Guide to General Chapters 通用章节指导
(标注底色部分为USP40-NF35新增章节)
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(本版本已删除)
<31>VOLUMETRIC APPARATUS 容量器具
<41>BALANCES 天平
Microbiological Tests 微生物检查法
北京冬奥会闭幕式
<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>冬天滑雪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
<89.1> COLLAGENASE蚂蚱怎么画Ⅰ 胶原酶Ⅰ
茶具品牌前十名排名榜<89.2> COLLAGENASEⅡ 胶原酶Ⅱ
<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)测定法苏沙
<121>INSULIN ASSAYS 胰岛素测定法
<121.1>笔谈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扬眉吐气的近义词 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
<127>FLOW CYTOMETRIC ENUMERATION OF CD34+ CELL 流式细胞术计术34阳性细胞
<129>ANALYTICAL PROCEDURES FOR RECOMBINANT THERAPEUTIC MONOCLONAL ANTIBODIES重组治疗性单克隆抗体的分析方法
<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
<162>DIPHTHERIA ANTITOXIN POTENCY TESTING FOR HUMAN IMMUNE GLOBULINS 人免疫球蛋白的白喉抗毒素效力检测
<165>PREKALLIKREIN ACTIVATOR前激肽释放酶原激活剂
<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
<202>IDENTIFICATION OF FIXED OILS BY THIN-LAYER CHROMATOGRAPHY 薄层色谱法对非挥发性油的鉴别
<203>HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHY PROCEDURE FOR IDENTIFICATION OF ARTICLES OF BOTANICAL ORIGIN 高性能薄层色谱法对植物的鉴别
Limit Tests 限度检查法
<206>ALUMINUM 铝
<207>TEST FOR 1,6-ANHYDRO DERIVATIVE 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
<212>OLIGOSACCHARIDE ANALYSIS 低聚糖的分析
<221>CHLORIDE AND SULFATE 氯和硫
<223>DIMETHYLANILINE 二甲基苯胺
<226>4-EPIANHYDRO-TETRACYCLINE 4-?-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>HEAVY 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>炸酱面的酱做法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