFET 离子选择场效应管：ISFET总离子强度调节缓冲剂：total ion strength adjustment buffer,TISAB永停滴定法：dead-stop titration双电流滴定法(双安培滴定法)：double amperometric titration 第十一章光谱分析法概论普朗克常数：Plank constant 电磁波谱：electromagnetic spectrum 光谱：spectrum光谱分析法：spectroscopic analysis 原子发射光谱法：atomicemission spectroscopy质量谱：mass spectrum 质谱法：mass spectroscopy,MS第十二章紫外-可见分光光度法紫外-可见分光光度法：ultraviolet and visible spectrophotometry；UV-vis肩峰：shoulder peak 末端吸收：end absorbtion生色团：chromophor 助色团：auxochrome 红移：red shift 长移：bathochromic shift 短移：hypsochromic shift蓝(紫)移：blue shift 增色效应(浓色效应)：hyperchromic effect 减色效应(淡色效应)：hypochromic effect强带：strong band 弱带：weak band 吸收带：absorption band 透光率：transmitance,T 吸光度：absorbance谱带宽度：band width 杂散光：stray light 噪声：noise 暗噪声：dark noise 散粒噪声：signal shot nois 闪耀光栅：blazed grating 全息光栅：holographic graaing 光二极管阵列检测器：photodiode array detector偏最小二乘法：partial least squares method,PLS 褶合光谱法：convolution spectrometry 褶合变换：convolution transform,CT 离散小波变换：wavelet transform,WT 多尺度细化分析：multiscale analysis 供电子取代基：electron donating group吸电子取代基：electron with-drawing group第十三章荧光分析法荧光：fluorescence 荧光分析法：fluorometry X-射线荧光分析法：X-ray fulorometry原子荧光分析法：atomic fluorometry 分子荧光分析法：molecular fluorometry 振动弛豫：vibrational relexation 内转换：internal conversion 外转换：external conversion 体系间跨越：intersystem crossing激发光谱：excitation spectrum 荧光光谱：fluorescence spectrum 斯托克斯位移：Stokes shift荧光寿命：fluorescence life time 荧光效率：fluorescence efficiency 荧光量子产率：fluorescence quantum yield荧光熄灭法：fluorescence quemching method 散射光：scattering light瑞利光：Reyleith scanttering light 拉曼光：Raman scattering light第十四章红外分光光度法红外线：infrared ray,IR 中红外吸收光谱：mid-infrared absorption spectrum,Mid-IR远红外光谱：Far-IR 微波谱：microwave spectrum,MV 红外吸收光谱法：infrared spectroscopy红外分光光度法：infrared spectrophotometry 振动形式：mode of vibration伸缩振动：stretching vibration 对称伸缩振动：symmetrical stretching vibration不对称伸缩振动：asymmetrical stretching vibration 弯曲振动：bending vibration变形振动：formation vibration 面内弯曲振动：in-plane bending vibration, 剪式振动：scissoring vibration,面内摇摆振动：rocking vibration, 面外弯曲振动：out-of-plane bending vibration,面外摇摆振动：wagging vibration, 蜷曲振动：twisting vibration,对称变形振动：symmetrical deformation vibration,s 不对称变形振动：asymmetrical deformation vibration,as特征吸收峰：charateristic avsorption band 特征频率：characteristic frequency相关吸收峰：correlation absorption band杂化影响：hybridization affect 环大小效应：ring size effect 吸收峰的强度：intensity of absorption band 环折叠振动：ringprckering vibration第十五章原子吸收分光光度法原子光谱法：atomic spectroscopy 原子吸收分光光度法：atomic absorption spectrophotometry,AAS原子发射分光光度法：atomic emmsion spectrophotometry,AES原子荧光分光光度法：atomic fluorescence spectrophotometry,AFS第十六章核磁共振波谱法核磁共振：nuclear magnetic resonance,NMR 核磁共振波谱：NMR spectrum核磁共振波谱法：NMR spectroscopy 扫场：swept field扫频：seept frequency 连续波核磁共振：continuous wave NMR,CW NMR Fourier 变换NMR：PFT-NMR,FT-NMR 二维核磁共振谱：2D-NMR 质子核磁共振谱：proton magnetic resonance spectrum,PMR氢谱：1H-NMR 碳-13 核磁共振谱：13C-NMR spectrum,13CNMR自旋角动量：spin angular momentum 磁旋比：magnetogyric ratio磁量子数：magnetic quantum number,m 进动：precession 弛豫历程：relaxation mechanism 局部抗磁屏蔽：local diamagnetic shielding屏蔽常数：shielding constant化学位移：chemical shift 国际纯粹与应用化学协会：IUPAC磁各向异性：magnetic anisotropy 远程屏蔽效应：long range shielding effect结面：nodal plane 自旋-自旋偶合：spin-spin coupling自旋-自旋分裂：spin=spin splitting 单峰：singlet,s双峰：doublet,d 三重峰：triplet,t 四重峰：quartet 五重峰：quintet六重峰：sextet偕偶：geminal coupling 邻偶：vicinal coupling远程偶合：long range coupling 磁等价：magnetic eqivalence 自旋系统：spin system 一级光谱：first order spectrum 二级光谱(二级图谱)：second order spectrum C-H 光谱：C-H correlated spectroscopy,C-H COSY第十七章质谱法质谱分析法：mass spectrometry 质谱：mass spectrum,MS 棒图：bar graph选择离子检测：selected ion monitoring,SIM 直接进样：direct probe inlet,DPI 接口：interface气相色谱-质谱联用：gas chromatography-mass spectrometry,GC-MS高效液相色谱-质谱联用：high performance liquid chromatography-mass spectrometry,HPLC-MS电子轰击离子源：electron impact source,EI 离子峰：quasi-molecular ions 化学离子源：chemical ionization source,CI 场电离：field ionization,FI 场解析：field desorptiion,FD 快速原子轰击离子源：fast stom bombardment,FAB质量分析器：mass analyzer 磁质谱仪：magnetic-sector mass spectrometer四极杆质谱仪(四极质谱仪)：quadrupole mass spectrometer 原子质量单位：amu离子丰度：ion abundance 相对丰度(相对强度)：relative avundance基峰：base peak 质量范围：mass range 分辨率：resolution 灵敏度：sensitivity 信噪比：S/N 分子离子：molecular ion 碎片离子：fragment ion 同位素离子：isotopic ion 亚稳离子：metastable ion亚稳峰：metastable peak 母离子：paren ion 子离子：daughter 含奇数个电子的离子：odd electron 含偶数个电子的离子：even eletron,EE均裂：hom olytic cleavage 异裂(非均裂)：heterolytic cleavage 半均裂：hemi-homolysis cleavage 重排：rearragement 分子量：MW-裂解：-cleavage第十八章色谱分析法概论色谱法(层析法)：chromatography 固定相：stationary phase 流动相：mobile phase超临界流体色谱法：SFC 高效毛细管电泳法：high performance capillary electroporesis,HPEC气相色谱法：gas chromatography,GC 液相色谱法：liquid cromatography,LC超临界流体色谱法：supercritical fluid chromatography,SFC 气-固色谱法：GSC 气-液色谱法：GLC 液-固色谱法：LSC液-液色谱法：LLC 柱色谱法：column chromatography填充柱：packed column 毛细管柱：capillary column微填充柱：icrobore packed column 高效液相色谱法：high performance liquid chromatography,HPLC平板色谱法：planar 平板色谱法：plane chromatography纸色谱法：paper chromatography 薄层色谱法：thin layer chromatography,TLC薄膜色谱法；thiin film chomatography 毛细管电泳法：capillary electrophoresis,CE分配色谱法：partition chromatography 吸附色谱法：adsorpion chromaography离子交换色谱法：ion exchange chromatography,IEC 空间排阻色谱法：steric exclusion chromatography,SEC亲和色谱法：affinity chromatography 分配系数：distribution cofficient狭义分配系数：partition coefficient 凝胶色谱法：gel chromatography凝胶渗透色谱法：gel permeation chromatography,GPC 凝胶过滤色谱法：gel filtration chromatography,GFC渗透系数：permeation coefficien；Kp 化学键合相色谱法：chemically bonded-phase chromatography分配系数：distribution coefficient 靛菁绿：indocyanine气相色谱-傅立叶变换红外光谱：GC-FTIR第十九章经典液相色谱法薄层色谱法：TLC 吸附：adsorption 活化：activation脱活性：deactivation 交联度：degree of cross linking 交换容量：exchange capacity薄层板：thin layer plate 展开剂：developing solvent,developer 临界胶束浓度：criticak micolle concentration,CMC相对比移值：relative Rf,Rr 分离度：resolution,R 分离数：separation number,SN煅石膏：Gypsum 羧甲基纤维素钠：CMC-Na 吸收光谱联用：TLC-UV薄层色谱-荧光联用：TLC-F 薄层色谱-红外吸收光谱联用：TLC-IR 薄层色谱法：TLC-MS纸色谱法：paper chromatography 上行展开：ascending development 下行法展开：descending development双向展开：two dimensional develoooment第二十章气相色谱法气相色谱法：gas chromatography 前延峰：leading peak 拖尾峰：tailing peak对称因子：symmetry factor,fs 保留时间：retention time 保留体积：retention volume死时间：dead time 调整保留时间：asjusted retention time 半峰宽：peak width at half height,W1/2 or Y1/2峰宽：peak width,W等温线：isotherm 理论塔板高度：height equivalent to atheoretical plate化学键合相：chemically bonded phase 丁二酸二乙二醇聚酯：polydiethylene glycol succinate,PDEGS,DEGS高分子多孔微球：GDX 苯乙烯：STY 乙基乙烯苯：EST二乙烯苯：DVB涂壁毛细管柱：wall coated open tubular column,WCOT 载体涂层毛细管柱：supprot coated open tubular column,SCOT 热导检测器：thermal conductivity detector,TCD 氢焰离子化检测器：hydrogen flame ionization detector,FID电子捕获检测器：electron capture detector,ECD 噪声：noise,N 漂移：drift,d 灵敏度：sensitivity检测限(敏感度)：detectability,D,M 分离度：resolution归一化法：normalization method 外标法：external standardization第二十一章高效液相色谱法高效液相色谱法：high performance liquid chromatography,HPLC 高速液相色谱法：high speed LC,HSLC 高压液相色谱法：high pressure LC,HPLC 高分辨液相色谱法：high resolution LC,HRLC液固吸附色谱法(液固色谱法)：liquid-solid adsorption chromatography,LSC液液色谱法：liquid-liquid chromatography,LLC 正相：normal phase,NP反相：reversed phase,RP 化学键合相色谱法：bonded phase chromatography,BPC十八烷基：octadecylselyl,ODS 离子对色谱法：paired ion chromatography,PIC反相离子对色谱法：RPIC 离子抑制色谱法：ion suppression chromatography,ISC离子色谱法：ion chromatography,IC 手性色谱法：chiral chromatography,CC环糊精色谱法：cyclodextrin chromatography,CDC 胶束色谱法：micellar chromatography,MC亲和色谱法：affinity chromatography,AC 固定相：station ary phase化学键合相：chemically bonde phase 封尾、封顶、遮盖：end capping手性固定相：chiral stationary phase,CSP 恒组成溶剂洗脱：isocraic elution梯度洗脱：gradient elution 紫外检测器：ultraviolet detector,UVD荧光检测器：fluorophotomeric detector,FD 电化学检测器：ECD 示差折光检测器：RID 光电二极管检测器：photodiode array detector,DAD 三维光谱-波谱图：3D-spectrochromatogram 蒸发光散射检测器：evaporative light scattering detector,ELSD 安培检测器：ampere detector,AD高效毛细管电泳法：high performance capillary electrophoresis,HPCE淌度：mobility 电泳：electrophoresis电渗：electroosmosis 动力进样：hydrodynamic injection电动进样：electrokinetic injection 毛细管区带电泳法：capillary zone electrophoresis,CZE胶束电动毛细管色谱：micellar electrokinetic capillary chromatography,MECC毛细管凝胶电泳：capillary gel electrophoresis,CGE 筛分：sieving特别声明：1 ：资料来源于互联网，版权归属原作者2 ：资料内容属于网络意见，与本账号立场无关3 ：如有侵权，请告知，立即删除。
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。
药物分析专业词汇中英文对照绪论释药系统（drug delivery system，DDS）中国药典（Chinese Pharmacopoeia,ChP）美国药典（The United States Pharmacopoeia,USP）美国国家处方集（The National Formulary,NF）英国药典（British Pharmacopoeia,BP）欧洲药典（European Pharmacopoeia,Ph.Eup）国际药典（The International Pharmacopoeia,Ph.Int）良好药品实验研究规范（Good Laboratory Practice,GLP）良好药品生产规范(Good Manufacture Practice,GMP)良好药品供应规范(Good Supply Practice,GSP)良好药品临床试验规范(Good Clinical Practice,GCP)分析质量管理(Analytical Quality Control,AQC)第1章药物的鉴别试验药物的鉴别试验identification test一般鉴别试验general identification test专属鉴别试验specific identification test灵敏度sensitivity最低检出量minimum detectable quantity最低检出浓度minimum detectable concentration第2章药物的杂质检查巯基醋酸mercaptoacetic acid古蔡氏Gutzeit二乙基二硫代氨基甲酸银siliver diethyldithio-carbamate 硫酸灰分sulphated ash炽灼残渣residue on ignition热重分析法thermogravimetric analysis,TGA差示热分析法differential thermal analysis,DTA差示扫描量热法differential scanning calorimetry,DSC碱性酒石酸铜试验Fehling’s reagent异红紫酸盐isopurpurate2，3-二氨基萘2,3-diaminonaphthalene4，5-苯并苯硒二唑4，5-benzopiazselenol第3章定量分析样品前处理与测定方法的效能指标汞齐化法amalgamation method氧瓶燃烧法oxygen flask combustion method葡萄糖醛酸甙glucuronides硫酸酯sulphates血浆plasma血清serum全血whole blood治疗药物浓度监测therapeutic drug monitoring,TDM结合bound游离free缀合物conjugate l液-液提取法liquid-liquid extraction,LLE离子对试剂ion pair reagent离子对提取法ion pair extraction method反离子counter液-固提取法liquid-solid extraction LSE半自动样品制备系统advanced automated sample processor,AASP 烷基化alkylations酰基化acylations L硅烷化silylations精密度precision标准差standard deviation,SD orS相对标准差relative standard deviation变异系数coefficient of variation,批内精密度within-run precision日内精密度within-day precision批间精密度between-run precision日间精密度day to day precision准确度accuracy定量限limit of quantitation,LOQ检测限limit of detection,LOD选择性selectivity专属性specificity线性与范围linearity and range重现性ruggedness耐用性robustness散布图scatter diagram+y r:L!z7\9^'T3l'h*M荧光偏振免疫测定法fluorescence polarization immunoassay第4章巴比妥类药物的分析溴化十六烷基三甲基苄铵cetyltrimethylbenzylammonium bromide，CTMA 氯化四癸基二甲基苄铵T etradacyldimethybenzylammonium chloride，TDBA第5章芳酸及其酯类药物的分析苯甲酸及其钠盐benzoic acid and sodium benzoate布美他尼bumetanide羟苯乙酯ethylparoben丙磺舒probenecid酚黄乙胺etamsylate第6章胺类药物的分析第7章杂环类药物的分析二硝基氯苯反应Vongerichten反应戊烯二醛反应反应第8章生物碱类药物的分析生物碱alkaloids阿片gum opium扫尾剂tailing-suppressing reagent蒂巴因thebaine诺司卡品noscapine竞争离子competing ions亲脂性lipophicity拖尾因子tailing factor金刚烷adamantane第9章维生素类药物的分析维生素vitamin去氢维生素A dehydroretinol去水维生素A anhydroretinol鲸醇kitol三氯化锑反应Carr-Price反应维生素B1 thiamine hydrochloride；盐酸硫胺2，3，5-三苯基氯化四氮唑2，3，5-triphenyltetrazolium chlorid，TTC红四氮唑red tetrazoline，RT蓝四氮唑blue tetrazoline，BT3，3’-二甲基氧苯基-双-4，4’-（3，5-二苯基）氯化四氮唑{3，3’-dianisole-bis[4，4’-（3，5-dipheny）tetrazolium chloride]}有色甲……formazan铁-酚试剂iron-phenol reagente铁-柯柏试剂iron-Kober reagent南药07药理复试题一、名词解释（5分*10）1、一级动力学消除；2、非竞争性拮抗剂；3、动作电位时程；4、前致癌物；5、初次接触效应；6、synergism；7、mutation；8、GLP；9、acute toxicity；10、uptake1。
Text B How Does FDA Approve New Drugs?Under current law, all new drugs need proof that they are effective, as well as safe, before they can be approved for marketing. But it’s important to realize that no drug is absolutely safe. There is always some risk of an adverse reaction. It’s when the benefits outweigh the risks that FDA considers a drug safe enough to approve.1.outweigh [a u tˊweɪ] vt. 在重量上超过；在重要性或价值方面超过根据现行法规，对于所有新药，只有经确认安全、有效，才会被批准上市。
但是，我们应该意识到没有所谓绝对安全的药物，认识到这一点是很重要的。
任何药物都可能有不良反应。
因此，只有认定某种药物的益处大于其风险时，FDA 才会认为某种药物足够安全，可批准其上市。
In fact, it was only 25 years ago that U.S. drug law first embraced the idea of risk vs. benefit that now the key to new drugs approval. Providing evidence of safety before marketing was first required by Federal Food, Drug and Cosmetic Act in 1938, but not until the Drug Amendments of 1962 did firms also have to show a drug’s effectiveness before marketing. Before any drug gets on the market today, FDA decides—as quickly as a thorough evaluation allows—whether the studies submitted by the drug’s sponsor(usually the manufacturer) show it to be safe and effective for its intend use.1.embrace [im'breis] vt. 包括; 包含；接受；信奉, 皈依vt. & vi.拥抱n.拥抱, 怀抱2.cosmetic [kɔz'metik]n.化妆品adj.化妆用的; 美容的；装点门面的Federal Food, Drug and Cosmetic Act联邦食品、药品和化妆法案3.Drug Amendments [ə'mendmənts] 药品法修正案4.thorough ['θʌrəu] adj.彻底的；十足的；考虑周到的5.sponsor ['spɔnsə] vt.赞助, 发起, 主办n. 申办者事实上，直到25年前美国药品管理法才刚刚引入“风险-益处评估”的概念。
常见化学术语的中英文对照（1）1.TheIdeal-GasEquation理想气体状态方程2.PartialPressures分压3.RealGases:DeviationfromIdealBehavior真实气体：对理想气体行为的偏离4.ThevanderWaalsEquation范德华方程5.SystemandSurroundings系统与环境6.StateandStateFunctions状态与状态函数7.Process过程8.Phase相9.TheFirstLawofThermodynamics热力学第一定律10.HeatandWork热与功11.EndothermicandExothermicProcesses吸热与发热过程12.EnthalpiesofReactions反应热13.Hess’sLaw盖斯定律14.EnthalpiesofFormation生成焓15.ReactionRates反应速率16.ReactionOrder反应级数17.RateConstants速率常数18.ActivationEnergy活化能19.TheArrheniusEquation阿累尼乌斯方程20.ReactionMechanisms反应机理21.HomogeneousCatalysis均相催化剂22.HeterogeneousCatalysis非均相催化剂23.Enzymes酶24.TheEquilibriumConstant平衡常数25.theDirectionofReaction反应方向26.LeChatelier’sPrinciple列·沙特列原理27.EffectsofV olume,Pressure,TemperatureChangesandCatalysts体积，压力，温度变化以及催化剂的影响28.SpontaneousProcesses自发过程29.EntropyStandardEntropy熵标准熵30.TheSecondLawofThermodynamics热力学第二定律31.EntropyChanges熵变32.StandardFree-EnergyChanges标准自由能变33.Acid酸34.Bases碱35.TheProtoninWater水合质子36.ThepHScalespH值37.TheDissociationofWater水离解38.Proton-TransferReactions质子转移反应39.ConjugateAcid-BasePairs共轭酸碱对40.RelativeStrengthofAcidsandBases酸碱的相对强度41.LewisAcidsandBases路易斯酸碱42.HydrolysisofMetalIons金属离子的水解43.BufferSolutions缓冲溶液44.TheCommon-IonEffects同离子效应45.BufferCapacity缓冲容量46.FormationofComplexIons配离子的形成47.Solubility溶解度48.TheSolubility-ProductConstant溶度积常数49.PrecipitationandseparationofIons离子的沉淀与分离50.SelectivePrecipitationofIons离子的选择沉淀51.Oxidation-ReductionReactions氧化还原反应52.OxidationNumber氧化数53.BalancingOxidation-ReductionEquations 氧化还原反应方程的配平54.Half-Reaction半反应55.GalvaniCell原电池56.V oltaicCell伏特电池57.CellEMF电池电动势58.StandardElectrodePotentials标准电极电势59.OxidizingandReducingAgents氧化剂和还原剂60.TheNernstEquation能斯特方程61.Electrolysis电解62.TheWaveBehaviorofElectrons电子的波动性63.Bohr’sModelofTheHyd rogenAtom氢原子的波尔模型64.LineSpectra线光谱65.QuantumNumbers量子数66.ElectronSpin电子自旋67.AtomicOrbital原子轨道68.Thesp,d,fOrbitalsp，d，f轨道69.Many-ElectronAtoms多电子原子70.EnergiesofOrbital轨道能量71.ThePauliExclusionPrinciple泡林不相容原理72.ElectronConfigurations电子构型73.ThePeriodicTable周期表74.Row行75.Group族76.Isotopes,AtomicNumbers,andMassNumber s同位素，原子数，质量数77.PeriodicPropertiesoftheElements元素的周期律78.RadiusofAtoms原子半径79.IonizationEnergy电离能80.Electronegativity电负性81.EffectiveNuclearCharge有效核电荷82.ElectronAffinities亲电性83.Metals金属84.Nonmetals非金属85.ValenceBondTheory价键理论86.CovalenceBond共价键87.OrbitalOverlap轨道重叠88.MultipleBonds重键89.HybridOrbital杂化轨道90.TheVSEPRModel价层电子对互斥理论91.MolecularGeometries分子空间构型92.MolecularOrbital分子轨道93.DiatomicMolecules双原子分子94.BondLength键长95.BondOrder键级96.BondAngles键角97.BondEnthalpies键能98.BondPolarity键矩99.DipoleMoments偶极矩100.PolarityMolecules极性分子101.PolyatomicMolecules多原子分子102.CrystalStructure晶体结构103.Non-Crystal非晶体104.ClosePackingofSpheres球密堆积105.MetallicSolids金属晶体106.MetallicBond金属键107.Alloys合金108.IonicSolids离子晶体109.Ion-DipoleForces离子偶极力110.MolecularForces分子间力111.IntermolecularForces分子间作用力112.HydrogenBonding氢键113.Covalent-NetworkSolids原子晶体/doc/2a19175160.htmlpounds化合物115.TheNomenclature,CompositionandStructu reofComplexes配合物的命名，组成和结构116.Charges,CoordinationNumbers,andGeome tries电荷数、配位数、及几何构型117.Chelates螯合物118.Isomerism异构现象119.StructuralIsomerism结构异构120.Stereoisomerism立体异构121.Magnetism磁性122.ElectronConfigurationsinOctahedralComp lexes八面体构型配合物的电子分布123.TetrahedralandSquare-planarComplexes 四面体和平面四边形配合物124.GeneralCharacteristics共性125.s-BlockElementss区元素126.AlkaliMetals碱金属127.AlkalineEarthMetals碱土金属128.Hydrides氢化物129.Oxides氧化物130.PeroxidesandSuperoxides过氧化物和超氧化物131.Hydroxides氢氧化物132.Salts盐133.p-BlockElementsp区元素134.BoronGroupBoron,Aluminium,Gallium,I ndium,Thallium 硼族硼，铝，镓，铟，铊135.Borane硼烷136.CarbonGroupCarbon,Silicon,Germanium, Tin,Lead碳族碳，硅，锗，锡，铅137.Graphite,CarbonMonoxide,CarbonDioxid e石墨，一氧化碳，二氧化碳138.CarbonicAcid,CarbonatesandCarbides碳酸，碳酸盐，碳化物139.OccurrenceandPreparationofSilicon硅的存在和制备140.SilicicAcid，Silicates硅酸，硅酸盐141.NitrogenGroupPhosphorus,Arsenic,Antimony,andBismuth氮族磷，砷，锑，铋142.Ammonia,NitricAcid,PhosphoricAcid氨，硝酸，磷酸143.Phosphorates,phosphorusHalides磷酸盐，卤化磷144.OxygenGroupOxygen,Sulfur,Selenium,an dTellurium氧族元素氧，硫，硒，碲145.Ozone,HydrogenPeroxide臭氧，过氧化氢146.Sulfides硫化物147.HalogensFluorine,Chlorine,Bromine,Iodi ne卤素氟，氯，溴，碘148.Halides,Chloride卤化物，氯化物149.TheNobleGases稀有气体150.Noble-GasCompounds稀有气体化合物151.d-Blockelementsd区元素152.TransitionMetals过渡金属153.PotassiumDichromate重铬酸钾154.PotassiumPermanganate高锰酸钾155.IronCopperZincMercury铁，铜，锌，汞156.f-BlockElementsf区元素/doc/2a19175160.htmlnthanides镧系元素158.Radioactivity放射性159.NuclearChemistry核化学160.NuclearFission核裂变161.NuclearFusion核聚变162.analyticalchemistry分析化学163.qualitativeanalysis定性分析164.quantitativeanalysis定量分析165.chemicalanalysis化学分析166.instrumentalanalysis仪器分析167.titrimetry滴定分析168.gravimetricanalysis重量分析法169.regent试剂170.chromatographicanalysis色谱分析171.product产物172.electrochemicalanalysis电化学分析173.on-lineanalysis在线分析174.macroanalysis常量分析175.characteristic表征176.microanalysis微量分析177.deformationanalysis形态分析178.semimicroanalysis半微量分析179.systematicalerror系统误差180.routineanalysis常规分析181.randomerror偶然误差182.arbitrationanalysis仲裁分析183.grosserror过失误差184.normaldistribution正态分布185.accuracy准确度186.deviation偏差187.precision精密度188.relativestandarddeviation相对标准偏差RSD189.coefficientvariation变异系数CV 190.confidencelevel置信水平191.confidenceinterval置信区间192.significanttest显著性检验193.significantfigure有效数字194.standardsolution标准溶液195.titration滴定196.stoichiometricpoint化学计量点197.endpoint滴定终点198.titrationerror滴定误差199.primarystandard基准物质200.amountofsubstance物质的量201.standardization标定202.chemicalreaction化学反应203.concentration浓度204.chemicalequilibrium化学平衡205.titer滴定度206.generalequationforachemicalreaction化学反应的通式207.protontheoryofacid-base酸碱质子理论208.acid-basetitration酸碱滴定法209.dissociationconstant解离常数210.conjugateacid-basepair共轭酸碱对211.aceticacid乙酸212.hydroniumion水合氢离子213.electrolyte电解质214.ion-productconstantofwater水的离子积215.ionization电离216.protoncondition质子平衡217.zerolevel零水准218.buffersolution缓冲溶液219.methylorange甲基橙220.acid-baseindicator酸碱指示剂221.phenolphthalein酚酞222.coordinationcompound配位化合物223.centerion中心离子224.cumulativestabilityconstant累积稳定常数225.alphacoefficient酸效应系数226.overallstabilityconstant总稳定常数227.ligand配位体228.ethylenediaminetetraaceticacid乙二胺四乙酸229.sidereactioncoefficient副反应系数230.coordinationatom 配位原子231.coordinationnumber配位数232.lonepairelectron孤对电子233.chelatecompound螯合物234.metalindicator金属指示剂235.chelatingagent螯合剂236.masking掩蔽237.demasking解蔽238.electron电子239.catalysis催化240.oxidation氧化241.catalyst催化剂242.reduction还原243.catalyticreaction催化反应244.reactionrate反应速率245.electrodepotential电极电势246.activationenergy反应的活化能247.redoxcouple氧化还原电对248.potassiumpermanganate高锰酸钾249.iodimetry碘量法250.potassiumdichromate重铬酸钾251.cerimetry铈量法252.redoxindicator氧化还原指示253.oxygenconsuming耗氧量OC254.chemicaloxygendemanded化学需氧量COD255.dissolvedoxygen溶解氧DO256.precipitation沉淀反应257.argentimetry银量法258.heterogeneousequilibriumofions多相离子平衡259.aging陈化260.postprecipitation继沉淀261.coprecipitation共沉淀262.ignition灼烧263.fitration过滤264.decantation倾泻法265.chemicalfactor化学因数266.spectrophotometry分光光度法267.colorimetry比色分析268.transmittance透光率269.absorptivity吸光率270.calibrationcurve校正曲线271.standardcurve标准曲线272.monochromator单色器273.source光源274.wavelengthdispersion色散275.absorptioncell吸收池276.detector检测系统277.bathochromicshift红移278.Molarabsorptivity摩尔吸光系数279.hypochromicshift紫移280.acetylene乙炔281.ethylene乙烯282.acetylatingagent乙酰化剂283.aceticacid乙酸284.adiethylether乙醚285.ethylalcohol乙醇286.acetaldehtde乙醛287.β-dicarbontlcompoundβ–二羰基化合物288.bimolecularelimination双分子消除反应289.bimolecularnucleophilicsubstitution双分子亲核取代反应290.openchaincompound开链族化合物291.molecularorbitaltheory分子轨道理论292.chiralmolecule手性分子293.tautomerism互变异构现象294.reactionmechanism反应历程295.chemicalshift化学位移296.Waldeninversio瓦尔登反转n297.Enantiomorph对映体298.additionreaction加成反应299.dextro-右旋300.levo-左旋301.stereochemistry立体化学302.stereoisomer立体异构体303.Lucasreagent卢卡斯试剂304.covalentbond共价键305.conjugateddiene共轭二烯烃306.conjugateddoublebond 共轭双键307.conjugatedsystem共轭体系308.conjugatedeffect共轭效应309.isomer同分异构体310.isomerism同分异构现象/doc/2a19175160.htmlanicchemistry有机化学312.hybridization杂化313.hybridorbital杂化轨道314.heterocycliccompound杂环化合物315.peroxideeffect过氧化物效应t 316.valencebondtheory价键理论317.sequencerule 次序规则318.electron-attractinggroup吸电子基319.Huckelrule休克尔规则320.Hinsbergtest兴斯堡试验321.infraredspectrum红外光谱322.Michaelreacton麦克尔反应323.halogenatedhydrocarbon 卤代烃324.haloformreaction卤仿反应325.systematicnomenclatur 系统命名法e 326.Newmanprojection纽曼投影式327.aromaticcompound芳香族化合物328.aromaticcharacter芳香性r329.Claisencondensationreaction克莱森酯缩合反应330.Claisenrearrangement克莱森重排331.Diels-Alderreation 狄尔斯-阿尔得反应332.Clemmensenreduction克莱门森还原333.Cannizzaroreaction坎尼扎罗反应334.positionalisomers位置异构体335.unimoleculareliminationreaction单分子消除反应336.unimolecularnucleophilicsubstitution单分子亲核取代反应337.benzene苯338.functionalgrou官能团p339.configuration构型340.conformation构象341.confomationalisome构象异构体342.electrophilicaddition亲电加成343.electrophilicreagent亲电试剂344.nucleophilicaddition亲核加成345.nucleophilicreagent亲核试剂346.nucleophilicsubstitutionreaction亲核取代反应347.activeintermediate活性中间体348.Saytzeffrule查依采夫规则349.cis-transisomerism顺反异构350.inductiveeffect诱导效应t351.Fehling’sreag ent费林试剂352.phasetransfercatalysis相转移催化作用353.aliphaticcompound脂肪族化合物354.eliminationreaction消除反应355.Grignardreagent格利雅试剂356.nuclearmagneticresonance核磁共振357.alkene烯烃358.allylcation烯丙基正离子359.leavinggroup离去基团360.opticalactivity旋光性361.boatconfomation船型构象362.silvermirrorreaction银镜反应363.Fischerprojection菲舍尔投影式364.Kekulestructure凯库勒结构式365.Friedel-Craftsreaction 傅列德尔-克拉夫茨反应366.Ketone酮367.carboxylicacid羧酸368.carboxylicacidderivative羧酸衍生物369.hydroboration硼氢化反应370.bondoength键长371.bondenergy键能372.bondangle键角373.carbohydrate碳水化合物374.carbocation碳正离子375.carbanion碳负离子376.alcohol醇377.Gofmannrule霍夫曼规则378.Aldehyde醛379.Ether醚380.Polymer聚合物普通化学General Chemistry分析化学Analytical Chemistry有机化学Organic Chemistry物理化学Physical Chemistry无机化学Inorganic Chemistry普通化学和分析化学实验Experiments of General and Analytical Chemistry有机化学实验Experiments of Organic Chemistry仪器分析和物理化学实验Experiments of Instrumental Analysis and Physical Chemistry。
应用化学专业英语1单元翻译第一篇：应用化学专业英语1单元翻译1.Chemistry can be broadly defines as the science of molecules and their transformations.化学可以广泛地定义为科学的分子和他们的转换。
化学可以广泛地定义为科学的分子和他们的转换。
与数学不同，化学比人类更久远。
生命的出现和人类生活在我们地球上都最可能是特殊化学过程的结果。
化学过程存从古至今存在人们的生活中。
•最初，这些过程不受我们的控制，例如，果汁的发酵，肉和鱼的腐烂，木材的燃烧。
后来，我们学着控制化学过程，用它们来准备一系列不同的产品例如食物。
在化学的发展中，四个阶段是突出的:史前化学，希腊化学，炼金术和科学化学。
The early beginnings of chemistry were clearly motivated by practical needs of people.早期的化学显然是出于实际的需要。
火的发现为远古人提供了第一个机会去实现控制化学反应过程。
他们学会制备铜制物品，铜和其它材料是现成的。
.由于化学过程的使用早于人们的书写，因而没有书面记录有关它们的化学技巧。
可以判断他们的化学能力只有从考古的发现的各个手工艺品。
正如早期的数学发展，清楚的预示着实际需求影响着化学的发展。
但化学和数学在这个阶段可能没有互相影响。
如果它们影响了，但是没有记录证明这个。
Greek chemistry was based mainly on speculation rather than on experiment.希腊化学主要基于猜测而不是实验。
这是所有古代希腊化学的一个共同特征。
古代希腊化学家实际是希腊哲学家。
所以不足为奇的是希腊人思考比实验更有兴趣。
实际上他们很少进行实验以外的思维实验。
对于数学来说这是一个好方法，但没有一个人把它推荐在物理、化学或生物科学上。
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。
硫酸阿托品检验操作规程1. 目的建立硫酸阿托品检验标准操作规程，使硫酸阿托品检验操作规范化。
2. 范围适用于硫酸阿托品的质量检验。
3. 术语或定义3.1 GMP：药品生产质量管理规范(Good Manufacturing Practice)的英文简称。
3.2 SMP：标准管理程序（Standard Management Procedure），用于指导工作的管理类文件。
3.3 SOP：标准操作程序（Standard Operating Procedure），用于指导如何完成一项工作的文件。
4. 职责质量控制部对本规程的实施负责。
5. 程序5.1 检验依据5.1.1 《中国药典》2020年版二部（1589页）。
5.1.2 硫酸阿托品质量标准（质量标准编号：）5.1.3 《中国药典》2020年版四部。
1.【性状】1.1本品为无色结晶或白色结晶性粉末；无臭。
本品在水中极易溶解，在乙醇中易溶。
1.2熔点取本品，在120℃干燥4小时后，立即依熔点测定法检验操作规程进行测定。
本品的熔点不得低于189℃，熔融时同时分解。
2.【鉴别】2.1鉴别⑴2.1.1仪器与用具双光束红外分光光度计、压片机、玛瑙研钵2.1.2操作方法取供试品约1mg，置入玛瑙研钵研细，再取溴化钾粉(约200mg)，在玛瑙研钵中充分研磨混匀，移置于直径13mm的压模中，使铺布均匀，加压至20MPa，约60秒取出。
目视检查应均匀，无明显颗粒。
将供试片置于仪器的样品光路中，进行光谱扫描。
供试品的红外光吸收图谱应与对照的图谱（光谱集487图）一致。
2.2鉴别⑵--托烷生物碱类鉴别反应2.2.1试药发烟硝酸、乙醇2.2.2操作方法取供试品约10mg，加发烟硝酸5滴，置水浴上蒸干，得黄色的残渣，放冷，加乙醇2～3滴湿润，加固体氢氧化钾一小粒，即显深紫色。
2.3鉴别⑶--硫酸盐鉴别反应本品的水溶液显硫酸盐的鉴别反应。
2.3.1试药与试液盐酸、硝酸、氯化钡试液、醋酸铅试液、醋酸铵试液、氢氧化钠试液、、2.3.2操作方法取本品适量，加水使溶解，取溶液做如下试验：⑴取供试品溶液，滴加氯化钡试液，即生成白色沉淀；分离，沉淀在盐酸或硝酸中均不溶解。
Appendix VI Qualitative Reactions and Tests(Ph. Eur. method 2.3.1)Acetates 乙酸酯A. Heat the substance to be examined with an equal quantity of oxalic acid R. Acidvapours with the characteristic odour of acetic acid are liberated, showing an acid reaction (2.2.4).用相同量的草酸加热供试品，显示出其特有的酸味，显酸性反应。
B. Dissolve about 30 mg of the substance to be examined in 3 mL of water R or use 3 mL of the prescribed solution. Add successively 0.25 mL of lanthanum nitrate solution R, 0.1 mL of 0.05 M iodine and 0.05 mL of dilute ammonia R2. Heat carefully to boiling.Within a few minutes a blue precipitate is formed or a dark blue colour develops. Acetyl GroupsIn a test-tube about 180 mm long and 18 mm in external diameter, place about 15 mg of the substance to be examined, or the prescribed quantity, and 0.15 mL of phosphoric acid R. Close the tube with a stopper through which passes a smalltest-tube about 100 mm long and 10 mm in external diameter containing water R to act as a condenser. On the outside of the smaller tube, hang a drop of lanthanum nitrate solution R. Except for substances hydrolysable only with difficulty, place the apparatus in a water-bath for 5 min,then take out the smaller tube. Remove the drop and mix it with 0.05 mL of 0.01 M iodine on a tile. Add at the edge 0.05 mL of dilute ammonia R2. After 1 min to 2 min, a blue colour develops at the junction of the two drops; the colour intensifies and persists for a short time.For substances hydrolysable only with difficulty heat the mixture slowly to boiling over an open flame and then proceed as prescribed above.AlkaloidsDissolve a few milligrams of the substance to be examined, or the prescribed quantity, in 5 mL of water R, add dilute hydrochloric acid R until an acid reaction occurs (2.2.4), then 1 mL of potassium iodobismuthate solution R. An orange or orange-red precipitate is formed immediately.Aluminium SaltsDissolve about 15 mg of the substance to be examined in 2 mL of water R or use 2 mL of the prescribed solution. Add about 0.5 mL of dilute hydrochloric acid R and about 0.5 mL of thioacetamide reagent R. No precipitate is formed. Add dropwise dilute sodium hydroxide solution R. A gelatinous white precipitate is formed which dissolves on further addition of dilute sodium hydroxide solution R. Gradually add ammonium chloride solution R. The gelatinous white precipitate is re-formed. Amines, Primary AromaticAcidify the prescribed solution with dilute hydrochloric acid R and add 0.2 mL of sodium nitrite solution R. After 1 min to 2 min, add 1 mL of b-naphthol solution R. An intense orange or red colour and usually a precipitate of the same colour are produced.Ammonium SaltsTo the prescribed solution add 0.2 g of magnesium oxide R. Pass a current of air through the mixture and direct the gas that escapes just beneath the surface of a mixture of 1 mL of 0.1 M hydrochloric acid and 0.05 mL of methyl red solution R. The colour of the indicator changes to yellow. On addition of 1 mL of a freshly prepared 100 g/L solution of sodium cobaltinitrite R a yellow precipitate is formed.Ammonium Salts and Salts of Volatile BasesDissolve about 20 mg of the substance to be examined in 2 mL of water R or use 2 mL of the prescribed solution. Add 2 mL of dilute sodium hydroxide solution R. On heating, the solution gives off vapour that can be identified by its odour and by its alkaline reaction (2.2.4).Antimony CompoundsDissolve with gentle heating about 10 mg of the substance to be examined in a solution of 0.5 g of sodium potassium tartrate R in 10 mL of water R and allow to cool: to 2 mL of this solution, or to 2 mL of the prescribed solution, add sodium sulfide solution R dropwise; an orange-red precipitate is formed which dissolves on addition of dilute sodium hydroxide solution R.Arsenic CompoundsHeat 5 mL of the prescribed solution on a water-bath with an equal volumeof hypophosphorous reagent R. A brown precipitate is formed.Barbiturates, Non-nitrogen SubstitutedDissolve about 5 mg of the substance to be examined in 3 mL of methanol R, add 0.1 mL of a solution containing 100 g/L of cobalt nitrate R and 100 g/L of calcium chloride R. Mix and add, with shaking, 0.1 mL of dilute sodium hydroxide solution R. Aviolet-blue colour and precipitate are formed.BenzoatesA. To 1 mL of the prescribed solution add 0.5 mL of ferric chloride solution R1. A dullyellowprecipitate, soluble in ether R, is formed.B. Place 0.2 g of the substance to be examined, treated if necessary as prescribed, in a test-tube. Moisten with 0.2 mL to 0.3 mL of sulfuric acid R. Gently warm the bottom of the tube. A white sublimate is deposited on the inner wall of the tube.C. Dissolve 0.5 g of the substance to be examined in 10 mL of water R or use 10 mL of the prescribed solution. Add 0.5 mL of hydrochloric acid R. The precipitate obtained,after crystallisation from warm water R and drying in vacuo, has a melting point (2.2.14)of 120 °C to 124 °C.BicarbonatesA. Introduce into a test tube 0.1 g of the substance being examined suspended in 2 mL of water or use 2 mL of the prescribed solution. Add 3 mL of 2M acetic acid , close the tube immediately using a stopper fitted with a glass tube bent at two right angles. The solution or suspension effervesces. Heat gently and collect the gas in 5 mL of a 4.73% w/v solution of barium hydroxide. A white precipitate is produced which dissolves on addition of an excess of 7M hydrochloric acid .B. Treat a solution of the substance being examined with a solution of magnesium sulfate; no precipitate is produced (distinction from carbonates). Boil; a white precipitate is produced.C. A solution liberates carbon dioxide when boiled.Bismuth and Bismuth CompoundsA. To 0.5 g of the substance to be examined add 10 mL of dilute hydrochloric acid R or use 10 mL of the prescribed solution. Heat to boiling for 1 min. Cool and filter if necessary. To 1 mL of the solution obtained add 20 mL of water R. A white or slightly yellow precipitate is formed which on addition of 0.05 mL to 0.1 mL of sodium sulfide solution R turns brown.B. To about 45 mg of the substance to be examined add 10 mL of dilute nitric acid R or use 10 mL of the prescribed solution. Boil for 1 min. Allow to cool and filter if necessary. To 5 mL of the solution obtained add 2 mL of a 100 g/L solution of thioureaR. A yellowish-orange colour or an orange precipitate is formed. Add 4 mL of a 25 g/L solution of sodium fluoride R. The solution is not decolorised within 30 min. BromidesA. Dissolve in 2 mL of water R a quantity of the substance to be examined equivalent to about 3 mg of bromide (Br–) or use 2 mL of the prescribed solution. Acidify with dilutenitric acid R and add 0.4 mL of silver nitrate solution R1. Shake and allow to stand. A curdled, pale yellow precipitate is formed. Centrifuge and wash the precipitate with three quantities, each of 1 mL, of water R. Carry out this operation rapidly in subdued light disregarding the fact that the supernatant solution may not become perfectly clear.Suspend the precipitate obtained in 2 mL of water R and add 1.5 mL of ammonia R. The precipitate dissolves with difficulty.B. Introduce into a small test-tube a quantity of the substance to be examined equivalent to about 5 mg of bromide (Br–) or the prescribed quantity. Add 0.25 mL of water R, about 75 mg of lead dioxide R, 0.25 mL of acetic acid R and shake gently. Drythe inside of the upper part of the test-tube with a piece of filter paper and allow to stand for 5 min. Prepare a strip of suitable filter paper of appropriate size. Impregnate itby capillarity, by dipping the tip in a drop of decolorised fuchsin solution R and introduce the impregnated part immediately into the tube. Starting from the tip, a violetcolour appears within 10 s that is clearly distinguishable from the red colour of fuchsin,which may be visible on a small area at the top of the impregnated part of the paper strip.Calcium and Calcium SaltsFor monographs from the European Pharmacopoeia, use tests A and B only.A. To 0.2 mL of a neutral solution containing a quantity of the substance to be examined equivalent to about 0.2 mg of calcium (Ca2+) per millilitre or to 0.2 mL of the prescribed solution add 0.5 mL of a 2 g/L solution of glyoxal-hydroxyanil R in ethanol (96 per cent) R, 0.2 mL of dilute sodium hydroxide solution R and 0.2 mL of sodium carbonate solution R. Shake with 1 mL to 2 mL of chloroform R and add 1 mL to 2 mL of water R. The chloroform layer is coloured red.B. Dissolve about 20 mg of the substance to be examined or the prescribed quantity in 5 mL of acetic acid R. Add 0.5 mL of potassium ferrocyanide solution R. The solutionremains clear. Add about 50 mg of ammonium chloride R. A white, crystalline precipitate is formed.C. To 5 mL of 0.4% w/v solution of the substance being examined add 0.2 mL of a 2% w/v solution of ammonium oxalate. A white precipitate is produced which is only sparingly soluble in 6M acetic acid but is soluble in hydrochloric acid .CarbonatesA. Introduce into a test tube 0.1 g of the substance being examined suspended in 2mL of water or use 2 mL of the prescribed solution. Add 3 mL of 2M acetic acid , close the tube immediately using a stopper fitted with a glass tube bent at two right angles. The solution or suspension effervesces evolving a colourless and odourless gas. Heatgently and collect the gas in 5 mL of 0.1M barium hydroxide. A white precipitate is produced which dissolves on addition of an excess of 7M hydrochloric acid .B. Treat a solution of the substance being examined with a solution of magnesium sulfate. A white precipitate is produced (distinction from bicarbonates).Carbonates and BicarbonatesIntroduce into a test-tube 0.1 g of the substance to be examined and suspend in 2 mL ofwater R or use 2 mL of the prescribed solution. Add 3 mL of dilute acetic acid R. Closethe tube immediately using a stopper fitted with a glass tube bent twice at right angles.The solution or the suspension becomes effervescent and gives off a colourless and odourless gas. Heat gently and collect the gas in 5 mL of barium hydroxide solution R. Awhite precipitate is formed that dissolves on addition of an excess of hydrochloric acid R1.ChloridesA. Dissolve in 2 mL of water R a quantity of the substance to be examined equivalent to about 2 mg of chloride (Cl–) or use 2 mL of the prescribed solution. Acidify with dilutenitric acid R and add 0.4 mL of silver nitrate solution R1. Shake and allow to stand. A curdled, white precipitate is formed. Centrifuge and wash the precipitate with three quantities, each of 1 mL, of water R. Carry out this operation rapidly in subdued light, disregarding the fact that the supernatant solution may not become perfectly clear. Suspend the precipitate in 2 mL of water R and add 1.5 mL of ammonia R. The precipitate dissolves easily with the possible exception of a few large particles which dissolve slowly.B. Introduce into a test-tube a quantity of the substance to be examined equivalent to about 15 mg of chloride (Cl–) or the prescribed quantity. Add 0.2 g of potassium dichromate R and 1 mL of sulfuric acid R. Place a filter-paper strip impregnated with 0.1mL of diphenylcarbazide solution R over the opening of the test-tube. The paper turns violet-red. The impregnated paper must not come into contact with the potassium dichromate.CitratesFor monographs from the European Pharmacopoeia, use test A only.A. Dissolve in 5 mL of water R a quantity of the substance to be examined equivalent to about 50 mg of citric acid or use 5 mL of the prescribed solution. Add 0.5 mL of sulfuric acid R and 1 mL of potassium permanganate solution R. Warm until the colourof the permanganate is discharged. Add 0.5 mL of a 100 g/L solution of sodium nitroprusside R in dilute sulfuric acid R and 4 g of sulfamic acid R. Make alkaline with concentrated ammonia R, added dropwise until all the sulfamic acid has dissolved. Addition of an excess of concentrated ammonia R produces a violet colour, turning toviolet-blue.B. To a neutral solution of the substance being examined add a solution of calcium chloride; no precipitate is produced. Boil the solution; a white precipitate is produced which is soluble in 6M acetic acid .EstersTo about 30 mg of the substance to be examined or the prescribed quantity add 0.5 mL ofa 70 g/L solution of hydroxylamine hydrochloride R in methanol R and 0.5 mL of a 100 g/Lsolution of potassium hydroxide R in ethanol (96 per cent) R. Heat to boiling, cool, acidifywith dilute hydrochloric acid R and add 0.2 mL of ferric chloride solution R1 diluted tentimes. A bluish-red or red colour is produced.IodidesA. Dissolve a quantity of the substance to be examined equivalent to about 4 mg of iodide (I–) in 2 mL of water R or use 2 mL of the prescribed solution. Acidify with dilute nitric acid R and add 0.4 mL of silver nitrate solution R1. Shake and allow to stand. A curdled, pale-yellow precipitate is formed. Centrifuge and wash with three quantities, each of 1 mL, of water R. Carry out this operation rapidly in subdued light disregardingthe fact that the supernatant solution may not become perfectly clear. Suspend the precipitate in 2 mL of water R and add 1.5 mL of ammonia R. The precipitate does not dissolve.B. To 0.2 mL of a solution of the substance to be examined containing about 5 mg of iodide (I–) per millilitre, or to 0.2 mL of the prescribed solution, add 0.5 mL of dilute sulfuric acid R, 0.1 mL of potassium dichromate solution R, 2 mL of water R and 2 mL sulfuric acid R, 0.1 mL of potassium dichromate solution R, 2 mL of water R and 2 mL of chloroform R. Shake for a few seconds and allow to stand. The chloroform layer is coloured violet or violet-red.Iron and Iron SaltsA. Dissolve a quantity of the substance to be examined equivalent to about 10 mg of iron (Fe2+) in 1 mL of water R or use 1 mL of the prescribed solution. Add 1 mL of potassium ferricyanide solution R. A blue precipitate is formed that does not dissolve on addition of 5 mL of dilute hydrochloric acid R.B. Dissolve a quantity of the substance to be examined equivalent to about 1 mg of iron (Fe3+) in 30 mL of water R. To 3 mL of this solution or to 3 mL of the prescribed solution, add 1 mL of dilute hydrochloric acid R and 1 mL of potassium thiocyanate solution R. The solution is coloured red. Take two portions, each of 1 mL, of the mixture. To one portion add 5 mL of isoamyl alcohol R or 5 mL of ether R. Shake and allow to stand. The organic layer is coloured pink. To the other portion add 2 mL of mercuric chloride solution R. The red colour disappears.C. Dissolve a quantity of the substance to be examined equivalent to not less than 1 mg of iron (Fe3+) in 1 mL of water R or use 1 mL of the prescribed solution. Add 1 mL ofpotassium ferrocyanide solution R. A blue precipitate is formed that does not dissolve on addition of 5 mL of dilute hydrochloric acid R.LactatesDissolve a quantity of the substance to be examined equivalent to about 5 mg of lacticacid in 5 mL of water R or use 5 mL of the prescribed solution. Add 1 mL of bromine water R and 0.5 mL of dilute sulfuric acid R. Heat on a water-bath until the colour is discharged, stirring occasionally with a glass rod. Add 4 g of ammonium sulfate R and mix. Add dropwise and without mixing 0.2 mL of a 100 g/L solution of sodium nitroprusside R in dilute sulfuric acid R. Still without mixing add 1 mL of concentrated ammonia R. Allow to stand for 30 min. A dark green ring appears at the junction of the two liquids.Lead and Lead CompoundsA. Dissolve 0.1 g of the substance to be examined in 1 mL of acetic acid R or use 1 mL of the prescribed solution. Add 2 mL of potassium chromate solution R. A yellow precipitate is formed that dissolves on addition of 2 mL of strong sodium hydroxide solution R.B. Dissolve 50 mg of the substance to be examined in 1 mL of acetic acid R or use 1 mL of the prescribed solution. Add 10 mL of water R and 0.2 mL of potassium iodide solution R. A yellow precipitate is formed. Heat to boiling for 1 min to 2 min. The precipitate dissolves. Allow to cool. The precipitate is re-formed as glistening, yellow plates.LigninA. Lignin cell walls are coloured bright red by soaking them in a 1% w/v solution of phloroglucinol in ethanol (90%) and adding 0.1 to 0.2 ml of hydrochloric acid .B. Lignified tissues are coloured yellow by aniline hydrochloride solution. Magnesium and Magnesium SaltsFor monographs from the European Pharmacopoeia, use test A only.A. Dissolve about 15 mg of the substance to be examined in 2 mL of water R or use 2 mL of the prescribed solution. Add 1 mL of dilute ammonia R1. A white precipitate is formed that dissolves on addition of 1 mL of ammonium chloride solution R. Add 1 mL of disodium hydrogen phosphate solution R. A white crystalline precipitate is formed.B. To 0.5 mL of a neutral or slightly acidic solution of the substance being examined add 0.2 mL of a 0.1% w/v solution of titan yellow and 0.5 mL of 0.1M sodium hydroxide.A bright red turbidity is produced which gradually settles to give a bright red precipitate.Mercury and Mercury CompoundsA. Place about 0.1 mL of a solution of the substance to be examined on well-scraped copper foil. A dark-grey stain that becomes shiny on rubbing is formed. Dry the foil andheat in a test-tube. The spot disappears.B. To the prescribed solution add dilute sodium hydroxide solution R until strongly alkaline (2.2.4). A dense yellow precipitate is formed (mercuric salts).NitratesTo a mixture of 0.1 mL of nitrobenzene R and 0.2 mL of sulfuric acid R, add a quantity ofthe powdered substance equivalent to about 1 mg of nitrate (NO3–) or the prescribedquantity. Allow to stand for 5 min. Cool in iced water and add slowly and with mixing 5 mLof water R, then 5 mL of strong sodium hydroxide solution R. Add 5 mL of acetone R. Shake and allow to stand. The upper layer is coloured deep violet.Phosphates (Orthophosphates)A. To 5 mL of the prescribed solution, neutralised if necessary, add 5 mL of silver nitrate solution R1. A yellow precipitate is formed whose colour is not changed by boiling and which dissolves on addition of ammonia R.B. Mix 1 mL of the prescribed solution with 2 mL of molybdovanadic reagent R. A yellow colour develops.Potassium and Potassium SaltsA. Dissolve 0.1 g of the substance to be examined in 2 mL of water R or use 2 mL of the prescribed solution. Add 1 mL of sodium carbonate solution R and heat. No precipitate is formed. Add to the hot solution 0.05 mL of sodium sulfide solution R. No precipitate is formed. Cool in iced water and add 2 mL of a 150 g/L solution of tartaric acid R. Allow to stand. A white crystalline precipitate is formed.B. Dissolve about 40 mg of the substance to be examined in 1 mL of water R or use 1 mL of the prescribed solution. Add 1 mL of dilute acetic acid R and 1 mL of a freshly prepared 100 g/L solution of sodium cobaltinitrite R. A yellow or orange-yellow precipitate is formed immediately.SalicylatesA. To 1 mL of the prescribed solution add 0.5 mL of ferric chloride solution R1. A violet colour is produced that persists after the addition of 0.1 mL of acetic acid R.B. Dissolve 0.5 g of the substance to be examined in 10 mL of water R or use 10 mL of the prescribed solution. Add 0.5 mL of hydrochloric acid R. The precipitate obtained,after recrystallisation from hot water R and drying in vacuo, has a melting point (2.2.14)of 156 °C to 161 °C.SilicatesMix the prescribed quantity of the substance to be examined in a lead or platinum crucibleby means of a copper wire with about 10 mg of sodium fluoride R and a few drops of sulfuric acid R to give a thin slurry. Cover the crucible with a thin, transparent plate of plastic under which a drop of water R is suspended and warm gently. Within a short timea white ring is rapidly formed around the drop of water.Silver and Silver CompoundsDissolve about 10 mg of the substance to be examined in 10 mL of water R or use 10 mLof the prescribed solution. Add 0.3 mL of hydrochloric acid R1. A curdled, white precipitate is formed that dissolves on addition of 3 mL of dilute ammonia R1. Sodium and Sodium SaltsA. Dissolve 0.1 g of the substance to be examined in 2 mL of water R or use 2 mL of the prescribed solution. Add 2 mL of a 150 g/L solution of potassium carbonate R and heat to boiling. No precipitate is formed. Add 4 mL of potassium pyroantimonate solution R and heat to boiling. Allow to cool in iced water and if necessary rub the inside of the test-tube with a glass rod. A dense white precipitate is formed.B. Dissolve a quantity of the substance to be examined equivalent to about 2 mg of sodium (Na+) in 0.5 mL of water R or use 0.5 mL of the prescribed solution. Add 1.5mLof methoxyphenylacetic reagent R and cool in ice-water for 30 min. A voluminous, white, crystalline precipitate is formed. Place in water at 20 °C and stir for 5 min. The precipitate does not disappear. Add 1 mL of dilute ammonia R1. The precipitate dissolves completely. Add 1 mL of ammonium carbonate solution R. No precipitate is formed.SulfatesA. Dissolve about 45 mg of the substance to be examined in 5 mL of water R or use 5 mL of the prescribed solution. Add 1 mL of dilute hydrochloric acid R and 1 mL of barium chloride solution R1. A white precipitate is formed.B. To the suspension obtained during reaction (a), add 0.1 mL of 0.05 M iodine. The suspension remains yellow (distinction from sulfites and dithionites), but is decolorisedby adding dropwise stannous chloride solution R (distinction from iodates). Boil the mixture. No coloured precipitate is formed (distinction from selenates and tungstates).TartratesA. Dissolve about 15 mg of the substance to be examined in 5 mL of water R or use 5 mL of the prescribed solution. Add 0.05 mL of a 10 g/L solution of ferrous sulfate R and0.05 mL of dilute hydrogen peroxide solution R. A transient yellow colour is produced. After the colour has disappeared add dilute sodium hydroxide solution R dropwise. A violet or purple colour is produced.B. To 0.1 mL of a solution of the substance to be examined containing the equivalent of about 15 mg of tartaric acid per millilitre or to 0.1 mL of the prescribed solution add 0.1 mL of a 100 g/L solution of potassium bromide R, 0.1 mL of a 20 g/L solution of resorcinol R and 3 mL of sulfuric acid R. Heat on a water-bath for 5 min to 10 min. A dark-blue colour develops. Allow to cool and pour the solution into water R. The colourchanges to red.XanthinesTo a few milligrams of the substance to be examined or the prescribed quantity add 0.1mL of strong hydrogen peroxide solution R and 0.3 mL of dilute hydrochloric acid R. Heatto dryness on a water-bath until a yellowish-red residue is obtained. Add 0.1 mL of diluteammonia R2. The colour of the residue changes to violet-red.Zinc and Zinc SaltsDissolve 0.1 g of the substance to be examined in 5 mL of water R or use 5 mL of the prescribed solution. Add 0.2 mL of strong sodium hydroxide solution R. A white precipitate is formed. Add a further 2 mL of strong sodium hydroxide solution R. The precipitate dissolves. Add 10 mL of ammonium chloride solution R. The solution remainsclear. Add 0.1 mL of sodium sulfide solution R. A flocculent white precipitate is formed.(Ph. Eur. method 2.3.4)OdourOn a watch-glass 6 cm to 8 cm in diameter, spread in a thin layer 0.5 g to 2.0 g of thesubstance to be examined. After 15 min, determine the odour or verify the absence of odour.。
