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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〉 Volumetric 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 rum quality attributes and functionality tests, 167
〈91〉 Calcium pantothenate assay, 171
〈92〉 Growth factors and cytokines ud in cell therapy manufacturing, 172
〈111〉 Design and analysis of biological assays, 176
〈115〉 Dexpanthenol assay, 191
〈121〉 Insulin assays, 193
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〈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 asmblies and similar medical devices, 212
<162> Diphtheria Antitoxin Potency Testing for Human Immune Globulins
〈171〉 the wantedVitamin B12 activity assay, 213
〈181〉 Identification—organic nitrogenous bas, 216
〈191〉 Identification tests—general, 216
〈193〉 not at all是什么意思 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 leonidasenoxaparin sodium, 223
〈208〉 Anti-factor Xa and anti-factor IIa assays for unfractionated and 英语 学习 网站 low molecular weight heparins, 228
〈在线英译汉211〉 Arnic, 233
〈221〉 Chloride and sulfate, 235
〈223〉 Dimethylaniline, 236
〈226〉 4-Epianhydrotetracycline, 236
〈227〉 4-Aminophenol 受欢迎的英文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 同胞兄弟on ignition, 260
〈291〉 Selenium, 261
〈301〉 Acid-neutralizing capacity, 261
〈311〉 Alginates assay, 262
〈341〉fragile 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 gas,290
〈415〉 Medical gas 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〉 caoadult comRiboflavin assay, 326
〈501〉 Salts of organic nitrogenous bas,327
〈503〉 Acetic acid in peptides, 327
<503.1> Trifluoroacetic Acid (TFA) in Peptides
〈511〉 Single-steroid assay, 328