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USP 36 Guide to General Chapters / Chart Guide 15
16 Chart 1 / Guide to General Chapters USP 36
USP 36 Guide to General Chapters / Chart 2 17
18 Chart 3 / Guide to General Chapters USP 36
USP 36 Guide to General Chapters / Chart 4 19
20 Chart 5 / Guide to General Chapters USP 36
USP 36 Guide to General Chapters / Chart 6 21
22 Chart 7 / Guide to General Chapters USP 36
USP 36 Guide to General Chapters / Chart 8 23
24 Chart 9 / Guide to General Chapters USP 36
USP 36 Guide to General Chapters / Chart 10 25
26 Chart 11 / Guide to General Chapters USP 36
USP 36 Guide to General Chapters / Chart 12 27
28 Chart 13 / Guide to General Chapters USP 36
USP 36 Guide to General Chapters 29
Guide to General Chapters
(For complete alphabetical list of all general chapters in this Pharmacopeia, see under “General chapters” in the index.)
GENERAL TESTS AND ASSAYSChemical Tests and Assays
General Requirements Identification Testsfor Tests and Assays
⟨181⟩ Identification—Organic Nitrogenous Bases . . . 135⟨191⟩ Identification Tests—General . . . . . . . . . . . . . . 136 ⟨1⟩ Injections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33⟨193⟩ Identification—Tetracyclines . . . . . . . . . . . . . . 138 ⟨3⟩ Topical and Transdermal Drug Products—⟨197⟩ Spectrophotometric Identification Tests . . . . . . 139Product Quality Tests . . . . . . . . . . . . . . . . . . . . . 37⟨201⟩ Thin-Layer Chromatographic Identification⟨11⟩ USP Reference Standards . . . . . . . . . . . . . . . . . . 41
Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Apparatus for Tests and AssaysLimit Tests
⟨16⟩ Automated Methods of Analysis . . . . . . . . . . . . . 43⟨17⟩ Prescription Container Labeling . . . . . . . . . . . . . 51 ⟨206⟩ Aluminum . . . . . . . . . . . . . . . . . . . . . . . . . . . 140⟨21⟩ Thermometers . . . . . . . . . . . . . . . . . . . . . . . . . 52 ⟨207⟩ Test for 1,6-Anhydro Derivative for Enoxaparin⟨31⟩ Volumetric Apparatus . . . . . . . . . . . . . . . . . . . . . 53 Sodium . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141⟨41⟩ Weights and Balances . . . . . . . . . . . . . . . . . . . . 53 ⟨211⟩ Arsenic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
⟨221⟩ Chloride and Sulfate . . . . . . . . . . . . . . . . . . . 146⟨223⟩ Dimethylaniline . . . . . . . . . . . . . . . . . . . . . . . 147Microbiological Tests⟨226⟩ 4-Epianhydrotetracycline . . . . . . . . . . . . . . . . 147⟨228⟩ Ethylene Oxide and Dioxane . . . . . . . . . . . . . 148⟨51⟩ Antimicrobial Effectiveness Testing . . . . . . . . . . . 54⟨231⟩ Heavy Metals . . . . . . . . . . . . . . . . . . . . . . . . 150⟨55⟩ Biological Indicators—Resistance Performance⟨232⟩ Elemental Impurities—Limits . . . . . . . . . . . . . . 151Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56⟨233⟩ Elemental Impurities—Procedures . . . . . . . . . . 153⟨61⟩ Microbiological Examination of Nonsterile⟨241⟩ Iron . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156Products: Microbial Enumeration Tests . . . . . . . . 58⟨251⟩ Lead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156⟨62⟩ Microbiological Examination of Nonsterile⟨261⟩ Mercury . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157Products: Tests for Specified Microorganisms . . . . 62⟨267⟩ Porosimetry by Mercury Intrusion . . . . . . . . . . 159⟨63⟩ Mycoplasma Tests . . . . . . . . . . . . . . . . . . . . . . . 67⟨271⟩ Readily Carbonizable Substances Test . . . . . . . 161⟨71⟩ Sterility Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . 71⟨281⟩ Residue on Ignition . . . . . . . . . . . . . . . . . . . . 161⟨291⟩ Selenium . . . . . . . . . . . . . . . . . . . . . . . . . . . 161Biological Tests and Assays
Other Tests and Assays⟨81⟩ Antibiotics—Microbial Assays . . . . . . . . . . . . . . . 76⟨85⟩ Bacterial Endotoxins Test . . . . . . . . . . . . . . . . . . 90
⟨301⟩ Acid-Neutralizing Capacity . . . . . . . . . . . . . . . 162⟨87⟩ Biological Reactivity Tests, In Vitro . . . . . . . . . . . 94⟨311⟩ Alginates Assay . . . . . . . . . . . . . . . . . . . . . . . 163⟨88⟩ Biological Reactivity Tests, In Vivo . . . . . . . . . . . . 95⟨341⟩ Antimicrobial Agents—Content . . . . . . . . . . . . 164⟨90⟩ Fetal Bovine Serum—Quality Attributes and⟨345⟩ Assay for Citric Acid/Citrate and Phosphate . . . 166Functionality Tests . . . . . . . . . . . . . . . . . . . . . . 100⟨351⟩ Assay for Steroids . . . . . . . . . . . . . . . . . . . . . 167⟨91⟩ Calcium Pantothenate Assay . . . . . . . . . . . . . . . 102⟨361⟩ Barbiturate Assay . . . . . . . . . . . . . . . . . . . . . . 167⟨92⟩ Growth Factors and Cytokines Used in Cell Therapy⟨371⟩ Cobalamin Radiotracer Assay . . . . . . . . . . . . . 167Manufacturing . . . . . . . . . . . . . . . . . . . . . . . . 105⟨381⟩ Elastomeric Closures for Injections . . . . . . . . . 168⟨111⟩ Design and Analysis of Biological Assays . . . . . 108⟨391⟩ Epinephrine Assay . . . . . . . . . . . . . . . . . . . . . 172⟨115⟩ Dexpanthenol Assay . . . . . . . . . . . . . . . . . . . 119⟨401⟩ Fats and Fixed Oils . . . . . . . . . . . . . . . . . . . . 173⟨121⟩ Insulin Assays . . . . . . . . . . . . . . . . . . . . . . . . 121⟨411⟩ Folic Acid Assay . . . . . . . . . . . . . . . . . . . . . . . 182⟨123⟩ Glucagon Bioidentity Tests . . . . . . . . . . . . . . . 123⟨413⟩ Impurities Testing in Medical Gases . . . . . . . . . 182⟨130⟩ Protein A Quality Attributes . . . . . . . . . . . . . . 125⟨415⟩ Medical Gases Assay . . . . . . . . . . . . . . . . . . . 183⟨151⟩ Pyrogen Test . . . . . . . . . . . . . . . . . . . . . . . . . 130⟨425⟩ Iodometric Assay—Antibiotics . . . . . . . . . . . . . 184⟨161⟩ Transfusion and Infusion Assemblies and Similar⟨429⟩ Light Diffraction Measurement of ParticleMedical Devices . . . . . . . . . . . . . . . . . . . . . . 131
Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185⟨171⟩ Vitamin B12 Activity Assay . . . . . . . . . . . . . . . . 132⟨431⟩ Methoxy Determination . . . . . . . . . . . . . . . . . 189⟨441⟩ Niacin or Niacinamide Assay . . . . . . . . . . . . . 191⟨451⟩ Nitrite Titration . . . . . . . . . . . . . . . . . . . . . . . 193⟨461⟩ Nitrogen Determination . . . . . . . . . . . . . . . . . 193⟨466⟩ Ordinary Impurities . . . . . . . . . . . . . . . . . . . . 194⟨467⟩ Residual Solvents . . . . . . . . . . . . . . . . . . . . . . 195
