USP38通用章节目录中文剖析

1、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 INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS) PRODUCT QUALITYTESTS 注射和植入药物产品 (注射用 ) 产品质量测试 INJECTIONS注射剂ORAL DRUG PRODUCTS PRODUCT QUALITY TESTS口服药物产品质量测试 TOPICAL AND TRANSDERMAL DRUG PRODUC

2、TSPRODUCT QUALITY TESTS局部和透皮药物产品 产品质量测试 MUCOSAL DRUG PRODUCTS PRODUCT QUALITY TESTS 粘膜药物产品质量测试 INHALATION AND NASAL DRUG PRODUCTSGENERAL INFORMATION AND PRODUCTQUALITY TESTS 吸入剂产品 产品质量测试 LABELING 标签 USP REFERENCE STANDARDS USP 标准品Apparatus for Test and Assays 用于检查与含量分析的器具 PRESCRIPTION CONTAINER LABE

3、LING处方容器标签 THERMOMETERS温度计 VOLUMETRIC APPARATUS容量器具 BALANCES 天平Microbiological Tests 微生物检查法 ANTIMICROBIAL EFFECTIVENESS TESTING抗菌剂有效性检查法 BIOLOGICAL INDICATORS RESISTANCE PERFORMANCE TESTS 生物指示剂耐药性实验 MICROBIOLOGICALEXAMINATIONOF NONSTERILEPRODUCTS: MICROBIALENUMERATION TESTS 非无菌产品的微生物限度检查：微生物列举检查法 MI

4、CROBIOLOGICALEXAMINATIONOF NONSTERILE PRODUCTS: TESTS FORSPECIFIED MICROORGANISMS 非无菌产品的微生物限度检查：特定微生物检查法 MYCOPLASMA TESTS 支原体检查法 STERILITY TESTS无菌检查法Biological tests and assays 生物检查法与测定法 ANTIBIOTICS MICROBIAL ASSAYS抗生素微生物测定 BACTERIAL ENDOTOXINS TEST细菌内毒素检查法 BIOLOGICAL REACTIVITY TESTS, IN VITRO体外的生物

5、反应性检查法 BIOLOGICAL REACTIVITY TESTS, IN VIVO体内的生物反应性检查法 ENZYMES USED AS ANCILLARY MATERIALS IN PHARMACEUTICAL MANUFACTURING药品生产中酶作为辅料所使用 FETAL BOVINE SERUM QUALITY ATTRIBUTES AND FUNCTIONALITY TESTS牛胎儿血清 -质量品质和功能检查法 CALCIUM PANTOTHENATE ASSAY泛酸钙测定法 GROWTH FACTORS AND CYTOKINES USED IN CELL THERAPY MA

6、NUFACTURING 在细胞疗法中使用生长因子和细胞因子 DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS生物测定法的设计与分析 DEXPANTHENOL ASSAY 右泛醇（拟胆碱药）测定法 INSULIN ASSAYS 胰岛素测定法 PHYSICOCHEMICAL ANALYTICAL PROCEDURES FOR INSULINS 胰岛素的物理化学分析程序 GLUCAGON BIOIDENTITY TESTS高血糖素的生物鉴别检查法 ERYTHROPOIETIN BIOASSAYS红细胞生成素的微生物测定 SOMATROPIN BIOIDENTITY T

7、ESTS生长激素的生物鉴别检查法 PROTEIN A QUALITY ATTRIBUTES蛋白质 A 的质量特征 PYROGEN TEST 热原检查法 TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR MEDICAL DEVICES 输血输液用具以及相类似的医疗器械 VITAMIN B 12 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 IDENTIFICATION ORGANIC NITROGENOUS BASES 鉴别有机氮碱化合物 IDENTI

8、FICATION TESTS GENERAL 鉴别实验通用 IDENTIFICATION TETRACYCLINES 鉴别四环素类 SPECTROPHOTOMETRIC IDENTIFICATION TESTS分光光度计鉴别实验 THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST 薄层色谱鉴别实验Limit Tests 限度检查法 ALUMINUM 铝 TEST FOR 1,6-ANHYDRO DERIV ATIVE FOR ENOXAPARIN SODIUM 依诺肝素钠的酐类衍生物实验 ANTI-FACTOR Xa AND ANTI-FACTOR I

9、Ia 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 LOW MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT DETERMINATIONS 低分子肝素钠分子量测定 ARSENIC 砷 CHLORIDE AND SULFATE氯和硫 DIMETHYLANILINE二甲基苯胺 4-EPIANHYDRO-TETRACYCLINE4？四环素 4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG PR

10、ODUCTS 对乙酰氨酚药物产品中氨基酚 ETHYLENE OXIDE AND DIOXANE环氧乙烷和二氧六环 HEA VY METALS重金属（删除） ELEMENTAL IMPURITIES LIMITS 元素杂质 -限度 ELEMENTAL IMPURITIES PROCEDURES 元素杂质 -规程 IRON 铁 LEAD 铅 MERCURY 汞 POROSIMETRY BY MERCURY INTRUSION水银孔隙仪 POROSITY BY NITROGEN ADSORPTIONDESORPTION 氮吸附 -解吸测定孔隙率 READILY CARBONIZABLE SUBSTA

11、NCES TEST易碳化物检查法 RESIDUE ON IGNITION炽灼残渣 SELENIUM 硒Other Tests and Assays 其它检查法与测定法 ACID-NEUTRALIZING CAPACITY酸中和容量 ALGINATES ASSAY藻酸盐测定法 ANTIMICROBIAL AGENTS CONTENT 抗菌剂含量 Assay for Citric Acid/Citrate and Phosphate 柠檬酸 / 柠檬酸盐和磷酸盐的测定 ASSAY FOR STEROIDS类固醇（甾类化合物）测定法 BARBITURATE ASSAY 巴比妥类药物测定法 COBAL

12、AMIN RADIOTRACER ASSAY钴铵素放射性跟踪剂测定法 ELASTOMERIC CLOSURES FOR INJECTIONS注射剂的弹性密封件 EPINEPHRINE ASSAY肾上腺素测定法 FATS AND FIXED OILS脂肪与混合油 FOLIC ACID ASSAY叶酸测定法 IMPURITIES TESTING IN MEDICAL GASES医用气体杂质检查 MEDICAL GASES ASSAY 医用气体含量检查 IODOMETRIC ASSAY ANTIBIOTICS 碘量检查法抗生素 LIGHT DIFFRACTION MEASUREMENT OF PAR

13、TICLE SIZE 粒径的光衍射测量法 METHOXY DETERMINATION甲氧基测定法 NIACIN OR NIACINAMIDE ASSAY烟酰或烟酰胺测定法 NITRITE TITRATION亚硝酸盐滴定 NITROGEN DETERMINATION氮测定法GLYCOL INSPRAYS, ANDNONSTERILE般杂质 ORDINARY IMPURITIES RESIDUAL SOLVENTS残留溶剂 ETHYLENE GLYCOL, DIETHYLENE GLYCOL, AND TRIETHYLENE ETHOXYLATED SUBSTANCES乙氧基物质中乙二醇、二甘醇、

14、三甘醇测定 OXYGEN FLASK COMBUSTION氧瓶燃烧法 RIBOFLAVIN ASSAY核黄素（维生素 B2）测定法 SALTS OF ORGANIC NITROGENOUS BASES有机氮盐 ACETIC ACID IN PEPTIDES多肽类中乙酸测定 SINGLE-STEROID ASSAY单一的类固醇测定法 SULFUR DIOXIDE二氧化硫 THIAMINE ASSAY硫胺素测定法 TITRIMETRY滴定法 VITAMIN E ASSAY维生素 E 测定法 ARTICLES OF BOTANICAL ORIGIN植物起源的药品 IDENTIFICATION OF

15、ARTICLES OF BOTANICAL ORIGIN植物药品的鉴别 BOTANICAL EXTRACTS植物提取 VITAMIN A ASSAY 维生素 A 测定法 VITAMIN D ASSAY维生素 D 测定法 ZINC DETERMINATION锌的测定法Physical Test and Determinations 物理检查与测定法 INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, POWDERS PERFORMANCE QUALITY TESTS 吸入剂、鼻雾剂：气溶胶，喷雾，干粉-质量通则 PROPELLANTS 推进剂 TOPICA

16、L AEROSOLS 局部喷雾剂 LEAK RATE 渗漏率 ALTERNATIVE MICROBIOLOGICAL SAMPLING METHODS FOR 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 ALCOHOL DETERMINATION乙醇测定法 BULK DENSITY AND TAPPED DENSITY堆密度与振实密度 CHROMATOGRAPHY色谱法 COLOR AND ACHROMICITY呈色与消色 COMPLETENESS OF SOLUTION溶解度 TOTAL ORGANIC CARBON总有机碳 WATER

17、CONDUCTIVITY水电导率 CONGEALING TEMPERATURE凝点温度 PACKAGING AND STORAGE REQUIREMENTS包装和储藏要求 CONTAINERS GLASS 容器 -玻璃 CONTAINERS PLASTICS 容器 -塑料 AUXILIARY PACKAGING COMPONENTS辅助包装部件 CONTAINERS PERFORMANCE TESTING容器性能测试 COTTON 棉花 CRYSTALLINITY结晶度AND CHARACTERIZATION OF CRYSTALLINE SOLIDS BY MICROCALORIMETRY

18、SOLUTION CALORIMETRY 通过溶液量热学测定结晶性 CONTAINER CONTENT FOR INJECTIONS注射剂容器容积 DELIVERABLE VOLUME抽取体积 DENSITY OF SOLIDS固体密度 DISINTEGRATION崩解时限 QUALITY ATTRIBUTES OF TABLETS LABELED AS HAVING A FUNCTIONAL SCORE？ DISSOLUTION 溶出度 DISTILLING RANGE馏程 DRUG RELEASE 药物释放度 GLOBULE SIZE DISTRIBUTION IN LIPID INJEC

19、TABLE EMULSIONS 脂类可注射的乳剂的粒径分布 Plasma Spectrochemistry 血浆光谱化学？ LOSS ON DRYING4干燥失重 LOSS ON IGNITION灼烧失重 X-RAY FLUORESCENCE SPECTROMETRYX 射线光谱 MASS SPECTROMETRY质谱 MELTING RANGE OR TEMPERATURE熔距或熔点 METAL PARTICLES IN OPHTHALMIC OINTMENTS眼用软膏中的金属粒子 MINIMUM FILL最低装量 NUCLEAR MAGNETIC RESONANCE核磁共振 OPHTHAL

20、MIC OINTMENTS眼用软膏 OPTICAL MICROSCOPY光学显微镜 OPTICAL ROTATION旋光度 OSMOLALITY AND OSMOLARITY渗透压 PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL SIEVING 筛分法估算粒径分布 SUBVISIBLE PARTICULATE MATTER IN THERAPEUTIC PROTEIN INJECTIONS显微计数法在治疗性蛋白注射剂中应用注射剂中的不溶性微粒 PARTICULATE MATTER IN INJECTIONS PARTICULATE MAT

21、TER IN OPHTHALMIC SOLUTIONS眼用溶液中的不溶性微粒 VISIBLE PARTICULATES IN INJECTIONS注射剂中可见异物 pH PHARMACEUTICAL COMPOUNDINGNONSTERILE PREPARATIONS药物混合非无菌制剂 PHARMACEUTICAL COMPOUNDINGSTERILE PREPARATIONS药物混合无菌制剂 POLAROGRAPHY极谱法 POWDER FINENESS粉剂细度 RADIOACTIVITY放射性 POSITRON EMISSION TOMOGRAPHY DRUGS FOR COMPOUNDI

22、NG, INVESTIGATIONAL,AND RESEARCH USES 用于正电子发射断层造影术的放射性药物 REFRACTIVE INDEX折光率 SPECIFIC GRAVITY比重 SPECIFIC SURFACE AREA比表面积 SPECTROPHOTOMETRY AND LIGHT-SCATTERING分光光度计与光散射 ATOMIC ABSORPTION SPECTROSCOPY原子吸收光谱 FLUORESCENCE SPECTROSCOPY 荧光光谱 MID-INFRARED SPECTROSCOPY 中红外光谱 ULTRAVIOLET-VISIBLE SPECTROSCO

23、PY紫外可见光谱SUTURES DIAMETER 缝线直径？ SUTURES NEEDLE ATTACHMENT缝线穿孔实验 TENSILE STRENGTH张力 THERMAL ANALYSIS热分析 UNIFORMITY OF DOSAGE UNITS制剂单位的含量均匀度 VISCOSITY CAPILLARY METHODS 黏度 -毛细管法 VISCOSITY ROTATIONAL METHODS黏度 -旋转法 VISCOSITY ROLLING BALL METHOD黏度-球法 WATER DETERMINATION水分测定 CHARACTERIZATIONOF CRYSTALLIN

24、E AND PARTIALLY CRYSTALLINE SOLIDS BYX-RAY POWDER DIFFRACTION (XRPD) X 光衍射General Information 通用信息 ACOUSTIC EMISSION声频发射 ANALYTICAL DATA INTERPRETATION AND TREATMENT 分析数据解释与处理 AUTOMATED RADIOCHEMICAL SYNTHESIS APPARATUS 放射性自动合成装置 BOVINE SERUM 牛血清 FLOW CYTOMETRY 流式细胞仪 BIOLOGICAL ASSAY CHAPTERS OVERVI

25、EW AND GLOSSARY 生物测定章节 -综述和术语 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 ANALYSIS OF BIOLOGICAL ASSAYS生物测定分析 BIOLOGICAL INDICATORS FOR STERILIZATION灭菌用生物指示剂 BIOLOGICS 生物制剂 Ancillary Material for Cell, Gene, and Tissue-Engineered

26、Products 细胞，基因与组织设计产品的辅助材料 CRYOPRESERV ATION OF CELLS 细胞低温保存 BIOTECHNOLOGY-DERIVED ARTICLES生物技术提取产品 CELLULAR AND TISSUE-BASED PRODUCTS细胞与组织产品 GENE THERAPY PRODUCTS基因治疗产品 QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF r-DNA DERIVED PROTEIN P

27、RODUCTS 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 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 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 CLE

28、ANING GLASS APPARATUS玻璃容器的清洗 BIOTECHNOLOGY-DERIVED ARTICLESAMINO ACID ANALYSIS生物技术提取法 - 氨基酸测定 CAPILLARY ELECTROPHORESIS毛细管电泳法 BIOTECHNOLOGY-DERIVED ARTICLESISOELECTRIC FOCUSING生物技术提取法 - 等电点聚集 BIOTECHNOLOGY-DERIVED ARTICLESPEPTIDE MAPPING生物技术提取法 -肽谱 BIOTECHNOLOGY-DERIVED ARTICLESPOLYACRYLAMIDE GEL EL

29、ECTROPHORESIS生物技术提取法 -凝胶电泳TOTAL PROTEIN ASSAY BIOTECHNOLOGY-DERIVED ARTICLES生物技术提取法 -总蛋白测定 ANALYTICAL INSTRUMENT QUALIFICATION分析仪器要求 EXCIPIENT PERFORMANCE赋形剂 COLOR INSTRUMENTAL MEASUREMENT显色仪器测量 Ion Chromatography 离子色谱法 PHYSICAL ENVIRONMENTS THAT PROMOTE SAFE MEDICATION USE 物理环境促使安全使用药物 DISINFECTANT

30、S AND ANTISEPTICS消毒剂和防腐剂 EXCIPIENT BIOLOGICAL SAFETY EVALUATION GUIDELINES赋形剂(辅料)生物安全性评估指导 GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS 批药品赋形剂的生产管理规范 Good Storage and Shipping Practices 良好的贮存与运输规范 BULK PHARMACEUTICAL EXCIPIENTSCERTIFICATE OF ANALYSIS批药品赋形剂 -COA GLYCOPROTEIN AND GL

31、YCAN ANALYSIS GENERAL CONSIDERATIONS糖蛋白和多糖分析 -一般通则 IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS药物和药物产品中的杂质 APPARENT INTRINSIC DISSOLUTION DISSOLUTION TESTING PROCEDURES FORROTATING DISK AND STATIONARY DISK 内部的溶出度 -旋转和静止溶出检测程序？ IN VITRO AND IN VIVO EV 体内与体外的剂型的评估 ASSESSMENT OF DRUG BIOEQUIV ALENCE

32、, AND DISSOLUTION LABELING OF INACTIVE INGREDIENTSALUATION OF DOSAGE FORMSPRODUCT PERFORMANCE-BIOAV AILABILITY, 药物产品性能评估：生物利用度、生物等效性和溶出 非活性成分的标示ALIDATION THE DISSOLUTION PROCEDURE: DEVELOPMENT AND V溶出程序：开发与验证 CAPSULES DISSOLUTION TESTING AND RELATED QUALITY ATTRIBUTES 胶囊 -关于产品质量的溶出测定 BULK POWDER SAM

33、PLING PROCEDURES：粉末样品取样程序 IMMUNOLOGICAL TEST METHODS GENERAL CONSIDERATIONS免疫测试方法 -总则 IMMUNOLOGICAL TEST METHODS ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) 免疫学测试方法 -酶联免疫吸附测定 IMMUNOLOGICAL TEST METHODS IMMUNOBLOT ANALYSIS免疫测试方法 -免疫印迹法 IMMUNOLOGICAL TEST METHODS SURFACE PLASMON RESONANCE免疫测试方法 -表面等离子体共

34、振 IMMUNOGENICITYASSAYS DESIGN AND VALIDATION OF IMMUNOASSAYS TODETECT ANTI-DRUG ANTIBODIES？ MICROBIOLOGICALEXAMINATION OF NONSTERILE PRODUCTS: ACCEPTANCECRITERIA 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 MICROBIAL CHARACTERIZATION, IDENTIFI

35、CATION, AND STRAIN TYPING 非无菌药物产品水活性测定应用 MICROBIOLOGICALATTRIBUTES OF NONSTERILE PHARMACEUTICAL PRODUCTS非无菌药品中的微生物分布 BIOBURDEN CONTROL OF NONSTERILE DRUG SUBSTANCES AND PRODUCTS 非无菌药物和产品的生物负载控制 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 MICROBIOLOGIC

36、AL BEST LABORATORY PRACTICES微生物最优实验室规范 MONITORING DEVICES TIME, TEMPERATURE, AND HUMIDITY 监控装置时间、温度与湿度 NEAR-INFRARED SPECTROPHOTOMETRY近红外分光光度测定法 Raman Spectrophotometry 拉曼分光光度测定法 NOMENCLATURE命名 NUCLEIC ACID-BASED TECHNIQUES GENERAL 核酸技术 -通则 NUCLEIC ACID-BASED TECHNIQUES EXTRACTION, DETECTION, AND SE

37、QUENCING核酸技术 -提取、检测、测序 NUCLEIC ACID-BASED TECHNIQUES AMPLIFICATION核酸技术 -扩增 NUCLEIC ACID-BASED TECHNIQUES MICROARRAY 核酸技术 -微阵列 NUCLEIC ACID-BASED TECHNIQUES GENOTYPING 核酸技术 -基因分型 NUCLEIC ACID-BASED TECHNIQUES APPROACHES FOR DETECTING TRACENUCLEIC ACIDS (RESIDUAL DNA TESTING)核酸技术 -探测微量核酸的应用(残留 DNA 测试)

38、 PACKAGING AND REPACKAGING SINGLE-UNIT CONTAINERS包装和再包装单一容器药物剂型 PHARMACEUTICAL DOSAGE FORMS ANIMAL DRUGS FOR USE IN ANIMAL FEEDS兽药在动物饲料中的使用 PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION COMPOUNDING 按处方混合的药物的计算 QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING 按处方混合的药物的质量保证 PHASE-SOLUBILITY ANALYSIS相溶解分析

39、 Powder Flow 粉末流动性 PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS处方天平与容量器具 Good Packaging Practices 良好的包装操作 Good Repackaging Practices 良好的再包装操作 HUMAN PLASMA 人血浆 SCANNING ELECTRON MICROSCOPY扫描电子显微镜 SENSITIZATION TESTING致敏测试 STABILITY CONSIDERATIONS IN DISPENSING PRACTICE分装操作中稳定性考察 SIGNIFICANT CHANGE

40、GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS 散装药用辅料更换指导原则 GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS 散装药用辅料良好的分装操作 STERILE PRODUCT PACKAGING INTEGRITY EV ALUATION 无菌产品包装完整性评估 STERILITY TESTING VALIDATION OF ISOLATOR SYSTEMS 无菌实验隔离系统的验证 STERILIZATION CHEMICALAND PHYSICOCHEMICAL INDICA

41、TORS ANDINTEGRATORS 灭菌化学与物理化学的指示剂以及二者的综合 STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES 药典物品中的灭菌与灭菌保证 TABLET FRIABILITY片剂的脆碎度 TABLET BREAKING FORCE片剂断裂力 TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTSPARAMETRIC RELEASE药品终端灭菌放行参数 VALIDATION OF ALTERNATIVE MICROBIOLOGICAL METHODS可供选择的微生物学方

42、法的验证 TRANSFER OF ANALYTICAL PROCEDURES分析方法转移 VALIDATION OF COMPENDIAL PROCEDURES药典方法的验证 VERIFICATION OF COMPENDIAL PROCEDURES药典方法的确认 VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES从药物中回收微生物的验证 STERILIZATION OF COMPENDIAL ARTICLES药典灭菌过程 STEAM STERILIZATION BY DIRECT CONTACT直接蒸汽灭菌 MOIST H

43、EAT STERILIZATION OF AQUEOUS LIQUIDS水溶液的湿热灭菌 MONITORING OF BIOBURDEN生物负载监控 STERILIZING FILTRATION OF LIQUIDS溶液的无菌过滤器 LIQUID-PHASE STERILIZATION液态灭菌 GASEOUS STERILIZATION气态灭菌 DRY HEAT STERILIZATION干热灭菌 RADIATION STERILIZATION辐射灭菌 WATER FOR HEMODIALYSIS APPLICATIONS血液透析过程用水 WATER FOR PHARMACEUTICAL PU

44、RPOSES制药用水 VACCINES FOR HUMAN USE POLYSACCHARIDE AND GLYCOCONJUGATE VACCINES 人用疫苗 -多糖和糖复合物疫苗 VACCINES FOR HUMAN USE GENERAL CONSIDERATIONS人用疫苗 -通则 VIROLOGY TEST METHODS病毒测试方法 VACCINES FOR HUMAN USE BACTERIAL V ACCINES 人用疫苗 -细菌疫苗 VIRUS TESTING OF HUMAN PLASMA FOR FURTHER MANUFACTURE 下一步使用人血浆的病毒测试WATER SOLID INTERACTIONS IN PHARMACEUTICAL SYSTEMS 在药物系统中水与固体的相互作用 WEIGHING ON AN ANALYTICAL BALANCE关于分析天平的称重 Written Prescription Drug Information Guidelines 书面的处方药信息指南 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 HEMATOXYLIN AND