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USP40-NF35通用章节目录


USP40-NF35 通用章节指导目录

Guide to General Chapters
(标注底色部分为 USP40-NF35 新增章节)
General Requirements for Test and Assays

通用章节指导

检查与含量分析的一般要求

<1>INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS 注射和植入药物产品(注射用) —产品质量测试 <1>INJECTIONS 注射剂 <2>ORAL DRUG PRODUCTS—PRODUCT QUALITY TESTS 口服药物产品质量测试 <3>TOPICAL AND TRANSDERMAL DRUG PRODUCTS—PRODUCT QUALITY TESTS 局部和透皮药物产品—产品质量测试 <4>MUCOSAL DRUG PRODUCTS—PRODUCT QUALITY TESTS 粘膜药物产品质量测试 <5>INHALATION AND NASAL DRUG PRODUCTS—GENERAL INFORMATION AND PRODUCT QUALITY TESTS 吸入剂产品—产品质量测试 <7>LABELING 标签 <11>USP REFERENCE STANDARDS USP 标准品

Apparatus for Test and Assays
<21>THERMOMETERS <41>BALANCES 天平

用于检查与含量分析的器具

<17>PRESCRIPTION CONTAINER LABELING 处方容器标签 温度计(本版本已删除) <31>VOLUMETRIC APPARATUS 容量器具

Microbiological Tests

微生物检查法
抗菌剂有效性检查法

<51>ANTIMICROBIAL EFFECTIVENESS TESTING 生物指示剂-耐药性实验

<55>BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS < 61 > MICROBIOLOGICAL EXAMINATION OF NONSTERILE 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 < 62 > MICROBIOLOGICAL EXAMINATION OF NONSTERILE 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 <63>MYCOPLASMA TESTS 支原体检查法 <71>STERILITY TESTS 无菌检查法

Biological tests and assays

生物检查法与测定法
细菌内毒素检查法 体外的生物反应性检查法

<81>ANTIBIOTICS—MICROBIAL ASSAYS 抗生素-微生物测定 <85>BACTERIAL ENDOTOXINS TEST <87>BIOLOGICAL REACTIVITY TESTS, IN VITRO

<88>BIOLOGICAL REACTIVITY TESTS, IN VIVO 体内的生物反应性检查法

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<89>ENZYMES USED AS ANCILLARY MATERIALS IN PHARMACEUTICAL MANUFACTURING 药品生产中酶作为辅料所使用 <89.1> COLLAGENASEⅠ 胶原酶Ⅰ <89.2> COLLAGENASEⅡ 胶原酶Ⅱ <90>FETAL BOVINE SERUM—QUALITY ATTRIBUTES AND FUNCTIONALITY TESTS 牛胎儿血清-质量品质和功能检查法 <91>CALCIUM PANTOTHENATE ASSAY 在细胞疗法中使用生长因子和细胞因子 <111>DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS 生物测定法的设计与分析 <115>DEXPANTHENOL ASSAY 右泛醇(拟胆碱药)测定法 <121>INSULIN ASSAYS 胰岛素测定法 <121.1>PHYSICOCHEMICAL ANALYTICAL PROCEDURES FOR INSULINS 胰岛素的物理化学分析程序 <123>GLUCAGON BIOIDENTITY TESTS 高血糖素的生物鉴别检查法 <124>ERYTHROPOIETIN BIOASSAYS 红细胞生成素的微生物测定 <126>SOMATROPIN BIOIDENTITY TESTS 生长激素的生物鉴别检查法 <127>FLOW CYTOMETRIC ENUMERATION OF CD34+ CELL 流式细胞术计术 34 阳性细胞 < 129 > ANALYTICAL PROCEDURES FOR RECOMBINANT THERAPEUTIC MONOCLONAL ANTIBODIES 重组治疗性单克隆抗体的分析方法 <130>PROTEIN A QUALITY ATTRIBUTES 蛋白质 A 的质量特征 <151>PYROGEN TEST 热原检查法 <161>TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR MEDICAL DEVICES 输血输液用具以及相类似的医疗器械 <162>DIPHTHERIA ANTITOXIN POTENCY TESTING FOR HUMAN IMMUNE GLOBULINS 人免 疫球蛋白的白喉抗毒素效力检测 <165>PREKALLIKREIN ACTIVATOR 前激肽释放酶原激活剂 <171>VITAMIN B12 ACTIVITY ASSAY……2548 维生素 B12 活性测定法 泛酸钙测定法 <92>GROWTH FACTORS AND CYTOKINES USED IN CELL THERAPY MANUFACTURING

Chemical Tests and assays 鉴别检查

化学实验检查与测定法

<181>IDENTIFICATION—ORGANIC NITROGENOUS BASES 鉴别-有机氮碱化合物 <191>IDENTIFICATION TESTS—GENERAL 鉴别实验-通用 <193>IDENTIFICATION—TETRACYCLINES 鉴别-四环素类 <197>SPECTROPHOTOMETRIC IDENTIFICATION TESTS 薄层色谱鉴别实验 <202>IDENTIFICATION OF FIXED OILS BY THIN-LAYER CHROMATOGRAPHY 薄层色谱法对非
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分光光度计鉴别实验

<201>THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST

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挥发性油的鉴别 <203>HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY PROCEDURE FOR IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN 高性能薄层色谱法对植物的鉴别

Limit Tests

限度检查法

<206>ALUMINUM 铝 <207>TEST FOR 1,6-ANHYDRO DERIVATIVE FOR ENOXAPARIN SODIUM 依诺肝素钠的酐类衍生物实验 <208>ANTI-FACTOR Xa AND ANTI-FACTOR IIa ASSAYS FOR UNFRACTIONATED AND LOW MOLECULAR WEIGHT HEPARINS 普通肝素和低分子肝素产品中抗体 Xa 和抗体 IIa 测定 <209>LOW MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT DETERMINATIONS 低分子肝素钠分子量测定 <211>ARSENIC 砷 <212>OLIGOSACCHARIDE ANALYSIS 低聚糖的分析 <221>CHLORIDE AND SULFATE <223>DIMETHYLANILINE 氯和硫 二甲基苯胺 4-?-四环素

<226>4-EPIANHYDRO-TETRACYCLINE 对乙酰氨酚药物产品中氨基酚

<227>4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG PRODUCTS <228>ETHYLENE OXIDE AND DIOXANE 环氧乙烷和二氧六环 <231>HEAVY METALS 重金属(删除) <232>ELEMENTAL IMPURITIES—LIMITS 元素杂质-限度 <233>ELEMENTAL IMPURITIES—PROCEDURES 元素杂质-规程 <241>IRON 铁 <251>LEAD 铅 <261>MERCURY 汞 <267>POROSIMETRY BY MERCURY INTRUSION 水银孔隙仪 <268>POROSITY BY NITROGEN ADSORPTION–DESORPTION 氮吸附-解吸测定孔隙率 <271>READILY CARBONIZABLE SUBSTANCES TEST <281>RESIDUE ON IGNITION <291>SELENIUM 硒 炽灼残渣 易碳化物检查法

Other Tests and Assays
<311>ALGINATES ASSAY

其它检查法与测定法
酸中和容量 藻酸盐测定法

<301>ACID-NEUTRALIZING CAPACITY

<341>ANTIMICROBIAL AGENTS—CONTENT 抗菌剂-含量 <345>Assay for Citric Acid/Citrate and Phosphate 柠檬酸/柠檬酸盐和磷酸盐的测定 <351>ASSAY FOR STEROIDS 类固醇(甾类化合物)测定法
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<361> BARBITURATE ASSAY 巴比妥类药物测定法(本版本已删除) <371>COBALAMIN RADIOTRACER ASSAY <391>EPINEPHRINE ASSAY <411>FOLIC ACID ASSAY 肾上腺素测定法 钴铵素放射性跟踪剂测定法 <381>ELASTOMERIC CLOSURES FOR INJECTIONS 注射剂的弹性密封件 <401>FATS AND FIXED OILS 脂肪与混合油 叶酸测定法 <413>IMPURITIES TESTING IN MEDICAL GASES 医用气体杂质检查 <415>MEDICAL GASES ASSAY 医用气体含量检查 <425>IODOMETRIC ASSAY—ANTIBIOTICS 碘量检查法-抗生素 <429>LIGHT DIFFRACTION MEASUREMENT OF PARTICLE SIZE 粒径的光衍射测量法 <431>METHOXY DETERMINATION 甲氧基测定法 <441>NIACIN OR NIACINAMIDE ASSAY 烟酰或烟酰胺测定法 <451>NITRITE TITRATION 亚硝酸盐滴定 氮测定法 <461>NITROGEN DETERMINATION

<466>ORDINARY IMPURITIES 一般杂质 <467>RESIDUAL SOLVENTS 残留溶剂 < 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 <471>OXYGEN FLASK COMBUSTION <481>RIBOFLAVIN ASSAY 氧瓶燃烧法

核黄素(维生素 B2)测定法 有机氮盐

<501>SALTS OF ORGANIC NITROGENOUS BASES <503>ACETIC ACID IN PEPTIDES 多肽类中乙酸测定

<503.1>TRIFLUOROACETIC ACID(TFA)IN PEPTIDES 肽中三氟乙酸 <507>PROTEIN DETERMINATION PROCEDURES 蛋白质测定程序 <511>SINGLE-STEROID ASSAY <531>THIAMINE ASSAY <551>VITAMIN E ASSAY 单一的类固醇测定法 <525>SULFUR DIOXIDE 二氧化硫 硫胺素测定法 <541>TITRIMETRY 滴定法 维生素 E 测定法 植物药品的鉴别 <561>ARTICLES OF BOTANICAL ORIGIN 植物起源的药品 <563>IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN <565>BOTANICAL EXTRACTS 植物提取 <571>VITAMIN A ASSAY 维生素 A 测定法 <580>VITAMIN C ASSAY 维生素 C 的测定法 <581>VITAMIN D ASSAY 维生素 D 测定法
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<591>ZINC DETERMINATION < 601 > INHALATION AND

锌的测定法

Physical Test and Determinations

物理检查与测定法
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 <602>PROPELLANTS 推进剂 <603>TOPICAL AEROSOLS 局部喷雾剂 <604>LEAK RATE 渗漏率 < 610 > ALTERNATIVE MICROBIOLOGICAL SAMPLING METHODS FOR NONSTERILE 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 <611>ALCOHOL DETERMINATION <621>CHROMATOGRAPHY 色谱法 <631>COLOR AND ACHROMICITY <643>TOTAL ORGANIC CARBON <645>WATER CONDUCTIVITY 呈色与消色 溶解度 <641>COMPLETENESS OF SOLUTION 乙醇测定法 堆密度与振实密度

<616>BULK DENSITY AND TAPPED DENSITY

总有机碳

水电导率 凝点温度

<651>CONGEALING TEMPERATURE <660>CONTAINERS—GLASS 容器-玻璃

<659>PACKAGING AND STORAGE REQUIREMENTS 包装和储藏要求 <661>CONTAINERS—PLASTICS 容器-塑料 <661.1>PLASTIC MATERIALS OF CONSTRUCTION 塑料包装材料 <661.2>PLASTIC PACKAGING SYSTEMS FOR PHARMACEUTICAL USE 药用塑料包装系统 <670>AUXILIARY PACKAGING COMPONENTS 辅助包装部件 <671>CONTAINERS—PERFORMANCE TESTING 容器-性能测试 <691>COTTON 棉花 <695>CRYSTALLINITY 结晶度 < 696 > CHARACTERIZATION OF CRYSTALLINE SOLIDS BY MICROCALORIMETRY AND SOLUTION CALORIMETRY 通过溶液量热学测定结晶性 <697>CONTAINER CONTENT FOR INJECTIONS 注射剂容器容积 <698>DELIVERABLE VOLUME <701>DISINTEGRATION ? <711>DISSOLUTION 溶出度
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抽取体积

<699>DENSITY OF SOLIDS 固体密度 崩解时限 <705>QUALITY ATTRIBUTES OF TABLETS LABELED AS HAVING A FUNCTIONAL SCORE

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<721>DISTILLING RANGE

馏程

<724>DRUG RELEASE 药物释放度 <729>GLOBULE SIZE DISTRIBUTION IN LIPID INJECTABLE EMULSIONS 脂类可注射的乳剂的粒径分布 <730>Plasma Spectrochemistry <731>LOSS ON DRYING4 <733>LOSS ON IGNITION 血浆光谱化学?

干燥失重 灼烧失重

<735>X-RAY FLUORESCENCE SPECTROMETRY X 射线光谱 <736>MASS SPECTROMETRY 质谱 <741>MELTING RANGE OR TEMPERATURE <755>MINIMUM FILL 最低装量 <761>NUCLEAR MAGNETIC RESONANCE <776>OPTICAL MICROSCOPY 光学显微镜 核磁共振 <771>OPHTHALMIC OINTMENTS 眼用软膏 <781>OPTICAL ROTATION 旋光度 <782>VIBRATIONAL CIRCULAR DICHROISM SPECTROSCOPY 振动圆二色谱 <785>OSMOLALITY AND OSMOLARITY 筛分法估算粒径分布 <787>SUBVISIBLE PARTICULATE MATTER IN THERAPEUTIC PROTEIN INJECTIONS 显微计数法在治疗性蛋白注射剂中应用 <788>PARTICULATE MATTER IN INJECTIONS 注射剂中的不溶性微粒 眼用溶液中的不溶性微粒 渗透压 <786>PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL SIEVING 熔距或熔点 眼用软膏中的金属粒子 <751>METAL PARTICLES IN OPHTHALMIC OINTMENTS

<789>PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS <791>pH

<790>VISIBLE PARTICULATES IN INJECTIONS 注射剂中可见异物 <795>PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS 药物混合-非无菌制剂 <797>PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS 药物混合-无菌制剂 <800>HAZARDOUS DRUGS—HANDLING IN HEALTHCARE SETTINGS 在医疗环境中危险药品的 处理 <801>POLAROGRAPHY 极谱法 <811>POWDER FINENESS 粉剂细度 <821>RADIOACTIVITY 放射性 <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

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<831>REFRACTIVE INDEX 折光率 <841>SPECIFIC GRAVITY 比重 <846>SPECIFIC SURFACE AREA 比表面积 <851>SPECTROPHOTOMETRY AND LIGHT-SCATTERING 分光光度计与光散射(本版本已删除) <852>ATOMIC ABSORPTION SPECTROSCOPY 原子吸收光谱 <853>FLUORESCENCE SPECTROSCOPY 荧光光谱 <854>MID-INFRARED SPECTROSCOPY 中红外光谱 <855>NEPHELOMETRY, TURBIDIMETRY, AND VISUAL COMPARISO 浊度测定、比浊法、视觉比 较 <857>ULTRAVIOLET-VISIBLE SPECTROSCOPY 紫外可见光谱 <861>SUTURES—DIAMETER 缝线-直径? 缝线-穿孔实验 <871>SUTURES—NEEDLE ATTACHMENT <881>TENSILE STRENGTH 张力 <891>THERMAL ANALYSIS 热分析 <905>UNIFORMITY OF DOSAGE UNITS 制剂单位的含量均匀度 <911>VISCOSITY—CAPILLARY METHODS 黏度-毛细管法 <912>VISCOSITY—ROTATIONAL METHODS 黏度-旋转法 <913>VISCOSITY—ROLLING BALL METHOD 黏度-球法 <914>VISCOSITY—PRESSURE DRIVEN METHODS <921>WATER DETERMINATION 水分测定 黏度-压力驱动方法

<941>CHARACTERIZATION OF CRYSTALLINE AND PARTIALLY CRYSTALLINE SOLIDS BY X-RAY POWDER DIFFRACTION (XRPD) X 光衍射

General

Information

通用信息

<1004>MUCOSAL DRUG PRODUCTS—PERFORMANCE TESTS 粘膜药物产品性能测试 <1005>ACOUSTIC EMISSION 声频发射 <1010>ANALYTICAL DATA—INTERPRETATION AND TREATMENT 分析数据-解释与处理 <1015>AUTOMATED RADIOCHEMICAL SYNTHESIS APPARATUS 放射性自动合成装置 <1024>BOVINE SERUM 牛血清 <1025>PANCREATIN 胰液素 <1027>FLOW CYTOMETRY 流式细胞仪 <1029>GOOD DOCUMENTATION GUIDELINES 好的文件指南 <1030>BIOLOGICAL ASSAY CHAPTERS—OVERVIEW AND GLOSSARY 生物测定章节-综述和术语 <1031>THE BIOCOMPATIBILITY OF MATERIALS USED IN DRUG CONTAINERS, MEDICAL DEVICES, AND IMPLANTS 用于药物容器、医疗设施和植入剂的材料的生物相容性
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<1032>DESIGN AND DEVELOPMENT OF BIOLOGICAL ASSAYS 生物试验的设计和开发 <1033>BIOLOGICAL ASSAY VALIDATION 生物试验的验证 <1034>ANALYSIS OF BIOLOGICAL ASSAYS 生物测定分析 <1035>BIOLOGICAL INDICATORS FOR STERILIZATION <1039>CHEMOMETRICS 化学 <1041>BIOLOGICS 生物制剂 <1043>Ancillary Material for Cell, Gene, and Tissue-Engineered Products 细胞,基因与组织设计产品的辅助材料 <1044>CRYOPRESERVATION OF CELLS 细胞低温保存 <1045>BIOTECHNOLOGY-DERIVED ARTICLES 生物技术提取产品(本版本已删除) <1046>CELLULAR AND TISSUE-BASED PRODUCTS 细胞与组织产品 <1047>GENE THERAPY PRODUCTS 基因治疗产品 < 1048 > QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT 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构的分析 < 1049 > QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF 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 < 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的生物技术产品的病毒安全性评估 <1050.1>DESIGN, EVALUATION,AND CHARACTERIZATION OF VIRAL CLEARANCE PROCEDURES 病毒清除过程的设计、评估和鉴定。 <1051>CLEANING GLASS APPARATUS 生物技术提取法-氨基酸测定 <1053>CAPILLARY ELECTROPHORESIS 毛细管电泳法 <1054>BIOTECHNOLOGY-DERIVED ARTICLES—ISOELECTRIC FOCUSING 生物技术提取法-等电点聚集 <1055>BIOTECHNOLOGY-DERIVED ARTICLES—PEPTIDE MAPPING 生物技术提取法-肽谱 <1056>BIOTECHNOLOGY-DERIVED ARTICLES—POLYACRYLAMIDE GEL ELECTROPHORESIS 生物技术提取法-凝胶电泳 <1057>BIOTECHNOLOGY-DERIVED ARTICLES—TOTAL PROTEIN ASSAY 生物技术提取法-总蛋白测定 <1058>ANALYTICAL INSTRUMENT QUALIFICATION 分析仪器要求 <1059>EXCIPIENT PERFORMANCE 赋形剂 玻璃容器的清洗 <1052>BIOTECHNOLOGY-DERIVED ARTICLES—AMINO ACID ANALYSIS 灭菌用生物指示剂(本版本已删除)

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<1061>COLOR—INSTRUMENTAL MEASUREMENT

显色-仪器测量

<1063>SHEAR CELL METHODOLOGY FOR POWDER FLOW TESTING 粉末流动试验的剪切方法 <1064>IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN BY HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY PROCEDURE 通过高性能的薄层色谱法鉴定植物原料 <1065>Ion Chromatography 离子色谱法 <1066>PHYSICAL ENVIRONMENTS THAT PROMOTE SAFE MEDICATION USE 物理环境促使安全使用药物 <1072>DISINFECTANTS AND ANTISEPTICS 消毒剂和防腐剂 <1074>EXCIPIENT BIOLOGICAL SAFETY EVALUATION GUIDELINES 赋形剂(辅料)生物安全性评估指导 < 1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS 批药品赋形剂的生产管理规范 <1079>Good Storage and Shipping Practices 良好的贮存与运输规范 <1080>BULK PHARMACEUTICAL EXCIPIENTS—CERTIFICATE OF ANALYSIS 批药品赋形剂-COA <1084>GLYCOPROTEIN AND GLYCAN ANALYSIS—GENERAL CONSIDERATIONS 糖蛋白和多糖分析-一般通则 <1086>IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS ROTATING DISK AND STATIONARY DISK 内部的溶出度-旋转和静止溶出检测程序? <1088>IN VITRO AND IN VIVO EVALUATION OF DOSAGE FORMS 体内与体外的剂型的评估 < 1090 > ASSESSMENT OF DRUG PRODUCT PERFORMANCE-BIOAVAILABILITY, 药物和药物产品中的杂质 < 1087 > APPARENT INTRINSIC DISSOLUTION—DISSOLUTION TESTING PROCEDURES FOR

BIOEQUIVALENCE, AND DISSOLUTION

药物产品性能评估:生物利用度、生物等效性和溶出 非活性成分的标示

<1091>LABELING OF INACTIVE INGREDIENTS 溶出程序:开发与验证

<1092>THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION <1094>CAPSULES—DISSOLUTION TESTING AND RELATED QUALITY ATTRIBUTES 胶囊-关于产品质量的溶出测定 <1097>BULK POWDER SAMPLING PROCEDURES:粉末样品取样程序 <1102>IMMUNOLOGICAL TEST METHODS—GENERAL CONSIDERATIONS 免疫测试方法-总则 < 1103 > IMMUNOLOGICAL TEST METHODS—ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) 免疫学测试方法-酶联免疫吸附测定 <1104>IMMUNOLOGICAL TEST METHODS—IMMUNOBLOT ANALYSIS 免疫测试方法-免疫印迹法

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<1105>IMMUNOLOGICAL TEST METHODS—SURFACE PLASMON RESONANCE 免疫测试方法-表面等离子体共振 < 1106 > IMMUNOGENICITY ASSAYS—DESIGN AND VALIDATION OF IMMUNOASSAYS TO DETECT ANTI-DRUG ANTIBODIES ? < 1106.1 > IMMUNOGENICITY ASSAYS—DESIGN AND VALIDATION OF ASSAYS TO DETECT ANTI-DRUG NEUTRALIZING ANTIBODY 免疫原性测定—抗血清中抗体测定试验的设计及验证 < 1111 > MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR

PHARMACEUTICAL USE 非无菌产品的微生物学检查:药用制剂和制药过程使用的物质接受标准 <1112>MICROBIAL CHARACTERIZATION, IDENTIFICATION, AND STRAIN TYPING 非无菌药物产品水活性测定应用 <1113>MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE PHARMACEUTICAL PRODUCTS 非无菌药品中的微生物分布 <1115>BIOBURDEN CONTROL OF NONSTERILE DRUG SUBSTANCES AND PRODUCTS 非无菌药物和产品的生物负载控制 < 1116 > MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING ENVIRONMENTS 洁净的房间与其它可控环境的微生物评估 <1117>MICROBIOLOGICAL BEST LABORATORY PRACTICES 微生物最优实验室规范 <1118>MONITORING DEVICES—TIME, TEMPERATURE, AND HUMIDITY 监控装置-时间、温度与湿度 <1119>NEAR-INFRARED SPECTROPHOTOMETRY <1120>Raman Spectrophotometry 拉曼分光光度测定法 <1121>NOMENCLATURE 命名 <1125>NUCLEIC ACID-BASED TECHNIQUES—GENERAL 核酸技术-通则 <1126>NUCLEIC ACID-BASED TECHNIQUES—EXTRACTION, DETECTION, AND SEQUENCING 核酸技术-提取、检测、测序 <1127>NUCLEIC ACID-BASED TECHNIQUES—AMPLIFICATION 核酸技术-扩增 <1128>NUCLEIC ACID-BASED TECHNIQUES—MICROARRAY 核酸技术-微阵列 <1129>NUCLEIC ACID-BASED TECHNIQUES—GENOTYPING 核酸技术-基因分型 < 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) <1132>Residual Host Cell Protein Measurement in Biopharmaceuticals 生物制药中残留宿主细胞蛋白的 近红外分光光度测定法

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测定 <1136>PACKAGING AND REPACKAGING—SINGLE-UNIT CONTAINERS 包装和再包装-单一容器 <1151>PHARMACEUTICAL DOSAGE FORMS 药物剂型 兽药在动物饲料中的使用

<1152>ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 按处方混合的药物的计算

<1160>PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION COMPOUNDING <1163>QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING 按处方混合的药物的质量保证 <1171>PHASE-SOLUBILITY ANALYSIS 相溶解分析 <1174>Powder Flow 粉末流动性 <1176>PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS <1177>Good Packaging Practices 良好的包装操作 <1178>Good Repackaging Practices 良好的再包装操作 <1180>HUMAN PLASMA 人血浆 <1181>SCANNING ELECTRON MICROSCOPY <1184>SENSITIZATION TESTING 致敏测试 <1191>STABILITY CONSIDERATIONS IN DISPENSING PRACTICE 散装药用辅料更换指导原则 <1197>GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS 散装药用辅料良好的分装操作 <1207>STERILE PRODUCT PACKAGING—INTEGRITY EVALUATION 无菌产品包装-完整性评估 <1207.1>PACKAGE INTEGRITY TESTING IN THE PRODUCT LIFE CYCLE —TEST METHOD SELECTION AND VALIDATION 产品生命周期中包装完整性测试—测试方法的选择和验证 <1207.2>PACKAGE INTEGRITY LEAK TEST TECHNOLOGIES 包装完整性泄露试验测试技术 <1207.3>PACKAGE SEAL QUALITY TEST TECHNOLOGIES 包装密封质量测试技术 <1208>STERILITY TESTING—VALIDATION OF ISOLATOR SYSTEMS 无菌实验-隔离系统的验证 < 1209 > STERILIZATION—CHEMICAL AND PHYSICOCHEMICAL INDICATORS AND 分装操作中稳定性考察 <1195>SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS 扫描电子显微镜 处方天平与容量器具

INTEGRATORS 灭菌-化学与物理化学的指示剂以及二者的综合(本版本已删除) <1211>STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES 药典物品中的灭菌与灭菌保证 <1216>TABLET FRIABILITY 片剂的脆碎度

<1217>TABLET BREAKING FORCE 片剂断裂力 <1222>TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE 药品终端灭菌-放行参数
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<1223>VALIDATION OF ALTERNATIVE MICROBIOLOGICAL METHODS 可供选择的微生物学方法的验证 <1223.1>VALIDATION OF ALTERNATIVE METHODS TO ANTIBIOTIC MICROBIAL ASSAYS 抗 生素微生物测定的备选方法的验证 <1224>TRANSFER OF ANALYTICAL PROCEDURES 分析方法转移 <1225>VALIDATION OF COMPENDIAL METHODS 药典方法的验证 <1226>VERIFICATION OF COMPENDIAL PROCEDURES 药典方法的确认 <1227>VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES 从药物中回收微生物的验证 <1228>DEPYROGENATION 去除热原法 <1228.1>DRY HEAT DEPYROGENATION 干热去除热原法 <1228.3>DEPYROGENATION BY FILTRATION 通过过滤去除热原法 <1228.5>ENDOTOXIN INDICATORS FOR DEPYROGENATION 去除热原细菌内毒素指示剂 <1229>STERILIZATION OF COMPENDIAL ARTICLES 药典灭菌过程 <1229.1>STEAM STERILIZATION BY DIRECT CONTACT 直接蒸汽灭菌 <1229.2>MOIST HEAT STERILIZATION OF AQUEOUS LIQUIDS 水溶液的湿热灭菌 <1229.3>MONITORING OF BIOBURDEN 生物负载监控 <1229.4>STERILIZING FILTRATION OF LIQUIDS 溶液的无菌过滤器 <1229.5>BIOLOGICAL INDICATORS FOR STERILIZATION 灭菌生物指示剂 <1229.6>LIQUID-PHASE STERILIZATION 液态灭菌 <1229.7>GASEOUS STERILIZATION 气态灭菌 <1229.8>DRY HEAT STERILIZATION 干热灭菌 <1229.9>PHYSICOCHEMICAL INTEGRATORS AND INDICATORS FOR STERILIZATION 灭菌物 理化学指示剂 <1229.10>RADIATION STERILIZATION 辐射灭菌 <1229.11>VAPOR PHASE STERILIZATION 蒸汽灭菌 <1229.12>NEW STERILIZATION METHODS 新的灭菌方法 <1229.13>STERILIZATION-IN-PLACE 灭菌 <1230>WATER FOR HEMODIALYSIS APPLICATIONS 血液透析过程用水 <1231>WATER FOR PHARMACEUTICAL PURPOSES 制药用水 <1234>VACCINES FOR HUMAN USE—POLYSACCHARIDE AND GLYCOCONJUGATE VACCINES 人用疫苗-多糖和糖复合物疫苗 <1235>VACCINES FOR HUMAN USE—GENERAL CONSIDERATIONS 人用疫苗-通则 <1237>VIROLOGY TEST METHODS 病毒测试方法 <1238>VACCINES FOR HUMAN USE—BACTERIAL VACCINES 人用疫苗-细菌疫苗 <1240>VIRUS TESTING OF HUMAN PLASMA FOR FURTHER MANUFACTURE 下一步使用人血浆的病毒测试
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<1241>WATER–SOLID INTERACTIONS IN PHARMACEUTICAL SYSTEMS 在药物系统中水与固体的相互作用 <1251>WEIGHING ON AN ANALYTICAL BALANCE < 1285 > PREPARATION 关于分析天平的称重

<1265>Written Prescription Drug Information-Guidelines 书面的处方药信息-指南 OF BIOLOGICAL SPECIMENS FOR HISTOLOGIC AND

IMMUNOHISTOCHEMICAL ANALYSIS 为了组织和免疫组织分析的生物标本制备 <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 <1601>PRODUCTS FOR NEBULIZATION—CHARACTERIZATION TESTS 产品雾化状态-性状描述 < 1602 > SPACERS AND VALVED HOLDING CHAMBERS USED WITH INHALATION AEROSOLS—CHARACTERIZATION TESTS 用于吸入气溶胶的间隔件和阀门—表征测试 < 1644 > THEORY AND PRACTICE OF ELECTRICAL CONDUCTIVITY MEASUREMENTS OF SOLUTIONS 溶液电导值测量方法的理论与实践 <1660>EVALUATION OF THE INNER SURFACE DURABILITY OF GLASS CONTAINERS 玻璃容器内表面耐久性评估 < 1661 > EVALUATION OF PLASTIC PACKAGING SYSTEMS AND THEIR MATERIALS OF CONSTRUCTION WITH RESPECT TO THEIR USER SAFETY IMPACT 塑料包装系统及 其对用户安全影响的评估 < 1663 > ASSESSMENT < 1664 > ASSESSMENT OF EXTRACTABLES OF DRUG ASSOCIATED WITH PHARMACEUTICAL ASSOCIATED WITH PACKAGING/DELIVERY SYSTEMS 与药品包装/递送系统相关可萃取物的评估 PRODUCT LEACHABLES PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS 与药品包装/递送系统相关可浸出物的评估 <1664.1>ORALLY INHALED AND NASAL DRUG PRODUCTS 口头吸入和鼻药物产品 <1724>SEMISOLID DRUG PRODUCTS—PERFORMANCE TESTS 半固态药物产品-性能测试 <1730>PLASMA SPECTROCHEMISTRY—THEORY AND PRACTICE 等离子体化学法—理论与实 践 <1735>X-RAY FLUORESCENCE SPECTROMETRY—THEORY AND PRACTICE X-射线荧光光谱法 —理论与实践 <1736>APPLICATIONS OF MASS SPECTROMETRY 质谱应用 <1761>APPLICATIONS OF NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY 核磁共振光谱应用 <1771>OPHTHALMIC PRODUCTS—PERFORMANCE TESTS 眼科产品—性能测试 ?1782? VIBRATIONAL CIRCULAR DICHROISM SPECTROSCOPY—THEORY AND PRACTICE 震动 循环二次光谱法—理论与实践 <1787>MEASUREMENT OF SUBVISIBLE PARTICULATE MATTER IN THERAPEUTIC PROTEIN INJECTIONS
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用显微镜测量方法测量治疗性蛋白注射剂的不溶性微粒 <1788>METHODS FOR THE DETERMINATION OF PARTICULATE MATTER IN INJECTIONS AND OPHTHALMIC SOLUTIONS 注射剂和眼用溶液的不溶性微粒测定的方法选择 <1821>RADIOACTIVITY—THEORY AND P RACTICE 放射性—理论与实践 <1823>POSITRON EMISSION TOMOGRAPHY DRUGS—INFORMATION 正电子发射断层扫描药物 —信息 <1852>ATOMIC ABSORPTION SPECTROSCOPY—THEORY AND PRACTICE 原子吸收光谱-理论与实践 <1853>FLUORESCENCE SPECTROSCOPY—THEORY AND PRACTICE 荧光光谱-理论与实践 <1854>MID-INFRARED SPECTROSCOPY—THEORY AND PRACTICE 中红外光谱-理论与实践 <1857>ULTRAVIOLET-VISIBLE SPECTROSCOPY—THEORY AND PRACTICE 紫外可见光谱-理论与实践 <1911>RHEOMETRY 流变测定

Dietary Supplements General Tests and Assays
< 2021 2022 >

营养补充剂 一般检查法与测定法
ENUMERATION TESTS—NUTRITIONAL FOR ABSENCE AND OF DIETARY SPECIFIED

MICROBIAL

SUPPLEMENTS…3080 微生物数量实验-营养与食品添加剂 < > MICROBIOLOGICAL PROCEDURES MICROORGANISMS—NUTRITIONAL AND DIETARY SUPPLEMENTS……3083 不得检出特定微生物的程序-营养与营养补充剂 < 2023>MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE NUTRITIONAL AND DIETARY SUPPLEMENTS……3087 非无菌的营养与食品添加剂中的微生物分布 <2030> SUPPLEMENTAL INFORMATION FOR ARTICLES OF BOTANICAL ORIGIN 植物起源文章 补充信息 <2040>DISINTEGRATION AND DISSOLUTION OF DIETARY SUPPLEMENTS……3089 食品添加剂的崩解与溶出 <2091>WEIGHT VARIATION OF DIETARY SUPPLEMENTS……3092 食品添加剂的重量差异 <2232> ELEMENTAL CONTAMINANTS IN DIETARY SUPPLEMENTS 膳食补充剂中的元素污染物 <2250> DETECTION OF IRRADIATED DIETARY SUPPLEMENTS 膳食补充剂的检测 <2251> ADULTERATION OF DIETARY SUPPLEMENTS WITH DRUGS AND DRUG ANALOGS 膳食 补充剂与药物及药物类似物的混合 <2750>MANUFACTURING PRACTICES FOR DIETARY SUPPLEMENTS……3093 食品添加剂的生产操作

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