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〉walk in the park USP reference standards, 93
〈17〉 Prescription container labeling, 96
〈21〉 Thermometers, 98
〈31〉 Volumetric apparatus, 99
〈41〉 Weights and getoffbalances, 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 世界十大巧克力牌子 cytokines ud 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 asmblies and similar medical devices, 212
<162> Diphtheria Antitoxin Potency Testing for Human Immune Globulins
osama bin laden〈陨落星辰3171〉 Vitamin B12 activity assay, 213
〈181〉 Identification—organic 推敲翻译 nitrogenous bas, 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〉 Arnic, 233
〈221〉 Chloride and sulfate, 置之死地而后生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
envisioned〈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 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 mature什么意思glycol, diethylene glycol,and triethylene glycol in ethoxylated substances, 324
〈471〉 Oxygen flask combustion, 325
〈481〉 Riboflavin jaggadassay, 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
〈525〉 Sulfur dioxide, 329
〈531〉 Thiamine assay, 334