USP-55生物指示剂-抗性测试

USP通则目录整理

USP〈21〉温度计USP〈31〉容量仪器USP〈41〉称量与天平USP〈51〉抗菌有效性测试USP〈55〉生物指示剂-耐受力测试USP〈61〉非无菌产品微生物检测：微生物计数测试USP〈62〉非无菌产品微生物检测：特定微生物测试USP〈71〉无菌测试USP〈85〉细菌内毒素测试USP〈87〉体外生物反应测试USP〈151〉热源测试USP〈191〉鉴别USP〈231〉重金属-背景和主题USP〈232〉重金属杂质-限度USP〈233〉重金属杂质-检测规程USP〈467〉残留溶剂USP〈695〉多晶型USP〈741〉熔点USP〈1035〉生物指示剂USP〈1072〉消毒剂与杀菌剂USP〈1111〉非无菌药品的微生物评估USP〈1112〉水分活性应用USP〈1113〉微生物特性确定、鉴定及菌株分型USP〈1116〉无菌工艺环境的微生物控制与监测USP〈1117〉微生物实验室规范USP〈1151〉药物剂型（pharmaceutical dosage forms）USP〈1196〉药典协调USP〈1207〉无菌产品包装-完整性评估USP〈1208〉无菌测试-隔离系统验证USP〈1209〉灭菌化学和物理化学指示剂及综合指示剂USP〈1211〉灭菌与无菌保证USP〈1222〉最终灭菌药品-参数放行USP〈1223〉微生物替代方法验证USP〈1224〉转移USP〈1225〉验证USP〈1226〉确认USP〈1227〉药物的微生物回收率验证USP〈1231〉制药用水USP〈2021〉微生物计数测试-营养和食品补充剂USP〈2022〉控制菌的微生物检查-营养和食品补充剂USP〈2023〉非无菌营养和食品补充剂的微生物评估USP〈2232〉试行版膳食补充剂中的重金属元素污染整理人*****************。

(完整word版)USP38通用章节目录中文

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 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 DERIV ATIVE 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＜221＞CHLORIDE AND SULFATE氯和硫＜223＞DIMETHYLANILINE二甲基苯胺＜226＞4-EPIANHYDRO-TETRACYCLINE4－？－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＞HEA VY 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, 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＜645＞W ATER 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 HA VING 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＞W ATER 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＞CRYOPRESERV ATION 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 EV ALUATION 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 EV ALUATION 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 EV ALUATION OF DOSAGE FORMS体内与体外的剂型的评估＜1090＞ASSESSMENT OF DRUG PRODUCT PERFORMANCE-BIOAV AILABILITY, BIOEQUIV ALENCE, 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 V ALIDATION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, 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 EV ALUATION无菌产品包装－完整性评估＜1208＞STERILITY TESTING—V ALIDATION 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＞V ALIDATION 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＞V ALIDATION OF COMPENDIAL PROCEDURES药典方法的验证＜1226＞VERIFICATION OF COMPENDIAL PROCEDURES 药典方法的确认＜1227＞V ALIDATION 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＞W ATER FOR HEMODIALYSIS APPLICATIONS 血液透析过程用水＜1231＞W ATER 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＞V ACCINES FOR HUMAN USE—GENERAL CONSIDERATIONS 人用疫苗-通则＜1237＞VIROLOGY TEST METHODS 病毒测试方法＜1238＞V ACCINES FOR HUMAN USE—BACTERIAL V ACCINES 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＞W ATER–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＞EV ALUATION 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 IN 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＞ULTRA VIOLET-VISIBLE SPECTROSCOPY—THEORY AND PRACTICE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 V ARIATION 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。

USP-55 生物指示剂-抗性测试

USP 55BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS生物指示剂－抗性测试TOTAL VIABLE SPORE COUNT活孢子数总数计数Remove three specimens of the relevant biological indicator from their original individual containers. Disperse the paper into component fibers by placing the test specimens in a sterile 250-mL cup of a suitable blender containing 100 mL of chilled, sterilized Purified Water and blending for 3 to 5 minutes to achieve a homogeneous suspension. Transfer a 10-mL aliquot of the suspension to a sterile, screw-capped 16- × 125-mm tube.从生物指示剂的原包装袋中取出3支作为样本。

把待测样品放入一个已灭菌的250mL有搅拌器的杯子里，杯子内装100 mL放冷的灭菌纯化水。

把杯子里的纸片磨碎成纤维状，并混合3～5min使之成为均一的悬浮液。

转移10ml的整数倍的悬浮液至一个已灭菌的16 × 125mm的螺盖管中。

For Biological Indicator for Steam Sterilization, Paper Carrier, heat the tube containing the suspension in a water bath at 95to 100for 15 minutes (heat shock), starting the timing when the temperature reaches 95.如果是纸载的蒸汽灭菌生物指示剂，则把装有悬浮液的管放入95℃～100℃水浴15min （热休克），在悬浮液温度达到95℃时开始计时。

USP38 通用章节目录中文

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 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 DERIV ATIVE 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＜221＞CHLORIDE AND SULFATE氯和硫＜223＞DIMETHYLANILINE二甲基苯胺＜226＞4-EPIANHYDRO-TETRACYCLINE4－？－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＞HEA VY 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, 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＜645＞W ATER 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 HA VING 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＞W ATER 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＞CRYOPRESERV ATION 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 EV ALUATION 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 EV ALUATION 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 EV ALUATION OF DOSAGE FORMS体内与体外的剂型的评估＜1090＞ASSESSMENT OF DRUG PRODUCT PERFORMANCE-BIOAV AILABILITY, BIOEQUIV ALENCE, 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 V ALIDATION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, 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 EV ALUATION无菌产品包装－完整性评估＜1208＞STERILITY TESTING—V ALIDATION 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＞V ALIDATION 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＞V ALIDATION OF COMPENDIAL PROCEDURES药典方法的验证＜1226＞VERIFICATION OF COMPENDIAL PROCEDURES 药典方法的确认＜1227＞V ALIDATION 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＞W ATER FOR HEMODIALYSIS APPLICATIONS 血液透析过程用水＜1231＞W ATER 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＞V ACCINES FOR HUMAN USE—GENERAL CONSIDERATIONS 人用疫苗-通则＜1237＞VIROLOGY TEST METHODS 病毒测试方法＜1238＞V ACCINES FOR HUMAN USE—BACTERIAL V ACCINES 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＞W ATER–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＞EV ALUATION 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 IN 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＞ULTRA VIOLET-VISIBLE SPECTROSCOPY—THEORY AND PRACTICE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 V ARIATION 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。

美国药典36版目录

<681>
固体的疏松密度和叩击密度测定
色谱法呈色与消色溶解的完全性检查总有机炭测定水导电性测定冻凝温度的测定包转和贮藏要求玻璃容器塑料容器附加包装构成容器性能检测
用于无菌固体和液体溶剂形式的单独单位容器和单位剂量容器的重新分配
<691> 棉花
<695> <696> <698>
<55>
生物指示剂：耐受性能检测
<61>
非无菌制品的微生物检查：计数试验
<62>
非无菌制品的特定菌检查
<63>
支原体检测
<71>
无菌检测
生物学试验和检定
<81>
抗生素微生物检定
<85>
细菌内毒素检测
如大肠杆菌、金葡菌、沙门氏菌等
<87>
体外生物反应性试验
<88>
体内生物反应性试验
<90> <91> <92> <111> <115> <121> <123> <130> <151>
美国药典目录
检测和含量分析的一般要求
<1>
注射剂
<3>
局部和经皮的药物产品-产品质量检测
<11>
USP对照标准品
检测和含量分析的仪器
<16>
自动分析方法
<17>
处方容器具标签
<21>
测温仪

usp美国药典结构梳理

USP35-NF-30结构整理vivi2010-10-02USP总目录：1 New Official Text修订文件加快修订过程包括勘误表，临时修订声明（IRAS），修订公告。

勘误表，临时修订声明，修订公告在USP网站上New Official Text部分刊出，勘误表，临时修订公告也会在PF上刊出2front matter前言药典与处方集增补删减情况，审核人员，辅料收录情况3凡例药典，1标题和修订2 药典地位和法律认可3标准复合性4专论和通则5 专论组成6 检验规范和检验方法7 测试结果8 术语和定义9 处方和配药10 包装存储与标签4通则4.1章节列表4.2一般检查和含量测定（章节编号小于1000）检查和含量分析的一般要求检查和含量分析的仪器，微生物检查，生物检查和含量测定，化学检查和含量测定，物理检查和测定4.3一般信息（章节号大于1000）5食物补充剂通则6试剂（试剂，指示剂，溶液等）7参考表性状描述和溶解性查询表（按字母顺序）8食品补充剂各论（字母顺序）9NF各论（辅料标准）10 USP各论11术语附件：通则的章节中文目录（使用起来比较方便，直接找对应章节号即可）一、通用试验和检定（1）试验和检定的总要求1 注射剂11 参比标准物（2）试验和检定的装置16 自动分析方法21 测温仪31 容量装置，如容量瓶、移液管、滴定管，各种规格的误差限度41 砝码和天平（3）微生物学试验51 抗菌效力试验55 生物指示剂：耐受性能试验61 微生物限度试验61 非灭菌制品的微生物检查：计数试验62 非灭菌制品的特定菌检查，如大肠杆菌、金葡菌、沙门氏菌等71 无菌试验（4）生物学试验和检定81 抗生素微生物检定85 细菌内毒素试验87 体外生物反应性试验：检查合成橡胶、塑料、高聚物对哺乳类细胞培养的影响88 体内生物反应性试验：检查上述物质对小鼠、兔iv、ip或肌内植入的影响91 泛酸钙检定111 生物检定法的设计和分析115 右泛醇检定121 胰岛素检定141 蛋白质——生物适应试验，用缺蛋白饲料大鼠，观察水解蛋白注射液和氨基酸混合物的作用151 热原检查法161 输血、输液器及类似医疗装置的内毒素、热原、无菌检查。

USP 通用章节目录

USP29-通用章节指导目录(附录)Guide to General Chapters 通用章节指导目录中此颜色并且带有“***”的为新增内容。

General Requirements for Test and Assays检查与含量分析的一般要求＜1＞INJECTIONS……2455注射剂＜11＞USP REFERENCE STANDARDS……2458USP对照品Apparatus for Test and Assays用于检查与含量分析的器具＜16＞AUTOMATED METHODS OF ANAL YSIS……2491自动化分析方法＜21＞THERMOMETERS……2497温度计＜31＞VOLUMETRIC APPARATUS……2497容量器具＜41＞WEIGHTS AND BALANCES……2499砝码与天平Microbiological Tests 微生物检查法＜51＞ANTIMICROBIAL EFFECTIVENESS TESTING……2499抗菌剂有效性检查法＜55＞BIOLOGICAL INDICATORS—RESISTANCE PERFORMANCE TESTS (2501)生物指示剂－耐药性实验＜61＞MICROBIAL LIMIT TESTS……2503微生物限度检查法＜71＞STERILITY TESTS……2508无菌检查法Biological tests and assays生物检查法与测定法＜81＞ANTIBIOTICS—MICROBIAL ASSAYS……2513抗生素－微生物测定＜85＞BACTERIAL ENDOTOXINS TEST……2521细菌内毒素检查法＜87＞BIOLOGICAL REACTIVITY TESTS, IN VITRO……2525体外的生物反应性检查法＜88＞BIOLOGICAL REACTIVITY TESTS, IN VIVO……2526体内的生物反应性检查法＜91＞CALCIUM PANTOTHENATE ASSAY……2530泛酸钙测定法＜111＞DESIGN AND ANAL YSIS OF BIOLOGICAL ASSAYS……2531 生物测定法的设计与分析＜115＞DEXPANTHENOL ASSAY……2543右泛醇（拟胆碱药）测定法＜121＞INSULIN ASSAYS……2544胰岛素测定法＜141＞PROTEIN—BIOLOGICAL ADEQUACY TEST……2546蛋白质－生物适应性试验＜151＞PYROGEN TEST……2546热原检查法＜161＞TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR MEDICAL DEVICES (2547)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化学实验与测定法＜181＞IDENTIFICATION—ORGANIC NITROGENOUS BASES (2549)鉴别－有机氮碱？＜191＞IDENTIFICATION TESTS—GENERAL……2550鉴别实验－通用＜193＞IDENTIFICATION—TETRACYCLINES……2551鉴别－四环素＜197＞SPECTROPHOTOMETRIC IDENTIFICATION TESTS......2552分光光度计鉴别实验＜201＞THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST.. (2553)薄层色谱鉴别实验Limit Test 限度检查法＜206＞ALUMINUM……2554铝＜211＞ARSENIC……2554砷＜221＞CHLORIDE AND SULFATE……2555氯和硫＜223＞DIMETHYLANILINE……2555二甲基苯胺＜226＞4-EPIANHYDRO-TETRACYCLINE……25564－？－四环素＜231＞HEA VY METALS……2556重金属＜241＞IRON……2557铁＜251＞LEAD……2558铅＜261＞MERCURY……2558汞＜271＞READIL Y CARBONIZABLE SUBSTANCES TEST……2560易碳化物检查法＜281＞RESIDUE ON IGNITION……2560灼烧残渣＜291＞SELENIUM……2560硒Other Tests and Assays 其它检查法与测定法＜301＞ACID-NEUTRALIZING CAPACITY……2561酸中和容量＜311＞ALGINATES ASSAY……2562藻酸盐测定法＜331＞AMPHETAMINE ASSAY……2562苯丙胺测定法<341> ANTIMICROBIAL AGENTS—CONTENT……2563 抗菌剂－含量<345> Assay for Citric Acid/Citrate and Phosphate……2565 柠檬酸/柠檬酸盐和磷酸盐的测定＜351＞ASSAY FOR STEROIDS……2565类固醇（甾类化合物）测定法＜361> BARBITURATE ASSAY……2565 巴比妥类药物测定法＜371＞COBALAMIN RADIOTRACER ASSAY……2566钴铵素放射性跟踪剂测定法＜381＞ELASTOMERIC CLOSURES FOR INJECTIONS……2567 注射剂的弹性密封件＜391＞EPINEPHRINE ASSAY……2567肾上腺测定法＜401＞FATS AND FIXED OILS……2568脂肪与混合油＜411＞FOLIC ACID ASSAY……2571叶酸测定法＜425＞IODOMETRIC ASSAY—ANTIBIOTICS……2572碘量检查法－抗生素＜429＞LIGHT DIFFRACTION MEASUREMENT OF PARTICLE SIZE (2572)粒子尺寸的光衍射测量＜431＞METHOXY DETERMINA TION……2575甲氧基测定法＜441＞NIACIN OR NIACINAMIDE ASSAY……2576烟酰或烟酰胺测定法＜451＞NITRITE TITRATION……2578亚硝酸盐滴定＜461＞NITROGEN DETERMINA TION……2578氮测定法＜466＞ORDINARY IMPURITIES……2579一般杂质＜467＞ORGANIC VOLATILE IMPURITIES……2580有机的易挥发杂质＜471＞OXYGEN FLASK COMBUSTION……2590氧瓶燃烧法＜481＞RIBOFLAVIN ASSAY……2590核黄素测定法＜501＞SALTS OF ORGANIC NITROGENOUS BASES……2591有机氮盐＜511＞SINGLE-STEROID ASSAY……2591单一的类固醇测定法＜521＞SULFONAMIDES……2592磺胺制剂＜531＞THIAMINE ASSAY……2593硫胺素测定法＜541＞TITRIMETRY……2593滴定法＜551＞ALPHA TOCOPHEROL ASSAY……2596α－维生素E测定法＜561＞ARTICLES OF BOTANICAL ORIGIN……2596植物起源的药品＜563＞IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN……2603植物药品的鉴别＜565＞BOTANICAL EXTRACTS……2609植物提取＜571＞VITAMIN A ASSAY……2611维生素A的测定法＜581＞VITAMIN D ASSAY……2612维生素D的测定法＜591＞ZINC DETERMINATION……2616锌的测定法Physical Test and Determinations物理检查与测定法INHALERS, AND DRY POWDER ＜601＞AEROSOLS, NASAL SPRAYS,USP28METERED-DOSEINHALERS……2617气溶胶，鼻用喷雾剂，定量吸入器与干粉吸入器＜611＞ALCOHOL DETERMINATION……2637乙醇测定法＜616＞BULK DENSITY AND TAPPED DENSITY……2638堆密度与拍实密度＜621＞CHROMATOGRAPHY…….2639色谱法＜631＞COLOR AND ACHROMICITY……2651呈色与消色＜641＞COMPLETENESS OF SOLUTION……2652完全溶解＜643＞TOTAL ORGANIC CARBON……2652总有机碳＜645＞WA TER CONDUCTIVITY……2653水电导率＜651＞CONGEALING TEMPERA TURE……2654凝点温度＜661＞CONTAINERS……2655容器＜671＞CONTAINERS—PERMEATION……2663容器－渗透＜691＞COTTON……2664棉花＜695＞CRYSTALLINITY……2665结晶性＜696＞Crystallinity Determination By Solution Calorimetry……2666 通过溶液量热学测定结晶性＜698＞DELIVERABLE VOLUME……2667可转移的体积＜699＞DENSITY OF SOLIDS……2669固体密度＜701＞DISINTEGRATION……2670崩解时限***＜701＞Disintegration (Harmonized Chapter, Official April 1,2006)………..2671崩解时限（协调的章节，法定日期，2006.4.1）＜711＞DISSOLUTION……2673 溶出度***＜711＞Dissolution (Harmonized Chapter, Official April 1,2006)………..2675 溶出度（协调的章节，法定日期，2006.4.1）＜721＞DISTILLING RANGE……2682馏程＜724＞DRUG RELEASE……2682药物释放度***＜724＞Drug releasee (Harmonized Chapter, Official April 1,2006)………..2690药物释放度（协调的章节，法定日期，2006.4.1）＜726＞ELECTROPHORESIS……2694电泳＜727＞CAPILLARY ELECTROPHORESIS……2696毛细管电泳法***＜730＞Plasma Spectrochemistry….2700 血浆光谱化学＜731＞LOSS ON DRYING……2704干燥失重＜733＞LOSS ON IGNITION……2704灼烧失重＜736＞MASS SPECTROMETRY……2705 质谱＜741＞MELTING RANGE OR TEMPERATURE……2708熔距或熔点＜751＞METAL PARTICLES IN OPHTHALMIC OINTMENTS……2709眼用软膏中的金属粒子＜755＞MINIMUM FILL……2710最低装填量＜761＞NUCLEAR MAGNETIC RESONANCE……2710核磁共振＜771＞OPHTHALMIC OINTMENTS……2715眼用软膏＜776＞OPTICAL MICROSCOPY……2716光学显微镜＜781＞OPTICAL ROTATION……2718旋光＜785＞OSMOLALITY AND OSMOLARITY……2718同渗重摩与同渗容摩＜786＞PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANAL YTICAL SIEVING (2720)通过筛分法估算粒子分布＜788＞PARTICULATE MATTER IN INJECTIONS……2722注射剂中的颗粒＜789＞PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS……2729眼用溶液中的颗粒＜791＞pH (2730)＜795＞PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS (2731)药物混合－非无菌制剂＜797＞PHARMACEUTICAL COMPOUNDING—STERILE PREPARATIONS (2735)药物混合－无菌制剂＜801＞POLAROGRAPHY……2752极谱法＜811＞POWDER FINENESS……2754粉剂细度＜821＞RADIOACTIVITY……2755放射性＜823＞RADIOPHARMACEUTICALS FOR POSITRON EMISSION TOMOGRAPHY —COMPOUNDING……2763用于正电子发射断层摄影术的放射性药物＜831＞REFRACTIVE INDEX……2766折光率＜841＞SPECIFIC GRA VITY……2766比重＜846＞SPECIFIC SURFACE AREA……2767 比表面积＜851＞SPECTROPHOTOMETRY AND LIGHT-SCA TTERING……2770分光光度计与光散射＜861＞SUTURES—DIAMETER…2775缝线－直径＜871＞SUTURES—NEEDLE ATTACHMENT……2775缝线－穿孔实验＜881＞TENSILE STRENGTH…..2776张力＜891＞THERMAL ANAL YSIS……2776热分析＜905＞UNIFORMITY OF DOSAGE UNITS……2778制剂单位的含量均匀度＜905＞UNIFORMITY OF DOSAGE UNITS (Harmonized Chapter, Official April 1,2006)……2780制剂单位的含量均匀度（协调的章节2006.4.1）＜911＞VISCOSITY……2785粘度＜921＞WA TER DETERMINA TION……2785水测定法＜941＞X-RAY DIFFRACTION……2788X光衍射General Information通用信息＜1010＞ANAL YTICAL DATA—INTERPRETA TION AND TREATMENT (2790)分析数据－解释与处理＜1015＞AUTOMA TED RADIOCHEMICAL SYNTHESIS APPARATUS (2801)放射性自动合成装置＜1031＞THE BIOCOMPATIBILITY OF MATERIALS USED IN DRUG CONTAINERS, MEDICAL DEVICES, AND IMPLANTS (2802)用于药物容器、医疗设施和植入剂的材料的生物相容性＜1035＞BIOLOGICAL INDICATORS FOR STERILIZATION……2811灭菌用生物指示剂＜1041＞BIOLOGICS……2814生物制剂***＜1043＞Ancillary Material for Cell, Gene, and Tissue-Engineered Products…….2814 细胞，基因与组织设计产品的辅助材料＜1045＞BIOTECHNOLOGY-DERIVED ARTICLES……2821生物技术提取产品＜1046＞CELL AND GENE THERAPY PRODUCTS……2831细胞与基因治疗产品＜1047＞BIOTECHNOLOGY-DERIVED ARTICLES—TESTS……2858生物技术产品－检查法＜1048＞QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANAL YSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF r-DNA DERIVED PROTEIN PRODUCTS1 (2883)生物产品质量：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 PRODUCTS1 (2884)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 EV ALUA TION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN (2887)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……2896玻璃容器的清洗＜1061＞COLOR—INSTRUMENTAL MEASUREMENT……2896显色－仪器测量***＜1065＞Ion Chromatography………2898 离子色谱法＜1074＞EXCIPIENT BIOLOGICAL SAFETY EV ALUA TION GUIDELINES (2900)赋形剂（辅料）生物安全性评估指导＜1075＞GOOD COMPOUNDING PRACTICES……2903好的混合操作＜1078＞GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS (2906)批药品赋形剂的生产管理规范***＜1079＞Good Storage and Shipping Practices……2915 良好的贮存与船运规范＜1081＞GEL STRENGTH OF GELATIN……2920白凝胶的凝胶强度＜1086＞IMPURITIES IN OFFICIAL ARTICLES……2920药典物品中的杂质＜1087＞INTRINSIC DISSOLUTION……2923内部的溶出度＜1088＞IN VITRO AND IN VIVO EV ALUA TION OF DOSAGE FORMS (2924)体内与体外的剂型的评估＜1090＞IN VIVO BIOEQUIV ALENCE GUIDANCES……29291体内生物等效性指导＜1091＞LABELING OF INACTIVE INGREDIENTS……2968非活性成分的标示＜1101＞MEDICINE DROPPER……2969医用滴管＜1111＞MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE PHARMACEUTICAL PRODUCTS (2969)非无菌药品中的微生物分布＜1116＞MICROBIOLOGICAL EV ALUA TION OF CLEAN ROOMS AND OTHER CONTROLLED ENVIRONMENTS……2969洁净的房间与其它可控环境的微生物评估＜1118＞MONITORING DEVICES—TIME, TEMPERATURE, AND HUMIDITY (2976)监控装置－时间、温度与湿度＜1119＞NEAR-INFRARED SPECTROPHOTOMETRY……2979近红外分光光度测定法***＜1120＞Raman Spectrophotometry……..2983 Raman分光光度测定法＜1121＞NOMENCLATURE……2988命名***＜1136＞Packaging－Unit-of-Use……2989包装－单元使用＜1146＞PACKAGING PRACTICE—REPACKAGING A SINGLE SOLID ORAL DRUG PRODUCT INTO A UNIT-DOSE CONTAINER……2990 包装操作－将单一固体口服药品产品再包装成单元剂量＜1150＞PHARMACEUTICAL STABILITY……2994药物稳定性＜1151＞PHARMACEUTICAL DOSAGE FORMS……2996药物剂型＜1160＞PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION COMPOUNDING (3006)按处方混合的药物的计算＜1171＞PHASE-SOLUBILITY ANAL YSIS……3016相溶解分析***＜1174＞Powder Flow….3017 粉末流动性＜1176＞PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS….3020 处方天平与容量器具***＜1177＞Good Packaging Practices….3021 良好的包装操作***＜1178＞Good Repackaging Practices….3023 良好的再包装操作＜1181＞SCANNING ELECTRON MICROSCOPY……3025扫描电子显微镜＜1191＞STABILITY CONSIDERATIONS IN DISPENSING PRACTICE……3029 分装操作中稳定性考察＜1196＞PHARMACOPEIAL HARMONIZATION……3031药典的一致性＜1207＞STERILE PRODUCT PACKAGING—INTEGRITY EV ALUATION (3035)无菌产品包装－完整性评估＜1208＞STERILITY TESTING—V ALIDATION OF ISOLATOR SYSTEMS (3037)无菌实验－隔离系统的验证＜1209＞STERILIZATION—CHEMICAL AND PHYSICOCHEMICAL INDICATORS AND INTEGRATORS……3040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 (3041)药典物品中的灭菌与灭菌保证＜1216＞TABLET FRIABILITY……3046片剂的脆碎度＜1221＞TEASPOON……3047茶匙＜1222＞TERMINALL Y STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE……3047最终灭菌产品－放行参数＜1225＞V ALIDATION OF COMPENDIAL METHODS……3050药典方法的验证＜1227＞V ALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES (3053)从药物中回收微生物的验证＜1230＞W ATER FOR HEALTH APPLICATIONS……3055健康用水＜1231＞W ATER FOR PHARMACEUTICAL PURPOSES……3056制药用水＜1241＞W ATER–SOLID INTERACTIONS IN PHARMACEUTICAL SYSTEMS (3074)在药物系统中水与固体的相互作用＜1251＞WEIGHING ON AN ANAL YTICAL BALANCE……3076关于分析天平的称重***＜1265＞Written Prescription Drug Information－Guidelines……….3078 书面的处方药信息－指南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 A TTRIBUTES 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。

USP微生物限度检查中文

USP微生物限度检查中文61）微生物限度检测（MICROBIAL LIMIT TESTS）此章提供方法来检测可能存在的好氧微生物其他制药过程中可能出现的微生物的数量，包括原材料和成品中的。

如果经过验证确认可以得到相同或更好的检测结论，也允许采用自动化的检测方法。

在样品检测过程中须进行无菌操作。

若无特别说明，则“培养（incubate）”一词指在30—35℃的培养箱内培养24至48小时；“生长（growth）”一词用于专门的判定，说明“存在和可能存在活的微生物”。

准备实验 (Preparatory Testing)本章涉及实验结果的有效性取决于：提供的被检测样品本身在实验条件下，被充分证明不会抑制可能存在的微生物的生长。

因此，在准备样品时，需要正规的实验操作和符合要求的实验条件，接种稀释样品到含有以下（微生物）培养物的培养基：金黄色（奥里斯）葡萄球菌（Staphylococcus aureus）,大肠埃希氏菌（Escherichia coli）, 铜绿假单胞菌(Pseudomonas aeruginosa), 和沙门氏菌（Salmonella）。

方法如下：将用肉汤培养基培养24小时后的（微生物）不小于10-3稀释的微生物培养物，加1 ml（微生物）培养液到磷酸(盐)缓冲液(pH 7.2)，液体大豆酪蛋白消化物培养基（Fluid Soybean-Casein Digest Medium），或者液体乳糖培养基（Fluid Lactose Medium）。

相应培养基培养失败则需要采取以下方法更改检测程序：（1）增加稀释液体积，检测样品加入量仍维持不变；或者（2）中和一定数量的干扰因子；或者（3）结合（1）、（2）得出适当条件，使接种物得以生长。

以下是一些物质的成分和浓度，该物质及浓度可用于加入培养基、阻止物质发挥抑菌作用：大豆卵磷脂（soy lecithin, 0.5%）或者聚山梨醇酯20（polysorbate 20, 4.0%）。