General Chapter
0-9 (15)
- 4-Epianhydrotetracycline
- 4-AMINOPHENOL IN ACETAMINOPHEN-CONTAINING DRUG PRODUCTS
- 〈1025〉 Pancreatin
- (E)-Anethole
- 0.002 N Sodium Thiosulfate VS
- 0.0025 N Sodium Hydroxide TS
- 0.004 M Benzethonium Chloride VS
- 0.02 M Monobasic Potassium Phosphate TS
- 0.05 M Zinc Sulfate VS
- 0.05 N Ceric Ammonium Nitrate VS
- 0.05 N Hydrochloric Acid TS
- 0.1 M Edetate Disodium VS
- 0.1 M Lead Perchlorate VS
- 0.1 M Mercuric Nitrate VS
- 〈525〉 SULFUR DIOXIDE
a (35)
- Antimicrobial Effectiveness Testing
- Antibiotics—Microbial Assays
- Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
- ANTI-FACTOR Xa AND ANTI-FACTOR IIa ASSAYS FOR UNFRACTIONATED AND LOW MOLECULAR WEIGHT HEPARINS
- Aluminum
- Arsenic
- Atomic Absorption Spectroscopy
- Acoustic Emission
- Analytical Data—Interpretation and Treatment
- Analysis of Biological Assays
- ACID-NEUTRALIZING CAPACITY
- Ancillary Materials for Cell, Gene, and Tissue-Engineered Products
- Alginates Assay
- ASSESSMENT OF SOLID ORAL DRUG PRODUCT PERFORMANCE AND INTERCHANGEABILITY, BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION
- Antimicrobial Agents-Content
- ASSAY FOR STEROIDS
- ASSAY FOR CITRIC ACID/CITRATE AND PHOSPHATE
- Assays to Evaluate Fragment Crystallizable (FC)—Mediated Effector Function
- Application of Water Activity Determination to Nonsterile Pharmaceutical Products
- ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
- ANALYTICAL PROCEDURE LIFE CYCLE
- ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—LIGHT DIFFRACTION MEASUREMENTS OF PARTICLE SIZE
- ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—DYNAMIC LIGHT SCATTERING
- ASSESSMENT OF ELASTOMERIC COMPONENT FUNCTIONAL SUITABILITY IN PARENTERAL PRODUCT PACKAGING/DELIVERY SYSTEMS
- ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—ELECTROPHORETIC LIGHT SCATTERING (DETERMINATION OF ZETA POTENTIAL)
- ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—PARTICLE COUNTING VIA LIGHT SCATTERING
- ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—NEPHELOMETRY AND TURBIDIMETRY
- ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA - STATIC LIGHT SCATTERING
- ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—GENERAL
- ASSESSMENT OF ELASTOMERIC COMPONENTS USED IN INJECTABLE PHARMACEUTICAL PRODUCT PACKAGING/DELIVERY SYSTEMS
- ANALYTICAL METHODOLOGIES BASED ON SCATTERING PHENOMENA—SMALL ANGLE X-RAY SCATTERING AND SMALL ANGLE NEUTRON SCATTERING
- Assessment of Extractables Associated with Pharmaceutical Packaging_Delivery Systems
- ASSESSMENT OF DRUG PRODUCT LEACHABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS
- Atomic Absorption Spectroscopy—Theory and Practice
- Acetic Acid in Peptides
b (21)
- Balances
- Biological Indicators—Resistance Performance Tests
- Bacterial Endotoxins Test
- Biological Reactivity Tests, In Vitro
- Biological Reactivity Tests, In Vivo
- Bovine Serum
- Biological Assay Validation
- Biologics
- Biological Assay Chapters-Overview and Glossary
- Biotechnology-Derived Articles-Amino Acid Analysis
- Biotechnology - Derived Articles - Isoelectric Focusing
- Biotechnology - Derived Articles - Peptide Mapping
- Biotechnology - Derived Articles - Polyacrylamide Gel Electrophoresis
- Biotechnology - Derived Articles - Total Protein Assay
- Bulk Pharmaceutical Excipients—Certificate of Analysis
- BULK POWDER SAMPLING PROCEDURES
- Bioburden Control of Nonsterile Drug Substances and Products
- BIOLOGICAL INDICATORS FOR STERILIZATION
- Biotechnology-Derived Drug Products
- Biotechnology-Derived Drug Substances
- Blood and Blood Products
c (18)
- Collagenase I
- Collagenase II
- Calcium Pantothenate Assay
- CHLORIDE AND SULFATE
- Characterization of Crystalline and Partially Crystalline Solids By X-Ray Powder Diffraction (XRPD)
- Chemometrics
- Cell Banking Practices for Recombinant Biologics
- Cleaning Glass Apparatus
- Cryopreservation of Cells
- Cell-Based Advanced Therapies and Tissue-Based Products
- Capillary Electrophoresis
- Color - Instrumental Measurement
- CAPSULES—DISSOLUTION TESTING AND RELATED QUALITY ATTRIBUTES
- Compounding for Phase I Investigational Studies
- CHARACTERIZATION AND QUALIFICATION OF PLASTIC COMPONENTS AND SYSTEMS USED TO MANUFACTURE PHARMACEUTICAL DRUG PRODUCTS AND BIOPHARMACEUTICAL DRUG SUBSTANCES AND PRODUCTS
- Chapter Charts
- Compounding—Substance_Preparation_Practice
- Control of Organic Impurities in Drug Substances and Drug Products
d (20)
- Dimethylaniline
- Design and Analysis of Biological Assays
- Dexpanthenol Assay
- Diphtheria Antitoxin Potency Testing For Human Immune Globulins
- Detection of Asbestos in Pharmaceutical Talc
- Design and Development of Biological Assays
- Design, Evaluation, and Characterization of Viral Clearance Procedures
- Disinfectants and Antiseptics
- DRUG PRODUCTS CONTAINING NANOMATERIALS
- DEPYROGENATION BY FILTRATION
- DEPYROGENATION BY RINSING
- DRY HEAT DEPYROGENATION
- DEPYROGENATION
- Determination of Zeta Potential by Electrophoretic Light Scattering
- DRY HEAT STERILIZATION
- Dietary Supplement Ingredients
- Dietary Supplement Products
- Drug Product Distribution
- DISINTEGRATION AND DISSOLUTION OF DIETARY SUPPLEMENTS
- DETECTION OF IRRADIATED DIETARY SUPPLEMENTS
e (17)
- Ethyl Acrylate and Methyl Methacrylate Copolymer Dispersion
- Enzymes Used as Ancillary Materials in Pharmaceutical Manufacturing
- ETHYLENE OXIDE AND DIOXANE
- Elemental Impurities—Limits
- Elemental Impurities—Procedures
- Evaluation Strategy for Trace Elements in Cell Culture Media Used in the Manufacture of Recombinant Therapeutic Proteins
- Excipient Performance
- Excipient Biological Safety Evaluation Guidelines
- Epinephrine Assay
- Elastomeric Components in Injectable Pharmaceutical Product Packaging_Delivery Systems
- ENDOTOXIN INDICATORS FOR DEPYROGENATION
- Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances
- Evaluation of the Inner Surface Durability of Glass Containers
- Evaluation of Plastic Packaging Systems for Pharmaceutical Use and Their Materials of Construction
- Evaluation of Screening Technologies for Assessing Medicine Quality
- Excipients
- ELEMENTAL CONTAMINANTS IN DIETARY SUPPLEMENTS
f (7)
- Fetal Bovine Serum - Quality Attributes and Functionality Tests
- Fluorescence Spectroscopy
- Flow Cytometry
- FOLIC ACID ASSAY
- FATS AND FIXED OILS
- Flow Imaging Method for the Determination of Subvisible Particulate Matter
- Fluorescence Spectroscopy—Theory and Practice
g (12)
- Glucagon Bioidentity Tests
- Growth Factors and Cytokines Used in Cell Therapy Manufacturing
- Gene Therapy Products
- Good Manufacturing Practices for Bulk Pharmaceutical Excipients
- Good Documentation Guidelines
- GLYCOPROTEIN AND GLYCAN ANALYSIS—GENERAL CONSIDERATIONS
- GUIDELINES ON THE ENDOTOXINS TEST
- GUIDELINES FOR ASSESSING AND CONTROLLING THE PHYSICAL STABILITY OF CHEMICAL AND BIOLOGICAL PHARMACEUTICAL RAW MATERIALS, INTERMEDIATES, AND DOSAGE FORMS
- GOOD DISTRIBUTION PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS
- GASEOUS STERILIZATION
- Good Cascade Impactor Practices
- Gene and Cell Therapy Products
h (5)
- Heavy Metals
- Hazardous Drugs-Handling in Healthcare Settings
- Human Plasma
- Histamine Test Method
- HEMATOXYLIN AND EOSIN STAINING OF SECTIONED TISSUE FOR MICROSCOPIC EXAMINATION
i (21)
- Injection and Implanted Drug Products (Parenterals) - Product Quality Tests
- Inhalation And Nasal Drug Products- General Information And Product Quality Tests
- Insulin Assays
- Identification - Organic Nitrogenous Bases
- Identification-Tetracyclines
- IRON
- In Vitro Release Test Methods for Parenteral Drug Preparations
- Ion Chromatography
- Identification of Articles of Botanical Origin by High-Performance Thin-Layer Chromatography Procedure
- Immunological Test Methods—General Considerations
- Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
- Immunological Test Methods—Immunoblot Analysis
- Immunological Test Methods—Surface Plasmon Resonance
- Immunogenicity Assays—Design and Validation of Assays to Detect Anti-Drug Neutralizing Antibody
- IN VITRO AND IN VIVO EVALUATION OF ORAL (USP 1-May-2021) DOSAGE FORMS
- IMPURITIES IN DRUG SUBSTANCES AND DRUG PRODUCTS
- INTRINSIC DISSOLUTION—DISSOLUTION TESTING PROCEDURES FOR ROTATING DISK AND STATIONARY DISK
- Immunogenicity Assays—Design and Validation of Immunoassays to Detect Anti-Drug Antibodies
- IODOMETRIC ASSAY- ANTIBIOTICS
- Image Analysis of Pharmaceutical Systems
- Identification Tests—General
l (7)
- Labeling
- LOW MOLECULAR WEIGHT HEPARIN MOLECULAR WEIGHT DETERMINATIONS
- LEAD
- Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples
- LABELING OF INACTIVE INGREDIENTS
- LIQUID-PHASE STERILIZATION
- Light Obscuration Method for the Determination of Subvisible Particulate Matter
m (38)
- Mucosal Drug Products-Product Quality Tests
- Microbiological Examination Of Nonsterile Products —Tests For Burkholderia Cepacia Complex
- Microbiological Examination Of Nonsterile Products: Microbial Enumeration Tests
- Microbiological Examination Of Nonsterile Products: Tests For Specified Microorganisms
- Mycoplasma Tests
- Medical Devices - Bacterial Endotoxin And Pyrogen Tests
- Monosaccharide Analysis
- Mercury
- Measurement of Structural Strength of Semisolids by Penetrometry
- Mucosal Drug Products—Performance Tests
- Mid-Infrared Spectroscopy
- Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
- Monitoring Devices—Time, Temperature, and Humidity
- Molecular Weight and Polymer Chain Length Determination for Polypropylene Glycol Fatty Ethers
- Molecular Weight Determination for Alginates
- MICROBIOLOGICAL CHAPTERS—GLOSSARY
- MICROBIOLOGICAL BEST LABORATORY PRACTICES
- Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
- Microbial Characterization, Identification, and Strain Typing
- Microbiological Control and Monitoring of Aseptic Processing Environments
- MEDICAL GASES ASSAY
- METHOXY DETERMINATION
- MYCOPLASMA STERILIZATION
- MOIST HEAT STERILIZATION OF AQUEOUS LIQUIDS
- MONITORING OF BIOBURDEN
- Membrane Microscope Method for the Determination of Subvisible Particulate Matter
- Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections
- MID-INFRARED SPECTROSCOPY—THEORY AND PRACTICE
- METHODS FOR THE DETERMINATION OF SUBVISIBLE PARTICULATE MATTER
- Measurement of Yield Stress of Semisolids
- Microbial Enumeration Tests—Nutritional and Dietary Supplements
- Microbiological Procedures for Absence of Specified Microorganisms—Nutritional and Dietary Supplements
- MANUFACTURING PRACTICES FOR DIETARY INGREDIENTS
- MANUFACTURING PRACTICES FOR DIETARY SUPPLEMENTS
- Multi-Ingredient Dietary Supplement Products - Product Quality Tests
- Medical Devices
- Microbiology Products
- MICROBIOLOGICAL ATTRIBUTES OF NONSTERILE NUTRITIONAL AND DIETARY SUPPLEMENTS
n (17)
- Nuclear Magnetic Resonance Spectroscopy Identity Testing of Bacterial Poylsaccharides Used in Vaccine Manufacture
- Nephelometry and Turbidimetry
- Near-Infrared Spectroscopy
- NOMENCLATURE
- NUCLEIC ACID-BASED TECHNIQUES—GENERAL
- NUCLEIC ACID-BASED TECHNIQUES—EXTRACTION, DETECTION, AND SEQUENCING
- NUCLEIC ACID-BASED TECHNIQUES—AMPLIFICATION
- Nucleic Acid-Based Techniques—Microarray
- NUCLEIC ACID-BASED TECHNIQUES—GENOTYPING
- NUCLEIC ACID-BASED TECHNIQUES—APPROACHES FOR DETECTING TRACE NUCLEIC ACIDS (RESIDUAL DNA TESTING)
- NEW STERILIZATION METHODS
- Nitrogen Determination
- Niacin Or Niacinamide Assay
- NITROSAMINE IMPURITIES
- NEAR-INFRARED SPECTROSCOPY—THEORY AND PRACTICE
- Non-Complex Active Drug Products
- Non-Complex Drug Substances
o (6)
- Oral drug products-Product Quality Tests
- OLIGOSACCHARIDE ANALYSIS
- ORDINARY IMPURITIES
- ORALLY INHALED AND NASAL DRUG PRODUCTS
- ORAL DOSAGE FORMS-PERFORMANCE TESTS
- OPHTHALMIC PRODUCTS—PERFORMANCE TESTS
p (35)
- Prescription Container Labeling
- Probiotics Tests
- Physicochemical Analytical Procedures For Insulins
- Pyrogen Test
- Prekallikrein Activator
- Particle Size Distribution Estimation by Analytical Sieving
- Particulate Matter in Injections
- pH
- Pharmaceutical Compounding-Nonsterile Preparations
- Pharmaceutical Compounding - Sterile Preparations
- Powder Fineness
- Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses
- Polarography
- POROSIMETRY BY MERCURY INTRUSION
- Potency Assays to Evaluate Coagulation Factor VIII and Factor IX
- Porosity by Nitrogen Adsorption–Desorption
- Physical Environments That Promote Safe Medication Use
- PHARMACEUTICAL DOSAGE FORMS
- PHARMACEUTICAL CALCULATIONS IN PHARMACY PRACTICE
- Powder Flow
- Particle Size Analysis by Dynamic Light Scattering
- Prescription Balances and Volumetric Apparatus Used in Compounding
- Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation
- Package Integrity Leak Test Technologies
- PROBE TACK TEST
- Package Integrity Evaluation—Sterile Products
- PRION INACTIVATION
- Package Seal Quality Test Technologies
- PHYSICOCHEMICAL INTEGRATORS AND INDICATORS FOR STERILIZATION
- Pyrrolizidine Alkaloids as Contaminants
- PREPARATION OF BIOLOGICAL SPECIMENS FOR HISTOLOGIC AND IMMUNOHISTOCHEMICAL ANALYSIS
- Products for Nebulization—Characterization Tests
- Presentation of Aerodynamic Particle Size Distribution (APSD) Measurement Data for Orally Inhaled Products
- POSITRON EMISSION TOMOGRAPHY DRUGS-INFORMATION
- Protein Determination Procedures - General Chapters - United States Pharmacopeia USP 2025
q (6)
- Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
- Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
- QUALITY ASSURANCE IN PHARMACEUTICAL COMPOUNDING
- Quality Attributes of Synthetic Peptide Drug Substances
- Quality Attributes of Starting Materials for the Chemical Synthesis of Therapeutic Peptides
- QUALITY ATTRIBUTES OF TABLETS LABELED AS HAVING A FUNCTIONAL SCORE
r (17)
- Radioactivity
- Raman Spectroscopy
- Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging
- Refractive Index
- READILY CARBONIZABLE SUBSTANCES TEST
- RESIDUE ON IGNITION
- Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach
- Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
- RESIDUAL HOST CELL PROTEIN MEASUREMENT IN BIOPHARMACEUTICALS
- RADIATION STERILIZATION
- RESIDUAL SOLVENTS
- RESIDUAL SOLVENTS—VERIFICATION OF COMPENDIAL PROCEDURES AND VALIDATION OF ALTERNATIVE PROCEDURES
- RADIOACTIVITY-THEORY AND PRACTICE
- RAMAN SPECTROSCOPY—THEORY AND PRACTICE
- Rheometry
- Residual DNA Testing
- Riboflavin Assay
s (31)
- Sterility Tests
- Spectrophotometric Identification Tests
- Subvisible Particulate Matter in Therapeutic Protein Injections
- Subvisible Particulate Matter in Intraocular Solutions
- Sutures - Diameter
- Sutures - Needle Attachment
- Specific Gravity
- Specific Surface Area
- Selenium
- Shear Cell Methodology for Powder Flow Testing
- Storage and Transportation of Investigational Drug Products
- Supplier Qualification
- STABILITY CONSIDERATIONS IN DISPENSING PRACTICE
- SIGNIFICANT CHANGE FOR BULK PHARMACEUTICAL EXCIPIENTS
- SCANNING ELECTRON MICROSCOPY
- SENSITIZATION TESTING
- STEAM STERILIZATION BY DIRECT CONTACT
- Sterilization Assurance
- STERILIZATION-IN-PLACE
- STERILIZATION CYCLE DEVELOPMENT
- STERILIZING FILTRATION OF GASES
- Sterility Testing—Validation of Isolator Systems
- Solubility Measurements
- STERILIZING FILTRATION OF LIQUIDS
- STERILIZATION OF COMPENDIAL ARTICLES
- Spacers and Valved Holding Chambers Used with Inhalation Aerosols—Characterization Tests
- SEMISOLID DRUG PRODUCTS-PERFORMANCE TESTS
- SCREENING FOR UNDECLARED DRUGS AND DRUG ANALOGUES
- SUPPLEMENTAL INFORMATION FOR ARTICLES OF BOTANICAL ORIGIN
- Single-Steroid Assay
- Salts of Organic Nitrogenous Bases
t (16)
- Topical and Transdermal Drug Products—Product Quality Tests
- TEST FOR 1,6-ANHYDRO DERIVATIVE FOR ENOXAPARIN SODIUM
- Tensile Strength
- Thermal Analysis
- The Biocompatibility of Pharmaceutical Packaging Systems and Their Materials of Construction
- Tablet Compression Characterization
- Temperature Mapping for the Qualification of Storage Areas
- THE DISSOLUTION PROCEDURE: DEVELOPMENT AND VALIDATION
- TABLET FRIABILITY
- TRANSFER OF ANALYTICAL PROCEDURES
- TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS - PARAMETRIC RELEASE
- TABLET BREAKING FORCE
- Theory and Practice of Electrical Conductivity Measurements of Solutions
- THE APPLICATION OF MOISTURE VAPOR TRANSMISSION RATES FOR SOLID ORAL DOSAGE FORMS IN PLASTIC PACKAGING SYSTEMS
- Theory and Practice of Asbestos Detection in Pharmaceutical Talc
- Trifluoroacetic Acid (TFA) in Peptides
u (5)
- USP Reference Standards
- Ultraviolet-Visible Spectroscopy
- Uniformity of Dosage Units
- Ultraviolet-Visible Spectroscopy—Theory and Practice
- User-Determined Reporting Thresholds
v (24)
- Volumetric Apparatus
- Vitamin B12 Activity Assay
- Visible Particulates in Injections
- Viscosity - Rotational Methods
- Viscosity—Rolling Ball Method
- Viscosity—Pressure Driven Methods
- Viscosity - Capillary Methods
- Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
- VALIDATION OF COMPENDIAL PROCEDURES
- VERIFICATION OF COMPENDIAL PROCEDURES
- VALIDATION OF MICROBIAL RECOVERY FROM PHARMACOPEIAL ARTICLES
- VAPOR PHASE STERILIZATION
- VALIDATION OF ALTERNATIVE MICROBIOLOGICAL METHODS
- VALIDATION OF ALTERNATIVE METHODS TO ANTIBIOTIC MICROBIAL ASSAYS
- VIRAL CLEARANCE METHODS
- VACCINES FOR HUMAN USE - POLYSACCHARIDE AND GLYCOCONJUGATE VACCINES
- Vaccines for Human Use—Bacterial Vaccines
- VIROLOGY TEST METHODS
- Vaccines for Human Use—Viral Vaccines
- Virus Testing of Human Plasma for Further Manufacture
- VACCINES FOR HUMAN USE - GENERAL CONSIDERATIONS
- Vibrational Circular Dichroism Spectroscopy—Theory and Practice
- VISUAL INSPECTION OF INJECTIONS
- Vaccines
