USP38-通用章节指导目录(附录)
Guide to General Chapters 通用章节指导
General Requirements for Test and Assays 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 用于检查与含量分析的器具
＜17＞PRESCRIPTION CONTAINER LABELING 处方容器标签
＜21＞THERMOMETERS 温度计
＜31＞VOLUMETRIC APPARATUS 容量器具
＜41＞BALANCES 天平
Microbiological Tests 微生物检查法
＜51＞ANTIMICROBIAL EFFECTIVENESS TESTING 抗菌剂有效性检查法
＜55＞BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS
生物指示剂－耐药性实验
＜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
＜81＞ANTIBIOTICS—MICROBIAL ASSAYS 抗生素－微生物测定
＜85＞BACTERIAL ENDOTOXINS TEST 细菌内毒素检查法
＜87＞BIOLOGICAL REACTIVITY TESTS, IN VITRO 体外的生物反应性检查法
＜88＞BIOLOGICAL REACTIVITY TESTS, IN VIVO 体内的生物反应性检查法
＜89＞ENZYMES USED AS ANCILLARY MATERIALS IN PHARMACEUTICAL MANUFACTURING
药品生产中酶作为辅料所使用
＜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 泛酸钙测定法
＜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
＜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
＜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 输血输液用具以及相类似的医疗器械
MEDICAL DEVICES
＜171＞VITAMIN B12 ACTIVITY ASSAY……2548 维生素B12活性测定法
Chemical Tests and assays 化学实验检查与测定法
鉴别检查
＜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 分光光度计鉴别实验
＜201＞THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST
薄层色谱鉴别实验
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 DETERMINATIONS
MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT
低分子肝素钠分子量测定
＜211＞ARSENIC 砷
＜221＞CHLORIDE AND SULFATE 氯和硫
＜223＞DIMETHYLANILINE 二甲基苯胺
＜226＞4-EPIANHYDRO-TETRACYCLINE 4－？－四环素
＜227＞4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG PRODUCTS
对乙酰氨酚药物产品中氨基酚
＜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 易碳化物检查法
＜281＞RESIDUE ON IGNITION 炽灼残渣
＜291＞SELENIUM 硒
Other Tests and Assays 其它检查法与测定法
＜301＞ACID-NEUTRALIZING CAPACITY 酸中和容量
＜311＞ALGINATES ASSAY 藻酸盐测定法
＜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
＜361> BARBITURATE ASSAY 巴比妥类药物测定法
＜371＞COBALAMIN RADIOTRACER ASSAY 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
＜391＞EPINEPHRINE ASSAY 肾上腺素测定法
＜401＞FATS AND FIXED OILS 脂肪与混合油
＜411＞FOLIC ACID ASSAY 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
＜461＞NITROGEN DETERMINATION 氮测定法
＜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 氧瓶燃烧法
＜481＞RIBOFLAVIN ASSAY 核黄素（维生素B2）测定法
＜501＞SALTS OF ORGANIC NITROGENOUS BASES 有机氮盐
＜503＞ACETIC ACID IN PEPTIDES 多肽类中乙酸测定
＜511＞SINGLE-STEROID ASSAY 单一的类固醇测定法
＜525＞SULFUR DIOXIDE 二氧化硫
＜531＞THIAMINE ASSAY 硫胺素测定法
＜541＞TITRIMETRY 滴定法
＜551＞VITAMIN E ASSAY 维生素E测定法
＜561＞ARTICLES OF BOTANICAL ORIGIN 植物起源的药品
＜563＞IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN 植物药品的鉴别
＜565＞BOTANICAL EXTRACTS 植物提取
＜571＞VITAMIN A ASSAY 维生素A测定法
＜581＞VITAMIN D ASSAY 维生素D测定法
＜591＞ZINC DETERMINATION 锌的测定法
Physical Test and Determinations 物理检查与测定法
＜601＞INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, SPRAYS, —PERFORMANCE QUALITY TESTS
AND POWDERS
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 乙醇测定法
＜616＞BULK DENSITY AND TAPPED DENSITY 堆密度与振实密度
＜621＞CHROMATOGRAPHY 色谱法
＜631＞COLOR AND ACHROMICITY 呈色与消色
＜641＞COMPLETENESS OF SOLUTION 溶解度
＜643＞TOTAL ORGANIC CARBON 总有机碳
＜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
＜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—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
＜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
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
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
＜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, 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
AND
＜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
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 PROCEDURES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
＜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
＜1229.6＞LIQUID-PHASE STERILIZATION 液态灭菌
＜1229.7＞GASEOUS STERILIZATION 气态灭菌
＜1229.8＞DRY HEAT STERILIZATION 干热灭菌
＜1229.10＞RADIATION STERILIZATION 辐射灭菌
＜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
＜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 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
＜1285＞PREPARATION 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
＜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
＜1724＞SEMISOLID DRUG PRODUCTS—PERFORMANCE TESTS 半固态药物产品-性能测试
＜1736＞APPLICATIONS OF MASS SPECTROMETRY 质谱应用
＜1761＞APPLICATIONS OF NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY
核磁共振光谱应用
＜1787＞MEASUREMENT OF SUBVISIBLE PARTICULATE MATTER IN THERAPEUTIC PROTEIN INJECTIONS
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 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
＜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
IN
紫外可见光谱-理论与实践
＜1911＞RHEOMETRY 流变测定
Dietary Supplements 营养补充剂
General Tests and Assays 一般检查法与测定法
＜2021＞MICROBIAL ENUMERATION TESTS—NUTRITIONAL AND DIETARY SUPPLEMENTS…3080 微生物数量实验－营养与食品添加剂
＜2022＞MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED 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
<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
<2750>MANUFACTURING PRACTICES FOR DIETARY SUPPLEMENTS……3093
食品添加剂的生产操作
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