USP38通用章节目录讲解

USP38-通用章节指导目录(附录) 第 5 页 共 12 页

＜645＞WATER CONDUCTIVITY 水电导率 ＜651＞CONGEALING TEMPERATURE 凝点温度

＜659＞PACKAGING AND STORAGE REQUIREMENTS 包装和储藏要求 ＜660＞CONTAINERS—GLASS 容器-玻璃 ＜661＞CONTAINERS—PLASTICS容器-塑料

＜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 抽取体积 ＜699＞DENSITY OF SOLIDS 固体密度 ＜701＞DISINTEGRATION 崩解时限

＜705＞QUALITY ATTRIBUTES OF TABLETS LABELED AS HAVING A FUNCTIONAL SCORE ？

＜711＞DISSOLUTION 溶出度 ＜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 血浆光谱化学？ ＜731＞LOSS ON DRYING4 干燥失重 ＜733＞LOSS ON IGNITION 灼烧失重

＜735＞X-RAY FLUORESCENCE SPECTROMETRY X射线光谱 ＜736＞MASS SPECTROMETRY 质谱

＜741＞MELTING RANGE OR TEMPERATURE 熔距或熔点

＜751＞METAL PARTICLES IN OPHTHALMIC OINTMENTS 眼用软膏中的金属粒子 ＜755＞MINIMUM FILL 最低装量

＜761＞NUCLEAR MAGNETIC RESONANCE 核磁共振 ＜771＞OPHTHALMIC OINTMENTS 眼用软膏 ＜776＞OPTICAL MICROSCOPY 光学显微镜 ＜781＞OPTICAL ROTATION 旋光度

＜785＞OSMOLALITY AND OSMOLARITY 渗透压

＜786＞PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL SIEVING 筛分法估算粒径分布

5

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