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查新日期: 2016 年 10 月 18 日
序号 目录内容(中英文对照)
1 General Requirements for Tests and Assays检查与含量分析的一般要求
2 <1>Injecti**注射剂
3 <2>Oral Drug Products-Product Quality Tests口服药物产品—产品质量测试
4 <3>Topical and Transdermal Drug Product Quality Tests局部和透皮药物产品—产品质量测试
5 <4>Mucosal Drug Products-Product Quality Tests粘膜药物产品-产品质量测试
6 <5>Inhalation and Nasal Drug Products-General Information and Product Quality Tests
吸入剂产品—一般信息和产品质量测试
7 <7>Labeling标签
8 <11>USP reference StandardsUSP标准品
9 Apparatus for Tests and Assays用于检查和含量分析的器具
10 <17>Prescription Container Labeling处方容器标签
11 <21>Thermometers温度计
12 <31>Volumetric Apparatus容量器具
13 <41>Balance天平
14 Microbiological Tests微生物检查法
15 <51>Antimicrobial Effectiveness Tests抗菌剂有效性检查法
16 <55>Biological Indicators-Resistance Performance Tests生物指示剂—耐药性实验
17 <61>Microbiological Examination of N**terile Products: Microbial Enumeration Tests
非无菌产品的微生物限度检查:微生物列举检查法
18 <62>Microbiological Examination of N**terile Products: Tests for Specified Microorganisms
非无菌产品的微生物限度检查:特定微生物检查法
19 <63>Mycoplasma Tests支原体检查法
20 <71>Sterility Tests无菌检查法
21 Biological Tests and Assays生物检查法和含量分析
22 <81>Antibiotics-Microbial Assays抗生素—微生物测定
23 <85>Bacterial Endotoxins Test细菌内毒素检查法
24 <87>Biological Reactivity Tests, In Vitro体外的生物反应性检查法
25 <88>Biological Reactivity Tests, In Vivo体内的生物反应性检查法
26 <89>Enzymes Used as Ancillary Materials in Pharmaceutical Manufacturing
药品生产中酶作为辅料使用
27 <90>Fetal Bovine Serum-Quality Attributes and Functionality Tests
牛胎儿血清—质量属性和功能检查法
28 <91>Calcium Pantothenate Tests泛酸钙测定法
29 <92>Growth Factors and Cytokines Used in Cell Therapy Manufacturing
在细胞疗法中使用生长因子和细胞因子
30 <111>Design and Analysis of Biological Assays生物测定法的设计和分析
31 <115>Dexpanthenol Assay右泛醇(拟胆碱药)测定法
32 <121>Insulin Assays胰岛素测定法
33 <121.1>Physicochemical Analytical Procedures for Insulins胰岛素的物理化学分析程序
34 <123>Glucagon Bioidentity Tests高血糖素的生物鉴别检查法
35 <124>Erythropoietin Bioassays红细胞生产素的微生物测定
36 <126>Somatropin Bioidentity Tests生长激素的生物鉴别检查法
37 <129>Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
重组治疗性单克隆抗体的分泌性能程序
38 <130>Protein A Quality Attributes蛋白质A的质量特征
39 <151>Pyrogen Test热原检查法
40 <161> Medical Devices-Bacterial Endoxoxin and Pyrogen Tests
医疗器械—细菌内毒素检查法和热原检查法
41 <162>Diphtheria Antitoxin Potency Testing for Human Immune Globulins
人的免疫球蛋白中白喉抗毒素效价检查法
42 <171>Vi**in B12 Activity Assay维生素B12活性测定法
43 Chemical Tests and Assays化学实验检查和测定法
44 Identification Tests鉴别检查
45 <181>Identification-Organic Nitrogenous Bases鉴别——有机氮碳化合物
46 <191>Identification Tests-General鉴别实验—通用
47 <193>Identification-Tetracylines鉴别—四环素类
48 <197>Spectrophotometric Identification Tests分光光度计鉴别实验
49 <201>Thin-Layer Chromatographic Identification Test薄层色谱鉴别实验
50 <202>Identification of Fixed Oils By Thin-Layer Chromatography
不挥发油的薄层色谱法鉴别实验
51 <203>High-Performance Thin-Layer Chromatography Procedure for Identification of Articles of Botanical Origin
高效薄层色谱法鉴别植物药品
52 Limit Test限度检查法
53 <206>Aluminum铝
54 <207>Test for 1,6-Anhydro Derivative for Enoxaparin Sodium
1,6-酐的衍生物依诺肝素钠测定法
55 <208>Anti-Factor Xa and Anti-Factor lla Assays for Unfractionated and Low Molecular Weight Heparins对普通肝素和低分子肝素进行抗Xa因素和抗lla因素实验
56 <209>Low Molecular Weight Heparins Molecular Weight Determinati**
低分子肝素的分子量测定
57 <211>Arsenic砷
58 <212>Oligosaccharide and Sulfate寡糖和硫酸盐
59 <221>Chloride and Sulfate 氯化物和硫化物
60 <223>Dimethylaniline二甲苯胺
61 <226>4-Epianhydrotetracycline4-脱水差向四环素
62 <227>4-Aminophenol in Ace**inophen-Containing Drug Products
对乙酰氨基酚药物产品中氨基酚
63 <228>Ethylene Oxide and Dioxane环氧乙烷和二氧六环
64 <231>Heavy Metals重金属
65 <232>Elemental Impurities-Limits元素杂质-限度
66 <233>Elemental Impurities-Procedures元素杂质-测定法
67 <241>Iron铁
68 <251>Lead铅
69 <261>Mercury汞
70 <267>Porosimetry by Mercury Intrusion 孔隙度测量法
71 <268>Porosity by Nitrogen Adsorption-Desorption
氮吸附-解析测定孔隙率
72 <271>Readily Carbonizable Substances Test易碳化物检查法
73 <281>Residue on Ignition炽灼残渣
74 <291>Selenium硒
75 Other Tests and Assays其他检查法和测定法
76 <301>Acid-Neutralizing Capacity酸中和容量
77 <311>Alginates Assay藻酸盐测定法
78 <341>Antimicrobial Agents-Content抗菌剂—含量
79 <345>Assay for Acid/Citrate and Phosphate柠檬酸/柠檬酸盐和磷酸盐的测定
80 <351>Assay for Steroids类固醇(甾类化合物)测定法
81 <371>Cobalamin Radiotracer Assay钴胺素放射性跟踪剂检查法
82 <381>Elastomeric Closures for Injecti**注射剂的弹性密封件
83 <391>Epinephrine Assay肾上腺素测定法
84 <401>Fats and Fixed Oils脂肪与混合油
85 <411>Folic Acid Assay叶酸测定法
86 <413>Impurities Testing in Medical Gases医用气体杂质检查
87 <415>Medical Gases Assay医用气体含量检查
88 <425>Iodometric Assay-Antibiotics碘量检查法-抗生素
89 <429>Light Diffraction Measurement of Particle Size粒径的光衍射测量法
90 <431>Methoxy Determination
甲氧基测定法
91 <441>Niacin or Niacinamide Assay
烟酰或烟酰胺测定法
92 <451>Nitrite Titration亚硝酸盐测定
93 <461>Nitrogen Determination氮测定法
94 <466>Ordinary Impurities一般杂质
95 <467>Residual Solvents残留溶剂
96 <469>Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances乙氧基物质中乙二醇、二甘醇、三甘醇测定
97 <471>Oxygen Flask Combustion氧瓶燃烧法
98 <481>Riboflavin Assay核黄素(微生物B2)测定法
99 <501>Salts of Organic Nitrogenous Bases有机氮盐
100 <503>Acetic Acid in Peptides多肽类中乙酸测定
101 <503.1>Trifluoroacetic Acid(TFA) in Peptides 多肽中的三氟乙酸(TFA)测定
102 <511>Singles-Steroid Assay单一的类固醇测定法
103 <525>Sulfur Dioxide
二氧化硫
104 <531>Thiamine Assay
硫胺素测定法
105 <541>Titrimetry
滴定法
106 <551>Vi**in E Assay维生素E测定法
107 <561>Articles of Botanical Origin植物起源药品
108 <563>Identification of Articles of Botanical Origin植物药品的鉴别
109 <565>Botanical Extracts 植物提取
110 <571>Vi**in A Assay维生素A测定法
111 <580> Vi**in C Assay维生素C测定法
112 <581>Vi**in D Assay维生素D测定法
113 <591>Zinc Determination锌的测定法
114 Physical Tests and Determinati**物理检查与测定法
115 <601>Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders-Performance Quality Tests吸入剂、鼻雾剂:气溶胶、喷雾,干粉-质量通则
116 <602>Propellants推进剂
117 <603>Topical Aerosols局部喷雾剂
118 <604>Leak Rate渗漏率
119 <610>Alternative Microbiological Sampling Methods for N**terile Inhaled and Nasal Products 非无菌吸入和鼻雾剂可供选择的微生物取样方法
120 <611>Alcohol Determination乙醇测定法
121 <616>Bulk Density and Tapped Density of Powders粉剂的堆密度与振实密度
122 <621>Chromatography色谱法
123 <631>Color and Achromicity呈色与消色
124 <641>Completeness of Solution溶解度
125 <643> Total Organic Carbon总有机碳
126 <645>Water Conductivity水电导率
127 <651>Congealing Temperature凝点温度
128 <659>Packaging and Storage Requirements包装和储藏要求
129 <660>Containers-Glass容器-玻璃
130 <661>Plastic Packaging Systems and Their Materials of C**truction
塑料包装系统和结构的材料
131 <661.1>Plastic Materials of C**truction塑料材质的结构
132 <661.2>Plastic Packaging Systems and for Pharmaceutical Use
用于制药的塑料包装系统
133 <670>Auxiliary Packaging Components辅助包装部件
134 <671>Containers-Performance Testing容器——性能测试
135 <691>Cotton棉花
136 <695>Crystallinity结晶度
137 <696>Characterization of Crystalline Solids by Microcalorimetry and Solution Calorimetry通过溶液量热学测定结晶性
138 <697>Container Content for Injecti** 注射剂容器体积
139 <698>Deliverable Volume抽取体积
140 <699>Density of Solids固体密度
141 <701>Disintegration崩解时限
142 <705>Quality Attributes of Tablets Labeled as Having a Functional Score
片剂的质量属性标记为功能性的得分
143 <711>Dissolution溶出度
144 <721>Distilling Range蒸馏范围
145 <724>Drug Release药物释放度
146 <729>Globule Size Distribution in Lipid Injectable Emulsi**脂类可注射的乳剂的粒径分布
147 <730>Plasma Spectrometry等离子体光谱学
148 <731>Loss on Drying干燥失重
149 <733>Loss on Ignition炽灼失重
150 <735>X-Ray Fluorescene Spectrometry X射线光谱
151 <736>Mass Spectrometry质谱
152 <741>Melting Range or Temperature熔距与熔点
153 <751>Metal Particles in Ophthalmic Ointments眼用软膏中的金属粒子
154 <755>Minimum fill最低装量
155 <761>Nuclear Magnetic Resonance核磁共振
156 <771>Ophthalmic Products-Quality Tests眼科产品质量实验
157 <776>Optical Microscopy光学显微镜
158 <781>Optical Rotation旋光度
159 <785>Osmolality and Osmolarity渗透压
160 <786>Particles Size Distribution Estimation by Analytical Sieving筛分法估算粒径分布
161 <787>Subvisible Particulate Matter in Therapeutic Protein Injecti**
显微计数法在治疗性蛋白注射剂中的应用
162 <788>Particulate Matter in Injecti**注射剂中的不溶性微粒
163 <789>Particulate Matter In Ophthalmic Soluti**眼用溶剂中的不溶性微粒
164 <790>Visible Particulates in Injecti**注射剂中的可见微粒
165 <791>pH
166 <795>Pharmaceutical Compounding-N**terile Preparati**药物混合—非无菌制剂
167 <797>Pharmaceutical Compounding-Sterile Preparati**药物混合—无菌制剂
168 <801>Polarography极谱法
169 <811> Powder Fineness粉剂细度
170 <821> Radioactivity放射性
171 <823> Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses 用于正电子发射断层造影术的放射性药物
172 <831>Refractive Index折光率
173 <841>Specific Gravity比重
174 <846>Specific Surface Area比表面积
175 <851>Spectrophotometry and Light-Scattering分光光度计与光散射
176 <852>Atomic Absorption Spectroscopy原子吸收光谱法
177 <853>Fluorescence Spectroscopy 荧光光谱法
178 <854>Mid-Infrared Spectroscopy中红外光谱法
179 <855>Nephelometry, Turbidimetry, and Visual Comparison比浊法、浊度发和目视比较法
180 <857>Ultraviolet-Visible Spectroscopy紫外可见光谱法
181 <861>Sutures-Diameter缝线—直径
182 <871>Sutures-Needle Attachment缝线—穿孔实验
183 <881>Tensile Strength张力
184 <891>Thermal Analysis热分析
185 <905>Uniformity of Dosage Units制剂单位的含量均匀度
186 <911>Viscosity-Capillary Methods黏度—
187 <912>Viscosity-Rotational Methods黏度-旋转法
188 <913>Viscosity-Rolling Ball Methods黏度-滚球法
189 <914>Viscosity-Pressure Driven Methods黏度-压力驱动法
190 <921>Water Determination水分测定
191 <941>Characterization of Crystalline and Partially Crystalline Solids by X-Ray Powder Diffraction(XRPD)固体通过X射线粉末衍射的结晶性和部分结晶性特征描述
192 General information通用信息
193 <1005>Acoustic Emission声频发声检测器
194 <1010>Analytical Data-Interpretation and Treatment分析数据——解释与处理
195 <1015>Automated Radiochemical Synthesis Apparatus放射性自动合成装置
196 <1024>Bovine Serum牛血清蛋白
197 <1025>Pancreatin
胰酶制剂
198 <1027>Flow Cytometry
流式细胞仪
199 <1030>Biological Assay Chapters-Overview and Glossary生物测定章节-综述和术语
200 <1031>The Biocompatibility of Materials Used in Drug Containers of Devices , and Implants用于药物容器、医疗设施和植入剂的材料的生物相溶容性
201 <1032>Design and Development of Biological Assays生物测定的设计与开发
202 <1033>Biological Assay Validation生物测定的验证
203 <1034>Analytical of Biological Assays生物测定的分析
204 <1035>Biological Indicators for Sterilization灭菌用生物指示剂
205 <1041>Biologics生物制剂
206 <1043>Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
细胞、基因与组织设计产品的辅助材料
207 <1044>Cryopreservation of Cells细胞低温保存
208 <1045>Biotechnology-Derived Articles生物技术提取产品
209 <1046>Cell and Tissue-Based Products细胞与组织产品
210 <1047>Gene Therapy Products 基因治疗产品
211 <1048>Quality of Biotechnological Products: Analysis of the Expression C**truct In Cells Used for Production of r-DNA Derived Protein Products
生物技术产品的质量:从蛋白质产品中提取的r-DNA产品在细胞中表达结果的分析
212 <1049> Quality of Biotechnological Products: Stability Biotechnological/Biological Products生物技术产品的质量:生物技术/生物产品的稳定性实验
213 <1050>Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin从人或动物细胞中提取中生物技术产品的病毒安全性评估
214 <1051>Cleaning Glass Apparatus玻璃容器的清洗
215 <1052>Biotechnology-Derived Article—Amino Acid Analysis生物技术提取法-氨基酸测定
216 <1053>Capillary Electrophoresis毛细管电泳法
217 <1054> Biotechnology-Derived Article—Isoelectric Focusing
生物技术提取法-等电点**
218 <1055> Biotechnology-Derived Article—Peptide Mapping
生物技术提取法-肽谱
219 <1056> Biotechnology-Derived Article—Polyacrylamide Gel Electrophoresis
生物技术提取法- 凝胶电泳
220 <1057> Biotechnology-Derived Article—Total Protein Assay
生物技术提取法-总蛋白测定
221 <1058>Analytical Instrument Qualification 分析仪器要求
222 <1059>Excipient Performance赋形剂
223 <1061>Color-Instrumental Measurement显色仪器测量
224 <1064>Identification of Articles of Botanical Origin by High-Performance Thin-Layer Chromatography Procedure通过高效薄层色谱法鉴别植物药品
225 <1065>Ion Chromatography 离子色谱法
226 <1066>Physical Environments That Promote Safe Medicati** Use物理环境促使安全使用药物
227 <1072>Disinfectants and Antiseptic消毒剂和防腐剂
228 <1074>Excipient Biological Safety Evaluation Guidelines赋形剂(辅料)生物安全性评估指导
229 <1078>Good Manufacturing Practices for Bulk Pharmaceutical Excipients
批药品赋形剂的生产管理规范
230 <1079>Good Storage and Shipping Practices良好的贮存与运输规范
231 <1080>Bulk Pharmaceutical Excipients-Certificate of Analysis
批药用辅料-分析证明书(COA)
232 <1084>Glycoprotein and Glycan Analysis-General C**iderati**糖蛋白和多肽分析-一般通则
233 <1086>Impurities in Drug Substance and Drug Products药物和药物产品中的杂质
234 <1087>Apparent Intrinsic Dissolution-Dissolution Testing Procedure for Rotating Disk and Stationary Disk内部的溶出度-旋转和静止的溶出度检测
235 <1088>In Vitro and Vivo Evaluation of Dosage Forms体内与体外的剂型评估
236 <1090>Assessment of Drug Product Performance-Bioavailability, Bioequivalence and Dissolution药物产品性能评估-生物利用度、生物等效性和溶出度
237 <1091>Labeling of Inactive Ingredients非活性成分标示
238 <1092>The Dissolution Procedure: Development and Validation溶出程序:开发和验证
239 <1094>Capsules-Dissolution Testing and related Quality Attributes
胶囊剂-关于产品质量的溶出测定
240 <1097>Bulk Powder Sampling Procedures粉末样品取样程序
241 <1102>Immunological Test Methods-General C**iderati**免疫测试法-一般通则
242 <1103> Immunological Test Methods-Enzyme-Linked Immunosorbent Assay(ELISA)
免疫测试法-酶联免疫法吸附测试方法(ELISA)
243 <1104> Immunological Test Methods-Immunoblot Analysis 免疫测试法-免疫印迹法
244 <1105> Immunological Test Methods-Surface Plasmon Resonance
免疫测试法-表面等离子体共振
245 <1106> Immunological Assays-Design and Validation of Immunoassays to Detect Anti-Drug Antibodies免疫测试法-设计和验证分析免疫禁毒抗体
246 <1106.1> Immunological Assays-Design and Validation of Assays to Detect Anti-Drug Neutralizing Antibody免疫测试法-分析设计和验证检测禁毒中和抗体
247 <1111>Microbiological Attributes of N**terile Products: Acceptance Criteria for Pharmaceutical Preparati** and Substances for Pharmaceutical Use
非无菌产品的微生物学检查:药用制剂和制剂过程使用的物质接受标准
248 <1112>Application of Water Activity Determination to N**terile Pharmaceutical Products非无菌药物产品水活性测定应用
249 <1113>Microbial Characterization, Identification, and Strain Typing
非无菌药品中的微生物分布
250 <1115>Bioburden Control of N**terile Drug Substance anfd Products
非无菌药物和产品的生物负载控制
251 <1116>Microbiological Control and Monitoring of Aseptic Processing Environments
无菌处理的环境的微生物控制和监测
251 <1117> Microbiological Best Laboratory Practices微生物最优的实验室规范
253 <1118>Monitoring devices-Time, Temperature, and Humidity监控装置—时间、温度和湿度
254 <1119>Near-Infrared Spectroscopy 近红外风光光度测定法
255 <1120>Raman Spectroscopy 拉曼风光光度法测定法
256 <1221>Nomenclatures命名
257 <1225>Nucleic Acid-Based Techniques-General核酸技术—通则
258 <1226> Nucleic Acid-Based Techniques-Extraction, Detection, and Sequencing
核酸技术-提取、检测和测序
259 <1127> Nucleic Acid-Based Techniques-Amplification核酸技术-扩增
260 <1128> Nucleic Acid-Based Techniques-Microarray核酸技术-微阵列
261 <1129> Nucleic Acid-Based Techniques-Genotyping核酸技术-基因分型
262 <1130> Nucleic Acid-Based Techniques-Approaches for Detecting Trace Nucleic Acids(Residual DNA Testing)核酸技术-探测微量核酸的应用(残留DNA测试)
263 <1132>Residual Host Cell Protein Measurement in Biopharmaceuticals
生物制药中残留宿主细胞蛋白测量
264 <1136>Packaging and Repackaging-Single-Unit Containers包装和再包装-单一容器
265 <1151> Pharmaceutical Dosage Forms药物剂型
266 <1152>Animal Drugs for Use in Animal Feeds兽药在动物饲料中的使用
267 <1160>Pharmaceutical Calculati** in Pharmacy Practices按处方混合的药物的计算
268 <1163> Quality Assurance in Pharmaceutical Compounding按处方混合的药物的质量保证
269 <1171>Phase-Solubility Analysis相溶解分析
270 <1174>Powder Flow粉末流动性
271 <1176>Prescription Balances and Volumetric Apparatus处方天平与容器量具
272 <1177>Good Packaging Practices良好的包装操作
273 <1178>Good Repackaging Practices良好的再包装操作
274 <1180>Human Plasma人血浆
275 <1181>Scanning Electron Microscopy扫描电子显微镜
276 <1184>Sensitization Testing致敏测试
277 <1191>Stability C**iderati** in Dispending Practice分装操作中稳定性考察
278 <1195>Significant Change Guide for Bulk Pharmaceutical Excipients
散装药用辅料更换指导原则
279 <1197>Good Distribution Practices for Bulk Pharmaceutical Excipients
散装药用辅料良好的分装操作
280 <1207>Sterile Product Packaging-Integrity Evaluation无菌产品包装—完整性评估
281 <1208>Sterility Testing-Validation Isolator Systems无菌试验—隔离系统的验证
282 <1209>Sterilization-Chemical and Physicochemical In Integrators
灭菌—化学与物理化学的指示剂以及二者的综合
283 <1211>Sterilization and Sterility Assurance of Compendial Articles
药典物品中的灭菌与灭菌保证
284 <1216>Tablet Friability片剂的脆碎度
285 <1217>Tablet Breaking Force片剂的断裂力
286 <1222>Terminally Sterilized Pharmaceutical Producys-Parametic Release
药品终端灭菌—放行参数
287 <1223>Validation of Alternative Microbiological Methods
可供选择的微生物学方法的验证
288 <1223.1> Validation of Alternative Methods to Antibiotic Microbial Assays
替代抗生素微生物检测方法的验证
289 <1224>Transfer of Analytical Procedures分析方法转移
290 <1225>Validation of Compendial Procedures药典方法的验证
291 <1226> Verification of Compendial Procedures药典方法的确认
292 <1227>Validation of Microbial Recovery From Pharmacopeial Articles
从药物中回收微生物的验证
293 <1229>Sterilization of Compendial Articles药典灭菌过程
294 <1229.1>Steam Sterilization by Direct Contact直接蒸汽灭菌
295 <1229.2>Moist Hest Sterilization of Aqueous Liquids水溶液的湿热灭菌
296 <1229.3>Monitoring of Bioburden生物负载监控
297 <1229.4>Sterilizing Filtration of Liquids溶液的无菌过滤器
298 <1229.6>Liquid-Phase Sterilization液态灭菌
299 <1229.7>Gaseous Sterilization 气态灭菌
300 <1229.8>Dry Heat Sterilization干热灭菌
301 <1229.10>Radiation Sterilization辐射灭菌
302 <1229.11>Vapor Phase Sterilization蒸汽相灭菌
303 <1230>Water for health Application血液透析过程用水
307 <1231>Water for Pharmaceutical Purposes制药用水
305 <1234> Vaccines for Human Use-Polysaccharide and Glycoconjugate Vaccines
人用疫苗-多糖和糖复合疫苗
306 <1235> Vaccines for Human Use-General C**iderati**人用疫苗-一般通则
307 <1237>Virology Test Methods病毒测试方法
308 <1238>Vaccines for Human Use-Bacterial Vaccines人用疫苗-细菌疫苗
309 <1240>Virus Testing of Human Plasma for Further Manufacture
下一步使用人血浆的病毒测试
310 <1241>Water-Solid Interacti** in Pharmaceutical Systems
在药物系统中水与固体的相互作用
311 <1251>Weighing on an Analytical Balance
关于分析天平的称重
312 <1265>Written Prescription Drug Information-Guidelines
书面的处方药信息-指南
313 <1285>Preparation of Biological Specimens for Histologic and Immunohistochemical Analysis组织和免疫组织化学分析准备的生物样品
314 <1285.1>Hematoxylin and Eosin Staining of Sectioned Tissue for Microscopic Examination
显微镜观察用苏木精和伊红染色的切片
315 <1601>Products for Nebulization-Characterization Tests
成品雾化状态-性状描述
316 <1644>Theory and Practice of Electrical Conductivity Measurements of Soluti**
溶液电导值测量方法的理论与实践
317 <1660>Evaluation of the Inner Surface Durability of Glass Containers
玻璃容器内表面耐久性评估
318 <1661> Evaluation of Plastic Packaging Systems and Their Materials of C**truction with Respect to Their User Safety Impact
关于塑料包装系统和材料结构使用安全影响的评估
319 <1663>Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
评估与制药相关的可提出的包装/交货系统
320 <1664>Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems评估药物产品中可滤取的制药包装/交货系统
321 <1664.1>Orally Inhaled and Nasal Drug Products 吸入口和鼻的药物产品
322 <1724>Semisolid Drug Products-Performance Tests半固态药物产品-性能测试
323 <1730>Plasma Spectrochemistry-Theory and Practice等离子光谱化学-理论和实践
324 <1735>X-Ray Fluorescene Spectrometry-Theory and PracticeX射线荧光光谱法-理论和实践
325 <1736>Applicati** of Mass Spectrometry质谱分析法的应用
326 <1761>Applicati** of Nuclear Magnetic Resonance Spectrometry核磁共振光谱的应用
327 <1771>Ophthalmic Products-Performance Tests眼用产品-性能测试
328 <1787>Measurement of Subvisible Particulate Matter Therapeutic Protein Injecti**
用显微镜测量方法测量治疗性蛋白注射剂的不溶性微粒
329 <1788>Methods for the Determination of Particulate Matter in Injecti** and Ophthalmic Soluti**注射剂和眼用溶液的不溶性微粒测定方法的选择
330 <1852>Atomic Absorption Spectroscopy-Theory and Practice原子吸收光谱法-理论和实践
331 <1853> Fluorescence Spectroscopy-Theory and Practice荧光光谱法-理论和实践
332 <1854> Mid-Infrared Spectroscopy-Theory and Practice中红外光谱法-理论和实践
333 <1857> Ultraviolet-Visible Spectroscopy-Theory and Practice紫外可见光谱学-理论和实践
334 <1911>Rheometry电流测定
335 Dietary Supplements营养补充剂
336 <2021>Microbial Enumeration Tests-Nutritional and Dietary Supplements
微生物数量实验——营养与食品添加剂
337 <2022>Microbiological Procedures for Absence Microorganisms-Nutritional and Dietary Supplements不得检出特定微生物的程序—营养与营养补充剂
338 <2023>Microbiological Attributes of N**terile Nutritional Supplements
非无菌的营养与食品添加剂中的微生物分布
339 <2030>Supplemental Information for Articles of Botanical Origin植物药品的增补信息
340 <2040>Disintegration and Dissolution of Dietary Supplements食品添加剂的崩解与溶出
341 <2091>Weight Variation of Dietary Supplements食品添加剂的重量差异
342 <2232>Elemental Con**inants in Dietary Supplements膳食补充剂中的元素污染物
343 <2250>Detection of Irradiated Dietary Supplements检测被辐射的膳食补充剂
344 <2750>Manufacturing Practiced for Dietary Supplements食品添加剂的生产操作
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