USP40-NF35通用章节目录

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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 药物和药物产品中的杂质 ＜1087＞APPARENT INTRINSIC DISSOLUTION—DISSOLUTION TESTING PROCEDURES FOR

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,

BIOEQUIVALENCE, AND DISSOLUTION 药物产品性能评估：生物利用度、生物等效性和溶出 ＜1091＞LABELING OF INACTIVE INGREDIENTS 非活性成分的标示

＜1092＞THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION 溶出程序：开发与验证

＜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 近红外分光光度测定法 ＜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

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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

＜1152＞ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 兽药在动物饲料中的使用 ＜1160＞PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION COMPOUNDING 按处方混合的药物的计算

＜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 处方天平与容量器具 ＜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 扫描电子显微镜 ＜1184＞SENSITIZATION TESTING 致敏测试

＜1191＞STABILITY CONSIDERATIONS IN DISPENSING PRACTICE 分装操作中稳定性考察 ＜1195＞SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS 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

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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