USP 通用章节目录.doc

USP29-通用章节指导目录(附录) 第8页 共7页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1INJECTIONS2455注射剂11USP REFERENCE STANDARDS2458USP对照品Apparatus for Test and Assays用于检查与含量分析的器具16AUTOMATED METHODS OF ANALYSIS2491自动化分析方法21THERMOMETERS2497温度计31VOLUMETRIC APPARATUS2497容量器具41WEIGHTS AND BALANCES2499砝码与天平Microbiological Tests 微生物检查法51ANTIMICROBIAL EFFECTIVENESS TESTING2499抗菌剂有效性检查法55BIOLOGICAL INDICATORSRESISTANCE PERFORMANCE TESTS2501生物指示剂耐药性实验61MICROBIAL LIMIT TESTS2503微生物限度检查法71STERILITY TESTS2508无菌检查法Biological tests and assays生物检查法与测定法81ANTIBIOTICSMICROBIAL ASSAYS2513抗生素微生物测定85BACTERIAL ENDOTOXINS TEST2521细菌内毒素检查法87BIOLOGICAL REACTIVITY TESTS, IN VITRO2525体外的生物反应性检查法88BIOLOGICAL REACTIVITY TESTS, IN VIVO2526体内的生物反应性检查法91CALCIUM PANTOTHENATE ASSAY2530泛酸钙测定法111DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS2531 生物测定法的设计与分析115DEXPANTHENOL ASSAY2543右泛醇（拟胆碱药）测定法121INSULIN ASSAYS2544胰岛素测定法141PROTEINBIOLOGICAL ADEQUACY TEST2546蛋白质生物适应性试验151PYROGEN TEST2546热原检查法161TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR MEDICAL DEVICES2547输血输液用具以及相类似的医疗器械171VITAMIN B12 ACTIVITY ASSAY2548维生素B12活性测定法Chemical Tests and assays化学实验与测定法181IDENTIFICATIONORGANIC NITROGENOUS BASES2549鉴别有机氮碱？191IDENTIFICATION TESTSGENERAL2550鉴别实验通用193IDENTIFICATIONTETRACYCLINES2551鉴别四环素197SPECTROPHOTOMETRIC IDENTIFICATION TESTS2552分光光度计鉴别实验201THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST.2553薄层色谱鉴别实验Limit Test 限度检查法206ALUMINUM2554铝211ARSENIC2554砷221CHLORIDE AND SULFATE2555氯和硫223DIMETHYLANILINE2555二甲基苯胺2264-EPIANHYDRO-TETRACYCLINE25564？四环素231HEAVY METALS2556重金属241IRON2557铁251LEAD2558铅261MERCURY2558汞271READILY CARBONIZABLE SUBSTANCES TEST2560易碳化物检查法281RESIDUE ON IGNITION2560灼烧残渣291SELENIUM2560硒Other Tests and Assays 其它检查法与测定法301ACID-NEUTRALIZING CAPACITY2561酸中和容量311ALGINATES ASSAY2562藻酸盐测定法331AMPHETAMINE ASSAY2562苯丙胺测定法 ANTIMICROBIAL AGENTSCONTENT2563 抗菌剂含量 Assay for Citric Acid/Citrate and Phosphate2565 柠檬酸/柠檬酸盐和磷酸盐的测定351ASSAY FOR STEROIDS2565类固醇（甾类化合物）测定法361 BARBITURATE ASSAY2565 巴比妥类药物测定法371COBALAMIN RADIOTRACER ASSAY2566钴铵素放射性跟踪剂测定法381ELASTOMERIC CLOSURES FOR INJECTIONS2567 注射剂的弹性密封件391EPINEPHRINE ASSAY2567肾上腺测定法401FATS AND FIXED OILS2568脂肪与混合油411FOLIC ACID ASSAY2571叶酸测定法425IODOMETRIC ASSAYANTIBIOTICS2572碘量检查法抗生素429LIGHT DIFFRACTION MEASUREMENT OF PARTICLE SIZE2572粒子尺寸的光衍射测量431METHOXY DETERMINATION2575甲氧基测定法441NIACIN OR NIACINAMIDE ASSAY2576烟酰或烟酰胺测定法451NITRITE TITRATION2578亚硝酸盐滴定461NITROGEN DETERMINATION2578氮测定法466ORDINARY IMPURITIES2579一般杂质467ORGANIC VOLATILE IMPURITIES2580有机的易挥发杂质471OXYGEN FLASK COMBUSTION2590氧瓶燃烧法481RIBOFLAVIN ASSAY2590核黄素测定法501SALTS OF ORGANIC NITROGENOUS BASES2591有机氮盐511SINGLE-STEROID ASSAY2591单一的类固醇测定法521SULFONAMIDES2592磺胺制剂531THIAMINE ASSAY2593硫胺素测定法541TITRIMETRY2593滴定法551ALPHA TOCOPHEROL ASSAY2596维生素E测定法561ARTICLES OF BOTANICAL ORIGIN2596植物起源的药品 563IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN2603植物药品的鉴别565BOTANICAL EXTRACTS2609植物提取571VITAMIN A ASSAY2611维生素A的测定法581VITAMIN D ASSAY2612维生素D的测定法591ZINC DETERMINATION2616锌的测定法Physical Test and Determinations物理检查与测定法601AEROSOLS, NASAL SPRAYS,USP28 METERED-DOSE INHALERS, AND DRY POWDER INHALERS2617气溶胶，鼻用喷雾剂，定量吸入器与干粉吸入器611ALCOHOL DETERMINATION2637乙醇测定法616BULK DENSITY AND TAPPED DENSITY2638堆密度与拍实密度621CHROMATOGRAPHY.2639色谱法631COLOR AND ACHROMICITY2651呈色与消色641COMPLETENESS OF SOLUTION2652完全溶解643TOTAL ORGANIC CARBON2652总有机碳645WATER CONDUCTIVITY2653水电导率651CONGEALING TEMPERATURE2654凝点温度661CONTAINERS2655容器671CONTAINERSPERMEATION2663容器渗透691COTTON2664棉花695CRYSTALLINITY2665结晶性696Crystallinity Determination By Solution Calorimetry2666 通过溶液量热学测定结晶性698DELIVERABLE VOLUME2667可转移的体积699DENSITY OF SOLIDS2669固体密度701DISINTEGRATION2670崩解时限*701Disintegration (Harmonized Chapter, Official April 1,2006).2671崩解时限（协调的章节，法定日期，2006.4.1）711DISSOLUTION2673 溶出度*711Dissolution (Harmonized Chapter, Official April 1,2006).2675 溶出度（协调的章节，法定日期，2006.4.1）721DISTILLING RANGE2682馏程724DRUG RELEASE2682药物释放度*724Drug 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）726ELECTROPHORESIS2694电泳727CAPILLARY ELECTROPHORESIS2696毛细管电泳法*730Plasma Spectrochemistry.2700 血浆光谱化学731LOSS ON DRYING2704干燥失重733LOSS ON IGNITION2704灼烧失重736MASS SPECTROMETRY2705 质谱741MELTING RANGE OR TEMPERATURE2708熔距或熔点751METAL PARTICLES IN OPHTHALMIC OINTMENTS2709眼用软膏中的金属粒子755MINIMUM FILL2710最低装填量761NUCLEAR MAGNETIC RESONANCE2710核磁共振771OPHTHALMIC OINTMENTS2715眼用软膏776OPTICAL MICROSCOPY2716光学显微镜781OPTICAL ROTATION2718旋光785OSMOLALITY AND OSMOLARITY2718同渗重摩与同渗容摩786PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL SIEVING2720通过筛分法估算粒子分布788PARTICULATE MATTER IN INJECTIONS2722注射剂中的颗粒789PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS2729眼用溶液中的颗粒791pH2730795PHARMACEUTICAL COMPOUNDINGNONSTERILE PREPARATIONS2731药物混合非无菌制剂797PHARMACEUTICAL COMPOUNDINGSTERILE PREPARATIONS2735药物混合无菌制剂801POLAROGRAPHY2752极谱法811POWDER FINENESS2754粉剂细度821RADIOACTIVITY2755放射性823RADIOPHARMACEUTICALS FOR POSITRON EMISSIONTOMOGRAPHYCOMPOUNDING2763用于正电子发射断层摄影术的放射性药物831REFRACTIVE INDEX2766折光率841SPECIFIC GRAVITY2766比重846SPECIFIC SURFACE AREA2767 比表面积851SPECTROPHOTOMETRY AND LIGHT-SCATTERING2770分光光度计与光散射861SUTURESDIAMETER2775缝线直径871SUTURESNEEDLE ATTACHMENT2775缝线穿孔实验881TENSILE STRENGTH.2776张力891THERMAL ANALYSIS2776热分析905UNIFORMITY OF DOSAGE UNITS2778制剂单位的含量均匀度905UNIFORMITY 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）911VISCOSITY2785粘度921WATER DETERMINATION2785水测定法941X-RAY DIFFRACTION2788X光衍射General Information通用信息1010ANALYTICAL DATAINTERPRETATION AND TREATMENT2790分析数据解释与处理1015AUTOMATED RADIOCHEMICAL SYNTHESIS APPARATUS2801放射性自动合成装置1031THE BIOCOMPATIBILITY OF MATERIALS USED IN DRUG CONTAINERS, MEDICAL DEVICES, AND IMPLANTS2802用于药物容器、医疗设施和植入剂的材料的生物相容性1035BIOLOGICAL INDICATORS FOR STERILIZATION2811灭菌用生物指示剂1041BIOLOGICS2814生物制剂*1043Ancillary 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1045BIOTECHNOLOGY-DERIVED ARTICLES2821生物技术提取产品1046CELL AND GENE THERAPY PRODUCTS2831细胞与基因治疗产品1047BIOTECHNOLOGY-DERIVED ARTICLESTESTS2858生物技术产品检查法1048QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF r-DNA DERIVED PROTEIN PRODUCTS12883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1049QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS12884生物技术产品的质量：生物技术/生物产品的稳定性实验1050VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN2887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1051CLEANING GLASS APPARATUS2896玻璃容器的清洗1061COLORINSTRUMENTAL MEASUREMENT2896显色仪器测量*1065Ion Chromatography2898 离子色谱法1074EXCIPIENT BIOLOGICAL SAFETY EVALUATION GUIDELINES2900赋形剂（辅料）生物安全性评估指导1075GOOD COMPOUNDING PRACTICES2903好的混合操作1078GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS2906批药品赋形剂的生产管理规范*1079Good Storage and Shipping Practices2915 良好的贮存与船运规范1081GEL STRENGTH OF GELATIN2920白凝胶的凝胶强度1086IMPURITIES IN OFFICIAL ARTICLES2920药典物品中的杂质1087INTRINSIC DISSOLUTION2923内部的溶出度1088IN VITRO AND IN VIVO EVALUATION OF DOSAGE FORMS2924体内与体外的剂型的评估1090IN VIVO BIOEQUIVALENCE GUIDANCES29291体内生物等效性指导1091LABELING OF INACTIVE INGREDIENTS2968非活性成分的标示1101MEDICINE DROPPER2969医用滴管1111MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE PHARMACEUTICAL PRODUCTS.2969非无菌药品中的微生物分布1116MICROBIOLOGICAL EVALUATION OF CLEAN ROOMS AND OTHER CONTROLLED ENVIRONMENTS2969洁净的房间与其它可控环境的微生物评估1118MONITORING DEVICESTIME, TEMPERATURE, AND HUMIDITY2976监控装置时间、温度与湿度1119NEAR-INFRARED SPECTROPHOTOMETRY2979近红外分光光度测定法*1120Raman Spectrophotometry.2983 Raman分光光度测定法1121NOMENCLATURE2988命名*1136PackagingUnit-of-Use2989包装单元使用1146PACKAGING PRACTICEREPACKAGING A SINGLE SOLID ORAL DRUG PRODUCT INTO A UNIT-DOSE CONTAINER2990 包装操作将单一固体口服药品产品再包装成单元剂量1150PHARMACEUTICAL STABILITY2994药物稳定性1151PHARMACEUTICAL DOSAGE FORMS2996药物剂型1160PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION COMPOUNDING3006按处方混合的药物的计算1171PHASE-SOLUBILITY ANALYSIS3016相溶解分析*1174Powder Flow.3017 粉末流动性1176PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS.3020 处方天平与容量器具*1177Good Packaging Practices.3021 良好的包装操作*1178Good Repackaging Practices.3023 良好的再包装操作1181SCANNING ELECTRON MICROSCOPY3025扫描电子显微镜1191STABILITY CONSIDERATIONS IN DISPENSING PRACTICE3029 分装操作中稳定性考察1196PHARMACOPEIAL HARMONIZATION3031药典的一致性1207STERILE PRODUCT PACKAGINGINTEGRITY EVALUATION3035无菌产品包装完整性评估1208STERILITY TESTINGVALIDATION OF ISOLATOR SYSTEMS3037无菌实验隔离系统的验证1209STERILIZATIONCHEMICAL AND PHYSICOCHEMICAL INDICATORS AND INTEGRATORS3040灭菌化学与物理化学的指示剂以及二者的综合1211STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES.3041 药典物品中的灭菌与灭菌保证1216TABLET FRIABILITY3046片剂的脆碎度1221TEASPOON3047茶匙1222TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTSPARAMETRIC RELEASE3047最终灭菌产品放行参数1225VAL