USP38通用章节目录讲解

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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

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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 MEDICAL DEVICES 输血输液用具以及相类似的医疗器械

＜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 MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT DETERMINATIONS

低分子肝素钠分子量测定

＜211＞ARSENIC 砷

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＜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

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＜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, 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 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

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＜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

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＜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

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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

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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

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＜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

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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

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