USP38-通用章节指导目录(附录) 第 6 页 共 12 页
＜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
＜789＞PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS 眼用溶液中的不溶性微粒 ＜790＞VISIBLE PARTICULATES IN INJECTIONS 注射剂中可见异物 ＜791＞pH
＜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 ＜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
＜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 ＜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
＜857＞ULTRAVIOLET-VISIBLE SPECTROSCOPY 紫外可见光谱 ＜861＞SUTURES—DIAMETER 缝线－直径？
＜871＞SUTURES—NEEDLE ATTACHMENT 缝线－穿孔实验 ＜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—CAPILLARYMETHODS 黏度-毛细管法
＜912＞VISCOSITY—ROTATIONAL METHODS 黏度-旋转法 ＜913＞VISCOSITY—ROLLING BALL METHOD 黏度-球法 ＜921＞WATER DETERMINATION 水分测定
＜941＞CHARACTERIZATION OF CRYSTALLINE AND PARTIALLY CRYSTALLINE SOLIDS BY
X-RAY POWDER DIFFRACTION (XRPD) X光衍射
General Information 通用信息
＜1005＞ACOUSTIC EMISSION 声频发射
＜1010＞ANALYTICAL DATA—INTERPRETATION AND TREATMENT
6
USP38-通用章节指导目录(附录) 第 7 页 共 12 页
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 ＜1027＞FLOW CYTOMETRY 流式细胞仪
＜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
＜1034＞ANALYSIS OF BIOLOGICAL ASSAYS 生物测定分析
＜1035＞BIOLOGICAL INDICATORS FOR STERILIZATION 灭菌用生物指示剂 ＜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 ＜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 ＜1051＞CLEANING GLASS APPARATUS 玻璃容器的清洗
＜1052＞BIOTECHNOLOGY-DERIVED ARTICLES—AMINO ACID ANALYSIS 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
7
USP38-通用章节指导目录(附录) 第 8 页 共 12 页
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
＜1061＞COLOR—INSTRUMENTAL MEASUREMENT 显色－仪器测量 ＜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
8
USP38-通用章节指导目录(附录) 第 9 页 共 12 页
＜1104＞IMMUNOLOGICAL TEST METHODS—IMMUNOBLOT ANALYSIS
免疫测试方法-免疫印迹法
＜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
？
＜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）
＜1136＞PACKAGING AND REPACKAGING—SINGLE-UNIT CONTAINERS
9
USP38-通用章节指导目录(附录) 第 10 页 共 12 页
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
＜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
＜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
＜1223＞VALIDATION OF ALTERNATIVE MICROBIOLOGICAL METHODS 可供选择的微生物学方法的验证
＜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
10