USP38通用章節(jié)目錄中文剖析

1、USP38通用章節(jié)指導(dǎo)目錄（附錄）Guide to General Chapters 通用章節(jié)指導(dǎo)General Requirements for Test and Assays 檢查與含量分析的一般要求 INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS) PRODUCT QUALITYTESTS 注射和植入藥物產(chǎn)品 (注射用 ) 產(chǎn)品質(zhì)量測(cè)試 INJECTIONS注射劑ORAL DRUG PRODUCTS PRODUCT QUALITY TESTS口服藥物產(chǎn)品質(zhì)量測(cè)試 TOPICAL AND TRANSDERMAL DRUG PRODUC

2、TSPRODUCT QUALITY TESTS局部和透皮藥物產(chǎn)品 產(chǎn)品質(zhì)量測(cè)試 MUCOSAL DRUG PRODUCTS PRODUCT QUALITY TESTS 粘膜藥物產(chǎn)品質(zhì)量測(cè)試 INHALATION AND NASAL DRUG PRODUCTSGENERAL INFORMATION AND PRODUCTQUALITY TESTS 吸入劑產(chǎn)品 產(chǎn)品質(zhì)量測(cè)試 LABELING 標(biāo)簽 USP REFERENCE STANDARDS USP 標(biāo)準(zhǔn)品Apparatus for Test and Assays 用于檢查與含量分析的器具 PRESCRIPTION CONTAINER LABE

3、LING處方容器標(biāo)簽 THERMOMETERS溫度計(jì) VOLUMETRIC APPARATUS容量器具 BALANCES 天平Microbiological Tests 微生物檢查法 ANTIMICROBIAL EFFECTIVENESS TESTING抗菌劑有效性檢查法 BIOLOGICAL INDICATORS RESISTANCE PERFORMANCE TESTS 生物指示劑耐藥性實(shí)驗(yàn) MICROBIOLOGICALEXAMINATIONOF NONSTERILEPRODUCTS: MICROBIALENUMERATION TESTS 非無(wú)菌產(chǎn)品的微生物限度檢查：微生物列舉檢查法 MI

4、CROBIOLOGICALEXAMINATIONOF NONSTERILE PRODUCTS: TESTS FORSPECIFIED MICROORGANISMS 非無(wú)菌產(chǎn)品的微生物限度檢查：特定微生物檢查法 MYCOPLASMA TESTS 支原體檢查法 STERILITY TESTS無(wú)菌檢查法Biological tests and assays 生物檢查法與測(cè)定法 ANTIBIOTICS MICROBIAL ASSAYS抗生素微生物測(cè)定 BACTERIAL ENDOTOXINS TEST細(xì)菌內(nèi)毒素檢查法 BIOLOGICAL REACTIVITY TESTS, IN VITRO體外的生物

5、反應(yīng)性檢查法 BIOLOGICAL REACTIVITY TESTS, IN VIVO體內(nèi)的生物反應(yīng)性檢查法 ENZYMES USED AS ANCILLARY MATERIALS IN PHARMACEUTICAL MANUFACTURING藥品生產(chǎn)中酶作為輔料所使用 FETAL BOVINE SERUM QUALITY ATTRIBUTES AND FUNCTIONALITY TESTS牛胎兒血清 -質(zhì)量品質(zhì)和功能檢查法 CALCIUM PANTOTHENATE ASSAY泛酸鈣測(cè)定法 GROWTH FACTORS AND CYTOKINES USED IN CELL THERAPY MA

6、NUFACTURING 在細(xì)胞療法中使用生長(zhǎng)因子和細(xì)胞因子 DESIGN AND ANALYSIS OF BIOLOGICAL ASSAYS生物測(cè)定法的設(shè)計(jì)與分析 DEXPANTHENOL ASSAY 右泛醇（擬膽堿藥）測(cè)定法 INSULIN ASSAYS 胰島素測(cè)定法 PHYSICOCHEMICAL ANALYTICAL PROCEDURES FOR INSULINS 胰島素的物理化學(xué)分析程序 GLUCAGON BIOIDENTITY TESTS高血糖素的生物鑒別檢查法 ERYTHROPOIETIN BIOASSAYS紅細(xì)胞生成素的微生物測(cè)定 SOMATROPIN BIOIDENTITY T

7、ESTS生長(zhǎng)激素的生物鑒別檢查法 PROTEIN A QUALITY ATTRIBUTES蛋白質(zhì) A 的質(zhì)量特征 PYROGEN TEST 熱原檢查法 TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR MEDICAL DEVICES 輸血輸液用具以及相類(lèi)似的醫(yī)療器械 VITAMIN B 12 ACTIVITY ASSAY 2548 維生素 B12活性測(cè)定法Chemical Tests and assays 化學(xué)實(shí)驗(yàn)檢查與測(cè)定法鑒別檢查 IDENTIFICATION ORGANIC NITROGENOUS BASES 鑒別有機(jī)氮堿化合物 IDENTI

8、FICATION TESTS GENERAL 鑒別實(shí)驗(yàn)通用 IDENTIFICATION TETRACYCLINES 鑒別四環(huán)素類(lèi) SPECTROPHOTOMETRIC IDENTIFICATION TESTS分光光度計(jì)鑒別實(shí)驗(yàn) THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST 薄層色譜鑒別實(shí)驗(yàn)Limit Tests 限度檢查法 ALUMINUM 鋁 TEST FOR 1,6-ANHYDRO DERIV ATIVE FOR ENOXAPARIN SODIUM 依諾肝素鈉的酐類(lèi)衍生物實(shí)驗(yàn) 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產(chǎn)品中抗體 Xa 和抗體 IIa 測(cè)定 LOW MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT DETERMINATIONS 低分子肝素鈉分子量測(cè)定 ARSENIC 砷 CHLORIDE AND SULFATE氯和硫 DIMETHYLANILINE二甲基苯胺 4-EPIANHYDRO-TETRACYCLINE4？四環(huán)素 4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG PR

10、ODUCTS 對(duì)乙酰氨酚藥物產(chǎn)品中氨基酚 ETHYLENE OXIDE AND DIOXANE環(huán)氧乙烷和二氧六環(huán) HEA VY METALS重金屬（刪除） ELEMENTAL IMPURITIES LIMITS 元素雜質(zhì) -限度 ELEMENTAL IMPURITIES PROCEDURES 元素雜質(zhì) -規(guī)程 IRON 鐵 LEAD 鉛 MERCURY 汞 POROSIMETRY BY MERCURY INTRUSION水銀孔隙儀 POROSITY BY NITROGEN ADSORPTIONDESORPTION 氮吸附 -解吸測(cè)定孔隙率 READILY CARBONIZABLE SUBSTA

11、NCES TEST易碳化物檢查法 RESIDUE ON IGNITION熾灼殘?jiān)?SELENIUM 硒Other Tests and Assays 其它檢查法與測(cè)定法 ACID-NEUTRALIZING CAPACITY酸中和容量 ALGINATES ASSAY藻酸鹽測(cè)定法 ANTIMICROBIAL AGENTS CONTENT 抗菌劑含量 Assay for Citric Acid/Citrate and Phosphate 檸檬酸 / 檸檬酸鹽和磷酸鹽的測(cè)定 ASSAY FOR STEROIDS類(lèi)固醇（甾類(lèi)化合物）測(cè)定法 BARBITURATE ASSAY 巴比妥類(lèi)藥物測(cè)定法 COBAL

12、AMIN RADIOTRACER ASSAY鈷銨素放射性跟蹤劑測(cè)定法 ELASTOMERIC CLOSURES FOR INJECTIONS注射劑的彈性密封件 EPINEPHRINE ASSAY腎上腺素測(cè)定法 FATS AND FIXED OILS脂肪與混合油 FOLIC ACID ASSAY葉酸測(cè)定法 IMPURITIES TESTING IN MEDICAL GASES醫(yī)用氣體雜質(zhì)檢查 MEDICAL GASES ASSAY 醫(yī)用氣體含量檢查 IODOMETRIC ASSAY ANTIBIOTICS 碘量檢查法抗生素 LIGHT DIFFRACTION MEASUREMENT OF PAR

13、TICLE SIZE 粒徑的光衍射測(cè)量法 METHOXY DETERMINATION甲氧基測(cè)定法 NIACIN OR NIACINAMIDE ASSAY煙?；驘燉０窚y(cè)定法 NITRITE TITRATION亞硝酸鹽滴定 NITROGEN DETERMINATION氮測(cè)定法GLYCOL INSPRAYS, ANDNONSTERILE般雜質(zhì) ORDINARY IMPURITIES RESIDUAL SOLVENTS殘留溶劑 ETHYLENE GLYCOL, DIETHYLENE GLYCOL, AND TRIETHYLENE ETHOXYLATED SUBSTANCES乙氧基物質(zhì)中乙二醇、二甘醇、

14、三甘醇測(cè)定 OXYGEN FLASK COMBUSTION氧瓶燃燒法 RIBOFLAVIN ASSAY核黃素（維生素 B2）測(cè)定法 SALTS OF ORGANIC NITROGENOUS BASES有機(jī)氮鹽 ACETIC ACID IN PEPTIDES多肽類(lèi)中乙酸測(cè)定 SINGLE-STEROID ASSAY單一的類(lèi)固醇測(cè)定法 SULFUR DIOXIDE二氧化硫 THIAMINE ASSAY硫胺素測(cè)定法 TITRIMETRY滴定法 VITAMIN E ASSAY維生素 E 測(cè)定法 ARTICLES OF BOTANICAL ORIGIN植物起源的藥品 IDENTIFICATION OF

15、ARTICLES OF BOTANICAL ORIGIN植物藥品的鑒別 BOTANICAL EXTRACTS植物提取 VITAMIN A ASSAY 維生素 A 測(cè)定法 VITAMIN D ASSAY維生素 D 測(cè)定法 ZINC DETERMINATION鋅的測(cè)定法Physical Test and Determinations 物理檢查與測(cè)定法 INHALATION AND NASAL DRUG PRODUCTS: AEROSOLS, POWDERS PERFORMANCE QUALITY TESTS 吸入劑、鼻霧劑：氣溶膠，噴霧，干粉-質(zhì)量通則 PROPELLANTS 推進(jìn)劑 TOPICA

16、L AEROSOLS 局部噴霧劑 LEAK RATE 滲漏率 ALTERNATIVE MICROBIOLOGICAL SAMPLING METHODS FOR INHALED AND NASAL PRODUCTS 非無(wú)菌吸入和鼻霧劑可供選擇的微生物取樣方法 ALCOHOL DETERMINATION乙醇測(cè)定法 BULK DENSITY AND TAPPED DENSITY堆密度與振實(shí)密度 CHROMATOGRAPHY色譜法 COLOR AND ACHROMICITY呈色與消色 COMPLETENESS OF SOLUTION溶解度 TOTAL ORGANIC CARBON總有機(jī)碳 WATER

17、CONDUCTIVITY水電導(dǎo)率 CONGEALING TEMPERATURE凝點(diǎn)溫度 PACKAGING AND STORAGE REQUIREMENTS包裝和儲(chǔ)藏要求 CONTAINERS GLASS 容器 -玻璃 CONTAINERS PLASTICS 容器 -塑料 AUXILIARY PACKAGING COMPONENTS輔助包裝部件 CONTAINERS PERFORMANCE TESTING容器性能測(cè)試 COTTON 棉花 CRYSTALLINITY結(jié)晶度AND CHARACTERIZATION OF CRYSTALLINE SOLIDS BY MICROCALORIMETRY

18、SOLUTION CALORIMETRY 通過(guò)溶液量熱學(xué)測(cè)定結(jié)晶性 CONTAINER CONTENT FOR INJECTIONS注射劑容器容積 DELIVERABLE VOLUME抽取體積 DENSITY OF SOLIDS固體密度 DISINTEGRATION崩解時(shí)限 QUALITY ATTRIBUTES OF TABLETS LABELED AS HAVING A FUNCTIONAL SCORE？ DISSOLUTION 溶出度 DISTILLING RANGE餾程 DRUG RELEASE 藥物釋放度 GLOBULE SIZE DISTRIBUTION IN LIPID INJEC

19、TABLE EMULSIONS 脂類(lèi)可注射的乳劑的粒徑分布 Plasma Spectrochemistry 血漿光譜化學(xué)？ LOSS ON DRYING4干燥失重 LOSS ON IGNITION灼燒失重 X-RAY FLUORESCENCE SPECTROMETRYX 射線(xiàn)光譜 MASS SPECTROMETRY質(zhì)譜 MELTING RANGE OR TEMPERATURE熔距或熔點(diǎn) METAL PARTICLES IN OPHTHALMIC OINTMENTS眼用軟膏中的金屬粒子 MINIMUM FILL最低裝量 NUCLEAR MAGNETIC RESONANCE核磁共振 OPHTHAL

20、MIC OINTMENTS眼用軟膏 OPTICAL MICROSCOPY光學(xué)顯微鏡 OPTICAL ROTATION旋光度 OSMOLALITY AND OSMOLARITY滲透壓 PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANALYTICAL SIEVING 篩分法估算粒徑分布 SUBVISIBLE PARTICULATE MATTER IN THERAPEUTIC PROTEIN INJECTIONS顯微計(jì)數(shù)法在治療性蛋白注射劑中應(yīng)用注射劑中的不溶性微粒 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注射劑中可見(jiàn)異物 pH PHARMACEUTICAL COMPOUNDINGNONSTERILE PREPARATIONS藥物混合非無(wú)菌制劑 PHARMACEUTICAL COMPOUNDINGSTERILE PREPARATIONS藥物混合無(wú)菌制劑 POLAROGRAPHY極譜法 POWDER FINENESS粉劑細(xì)度 RADIOACTIVITY放射性 POSITRON EMISSION TOMOGRAPHY DRUGS FOR COMPOUNDI

22、NG, INVESTIGATIONAL,AND RESEARCH USES 用于正電子發(fā)射斷層造影術(shù)的放射性藥物 REFRACTIVE INDEX折光率 SPECIFIC GRAVITY比重 SPECIFIC SURFACE AREA比表面積 SPECTROPHOTOMETRY AND LIGHT-SCATTERING分光光度計(jì)與光散射 ATOMIC ABSORPTION SPECTROSCOPY原子吸收光譜 FLUORESCENCE SPECTROSCOPY 熒光光譜 MID-INFRARED SPECTROSCOPY 中紅外光譜 ULTRAVIOLET-VISIBLE SPECTROSCO

23、PY紫外可見(jiàn)光譜SUTURES DIAMETER 縫線(xiàn)直徑？ SUTURES NEEDLE ATTACHMENT縫線(xiàn)穿孔實(shí)驗(yàn) TENSILE STRENGTH張力 THERMAL ANALYSIS熱分析 UNIFORMITY OF DOSAGE UNITS制劑單位的含量均勻度 VISCOSITY CAPILLARY METHODS 黏度 -毛細(xì)管法 VISCOSITY ROTATIONAL METHODS黏度 -旋轉(zhuǎn)法 VISCOSITY ROLLING BALL METHOD黏度-球法 WATER DETERMINATION水分測(cè)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聲頻發(fā)射 ANALYTICAL DATA INTERPRETATION AND TREATMENT 分析數(shù)據(jù)解釋與處理 AUTOMATED RADIOCHEMICAL SYNTHESIS APPARATUS 放射性自動(dòng)合成裝置 BOVINE SERUM 牛血清 FLOW CYTOMETRY 流式細(xì)胞儀 BIOLOGICAL ASSAY CHAPTERS OVERVI

25、EW AND GLOSSARY 生物測(cè)定章節(jié) -綜述和術(shù)語(yǔ) THE BIOCOMPATIBILITY OF MATERIALS USED IN DRUG CONTAINERS, MEDICAL DEVICES, AND IMPLANTS 用于藥物容器、醫(yī)療設(shè)施和植入劑的材料的生物相容性 ANALYSIS OF BIOLOGICAL ASSAYS生物測(cè)定分析 BIOLOGICAL INDICATORS FOR STERILIZATION滅菌用生物指示劑 BIOLOGICS 生物制劑 Ancillary Material for Cell, Gene, and Tissue-Engineered

26、Products 細(xì)胞，基因與組織設(shè)計(jì)產(chǎn)品的輔助材料 CRYOPRESERV ATION OF CELLS 細(xì)胞低溫保存 BIOTECHNOLOGY-DERIVED ARTICLES生物技術(shù)提取產(chǎn)品 CELLULAR AND TISSUE-BASED PRODUCTS細(xì)胞與組織產(chǎn)品 GENE THERAPY PRODUCTS基因治療產(chǎn)品 QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF r-DNA DERIVED PROTEIN P

27、RODUCTS 生物技術(shù)產(chǎn)品的質(zhì)量：從蛋白質(zhì)產(chǎn)品中提取的 r-DNA 產(chǎn)品在細(xì)胞中表達(dá)結(jié)構(gòu)的分析 QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS生物技術(shù)產(chǎn)品的質(zhì)量：生物技術(shù) /生物產(chǎn)品的穩(wěn)定性實(shí)驗(yàn) VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN 從人或動(dòng)物細(xì)胞中提取的生物技術(shù)產(chǎn)品的病毒安全性評(píng)估 CLE

28、ANING GLASS APPARATUS玻璃容器的清洗 BIOTECHNOLOGY-DERIVED ARTICLESAMINO ACID ANALYSIS生物技術(shù)提取法 - 氨基酸測(cè)定 CAPILLARY ELECTROPHORESIS毛細(xì)管電泳法 BIOTECHNOLOGY-DERIVED ARTICLESISOELECTRIC FOCUSING生物技術(shù)提取法 - 等電點(diǎn)聚集 BIOTECHNOLOGY-DERIVED ARTICLESPEPTIDE MAPPING生物技術(shù)提取法 -肽譜 BIOTECHNOLOGY-DERIVED ARTICLESPOLYACRYLAMIDE GEL EL

29、ECTROPHORESIS生物技術(shù)提取法 -凝膠電泳TOTAL PROTEIN ASSAY BIOTECHNOLOGY-DERIVED ARTICLES生物技術(shù)提取法 -總蛋白測(cè)定 ANALYTICAL INSTRUMENT QUALIFICATION分析儀器要求 EXCIPIENT PERFORMANCE賦形劑 COLOR INSTRUMENTAL MEASUREMENT顯色儀器測(cè)量 Ion Chromatography 離子色譜法 PHYSICAL ENVIRONMENTS THAT PROMOTE SAFE MEDICATION USE 物理環(huán)境促使安全使用藥物 DISINFECTANT

30、S AND ANTISEPTICS消毒劑和防腐劑 EXCIPIENT BIOLOGICAL SAFETY EVALUATION GUIDELINES賦形劑(輔料)生物安全性評(píng)估指導(dǎo) GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS 批藥品賦形劑的生產(chǎn)管理規(guī)范 Good Storage and Shipping Practices 良好的貯存與運(yùn)輸規(guī)范 BULK PHARMACEUTICAL EXCIPIENTSCERTIFICATE OF ANALYSIS批藥品賦形劑 -COA GLYCOPROTEIN AND GL

31、YCAN ANALYSIS GENERAL CONSIDERATIONS糖蛋白和多糖分析 -一般通則 IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS藥物和藥物產(chǎn)品中的雜質(zhì) APPARENT INTRINSIC DISSOLUTION DISSOLUTION TESTING PROCEDURES FORROTATING DISK AND STATIONARY DISK 內(nèi)部的溶出度 -旋轉(zhuǎn)和靜止溶出檢測(cè)程序？ IN VITRO AND IN VIVO EV 體內(nèi)與體外的劑型的評(píng)估 ASSESSMENT OF DRUG BIOEQUIV ALENCE

32、, AND DISSOLUTION LABELING OF INACTIVE INGREDIENTSALUATION OF DOSAGE FORMSPRODUCT PERFORMANCE-BIOAV AILABILITY, 藥物產(chǎn)品性能評(píng)估：生物利用度、生物等效性和溶出 非活性成分的標(biāo)示ALIDATION THE DISSOLUTION PROCEDURE: DEVELOPMENT AND V溶出程序：開(kāi)發(fā)與驗(yàn)證 CAPSULES DISSOLUTION TESTING AND RELATED QUALITY ATTRIBUTES 膠囊 -關(guān)于產(chǎn)品質(zhì)量的溶出測(cè)定 BULK POWDER SAM

33、PLING PROCEDURES：粉末樣品取樣程序 IMMUNOLOGICAL TEST METHODS GENERAL CONSIDERATIONS免疫測(cè)試方法 -總則 IMMUNOLOGICAL TEST METHODS ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) 免疫學(xué)測(cè)試方法 -酶聯(lián)免疫吸附測(cè)定 IMMUNOLOGICAL TEST METHODS IMMUNOBLOT ANALYSIS免疫測(cè)試方法 -免疫印跡法 IMMUNOLOGICAL TEST METHODS SURFACE PLASMON RESONANCE免疫測(cè)試方法 -表面等離子體共

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 非無(wú)菌產(chǎn)品的微生物學(xué)檢查：藥用制劑和制藥過(guò)程使用的物質(zhì)接受標(biāo)準(zhǔn) MICROBIAL CHARACTERIZATION, IDENTIFI

35、CATION, AND STRAIN TYPING 非無(wú)菌藥物產(chǎn)品水活性測(cè)定應(yīng)用 MICROBIOLOGICALATTRIBUTES OF NONSTERILE PHARMACEUTICAL PRODUCTS非無(wú)菌藥品中的微生物分布 BIOBURDEN CONTROL OF NONSTERILE DRUG SUBSTANCES AND PRODUCTS 非無(wú)菌藥物和產(chǎn)品的生物負(fù)載控制 MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING ENVIRONMENTS 潔凈的房間與其它可控環(huán)境的微生物評(píng)估 MICROBIOLOGIC

36、AL BEST LABORATORY PRACTICES微生物最優(yōu)實(shí)驗(yàn)室規(guī)范 MONITORING DEVICES TIME, TEMPERATURE, AND HUMIDITY 監(jiān)控裝置時(shí)間、溫度與濕度 NEAR-INFRARED SPECTROPHOTOMETRY近紅外分光光度測(cè)定法 Raman Spectrophotometry 拉曼分光光度測(cè)定法 NOMENCLATURE命名 NUCLEIC ACID-BASED TECHNIQUES GENERAL 核酸技術(shù) -通則 NUCLEIC ACID-BASED TECHNIQUES EXTRACTION, DETECTION, AND SE

37、QUENCING核酸技術(shù) -提取、檢測(cè)、測(cè)序 NUCLEIC ACID-BASED TECHNIQUES AMPLIFICATION核酸技術(shù) -擴(kuò)增 NUCLEIC ACID-BASED TECHNIQUES MICROARRAY 核酸技術(shù) -微陣列 NUCLEIC ACID-BASED TECHNIQUES GENOTYPING 核酸技術(shù) -基因分型 NUCLEIC ACID-BASED TECHNIQUES APPROACHES FOR DETECTING TRACENUCLEIC ACIDS (RESIDUAL DNA TESTING)核酸技術(shù) -探測(cè)微量核酸的應(yīng)用(殘留 DNA 測(cè)試)

38、 PACKAGING AND REPACKAGING SINGLE-UNIT CONTAINERS包裝和再包裝單一容器藥物劑型 PHARMACEUTICAL DOSAGE FORMS ANIMAL DRUGS FOR USE IN ANIMAL FEEDS獸藥在動(dòng)物飼料中的使用 PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION COMPOUNDING 按處方混合的藥物的計(jì)算 QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING 按處方混合的藥物的質(zhì)量保證 PHASE-SOLUBILITY ANALYSIS相溶解分析

39、 Powder Flow 粉末流動(dòng)性 PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS處方天平與容量器具 Good Packaging Practices 良好的包裝操作 Good Repackaging Practices 良好的再包裝操作 HUMAN PLASMA 人血漿 SCANNING ELECTRON MICROSCOPY掃描電子顯微鏡 SENSITIZATION TESTING致敏測(cè)試 STABILITY CONSIDERATIONS IN DISPENSING PRACTICE分裝操作中穩(wěn)定性考察 SIGNIFICANT CHANGE

40、GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS 散裝藥用輔料更換指導(dǎo)原則 GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS 散裝藥用輔料良好的分裝操作 STERILE PRODUCT PACKAGING INTEGRITY EV ALUATION 無(wú)菌產(chǎn)品包裝完整性評(píng)估 STERILITY TESTING VALIDATION OF ISOLATOR SYSTEMS 無(wú)菌實(shí)驗(yàn)隔離系統(tǒng)的驗(yàn)證 STERILIZATION CHEMICALAND PHYSICOCHEMICAL INDICA

41、TORS ANDINTEGRATORS 滅菌化學(xué)與物理化學(xué)的指示劑以及二者的綜合 STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES 藥典物品中的滅菌與滅菌保證 TABLET FRIABILITY片劑的脆碎度 TABLET BREAKING FORCE片劑斷裂力 TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTSPARAMETRIC RELEASE藥品終端滅菌放行參數(shù) VALIDATION OF ALTERNATIVE MICROBIOLOGICAL METHODS可供選擇的微生物學(xué)方

42、法的驗(yàn)證 TRANSFER OF ANALYTICAL PROCEDURES分析方法轉(zhuǎn)移 VALIDATION OF COMPENDIAL PROCEDURES藥典方法的驗(yàn)證 VERIFICATION OF COMPENDIAL PROCEDURES藥典方法的確認(rèn) VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES從藥物中回收微生物的驗(yàn)證 STERILIZATION OF COMPENDIAL ARTICLES藥典滅菌過(guò)程 STEAM STERILIZATION BY DIRECT CONTACT直接蒸汽滅菌 MOIST H

43、EAT STERILIZATION OF AQUEOUS LIQUIDS水溶液的濕熱滅菌 MONITORING OF BIOBURDEN生物負(fù)載監(jiān)控 STERILIZING FILTRATION OF LIQUIDS溶液的無(wú)菌過(guò)濾器 LIQUID-PHASE STERILIZATION液態(tài)滅菌 GASEOUS STERILIZATION氣態(tài)滅菌 DRY HEAT STERILIZATION干熱滅菌 RADIATION STERILIZATION輻射滅菌 WATER FOR HEMODIALYSIS APPLICATIONS血液透析過(guò)程用水 WATER FOR PHARMACEUTICAL PU

44、RPOSES制藥用水 VACCINES FOR HUMAN USE POLYSACCHARIDE AND GLYCOCONJUGATE VACCINES 人用疫苗 -多糖和糖復(fù)合物疫苗 VACCINES FOR HUMAN USE GENERAL CONSIDERATIONS人用疫苗 -通則 VIROLOGY TEST METHODS病毒測(cè)試方法 VACCINES FOR HUMAN USE BACTERIAL V ACCINES 人用疫苗 -細(xì)菌疫苗 VIRUS TESTING OF HUMAN PLASMA FOR FURTHER MANUFACTURE 下一步使用人血漿的病毒測(cè)試WATER SOLID INTERACTIONS IN PHARMACEUTICAL SYSTEMS 在藥物系統(tǒng)中水與固體的相互作用 WEIGHING ON AN ANALYTICAL BALANCE關(guān)于分析天平的稱(chēng)重 Written Prescription Drug Information Guidelines 書(shū)面的處方藥信息指南 PREPARATION OF BIOLOGICAL SPECIMENS FOR HISTOLOGIC AND IMMUNOHISTOCHEMICAL ANALYSIS 為了組織和免疫組織分析的生物標(biāo)本制備 HEMATOXYLIN AND