優(yōu)質(zhì)USP通用章節(jié)目錄

1、USP29-通用章節(jié)指導目錄（附錄）第2頁 共7頁8通用章節(jié)指導Guide to General Chapters目錄中此顏色并且?guī)в小?* ”的為新增內(nèi)容General Requirements for Test and Assays 檢查與含量分析的一般要求V 1 INJECTIONS 2455 注射劑V 11 USP REFERENCE STANDARDS 2458 USP 對照品Apparatus for Test and Assays 用于檢查與含量分析的器具V 16AUTOMATED METHODS OF ANAL YSIS 2491 自動化分析方法V 21 THERMOMETER

2、S 2497 溫度計V 31 VOLUMETRIC APPARATUS 2497 容量器具V 41 WEIGHTS AND BALANCES 2499 砝碼與天平Microbiological Tests 微生物檢查法V 51 ANTIMICROBIAL EFFECTIVENESS TESTING 2499 抗菌齊U有效性檢查法V 55 BIOLOGICAL INDICATORS RESISTANCE PERFORMANCE TESTS 2501生物指示劑-耐藥性實驗V 61 MICROBIAL LIMIT TESTS 2503 微生物限度檢查法V 71 STERILITY TESTS 250

3、8 無菌檢查法Biological tests and assays 生物檢查法與測定法V 81 ANTIBIOTICS MICROBIAL ASSAYS 2513 抗生素微生物測定V 85 BACTERIAL ENDOTOXINS TEST 2521 細菌內(nèi)毒素檢查法V 87 BIOLOGICAL REACTIVITY TESTS, IN VITRO 2525 體外的生物反應性檢查法V 88 BIOLOGICAL REACTIVITY TESTS, IN VIVO 2526 體內(nèi)的生物反應性檢查法V 91 CALCIUM PANTOTHENATE ASSAY 2530 泛酸鈣測定法V 111

4、 DESIGN AND ANAL YSIS OF BIOLOGICAL ASSAYS 2531 生物測定法的設計與分析V 115 DEXPANTHENOL ASSAY 2543 右泛醇（擬膽堿藥）測定法V 121 INSULIN ASSAYS2544 胰島素測定法V 141 PROTEIN BIOLOGICAL ADEQUACY TEST 2546 蛋白質(zhì)生物適應性試驗V 151 PYROGEN TEST2546 熱原檢查法V 161 TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR MEDICAL DEVICES2547輸血輸液用具以及相類似的醫(yī)

5、療器械V 171 VITAMIN B 12 ACTIVITY ASSAY 2548 維生素 B12 活性測定法Chemical Tests and assays化學實驗與測定法V 181 IDENTIFICATION ORGANIC NITROGENOUS BASES 2549鑒別-有機氮堿？V 191 IDENTIFICATION TESTS GENERAL 2550 鑒另U實驗一通用V 193 IDENTIFICATION TETRACYCLINES2551 鑒別四環(huán)素V 197 SPECTROPHOTOMETRIC IDENTIFICATION TESTS 2552分光光度計鑒另U實驗V

6、 201 THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST .2553薄層色譜鑒別實驗Limit Test限度檢查法V 206 ALUMINUM 2554 鋁V 211 ARSENIC 2554 砷V 221 CHLORIDE AND SULFATE 2555 氯和硫V 223 DIMETHYLANILINE 2555 二甲基苯胺V 2264-EPIANHYDRO-TETRACYCLINE 25564 ?四環(huán)素V 231 HEAVY METALS 2556 重金屬V 241 IRON 2557 鐵V 251 LEAD 2558 鉛V 261 MERC

7、URY 2558 汞V 271 READIL Y CARBONIZABLE SUBSTANCES TEST 2560 易碳化物檢查法V 281 RESIDUE ON IGNITION 2560 灼燒殘渣V 291 SELENIUM 2560 硒Other Tests and Assays 其它檢查法與測定法V 301 ACID-NEUTRALIZING CAPACITY 2561 酸中和容量V 311 ALGINATES ASSAY 2562 藻酸鹽測定法V 331 AMPHETAMINE ASSAY 2562 苯丙胺測定法 ANTIMICROBIAL AGENTS CONTENT 2563

8、抗菌劑含量 Assay for Citric Acid/Citrate and Phosphate 2565檸檬酸 /檸檬酸鹽和磷酸鹽的測定V 351 ASSAY FOR STEROIDS2565 類固醇（甾類化合物）測定法V 361 BARBITURATE ASSAY 2565巴比妥類藥物測定法V 371 COBALAMIN RADIOTRACER ASSAY 2566 鈷銨素放射性跟蹤劑測定法V 381 ELASTOMERIC CLOSURES FOR INJECTIONS 2567 注射劑的彈性密封件V 391 EPINEPHRINE ASSAY 2567 腎上腺測定法V 401 FAT

9、S AND FIXED OILS 2568 脂肪與混合油V 411 FOLIC ACID ASSAY 2571 葉酸測定法V 425 IODOMETRIC ASSAY ANTIBIOTICS 2572 碘量檢查法抗生素V 429 LIGHT DIFFRACTION MEASUREMENT OF PARTICLE SIZE 2572粒子尺寸的光衍射測量V 431 METHOXY DETERMINA TION 2575 甲氧基測定法V 441 NIACIN OR NIACINAMIDE ASSAY 2576 煙?；驘燉０窚y定法V 451 NITRITE TITRATION 2578 亞硝酸鹽滴定V

10、 461 NITROGEN DETERMINA TION 2578 氮測定法V 466 ORDINARY IMPURITIES 2579 一般雜質(zhì)V 467 ORGANIC VOLATILE IMPURITIES 2580 有機的易揮發(fā)雜質(zhì)V 471 OXYGEN FLASK COMBUSTION 2590 氧瓶燃燒法V 481 RIBOFLAVIN ASSAY 2590 核黃素測定法V 501 SALTS OF ORGANIC NITROGENOUS BASES 2591 有機氮鹽V 511 SINGLE-STEROID ASSAY 2591 單一的類固醇測定法V 521 SULFONAMI

11、DES 2592 磺胺制劑V 531 THIAMINE ASSAY 2593 硫胺素測定法V 541 TITRIMETRY 2593 滴定法V 551 ALPHA TOCOPHEROL ASSAY 2596 a 維生素 E 測定法V 561 ARTICLES OF BOTANICAL ORIGIN 2596 植物起源的藥品V 563 IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN 2603 植物藥品的鑒別V 565 BOTANICAL EXTRACTS 2609 植物提取V 571 VITAMIN A ASSAY 2611 維生素 A的測定法V 5

12、81 VITAMIN D ASSAY 2612 維生素 D的測定法V 591 ZINC DETERMINATION 2616 鋅的測定法Physical Test and Determinations物理檢查與測定法V 601 AEROSOLS,血 NASAL SPRAYS,血 usp28 METERED-DOSE INHALERS, AND DRY POWDERINHALERS2617氣溶膠，鼻用噴霧劑，定量吸入器與干粉吸入器V 611 ALCOHOL DETERMINATION 2637 乙醇測定法V 616 BULK DENSITY AND TAPPED DENSITY 2638 堆密度

13、與拍實密度V 621 CHROMATOGRAPHY .2639 色譜法V 631 COLOR AND ACHROMICITY 2651 呈色與消色V 641 COMPLETENESS OF SOLUTION 2652 完全溶解V 643 TOTAL ORGANIC CARBON 2652 總有機碳V 645 WATER CONDUCTIVITY 2653 水電導率V 651 CONGEALING TEMPERA TURE 2654 凝點溫度V 661 CONTAINERS 2655 容器V 671 CONTAINERS PERMEATION 2663 容器滲透V 691 COTTON 2664

14、 棉花V 695 CRYSTALLINITY 2665 結(jié)晶性V 696 Crystalli nity Determi nation By Solution Calorimetry 2666通過溶液量熱學測定結(jié)晶性V 698 DELIVERABLE VOLUME 2667 可轉(zhuǎn)移的體積V 699 DENSITY OF SOLIDS 2669 固體密度V 701 DISINTEGRATION 2670 崩解時限* V 701 Disintegration (Harmonized Chapter, Official April 1,2006) .2671 崩解時限(協(xié)調(diào)的章節(jié)，法定日期，2006.

15、4.1)V 711 DISSOLUTION 2673 溶出度* v 711 Dissolution (Harmonized Chapter, Official April 1,2006) .2675 溶出度(協(xié)調(diào)的章節(jié)，法定日期，2006.4.1)V 721 DISTILLING RANGE 2682 餾程V 724 DRUG RELEASE2682 藥物釋放度* v 724 Drug releasee (Harmonized Chapter, Official April 1,2006) .2690 藥物釋放度(協(xié)調(diào)的章節(jié)，法定日期，2006.4.1)V 726 ELECTROPHORESI

16、S 2694 電泳V 727 CAPILLARY ELECTROPHORESIS 2696 毛細管電泳法* v 730 Plasma Spectrochemistry .2700 血漿光譜化學V 731 LOSS ON DRYING 2704 干燥失重V 733 LOSS ON IGNITION 2704 灼燒失重V 736 MASS SPECTROMETRY 2705 質(zhì)譜V 741 MELTING RANGE OR TEMPERATURE 2708 熔距或熔點V 751 METAL PARTICLES IN OPHTHALMIC OINTMENTS 2709 眼用軟膏中的金屬粒子V 755

17、 MINIMUM FILL 2710 最低裝填量V 761 NUCLEAR MAGNETIC RESONANCE 2710 核磁共振V 771 OPHTHALMIC OINTMENTS 2715 眼用軟膏V 776 OPTICAL MICROSCOPY 2716 光學顯微鏡V 781 OPTICAL ROTATION 2718 旋光V 785 OSMOLALITY AND OSMOLARITY2718 同滲重摩與同滲容摩V 786 PARTICLE SIZE DISTRIBUTION ESTIMATION BY ANAL YTICAL SIEVING 2720通過篩分法估算粒子分布V 788

18、PARTICULATE MATTER IN INJECTIONS 2722 注射劑中的顆粒V 789 PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS 2729 眼用溶液中的顆粒V 791 pH 2730V 795 PHARMACEUTICAL COMPOUNDING NONSTERILE PREPARATIONS 2731藥物混合一非無菌制劑V 797 PHARMACEUTICAL COMPOUNDING STERILE PREPARATIONS 2735藥物混合-無菌制劑V 801 POLAROGRAPHY 2752 極譜法V 811 POWDER FI

19、NENESS 2754 粉齊U細度V 821 RADIOACTIVITY 2755 放射性V 823 RADIOPHARMACEUTICALS FOR POSITRON EMISSION TOMOGRAPHYCOMPOUNDING2763用于正電子發(fā)射斷層攝影術(shù)的放射性藥物V 831 REFRACTIVE INDEX 2766 折光率V 841 SPECIFIC GRAVITY 2766 比重V 846 SPECIFIC SURFACE AREA 2767 比表面積V 851 SPECTROPHOTOMETRY AND LIGHT-SCA TTERING 2770 分光光度計與光散射V 861

20、 SUTURES DIAMETER 2775 縫線直徑V 871 SUTURES NEEDLE ATTACHMENT 2775 縫線穿孔實驗V 881 TENSILE STRENGTH .2776 張力V 891 THERMAL ANAL YSIS 2776 熱分析V 905 UNIFORMITY OF DOSAGE UNITS 2778 制劑單位的含量均勻度V 905 UNIFORMITY OF DOSAGE UNITS (Harmonized Chapter, Official April 1,2006)2780 制劑單位的含量均勻度(協(xié)調(diào)的章節(jié)2006.4.1)V 911 VISCOSI

21、TY 2785 粘度V 921 WATER DETERMINA TION 2785 水測定法V 941 X-RAY DIFFRACTION 2788 X 光衍射General Information 通用信息V 1010 ANAL YTICAL DATA INTERPRETA TION AND TREATMENT 2790分析數(shù)據(jù)-解釋與處理V 1015 AUTOMA TED RADIOCHEMICAL SYNTHESIS APPARATUS 2801放射性自動合成裝置V 1031 THE BIOCOMPATIBILITY OF MATERIALS USED IN DRUG CONTAINER

22、S, MEDICALDEVICES, AND IMPLANTS 2802用于藥物容器、醫(yī)療設施和植入劑的材料的生物相容性V 1035 BIOLOGICAL INDICATORS FOR STERILIZATION 2811 滅菌用生物指示劑V 1041 BIOLOGICS 2814 生物制劑* V 1043 Ancillary Material for Cell, Gene, and Tissue-Engineered Products .2814 細胞，基因與組織設計產(chǎn)品的輔助材料V 1045 BIOTECHNOLOGY-DERIVED ARTICLES 2821 生物技術(shù)提取產(chǎn)品V 104

23、6 CELL AND GENE THERAPY PRODUCTS 2831 細胞與基因治療產(chǎn)品V 1047 BIOTECHNOLOGY-DERIVED ARTICLES TESTS 2858 生物技術(shù)產(chǎn)品檢查法V 1048 QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANAL YSIS OF THE EXPRESSIONCONSTRUCT IN CELLS USED FOR PRODUCTION OF r-DNA DERIVED PROTEIN PRODUCTS 12883 生物產(chǎn)品質(zhì)量：從蛋白質(zhì)產(chǎn)品中提取的r-DNA產(chǎn)品在細胞中表達結(jié)構(gòu)的分析V 1049 QU

24、ALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS 12884生物技術(shù)產(chǎn)品的質(zhì)量：生物技術(shù)/生物產(chǎn)品的穩(wěn)定性實驗V 1050 VIRAL SAFETY EVALUA TION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELLLINES OF HUMAN OR ANIMAL ORIGIN 2887從人或動物細胞中提取的生物技術(shù)產(chǎn)品的病毒安全性評估V 1051 CLEANING GLASS APPARATUS 2896 玻璃容

25、器的清洗V 1061 COLOR INSTRUMENTAL MEASUREMENT 2896 顯色一儀器測量* v 1065 Ion Chromatography 2898 離子色譜法V 1074 EXCIPIENT BIOLOGICAL SAFETY EV ALUA TION GUIDELINES 2900賦形劑（輔料）生物安全性評估指導V 1075GOOD COMPOUNDING PRACTICES 2903 好的混合操作V 1078 GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS 2906 批藥品賦形劑的生產(chǎn)

26、管理規(guī)范* v 1079 Good Storage and Shipping Practices2915 良好的貯存與船運規(guī)范V 1081 GEL STRENGTH OF GELATIN 2920 白凝膠的凝膠強度V 1086 IMPURITIES IN OFFICIAL ARTICLES 2920 藥典物品中的雜質(zhì)V 1087 INTRINSIC DISSOLUTION 2923 內(nèi)部的溶出度V 1088 IN VITRO AND IN VIVO EV ALUA TION OF DOSAGE FORMS 2924體內(nèi)與體外的劑型的評估V 1090 IN VIVO BIOEQUIV ALENC

27、E GUIDANCES 29291 體內(nèi)生物等效性指導V 1091 LABELING OF INACTIVE INGREDIENTS 2968 非活性成分的標示V 1101 MEDICINE DROPPER 2969 醫(yī)用滴管V 1111 MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE PHARMACEUTICAL PRODUCTS.2969非無菌藥品中的微生物分布V 1116 MICROBIOLOGICAL EVALUA TION OF CLEAN ROOMS AND OTHER CONTROLLEDENVIRONMENTS2969 潔凈的房間與其它可控環(huán)境

28、的微生物評估V 1118MONITORING DEVICES TIME, TEMPERATURE, AND HUMIDITY 2976監(jiān)控裝置-時間、溫度與濕度V 1119NEAR-INFRARED SPECTROPHOTOMETRY 2979 近紅外分光光度測定法* V 1120 Raman Spectrophotometry.2983 Raman 分光光度測定法V 1121 NOMENCLATURE 2988 命名* V 1136Packaging Unit-of-Use 2989 包裝單元使用V 1146 PACKAGING PRACTICE REPACKAGING A SINGLE S

29、OLID ORAL DRUG PRODUCT INTO AUNIT-DOSE CONTAINER2990 包裝操作將單一固體口服藥品產(chǎn)品再包裝成單元劑量V 1150 PHARMACEUTICAL STABILITY 2994 藥物穩(wěn)定性V 1151 PHARMACEUTICAL DOSAGE FORMS 2996 藥物劑型V 1160 PHARMACEUTICAL CALCULATIONS IN PRESCRIPTION COMPOUNDING 3006按處方混合的藥物的計算V 1171 PHASE-SOLUBILITY ANAL YSIS 3016 相溶解分析* V 1174 Powder

30、Flow .3017 粉末流動性V 1176 PRESCRIPTION BALANCES AND VOLUMETRIC APPARATUS .3020處方天平與容量器具* V 1177 Good Packaging Practices.3021 良好的包裝操作* V 1178 Good Repackaging Practices.3023 良好的再包裝操作V 1181 SCANNING ELECTRON MICROSCOPY 3025 掃描電子顯微鏡V 1191 STABILITY CONSIDERATIONS IN DISPENSING PRACTICE 3029 分裝操作中穩(wěn)定性考察V 1

31、196 PHARMACOPEIAL HARMONIZATION 3031 藥典的一致性V 1207STERILE PRODUCT PACKAGING INTEGRITY EV ALUATION 3035無菌產(chǎn)品包裝-完整性評估V 1208 STERILITY TESTING VALIDATION OF ISOLATOR SYSTEMS 3037無菌實驗一隔離系統(tǒng)的驗證V 1209 STERILIZATION CHEMICAL AND PHYSICOCHEMICAL INDICATORS ANDINTEGRATORS3040 滅菌化學與物理化學的指示劑以及二者的綜合V 1211 STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES .3041藥典物品中的滅菌與滅菌保證V 1216TABLET FRIABILITY 3046 片劑的脆碎度V 1221 TEASPOON 3047 茶匙V 1222 TERMINALL Y STERILIZED PHARMACEUTICAL PRODUCTSPARAMETRIC RELEAS