USP38 通用章节目录中文

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USP39 General chapters 目录(优选.)

USP39 General chapters 目录(优选.)

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General chapters备注:蓝色字体章节为新增内容,红色字体章节为在USP38基本上修改内容。

〈1〉Injections, 53〈2〉Oral drug products—product quality tests, 66〈3〉Topical and transdermal drug products—product quality tests, 71〈5〉Inhalation and nasal drug products general information and product quality tests, 80〈11〉USP reference standards, 93〈17〉Prescription container labeling, 96〈21〉Thermometers, 98〈31〉V olumetric apparatus, 99〈41〉Weights and balances, 99〈51〉Antimicrobial effectiveness testing,100〈55〉 Biological indicators—resistance performance tests, 103〈61〉Microbiological examination of nonsterile products: microbial enumeration tests, 106〈62〉Microbiological examination of nonsterile products: tests for specified organisms, 112〈63〉Mycoplasma tests, 120〈71〉Sterility tests, 125〈81〉Antibiotics—microbial assays, 133〈85〉Bacterial endotoxins test, 151〈87〉Biological reactivity tests, in vitro, 156〈88〉Biological reactivity tests, in vivo, 158〈90〉Fetal bovine serum quality attributes and functionality tests, 167〈91〉Calcium pantothenate assay, 171〈92〉Growth factors and cytokines used in cell therapy manufacturing, 172〈111〉 Design and analysis of biological assays, 176〈115〉 Dexpanthenol assay, 191〈121〉 Insulin assays, 193〈121.1〉 Physicochemical analytical procedures for insulins, 195〈123〉 Glucagon bioidentity tests, 198〈124〉 Erythropoietin bioassays, 200〈126〉 Somatropin bioidentity tests, 202<129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies〈130〉 Protein A quality attributes, 204〈151〉 Pyrogen test, 211〈161〉 Transfusion and infusion assemblies and similar medical devices, 212<162> Diphtheria Antitoxin Potency Testing for Human Immune Globulins〈171〉V itamin B12activity assay, 213〈181〉 Identification—organic nitrogenous bases, 216〈191〉 Identification tests—general, 216〈193〉 Identification—tetracyclines, 219〈197〉 Spectrophotometric identification tests, 220〈201〉 Thin-layer chromatographic identification test, 221〈206〉 Aluminum, 222〈207〉 Test for 1,6-anhydro derivative for enoxaparin sodium, 223〈208〉 Anti-factor Xa and anti-factor IIa assays for unfractionated and low molecular weight heparins, 228〈211〉 Arsenic, 233〈221〉 Chloride and sulfate, 235〈223〉 Dimethylaniline, 236〈226〉 4-Epianhydrotetracycline, 236〈227〉 4-Aminophenol in acetaminophen-containing drug products, 237〈228〉 Ethylene oxide and dioxane, 238〈231〉 Heavy metals, 241〈232〉 Elemental impurities—limits, 243〈233〉 Elemental impurities—procedures,245〈241〉 Iron, 249〈251〉 Lead, 250〈261〉 Mercury, 251〈267〉 Porosimetry by mercury intrusion,253〈268〉 Porosity by nitrogen adsorption–desorption, 256〈271〉 Readily carbonizable substances test,260〈281〉 Residue on ignition, 260〈291〉 Selenium, 261〈301〉 Acid-neutralizing capacity, 261〈311〉 Alginates assay, 262〈341〉 Antimicrobial agents—content, 264〈345〉 Assay for citric acid/citrate and phosphate, 267〈351〉 Assay for steroids, 268〈361〉 Barbiturate assay, 268〈371〉 Cobalamin radiotracer assay, 268〈381〉 Elastomeric closures for injections,270〈391〉 Epinephrine assay, 275〈401〉 Fats and fixed oils, 276〈411〉 Folic acid assay, 290〈413〉 Impurities testing in medical gases,290〈415〉 Medical gases assay, 291〈425〉 Iodometric assay—antibiotics, 293〈429〉 Light diffraction measurement of particle size, 294 〈431〉 Methoxy determination, 299〈441〉 Niacin or niacinamide assay, 301〈451〉 Nitrite titration, 306〈461〉 Nitrogen determination, 306〈466〉 Ordinary impurities, 307〈467〉 Residual solvents, 309〈469〉 Ethylene glycol, diethylene glycol,and triethylene glycol in ethoxylated substances, 324〈471〉 Oxygen flask combustion, 325〈481〉 Riboflavin assay, 326〈501〉 Salts of organic nitrogenous bases,327〈503〉 Acetic acid in peptides, 327<503.1> Trifluoroacetic Acid (TFA) in Peptides〈511〉 Single-steroid assay, 328〈525〉 Sulfur dioxide, 329〈531〉 Thiamine assay, 334〈541〉 Titrimetry, 335〈551〉V itamin E assay, 338〈561〉 Articles of botanical origin, 345〈563〉 Identification of articles of botanical origin, 358〈565〉 Botanical extracts, 370〈571〉V itamin A assay, 373<580> Vitamin C Assay〈581〉V itamin D assay, 378〈591〉 Zinc determination, 387〈601〉 Inhalation and nasal drug products:aerosols, sprays, andpowders–performance quality tests, 388〈602〉 Propellants, 414〈603〉 Topical aerosols, 415〈604〉 Leak rate, 416〈610〉 Inhalation and nasal drug products:aerosols, sprays, and powders–performance quality tests, 416〈611〉 Alcohol determination, 418〈616〉 Bulk density and tapped density, 420〈621〉 Chromatography, 424〈631〉 Color and achromicity, 434〈641〉 Completeness of solution, 436〈643〉 Total organic carbon, 436〈645〉 Water conductivity, 438〈651〉 Congealing temperature, 441〈659〉 Packaging and storage requirements,443〈660〉 Containers—glass, 450〈661〉 Containers—plastics, 457<661.1> Plastic Materials of Construction<661.2> Plastic Packaging Systems for Pharmaceutical Use〈670〉 Containers—Auxiliary Components〈671〉 Containers—performance testing,465〈691〉 Cotton, 472〈695〉 Crystallinity, 474〈696〉 Crystallinity determination by solution calorimetry, 474〈698〉 Deliverable volume, 478〈699〉 Density of solids, 481〈701〉 Disintegration, 483〈705〉 Quality attributes of tablets labeled as having a functional score, 485〈711〉 Dissolution, 486〈721〉 Distilling range, 496〈724〉 Drug release, 497〈729〉 Globule size distribution in lipid injectable emulsions, 504〈730〉 Plasma spectrochemistry, 506〈731〉 Loss on drying, 513〈733〉 Loss on ignition, 514〈735〉 X-ray fluorescence spectrometry, 514〈736〉 Mass spectrometry, 519〈741〉 Melting range or temperature, 525〈751〉 Metal particles in ophthalmic ointments, 527〈755〉 Minimum fill, 527〈761〉 Nuclear magnetic resonance, 528〈771〉 Ophthalmic Products—Quality Tests〈776〉 Optical microscopy, 537〈781〉 Optical rotation, 540〈785〉 Osmolality and osmolarity, 541〈786〉 Particle size distribution estimation by analytical sieving, 543〈787〉 Subvisible particulate matter in therapeutic protein injections, 547〈788〉 Particulate matter in injections, 550〈789〉 Particulate matter in ophthalmic solutions, 553〈790〉Visible Particulates in Injections〈791〉 pH, 556〈795〉 Pharmaceutical compounding—nonsterile preparations, 559〈797〉 Pharmaceutical compounding—sterile preparations, 567〈801〉 Polarography, 611〈811〉 Powder fineness, 616〈821〉 Radioactivity, 616〈823〉 Positron emission tomography drugs for compounding, investigational, andresearch uses, 627〈831〉 Refractive index, 636〈841〉 Specific gravity, 636〈846〉 Specific surface area, 638〈851〉 Spectrophotometry and light-scattering, 641<855> Nephelometry, Turbidimetry, and Visual Comparison〈861〉 Sutures—diameter, 669〈871〉 Sutures—needle attachment, 670〈881〉 Tensile strength, 671〈891〉 Thermal analysis, 672〈905〉 Uniformity of dosage units, 675〈911〉V iscosity—capillar y viscometer methods, 679〈912〉 Rotational rheometer methods, 681〈913〉 Rolling ball viscometer method, 686<914> Viscosity-Pressure Driven Methods〈921〉 Water determination, 688〈941〉 Characterization of crystalline and partially crystalline solids by X-ray powder diffraction (XRPD), 692〈1005〉 Acoustic emission, 699〈1010〉 Analytical data—interpretation and treatment, 703〈1015〉 Automated radiochemical synthesis apparatus, 717〈1024〉 Bovine serum, 719〈1027〉 Flow cytometry, 732〈1030〉 Biological assay chapters—overview and glossary, 748〈1031〉 The biocompatibility of materials used in drug containers, medical devices, and implants, 759〈1032〉 Design and development of biological assays, 769〈1033〉 Biological assay validation, 787〈1034〉 Analysis of biological assays, 801〈1035〉 Biological indicators for sterilization,814〈1041〉 Biologics, 818〈1043〉 Ancillary materials for cell, gene,and tissue-engineered products, 819〈1044〉 Cryopreservation of cells, 827〈1045〉 Biotechnology-derived articles, 840〈1046〉 Cellular and tissue-based products,854〈1047〉 Gene therapy products, 883〈1048〉 Quality of biotechnological products: analysis of the expressionconstruct in cells used for production of r-DNA derived protein roducts, 911〈1049〉 Quality of biotechnological products: stability testing of biotechnological/biological products,913〈1050〉Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, 918〈1051〉 Cleaning glass apparatus, 931〈1052〉 Biotechnology-derived articles—amino acid analysis, 931〈1053〉 Biotechnology-derived articles—capillary electrophoresis, 944〈1054〉 Biotechnology-derived articles—isoelectric focusing, 951〈1055〉 Biotechnology-derived articles—peptide mapping, 954〈1056〉 Biotechnology-derived articles—polyacrylamide gel electrophoresis, 960〈1057〉 Biotechnology-derived articles—total protein assay, 967〈1058〉 Analytical instrument qualification,971〈1059〉 Excipient performance, 977〈1061〉 Color—instrumental measurement,997〈1065〉 Ion chromatography, 1000〈1066〉 Physical environments that promote safe medication use, 1003〈1072〉 Disinfectants and antiseptics, 1010〈1074〉 Excipient biological safety evaluation guidelines, 1015〈1078〉 Good manufacturing practices for bulk pharmaceutical excipients, 1019〈1079〉 Good storage and shipping practices, 1035〈1080〉 Bulk pharmaceutical excipients—certificate of analysis, 1044〈1084〉 Glycoprotein and glycan analysis—general considerations, 1052〈1086〉 Impurities in official articles, 1063〈1087〉 Apparent intrinsic dissolution—dissolution testing procedures for rotating disk and stationary disk, 1066〈1088〉 In vitro and in vivo evaluation of dosage forms, 1070〈1090〉 Assessment of drug product performance—bioavailability, bioequivalence, and dissolution, 1081〈1091〉 Labeling of inactive ingredients,1089〈1092〉 The dissolution procedure:development and validation, 1090〈1094〉 Capsules—dissolution testing and related quality attributes, 1097〈1097〉 Bulk powder sampling procedures,1105〈1102〉 Immunological test methods—general considerations, 1118〈1103〉 Immunological test methods— enzyme-linked immunosorbent assay (ELISA), 1125〈1104〉 Immunological test methods—immunoblot analysis, 1135〈1105〉 Immunological test methods—surface plasmon resonance, 1146〈1106〉 Immunogenicity assays—design and validation of immunoassays to detect anti-drug antibodies, 1161〈1111〉 Microbiological examination of nonsterile products: acceptance criteria for pharmaceutical preparations and substances forpharmaceutical use, 1176〈1112〉 Application of water activity determination to nonsterile pharmaceutical products, 1178〈1113〉 Microbial characterization, identification, and strain typing, 1180〈1115〉 Bioburden control of nonsterile drug substances and products, 1185〈1116〉Microbiological control and monitoring of aseptic processing environments, 1191〈1117〉 Microbiological best laboratory practices, 1204〈1118〉 Monitoring devices—time, temperature, and humidity, 1210〈1119〉 Near-infrared spectrophotometry,1215〈1120〉 Raman spectroscopy, 1222〈1121〉 Nomenclature, 1230〈1125〉 Nucleic acid-based techniques—general, 1232〈1126〉 Nucleic acid-based techniques—extraction, detection, and sequencing,1237〈1127〉 Nucleic acid-based techniques—amplification, 1247〈1128〉 Nucleic acid-based techniques—microarray, 1256〈1129〉 Nucleic acid-based techniques—genotyping, 1262〈1130〉 Nucleic acid-based techniques— approaches for detecting trace nucleic acids (residual DNA testing), 1267〈1136〉 Packaging—unit-of-use, 1269〈1151〉 Pharmaceutical dosage forms, 1278〈1160〉 Pharmaceutical calculations in prescription compounding, 1303〈1163〉 Quality assurance in pharmaceutical compounding, 1317〈1171〉 Phase-solubility analysis, 1324〈1174〉 Powder flow, 1326〈1176〉 Prescription balances and volumetric apparatus, 1331〈1177〉 Good packaging practices, 1332〈1178〉 Good repackaging practices, 1335〈1180〉 Human plasma, 1337〈1181〉 Scanning electron microscopy,1360〈1184〉 Sensitization testing, 1370〈1191〉 Stability considerations in dispensing practice, 1381〈1195〉 Significant change guide for bulk pharmaceutical excipients, 1385〈1197〉 Good distribution practices for bulk pharmaceutical excipients, 1396〈1207〉 Sterile product packaging—integrity evaluation, 1418〈1208〉 Sterility testing—validation of isolator systems, 1420〈1209〉 Sterilization—chemical and physicochemical indicators and integrators, 1424〈1211〉 Sterilization and sterility assurance of compendial articles, 1427〈1216〉 Tablet friability, 1432〈1217〉 Tablet breaking, 1433〈1222〉 Terminally sterilized pharmaceutical products—parametric release, 1436〈1223〉 Validation of alternative microbiological methods, 1439〈1224〉 Transfer of analytical procedures,1443〈1225〉 Validation of compendial procedures, 1445〈1226〉 Verification of compendial procedures, 1451〈1227〉 Validation of microbial recovery from pharmacopeial articles, 1452〈1229〉 Sterilization of compendial articles,1456〈1229.1〉 Steam sterilization by direct contact, 1461〈1229.2〉 Moist heat sterilization of aqueous liquids, 1464〈1229.3〉 Monitoring of bioburden, 1468〈1229.4〉 Sterilizing filtration of liquids,1472〈1229.6〉 Liquid-phase sterilization, 1479〈1229.7〉 Gaseous sterilization, 1482〈1229.8〉 Dry heat sterilization, 1485〈1229.10〉 Radiation sterilization, 1487〈1230〉 Water for hemodialysis applications,1491〈1231〉 Water for pharmaceutical purposes,1492〈1234〉 Vaccines for human use— polysaccharide and glycoconjugate vaccines, 1518〈1235〉 Vaccines for human use—general considerations, 1534〈1237〉 Virology test methods, 1550〈1238〉 Vaccines for human use—bacterial vaccines, 1570〈1240〉 Virus testing of human plasma for further manufacture, 1582〈1241〉 Water–solid interactions in pharmaceutical systems, 1592〈1251〉 Weighing on an analytical balance,1597〈1265〉 Written prescription drug information—guidelines, 1602〈1285〉 Preparation of biological specimens for histologic and immunohistochemical analysis, 1603〈1285.1〉 Hematoxylin and eosin staining of sectioned tissue for microscopic examination, 1607〈1601〉 Products for nebulization—characterization tests, 1610〈1644〉 Theory and practice of electrical conductivity measurements of solutions,1613〈1660〉 Evaluation of the inner surface durability of glass containers, 1620<1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact〈1724〉 Semi-solid drug products—performance tests, 1625<1730> Plasma Spectrochemistry—Theory and Practice<1735> X-Ray Fluorescence Spectrometry —Theory and Practice〈1736〉 Applications of mass spectrometry,1637〈1761〉 Applications of nuclear magnetic resonance spectroscopy, 1659<1771> Ophthalmic Products—Performance Tests〈1788〉 Methods for the determination of particulate matter in injections and ophthalmic solutions, 1693〈1911〉 Rheometry, 1742〈2021〉 Microbial enumeration tests—nutritional and dietary supplements,1751〈2022〉 Microbiological procedures for absence of specified microorganisms— nutritional and dietary supplements,1756〈2023〉 Microbiological attributes of nonsterile nutritional and dietary supplements, 1762〈2030〉 Supplemental information for articles of botanical origin, 1765<2040> Disintegration and Dissolution of Dietary Supplements〈2091〉 Weight variation of dietary supplements, 1782〈2232〉 Elemental contaminants in dietary supplements, 1783〈2250〉 Detection of irradiated dietary supplements, 1786〈2750〉 Manufacturing practices for dietary supplements, 1789最新文件---------------- 仅供参考--------------------已改成-----------word文本 --------------------- 方便更改赠人玫瑰,手留余香。

(完整word版)USP38通用章节目录中文

(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。

(完整word版)USP38通用章节目录中文

(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 通则 61 62 71 1225 1226

USP 通则 61 62 71 1225  1226

<1225>V ALIDATION OF COMPENDIAL PROCEDURES药典规程的验证Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards. The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in USP-NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposal for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity.用于评价药物质量水平的测试规程受到多种要求的影响。

USP凡例37翻译全文

USP凡例37翻译全文

凡例综合通告和要求部分(凡例),是为解读与使用USP和NF,提供的基本假设,定义,默认(预先规定)的条件。

除非另有说明,本凡例中的要求适用于USP和NF(“药典”)收载的所有文章和通用章节(以下简称:“附录”)。

如果各论的要求与凡例或附录不同,无论各论是否明确说明了这些不同,均遵循各论而非凡例和附录的要求。

名称和修订本出版物(共4册,包括增补在内)的全称,是美利坚合众国(the United States of America)药典第37版和国家处方集第32版。

可以简写成USP37,或NF32,或USP 37-NF 32。

美国药典第37版和国家处方集第32版,将取代所有比他早的版本。

在它正式生效期间,如果没有更多的限制说明,“USP”和“NF”,仅指USP37和NF32及其增补。

这也适用于这些内容的打印版或电子扫描版。

尽管USP和NF属同一出版物,且共享凡例的内容,但二者分别单独成卷。

如果没有特别说明,本版药典将于2014年5月1日正式生效。

USP和NF的增补定期发布。

过渡修订公告在USP网站发布,是对USP和NF的修订。

过渡修订公告包括正式修订版和生效日期,新USP对照品有效性(批号)的通知和由于USP对照品的有效性待批准而导致涉及的检测项目或方法暂停的通知也可在USP网站的“新官方主题”上获得。

修订公报是要求加快公布的药典文章的修订或延缓生效。

在USP网站上发布;通常,如果没有另外说明,修订公报立即生效。

勘误表是对因排版错误而产生的未经专家委员会批准、且不影响药典规定的错误条款的更正,勘误表出版即生效。

2.药典地位和法律承认2.10. 药典文章药典文章是指USP和NF收载的包括专论,附录和本凡例等文章。

药典文章的修订版在(药典)增补、过渡修订公告和修订公报中发布。

附录中编号1000-1999的章节,是对特定主题进行解释或提供定义或描述的信息,其中不含对药典文章的强制要求,除非本凡例、专论,或附录中编号低于1000的有关章节明确引用。

USP Quality Standards for Medicines USP 药品质量标准

USP Quality Standards for Medicines USP 药品质量标准
– USP-NF method must be used if the company has committed to FDA to use it, or if it is the only appropriate test 以下情况必须使用USP-NF方法:如果生产商向 方法: 承诺使用, 以下情况必须使用 方法 如果生产商向FDA承诺使用,或者 承诺使用 或者USP-NF的方法 的方法 是唯一恰当的方法 – In other cases, manufacturers can use an alternative test method if it is: 其他情况下生产商可以使用替代方法,如果(替代方法): 其他情况下生产商可以使用替代方法,如果(替代方法):
– No further characterization required as primary standards. 作为法定标准品不需进一步的标定(直接使用) 作为法定标准品不需进一步的标定(直接使用) – FDA guidance requires testing of in-house standard against a primary reference standard (USP or other). FDA指南要求内部标准品要按法定标准品(USP或其它)标 指南要求内部标准品要按法定标准品( 或其它) 指南要求内部标准品要按法定标准品 或其它 定。
• At least as stringent as the compendial method and 至少和药典方法一样严格, 至少和药典方法一样严格,并且 • “Scientifically sound.” “科学合理 科学合理.” 科学合理
– Manufacturer must assure conformance to USP standard “by suitable means, including adequate manufacturing process validation and control.” 生产商必须“通过恰当的方式,包括充分的生产工艺验证和控制”保证符合USP标准 生产商必须“通过恰当的方式,包括充分的生产工艺验证和控制”保证符合 标准 。 – FDA will always use the compendial method as the “referee test.” USP is “regulatory analytical procedure” FDA总是使用药典方法作为“仲裁方法”。USP是“法定分析方法” 总是使用药典方法作为“ 总是使用药典方法作为 仲裁方法” 是 法定分析方法”

USP 通用章节目录-推荐下载

USP 通用章节目录-推荐下载

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……2458 USP对照品Apparatus for Test and Assays 用于检查与含量分析的器具<16>AUTOMATED METHODS OF ANALYSIS……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 ANALYSIS 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……2556 4-?-四环素<231>HEAVY METALS……2556 重金属<241>IRON……2557 铁<251>LEAD……2558 铅<261>MERCURY……2558 汞<271>READILY 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 DETERMINATION……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 DETERMINATION……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……2596 α-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>WATER CONDUCTIVITY……2653 水电导率<651>CONGEALING TEMPERATURE……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 ANALYTICAL 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 GRAVITY……2766 比重<846>SPECIFIC SURFACE AREA……2767 比表面积<851>SPECTROPHOTOMETRY AND LIGHT-SCATTERING……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 ANALYSIS……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>WATER DETERMINATION……2785 水测定法<941>X-RAY DIFFRACTION……2788 X光衍射General Information 通用信息<1010>ANALYTICAL DATA—INTERPRETATION AND TREATMENT (2790)分析数据-解释与处理<1015>AUTOMATED 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: ANALYSIS 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 EVALUATION 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 EVALUATION 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 EVALUATION OF DOSAGE FORMS (2924) 体内与体外的剂型的评估<1090>IN VIVO BIOEQUIVALENCE 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 EVALUATION 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 ANALYSIS……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 EVALUATION (3035) 无菌产品包装-完整性评估<1208>STERILITY TESTING—VALIDATION 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>TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE……3047 最终灭菌产品-放行参数<1225>VALIDATION OF COMPENDIAL METHODS……3050 药典方法的验证<1227>VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES (3053) 从药物中回收微生物的验证<1230>WATER FOR HEALTH APPLICATIONS……3055 健康用水<1231>WATER FOR PHARMACEUTICAL PURPOSES……3056 制药用水<1241>WATER–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 ANALYTICAL 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 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 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。

USP38-NF33_C71_无菌检查法-中英对照

USP38-NF33_C71_无菌检查法-中英对照

USP38 NF33<71> STERILITY TESTS<71>无菌检查法◆Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japanese Pharmacopeia. Those portions that are not harmonized are marked with symbols (◆) to specify this fact.◆◆◆本检查法已与《欧洲药典》和《日本药局方》对应部分进行了协调,不一致的部分用符号()标注。

◆These Pharmacopeial procedures are not by themselves designed to ensure that a batch of product is sterile or has been sterilized. This is accomplished primarily by validation of the sterilization process or of the aseptic processing procedures.按药典规定的无菌检验本身并不能确保一批产品无菌或已经灭菌,产品的无菌性主要通过对灭菌工艺或者无菌保障程序的验证来完成。

The test is applied to substances, preparations, or articles which, according to the Pharmacopeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test.无菌检查法系用于检查药典要求无菌的药物、制剂产品和其他物品是否无菌的一种方法。

【免费下载】USP 通用章节目录

【免费下载】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……2458 USP对照品Apparatus for Test and Assays 用于检查与含量分析的器具<16>AUTOMATED METHODS OF ANALYSIS……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 ANALYSIS 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……2556 4-?-四环素<231>HEAVY METALS……2556 重金属<241>IRON……2557 铁<251>LEAD……2558 铅<261>MERCURY……2558 汞<271>READILY 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 DETERMINATION……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 DETERMINATION……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……2596 α-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>WATER CONDUCTIVITY……2653 水电导率<651>CONGEALING TEMPERATURE……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 ANALYTICAL 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 GRAVITY……2766 比重<846>SPECIFIC SURFACE AREA……2767 比表面积<851>SPECTROPHOTOMETRY AND LIGHT-SCATTERING……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 ANALYSIS……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>WATER DETERMINATION……2785 水测定法<941>X-RAY DIFFRACTION……2788 X光衍射General Information 通用信息<1010>ANALYTICAL DATA—INTERPRETATION AND TREATMENT (2790)分析数据-解释与处理<1015>AUTOMATED 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: ANALYSIS 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 EVALUATION 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 EVALUATION 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 EVALUATION OF DOSAGE FORMS (2924) 体内与体外的剂型的评估<1090>IN VIVO BIOEQUIVALENCE 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 EVALUATION 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 ANALYSIS……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 EVALUATION (3035) 无菌产品包装-完整性评估<1208>STERILITY TESTING—VALIDATION 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>TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE……3047 最终灭菌产品-放行参数<1225>VALIDATION OF COMPENDIAL METHODS……3050 药典方法的验证<1227>VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES (3053) 从药物中回收微生物的验证<1230>WATER FOR HEALTH APPLICATIONS……3055 健康用水<1231>WATER FOR PHARMACEUTICAL PURPOSES……3056 制药用水<1241>WATER–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 ANALYTICAL 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 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 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。

FDA_QSR_820_中文-1详解

FDA_QSR_820_中文-1详解

Part 820——质量体系法规——目录Subpart A——通用要求Sec.820.1 范围(a)适用性。

(1)本质量体系法规阐明了现行良好操作规范Current good manufacturing practice(CGMP)的要求。

本法规适用于所有应用于人类的最终产品所采用的方式、设备和控制,包括设计、制造、包装、标识、贮存、安装和服务的各个环节。

所适用的管理方法、设备和控制。

本法规是为了确保最终器械的安全性和有效性,并符合联邦食品、药品和化妆品法。

本法规的基本要求适用于所有的最终医疗器械制造商。

如果制造商仅从事本法规中的某些过程而未从事其它过程,则只需符合其实施的过程的要求。

对于Ⅰ类器械,设计控制仅适用于Sec.820.30(a)(2)中列出的器械。

本法规不适用于最终产品的部件或零件制造商,但鼓励这类制造商把本法规的适当规定作为指南来使用。

人血和血类产品制造商不受本法规的限制,但应遵循本章606部分法规的要求。

(2)本法规的规定应适用于任何本法规所定义的应用于人体的最终器械,不论其被制造,进口或者将进口至美国本土,哥伦比亚特区,或波多黎各联邦。

(3)在本法规中,术语“在适当时”(where appropriate)出现过多次。

当某个要求符合“在适当时”的条件时,则这个要求应被认为是“适用的”(appropriate),除非制造商能提供文件证明其理由。

如果不执行将会导致产品不满足其性能要求,或者制造商不能够进行任何必要的纠正措施,那么该要求就是适用的(appropriate)。

(b)限制。

除非另有明确规定,该质量体系法规是本章其它法规的补充。

如果在适用的法规和本章其他法规有冲突时,对于有争议的器械,特别适用的法规将取代任何其它通用的要求。

(c)权限。

PART820是在(21U.S.C.法令351、352、360、360c、360d、360e、360h、360i、360j、360l、370、374、381、383)章节501、502、510、513、514、515、518、519、520、522、701、704、801、803建立并发布的。

USP 通则 61 62 71 1225 1226

USP 通则 61 62 71 1225  1226

<1225>V ALIDATION OF COMPENDIAL PROCEDURES药典规程的验证Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards. The Current Good Manufacturing Practice regulations [21 CFR 211.194(a)] require that test methods, which are used for assessing compliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in USP-NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposal for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity.用于评价药物质量水平的测试规程受到多种要求的影响。

【标准】usp原文翻译

【标准】usp原文翻译

【关键字】标准232元素杂质—限度介绍本通则明确了药品中各元素杂质的限度。

元素杂质包括催化剂、环境污染物,可能存在于原料药、赋形剂、制剂中。

这些杂质或自然产生,或有意添加,或由于不注意而引入(例如,与处理设备相互作用)。

当知道元素杂质存在,或有意添加,或有引入的可能性,应当保证这些杂质符合限度要求。

可以采用基于风险的控制策略来确保产品满足限度标准。

由于砷、镉、铅和汞普遍存在的特性,风险控制策略至少应考虑这四种元素。

不管采用什么分析方法,所有药品均应满足元素杂质限度标准。

本章提出的限度标准不适用于赋形剂与原料药,除非本章或各论中明确说明。

然而赋形剂与原料药中元素杂质水平必须报告。

本章提出的限度标准同样不适用于兽用产品和常规疫苗。

饮食补充剂和它们的成份的相关规定见于《饮食补充剂中的元素杂质》.形态分析对于元素氧化态、有机络合态、化合态的测定,称为形态分析。

每种元素可能存在不同的氧化态或络合态。

然而,砷和汞应特别关注,因为它们的无机态和络合有机态具有不同的毒性。

砷的限度标准是基于无机态(毒性最大)。

假定样品中所有砷都是无机态,可用总砷测定法检测。

当总砷法结果超过限度标准,应当使用能够对不同形态砷定量的分析方法,以确定无机态砷是否满足法定要求。

汞的限度标准是基于无机(2+)氧化态。

甲基汞(毒性最强),但对于药品,通常不是问题。

这样,汞限度标准的确定是基于汞最常见的无机形态。

对于可能含有甲基汞的产品(例如,从鱼中得到的物质),相应的汞限度标准将在各论中提及。

接触途径元素杂质的毒性跟接触程度(生物利用度)有关。

对于每一种元素杂质接触程度取决于给药途径:口服、肠外注射、吸入。

这些限度确定是基于慢性接触。

为建立标准需要,另两种给药途径,黏膜和局部接触可认为跟口服相同,而表1中的PDE值也适用于这些产品[注意—药品的给药途径在制剂通则中介绍制剂通则1151 . ]Change to read:药品表1的第二至第四栏给出的限度值是一些元素杂质的基本日剂量PDE值(病人按指定给药途径服用)。

USP凡例——精选推荐

USP凡例——精选推荐

USP凡例⽬录标题 (2)法定以及法定药品 (2)原⼦量及化学式 (2)缩写 (2)有效数字及限差 (3)需求的解释 (3)总章 (4)药典论坛报 (4)补充 (4)试剂规程 (4)参考制剂 (4)美国药典对照标准品 (4)单位及效能 (5)成分及步骤 (5)试验及分析 (5)装置 (5)异物及杂质 (5)残留溶剂 (6)操作 (6)实验结果、统计及规程 (8)概述 (8)溶解度 (9)可互换的⽅法 (9)处⽅及调剂 (9)保存、包装、贮存及贴标签 (9)器⽫ (9)毒品预防包装准则 (10)存储温度和湿度 (11)⾮特异性条件存储 (11)标签 (11)USP-NF专著包装与存储指导说明 (13)植物体和动物体 (13)度量衡 (13)浓度 (14)通则及要求(以下称通则)和总则中的⼀般要求以概要的形式为USP 中的标准,试验,分析及其他规范提供了⼀个总体上的指导⽅针和解释说明,排除了⼤量的反复引⽤的恰当实证。

若没有特殊说明的反例,适⽤于整篇通则及要求。

通则或总章制订之外,个别专著中的措辞表现优越且有明确的指导⽅向和意图。

强调这些免责条款的存在,通则和总章在某种程度上利⽤明确且经过认证的条款,如“除⾮另有说明”。

在个别专著中,不论是否有陈述性的特例,标准,试验,分析及其他规范的特殊说明是同衍⽣于通则或总章中的条例是相结合的。

标题该出版物的全称包括补录,是美利坚合众国药典-30修正版。

该名称可以缩写为美国药典-30修正版或USP-30。

USP-30修正版替代所有以往的版本。

USP,不经过进⼀步鉴定,在使⽤官⽅药典期间,指USP 30及相关的附录。

同样的标题,不进⼀步区别,适⽤于该项下的出版物及电⼦⽂档。

法定以及法定药品原⼦量及化学式计算相对分⼦质量以及分析中的因素的原⼦量,是1997年IUPAC委托原⼦量及同位素丰度推荐使⽤的。

化学式,与定义、试验和分析中的不同,⽬的就是提供信息和计算。

特定专著中的格式是这样的,法定标题之后,部分正⽂的主要信息,缩写有效数字及限差限度以数字的形式表⽰,因此,最⾼限及最低限的范围包括这两个数值及其中间的数字,但是不包括限度外⾯的数字。

USP38通用章节目录讲解

USP38通用章节目录讲解

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 METHODS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。

USP40通则目录-中英文

USP40通则目录-中英文

<841> 比重测定 <846> 粉末的比表面积测定 <852> 原子吸收光谱法 <853> 荧光光谱法 <854> 中红外光谱法 <855> 散射比浊法、比浊法、和视觉比较 <857> 紫外-可见光谱法 <861> 外科缝合线直径检查 <871> 附有针的缝合线检查 <881> 外科缝合线、纺织品与膜片的弹力强度检查 <891> 热分析 <905> 含量均匀度检查 <911> 黏度--毛细管测定法 <912> 黏度--旋转流变仪方法 <913> 黏度--滚球式密度计方法 <914> 黏度--压力驱动测定法 <921> 水分测定 <941> 结晶型药物的X线衍射分析 基本信息 <1004> 粘膜药物产品--性能测定 <1005> 声发射检测
<1191> 调剂工作中的药品稳定性保持
<1195> 大批量药用辅料的显著变化指南
<1197> 大批量药用辅料的分配原则
<1207.1 ><1207.2 ><1207.3 >
包装完整性和检查法的选择 包装完整性泄漏检查技术 包装密封性质量检查技术
<1207> 无菌产品包装:完整性评价
<1208> 灭菌试验:隔离系统的验证
<1115> 非无菌原料药和产品生物负荷的控制
<1116> 无菌生产环境的微生物控制与监测
<1117> 微生物实验室的质量规范(GLP)

USP通则目录整理

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*****************。

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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。

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