USP39 General chapters 目录

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 serum quality attributes and functionality tests, 167 ?91? Calcium pantothenate assay, 171

?92? Growth factors and cytokines used 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 assemblies and similar medical devices, 212 <162> Diphtheria Antitoxin Potency Testing for Human Immune Globulins ?171? Vitamin B12 activity assay, 213

?181? Identification—organic nitrogenous bases, 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? Arsenic, 233

?221? Chloride and sulfate, 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 ?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 gases,290 ?415? Medical gases 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? Riboflavin assay, 326

?501? Salts of organic nitrogenous bases,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 ?541? Titrimetry, 335

?551? Vitamin E assay, 338

?561? Articles of botanical origin, 345

?563? Identification of articles of botanical origin, 358 ?565? Botanical extracts, 370 ?571? Vitamin A assay, 373 <580> Vitamin C Assay ?581? Vitamin D assay, 378 ?591? Zinc determination, 387

?601? Inhalation and nasal drug products:aerosols, sprays, and powders–performance quality tests, 388 ?602? Propellants, 414 ?603? Topical aerosols, 415 ?604? Leak rate, 416

?610? Inhalation and nasal drug products:aerosols, sprays, and powders–performance quality tests, 416 ?611? Alcohol determination, 418

?616? Bulk density and tapped density, 420 ?621? Chromatography, 424 ?631? Color and achromicity, 434 ?641? Completeness of solution, 436 ?643? Total organic carbon, 436 ?645? Water conductivity, 438 ?651? Congealing temperature, 441

?659? Packaging and storage requirements,443 ?660? Containers—glass, 450 ?661? Containers—plastics, 457 <661.1> Plastic Materials of Construction

<661.2> Plastic Packaging Systems for Pharmaceutical Use ?670? Containers—Auxiliary Components ?671? Containers—performance testing,465 ?691? Cotton, 472 ?695? Crystallinity, 474

?696? Crystallinity determination by solution calorimetry, 474 ?698? Deliverable volume, 478