General Chapter

General Chapter
〈1〉 Injections and Implanted Drug Products (Parenterals)—Product Quality Tests
〈2〉 Oral Drug Products—Product Quality Tests
〈3〉 Topical and Transdermal Drug Products—Product Quality Tests
〈4〉 Mucosal Drug Products—Product Quality Tests
〈5〉 Inhalation and Nasal Drug Products—General Information and Product Quality Tests
〈7〉 Labeling
〈11〉 USP Reference Standards
〈17〉 Prescription Container Labeling
〈31〉 Volumetric Apparatus
〈41〉 Balances
〈51〉 Antimicrobial Effectiveness Testing
〈55〉 Biological Indicators—Resistance Performance Tests
〈60〉 Microbiological Examination of Nonsterile Products Tests for Burkholderia Cepacia Complex
〈61〉 Microbiological Examination of Nonsterile Products_ Microbial Enumeration Tests
〈62〉 Microbiological Examination of Nonsterile Products_ Tests for Specified Microorganisms
〈63〉 Mycoplasma Tests
〈64〉 Probiotic Tests
〈71〉 Sterility Tests
〈81〉 Antibiotics—Microbial Assays
〈85〉 Bacterial Endotoxins Test
〈87〉 Biological Reactivity Tests, In Vitro
〈88〉 Biological Reactivity Tests, In Vivo
〈89〉 Enzymes Used as Ancillary Materials in Pharmaceutical Manufacturing
〈89.1〉 Collagenase I
〈89.2〉 Collagenase II
〈90〉 Fetal Bovine Serum—Quality Attributes and Functionality Tests
〈91〉 Calcium Pantothenate Assay
〈92〉 Growth Factors and Cytokines Used in Cell Therapy Manufacturing
〈111〉 Design and Analysis of Biological Assays
〈115〉 Dexpanthenol Assay
〈121.1〉 Physicochemical Analytical Procedures for Insulins
〈121〉 Insulin Assays
〈123〉 Glucagon Bioidentity Tests
〈124〉 Erythropoietin Bioassays
〈126〉 Somatropin Bioidentity Test
〈127〉 Flow Cytometric Enumeration of CD34+ Cells
〈129〉 Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
〈151〉 Pyrogen Test
〈161〉 Medical Devices—Bacterial Endotoxin and Pyrogen Tests
〈162〉 Diphtheria Antitoxin Potency Testing for Human Immune Globulins
〈165〉 Prekallikrein Activator
〈171〉 Vitamin B12 Activity Assay
〈181〉 Identification—Organic Nitrogenous Bases
〈193〉 Identification—Tetracyclines
〈197〉 Spectrophotometric Identification Tests
〈198〉 Nuclear Magnetic Resonance Spectroscopy Identity Testing of Bacterial Poylsaccharides Used in Vaccine Manufacture
〈201〉 Thin-Layer Chromatographic Identification Test
〈202〉 Identification of Fixed Oils By Thin-Layer Chromatography
〈203〉 High-Performance Thin-Layer Chromatography Procedure for Identification of Articles of Botanical Origin
〈206〉 Aluminum
〈207〉 Test for 1,6-Anhydro Derivative for Enoxaparin Sodium
〈208〉 Anti-Factor Xa and Anti-Factor IIa Assays for Unfractionated and Low Molecular Weight Heparins
〈209〉 Low Molecular Weight Heparin Molecular Weight Determinations
〈210〉 Monosaccharide Analysis
〈211〉 Arsenic
〈212〉 Oligosaccharide Analysis
〈221〉 Chloride and Sulfate
〈223〉 Dimethylaniline
〈226〉 4-Epianhydrotetracycline
〈227〉 4-Aminophenol in Acetaminophen-Containing Drug Products
〈228〉 Ethylene Oxide and Dioxane
〈231〉 Heavy Metals
〈232〉 Elemental Impurities—Limits
〈233〉 Elemental Impurities—Procedures
〈241〉 Iron
〈251〉 Lead
〈261〉 Mercury
〈267〉 Porosimetry by Mercury Intrusion
〈268〉 Porosity by Nitrogen Adsorption–Desorption
〈271〉 Readily Carbonizable Substances Test
〈281〉 Residue on Ignition
〈291〉 Selenium
〈301〉 Acid-Neutralizing Capacity
〈311〉 Alginates Assay
〈312〉 Molecular Weight Determination for Alginates
〈313〉 Molecular Weight and Polymer Chain Length Determination for Polypropylene Glycol Fatty Ethers
〈314〉 Molecular Weight Determination for Copolymers Containing Alkyl Methacrylate or Alkyl Acrylate
〈341〉 Antimicrobial Agents—Content
〈345〉 Assay for Citric Acid_Citrate and Phosphate
〈351〉 Assay for Steroids
〈381〉 Elastomeric Components in Injectable Pharmaceutical Product Packaging_Delivery Systems
〈391〉 Epinephrine Assay
〈401〉 Fats and Fixed Oils
〈411〉 Folic Acid Assay
〈413〉 Impurities Testing in Medical Gases
〈415〉 Medical Gases Assay
〈425〉 Iodometric Assay—Antibiotics
〈426〉 Histamine Test Method
〈429〉 Light Diffraction Measurement of Particle Size
〈430〉 Particle Size Analysis by Dynamic Light Scattering
〈431〉 Methoxy Determination
〈432〉 Determination of Zeta Potential by Electrophoretic Light Scattering
〈441〉 Niacin Or Niacinamide Assay
〈451〉 Nitrite Titration
〈461〉 Nitrogen Determination
〈466〉 Ordinary Impurities
〈467〉 Residual Solvents
〈469〉 Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances
〈471〉 Oxygen Flask Combustion
〈476〉 Control of Organic Impurities in Drug Substances and Drug Products
〈477〉 User-Determined Reporting Thresholds
〈481〉 Riboflavin Assay
〈501〉 Salts of Organic Nitrogenous Bases
〈503.1〉 Trifluoroacetic Acid (TFA) in Peptides
〈503〉 Acetic Acid in Peptides
〈507〉 Protein Determination Procedures
〈509〉 Residual DNA Testing
〈511〉 Single-Steroid Assay
〈525〉 Sulfur Dioxide
〈531〉 Thiamine Assay
〈541〉 Titrimetry
〈551〉 Vitamin E Assay
〈56〉 Methods for Determination of Resistance of Microorganisms to Sterilization Processes
〈561〉 Articles of Botanical Origin
〈563〉 Identification of Articles of Botanical Origin
〈565〉 Botanical Extracts
〈571〉 Vitamin A Assay
〈580〉 Vitamin C Assay
〈581〉 Vitamin D Assay
〈591〉 Zinc Determination
〈601〉 Inhalation and Nasal Drug Products_ Aerosols, Sprays, and Powders—Performance Quality Tests
〈602〉 Propellants
〈603〉 Topical Aerosols
〈604〉 Leak Rate
〈607〉 Pharmaceutical Foams—Product Quality Tests
〈610〉 Alternative Microbiological Sampling Methods for Nonsterile Inhaled and Nasal Products
〈611〉 Alcohol Determination
〈616〉 Bulk Density of Powders
〈621〉 Chromatography
〈630〉 Visual Comparison
〈631〉 Color and Achromicity
〈641〉 Completeness of Solution
〈643〉 Total Organic Carbon
〈644〉 Conductivity of Solutions
〈645〉 Water Conductivity
〈651〉 Congealing Temperature
〈659〉 Packaging and Storage Requirements
〈660〉 Containers—Glass
〈661〉 Plastic Packaging Systems and Their Materials of Construction
〈670〉 Auxiliary Packaging Components
〈671〉 Containers—Performance Testing
〈695〉 Crystallinity
〈696〉 Characterization of Crystalline Solids by Microcalorimetry and Solution Calorimetry
〈697〉 Container Content for Injections
〈698〉 Deliverable Volume
〈699〉 Density of Solids
〈701〉 Disintegration
〈711〉 Dissolution
〈721〉 Distilling Range
〈724〉 Drug Release
〈729〉 Globule Size Distribution in Lipid Injectable Emulsions
〈730〉 Plasma Spectrochemistry
〈731〉 Loss on Drying
〈733〉 Loss on Ignition
〈735〉 X-Ray Fluorescence Spectrometry
〈736〉 Mass Spectrometry
〈741〉 Melting Range or Temperature
〈755〉 Minimum Fill
〈761〉 Nuclear Magnetic Resonance Spectroscopy
〈771〉 Ophthalmic Products—Quality Tests
〈776〉 Optical Microscopy
〈781〉 Optical Rotation
〈782〉 Vibrational Circular Dichroism Spectroscopy
〈785〉 Osmolality and Osmolarity
〈786〉 Particle Size Distribution Estimation by Analytical Sieving
〈787〉 Subvisible Particulate Matter in Therapeutic Protein Injections
〈788〉 Particulate Matter in Injections
〈789〉 Particulate Matter in Ophthalmic Solutions
〈790〉 Visible Particulates in Injections
〈791〉 pH
〈795〉 Pharmaceutical Compounding—Nonsterile Preparations
〈797〉 Pharmaceutical Compounding—Sterile Preparations
〈800〉 Hazardous Drugs—Handling in Healthcare Settings
〈801〉 Polarography
〈811〉 Powder Fineness
〈821〉 Radioactivity
〈823〉 Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses
〈825〉 Radiopharmaceuticals — Preparation, Compounding, Dispensing, and Repackaging
〈831〉 Refractive Index
〈841〉 Specific Gravity
〈846〉 Specific Surface Area
〈852〉 Atomic Absorption Spectroscopy
〈853〉 Fluorescence Spectroscopy
〈854〉 Mid-Infrared Spectroscopy
〈855〉 Nephelometry and Turbidimetry
〈856〉 Near-Infrared Spectroscopy
〈857〉 Ultraviolet-Visible Spectroscopy
〈858〉 Raman Spectroscopy
〈861〉 Sutures—Diameter
〈871〉 Sutures—Needle Attachment
〈881〉 Tensile Strength
〈891〉 Thermal Analysis
〈901〉 Detection of Asbestos in Pharmaceutical Talc
〈905〉 Uniformity of Dosage Units
〈911〉 Viscosity—Capillary Methods
〈912〉 Viscosity—Rotational Methods
〈913〉 Viscosity—Rolling Ball Method
〈914〉 Viscosity—Pressure Driven Methods
〈915〉 Measurement of Structural Strength of Semisolids by Penetrometry
〈921〉 Water Determination
〈922〉 Water Activity
〈941〉 Characterization of Crystalline and Partially Crystalline Solids By X-Ray Powder Diffraction (XRPD)
〈1001〉 In Vitro Release Test Methods for Parenteral Drug Preparations
〈1004〉 Mucosal Drug Products—Performance Tests
〈1005〉 Acoustic Emission
〈1010〉 Analytical Data—Interpretation and Treatment
〈1023〉 Evaluation Strategy for Trace Elements in Cell Culture Media Used in the Manufacture of Recombinant Therapeutic Proteins
〈1024〉 Bovine Serum
〈1025〉 Pancreatin
〈1027〉 Flow Cytometry
〈1029〉 Good Documentation Guidelines
〈1030〉 Biological Assay Chapters—Overview and Glossary
〈1031〉 The Biocompatibility of Pharmaceutical Packaging Systems and Their Materials of Construction
〈1032〉 Design and Development of Biological Assays
〈1033〉 Biological Assay Validation
〈1034〉 Analysis of Biological Assays
〈1035〉 Potency Assays to Evaluate Coagulation Factor VIII and Factor IX
〈1039〉 Chemometrics
〈1041〉 Biologics
〈1042〉 Cell Banking Practices for Recombinant Biologics
〈1043〉 Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
〈1044〉 Cryopreservation of Cells
〈1046〉 Cell-Based Advanced Therapies and Tissue-Based Products
〈1047〉 Gene Therapy Products
〈1048〉 Quality of Biotechnological Products_ Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
〈1049〉 Quality of Biotechnological Products_ Stability Testing of Biotechnological_Biological Products
〈1050.1〉 Design, Evaluation, and Characterization of Viral Clearance Procedures
〈1050〉 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
〈1051〉 Cleaning Glass Apparatus
〈1052〉 Biotechnology-Derived Articles—Amino Acid Analysis
〈1053〉 Capillary Electrophoresis
〈1054〉 Biotechnology-Derived Articles—Isoelectric Focusing
〈1055〉 Biotechnology-Derived Articles—Peptide Mapping
〈1056〉 Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis
〈1057〉 Biotechnology-Derived Articles—Total Protein Assay
〈1058〉 Analytical Instrument Qualification
〈1059〉 Excipient Performance
〈1061〉 Color—Instrumental Measurement
〈1062〉 Tablet Compression Characterization
〈1063〉 Shear Cell Methodology for Powder Flow Testing
〈1064〉 Identification of Articles of Botanical Origin by High-Performance Thin-Layer Chromatography Procedure
〈1065〉 Ion Chromatography
〈1066〉 Physical Environments That Promote Safe Medication Use
〈1071〉 Rapid Microbial Tests for Release of Sterile Short-Life Products_ A Risk-Based Approach
〈1072〉 Disinfectants and Antiseptics
〈1074〉 Excipient Biological Safety Evaluation Guidelines
〈1078〉 Good Manufacturing Practices for Bulk Pharmaceutical Excipients
〈1079.1〉 Storage and Transportation of Investigational Drug Products
〈1079.2〉 Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
〈1079.3〉 Monitoring Devices—Time, Temperature, and Humidity
〈1079.4〉 Temperature Mapping for the Qualification of Storage Areas
〈1079〉 Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
〈1080〉 Bulk Pharmaceutical Excipients—Certificate of Analysis
〈1083〉 Supplier Qualification
〈1084〉 Glycoprotein and Glycan Analysis—General Considerations
〈1085〉 Guidelines on the Endotoxins Test
〈1086〉 Impurities in Drug Substances and Drug Products
〈1087〉 Intrinsic Dissolution—Dissolution Testing Procedures for Rotating Disk and Stationary Disk
〈1088〉 in Vitro and in Vivo Evaluation of Oral Dosage Forms
〈1090〉 Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution
〈1091〉 Labeling of Inactive Ingredients
〈1092〉 The Dissolution Procedure_ Development and Validation
〈1094〉 Capsules—Dissolution Testing and Related Quality Attributes
〈1097〉 Bulk Powder Sampling Procedures
〈1099〉 Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples
〈1102〉 Immunological Test Methods—General Considerations
〈1103〉 Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
〈1104〉 Immunological Test Methods—Immunoblot Analysis
〈1105〉 Immunological Test Methods—Surface Plasmon Resonance
〈1106.1〉 Immunogenicity Assays—Design and Validation of Assays to Detect Anti-Drug Neutralizing Antibody
〈1106〉 Immunogenicity Assays—Design and Validation of Immunoassays to Detect Anti-Drug Antibodies
〈1108〉 Assays to Evaluate Fragment Crystallizable (FC)—Mediated Effector Function
〈1111〉 Microbiological Examination of Nonsterile Products_ Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
〈1112〉 Application of Water Activity Determination to Nonsterile Pharmaceutical Products
〈1113〉 Microbial Characterization, Identification, and Strain Typing
〈1115〉 Bioburden Control of Nonsterile Drug Substances and Products
〈1116〉 Microbiological Control and Monitoring of Aseptic Processing Environments
〈1117.1〉 Microbiological Chapters—Glossary
〈1117〉 Microbiological Best Laboratory Practices
〈1121〉 Nomenclature
〈1125〉 Nucleic Acid-Based Techniques—General
〈1126〉 Nucleic Acid-Based Techniques—Extraction, Detection, and Sequencing
〈1127〉 Nucleic Acid-Based Techniques—Amplification
〈1128〉 Nucleic Acid-Based Techniques—Microarray
〈1129〉 Nucleic Acid-Based Techniques—Genotyping
〈1130〉 Nucleic Acid-Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing)
〈1132〉 Residual Host Cell Protein Measurement in Biopharmaceuticals
〈1149〉 Guidelines for Assessing and Controlling the Physical Stability of Chemical Biological Pharmaceutical Raw Materials, Intermediates, Dosage Forms
〈1151〉 Pharmaceutical Dosage Forms
〈1152〉 Animal Drugs for Use in Animal Feeds
〈1153〉 Drug Products Containing Nanomaterials
〈1160〉 Pharmaceutical Calculations in Pharmacy Practice
〈1163〉 Quality Assurance in Pharmaceutical Compounding
〈1168〉 Compounding for Phase I Investigational Studies
〈1174〉 Powder Flow
〈1176〉 Prescription Balances and Volumetric Apparatus Used in Compounding
〈1178〉 Good Repackaging Practices
〈1180〉 Human Plasma
〈1181〉 Scanning Electron Microscopy
〈1184〉 Sensitization Testing
〈1191〉 Stability Considerations in Dispensing Practice
〈1195〉 Significant Change for Bulk Pharmaceutical Excipients
〈1197〉 Good Distribution Practices for Bulk Pharmaceutical Excipients
〈1207.1〉 Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation
〈1207.2〉 Package Integrity Leak Test Technologies
〈1207.3〉 Package Seal Quality Test Technologies
〈1207〉 Package Integrity Evaluation—Sterile Products
〈1208〉 Sterility Testing—Validation of Isolator Systems
〈1210〉 Statistical Tools for Procedure Validation
〈1211〉 Sterilization Assurance
〈1212〉 Probe Tack Test
〈1216〉 Tablet Friability
〈1217〉 Tablet Breaking Force
〈1220〉 Analytical Procedure Life Cycle
〈1222〉 Terminally Sterilized Pharmaceutical Products—Parametric Release
〈1223.1〉 Validation of Alternative Methods to Antibiotic Microbial Assays
〈1223〉 Validation of Alternative Microbiological Methods
〈1224〉 Transfer of Analytical Procedures
〈1225〉 Validation of Compendial Procedures
〈1226〉 Verification of Compendial Procedures
〈1227〉 Validation of Microbial Recovery from Pharmacopeial Articles
〈1228.1〉 Dry Heat Depyrogenation
〈1228.3〉 Depyrogenation by Filtration
〈1228.4〉 Depyrogenation by Rinsing
〈1228.5〉 Endotoxin Indicators for Depyrogenation
〈1228〉 Depyrogenation
〈1229.1〉 Steam Sterilization by Direct Contact
〈1229.10〉 Radiation Sterilization
〈1229.11〉 Vapor Phase Sterilization
〈1229.12〉 New Sterilization Methods
〈1229.13〉 Sterilization-In-Place
〈1229.14〉 Sterilization Cycle Development
〈1229.15〉 Sterilizing Filtration of Gases
〈1229.16〉 Prion Inactivation
〈1229.17〉 Mycoplasma Sterilization
〈1229.18〉 Viral Clearance Methods
〈1229.2〉 Moist Heat Sterilization of Aqueous Liquids
〈1229.3〉 Monitoring of Bioburden
〈1229.4〉 Sterilizing Filtration of Liquids
〈1229.5〉 Biological Indicators for Sterilization
〈1229.6〉 Liquid-Phase Sterilization
〈1229.7〉 Gaseous Sterilization
〈1229.8〉 Dry Heat Sterilization
〈1229.9〉 Physicochemical Integrators and Indicators for Sterilization
〈1229〉 Sterilization of Compendial Articles
〈1230〉 Water for Hemodialysis Applications
〈1231〉 Water for Pharmaceutical Purposes
〈1234〉 Vaccines for Human Use—Polysaccharide and Glycoconjugate Vaccines
〈1235〉 Vaccines for Human Use—General Considerations
〈1236〉 Solubility Measurements
〈1237〉 Virology Test Methods
〈1238〉 Vaccines for Human Use—Bacterial Vaccines
〈1239〉 Vaccines for Human Use—Viral Vaccines
〈1240〉 Virus Testing of Human Plasma for Further Manufacture
〈1241〉 Water–Solid Interactions in Pharmaceutical Systems
〈1251〉 Weighing on an Analytical Balance
〈1265〉 Written Prescription Drug Information—Guidelines
〈1285.1〉 Hematoxylin and Eosin Staining of Sectioned Tissue for Microscopic Examination
〈1285〉 Preparation of Biological Specimens for Histologic and Immunohistochemical Analysis
〈1381〉 Assessment of Elastomeric Component Used in Injectable Pharmaceutical Product Packaging_Delivery Systems
〈1382〉 Assessment of Elastomeric Component Functional Suitability in Parenteral Product Packaging_Delivery Systems
〈1430.1〉 Analytical Methodologies Based on Scattering Phenomena — Static Light Scattering
〈1430.2〉 Analytical Methodologies Based on Scattering Phenomena — Light Diffraction Measurements of Particle Size
〈1430.3〉 Analytical Methodologies Based on Scattering Phenomena—Dynamic Light Scattering
〈1430.4〉 Analytical Methodologies Based on Scattering Phenomena — Electrophoretic Light Scattering (Determination of Zeta Potential)
〈1430.5〉 Analytical Methodologies Based on Scattering Phenomena — Small Angle X-Ray Scattering and Small Angle Neutron Scattering
〈1430.6〉 Analytical Methodologies Based on Scattering Phenomena—Particle Counting via Light Scattering
〈1430.7〉 Analytical Methodologies Based on Scattering Phenomena—Nephelometry and Turbidimetry
〈1430〉 Analytical Methodologies Based on Scattering Phenomena—General
〈1467〉 Residual Solvents—Verification of Compendial Procedures and Validation of Alternative Procedures
〈1469〉 Nitrosamine Impurities
〈1503〉 Quality Attributes of Synthetic Peptide Drug Substances
〈1504〉 Quality Attributes of Starting Materials for the Chemical Synthesis of Therapeutic Peptides
〈1567〉 Pyrrolizidine Alkaloids as Contaminants
〈1601〉 Products for Nebulization—Characterization Tests
〈1602〉 Spacers and Valved Holding Chambers Used with Inhalation Aerosols—Characterization Tests
〈1603〉 Good Cascade Impactor Practices
〈1604〉 Presentation of Aerodynamic Particle Size Distribution (APSD) Measurement Data for Orally Inhaled Products
〈1644〉 Theory and Practice of Electrical Conductivity Measurements of Solutions
〈1660〉 Evaluation of the Inner Surface Durability of Glass Containers
〈1661〉 Evaluation of Plastic Packaging Systems for Pharmaceutical Use and Their Materials of Construction
〈1663〉 Assessment of Extractables Associated with Pharmaceutical Packaging_Delivery Systems
〈1664.1〉 Orally Inhaled and Nasal Drug Products
〈1664〉 Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging_Delivery Systems
〈1665〉 Characterization and Qualification of Plastic Components Systems Used to Manufacture Pharmaceutical Drug Products Biopharmaceutical Substances
〈1671〉 The Application of Moisture Vapor Transmission Rates for Solid Oral Dosage Forms in Plastic Packaging Systems
〈1705〉 Quality Attributes of Tablets Labeled as Having a Functional Score
〈1711〉 Oral Dosage Forms—Performance Tests
〈1724〉 Semisolid Drug Products—Performance Tests
〈1730〉 Plasma Spectrochemistry—Theory and Practice
〈1735〉 X-Ray Fluorescence Spectrometry—Theory and Practice
〈1736〉 Applications of Mass Spectrometry
〈1761〉 Applications of Nuclear Magnetic Resonance Spectroscopy
〈1771〉 Ophthalmic Products—Performance Tests
〈1776〉 Image Analysis of Pharmaceutical Systems
〈1782〉 Vibrational Circular Dichroism Spectroscopy—Theory and Practice
〈1787〉 Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections
〈1788.1〉 Light Obscuration Method for the Determination of Subvisible Particulate Matter
〈1788.2〉 Membrane Microscope Method for the Determination of Subvisible Particulate Matter
〈1788.3〉 Flow Imaging Method for the Determination of Subvisible Particulate Matter
〈1788〉 Methods for the Determination of Subvisible Particulate Matter
〈1790〉 Visual Inspection of Injections
〈1821〉 Radioactivity—Theory and Practice
〈1823〉 Positron Emission Tomography Drugs—Information
〈1850〉 Evaluation of Screening Technologies for Assessing Medicine Quality
〈1852〉 Atomic Absorption Spectroscopy—Theory and Practice
〈1853〉 Fluorescence Spectroscopy—Theory and Practice
〈1854〉 Mid-Infrared Spectroscopy—Theory and Practice
〈1856〉 Near-Infrared Spectroscopy—Theory and Practice
〈1857〉 Ultraviolet-Visible Spectroscopy—Theory and Practice
〈1858〉 Raman Spectroscopy-Theory and Practice
〈1901〉 Theory and Practice of Asbestos Detection in Pharmaceutical Talc
〈191〉 Identification Tests—General
〈1911〉 Rheometry
〈1912〉 Measurement of Yield Stress of Semisolids
〈2021〉 Microbial Enumeration Tests—Nutritional and Dietary Supplements
〈2022〉 Microbiological Procedures for Absence of Specified Microorganisms—Nutritional and Dietary Supplements
〈2023〉 Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements
〈2030〉 Supplemental Information for Articles of Botanical Origin
〈2040〉 Disintegration and Dissolution of Dietary Supplements
〈2091〉 Weight Variation of Dietary Supplements
〈2232〉 Elemental Contaminants in Dietary Supplements
〈2250〉 Detection of Irradiated Dietary Supplements
〈2251〉 Screening for Undeclared Drugs and Drug Analogues
〈2740〉 Manufacturing Practices For Dietary Ingredients
〈2750〉 Manufacturing Practices for Dietary Supplements
〈2800〉 Multi-Ingredient Dietary Supplement Products – Product Quality Tests
Biotechnology-Derived Drug Products
Biotechnology-Derived Drug Substances
Blood and Blood Products
Chapter Charts
Compounding—Substance_Preparation_Practice
Dietary Supplement Ingredients
Dietary Supplement Products
Drug Product Distribution
Excipients
Gene and Cell Therapy Products
Medical Devices
Microbiology Products
Non-Complex Active Drug Products
Non-Complex Drug Substances
Vaccines