USP38通用章节目录讲解.docx

USP38通用章节目录讲解 USP38-通用章节指导书目(附录) 第 1 页 共 12 页 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－耐药性试验＜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 体外的生物反响性检查法 ＜88＞BIOLOGICAL REACTIVITY TESTS, IN VIVO 体内的生物反响性检查法＜89＞ENZYMES USED AS ANCILLARY MATERIALS IN PHARMACEUTICAL MANUFACTURING USP38-通用章节指导书目(附录) 第 2 页 共 12 页 药品生产中酶作为辅料所运用 ＜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 在细胞疗法中运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 化学试验检查与测定法 鉴别检查＜181＞IDENTIFICATION—ORGANIC NITROGENOUS BASES鉴别－有机氮碱化合物 ＜191＞IDENTIFICATION TESTS—GENERAL 鉴别试验－通用 ＜193＞IDENTIFICATION—TETRACYCLINES 鉴别－四环素类＜197＞SPECTROPHOTOMETRIC IDENTIFICATION TESTS 分光光度计鉴别试验 ＜201＞THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST薄层色谱鉴别试验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试验＜208＞ANTI-FACTOR Xa AND ANTI-FACTOR IIa ASSAYS FOR UNFRACTIONATED AND LOW MOLECULAR WEIGHT HEPARINS平凡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 2 USP38-通用章节指导书目(附录) 第 3 页 共 12 页 ＜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＞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 3 USP38-通用章节指导书目(附录) 第 4 页 共 12 页 ＜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 INETHOXYLATED 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 ＜51。