USP39 General chapters 目录

更新时间:2023-05-19 16:12:25 阅读: 评论:0

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
11walk 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
envisioned261 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

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