US Pharmacopoeia 2023 (USP 46

The United States Pharmacopeia (USP) and the National Formulary (NF) are combined to form the USP-NF. It includes specifications for drugs, dosage forms, active ingredients, excipients, biologics, prepared products that are compounded, medical equipment, nutritional supplements, and other treatments. For medicines produced and marketed in the United States, the USP-NF criteria as they stand now are enforced by the U.S. Food and Drug Administration. On May 1, 2023, the current version, USP-NF 2023, Issue 1, becomes legally binding.

The Food and Drug Administration has the authority to enforce the most recent version of the USP-NF standard for medicines made and marketed in the US. This version is recognized by USP as being official. You may easily learn online for free or download PDF files.

Features

More than 4,900 monographs contain requirements for the identification, strength, quality, and purity of drugs and dosage forms, as well as their packaging and labeling. View a USP-NF monograph example.

Giving comprehensive, step-by-step instructions for assays, tests, and procedures are more than 330 general chapters.

Reference tables and helpful sections on reagents, indicators, and solutions

Advantages and Applications

For all stages of creating high-quality prescription, over-the-counter, and compounded medications, excipients, biologics, medical devices, and nutritional supplements, the USP-NF provides simple, complete information. Research and development, method development/analytical services, regulatory/compendial affairs, quality control, quality assurance, and corporate management all depend on it. The use of USP-NF monographs and procedures can

Ensure adherence to the necessary U.S. quality standards.
Work to precision and accuracy standards that are acknowledged worldwide.
Check test findings against established benchmarks.
Create and verify internal standards, specifications, and operating procedures.
Hasten the development and approval of new products.

A Helpful Reference for Researchers, Experts, and Students Working in or with

Pharmaceuticals: both prescription and over-the-counter medications
Products made using biology and biotechnology
Blood and its derivatives
Mixed-up preparations
Cosmetics
Nutritional supplements
Excipients and other medication components
Medical equipment
Healthcare gases
Health libraries
Pharmacies
Medical and pharmacy schools
Drugs for animals

In this pdf format, you find a pdf of every Drug monograph as given below.

1. General Chapters

Each general chapter has a unique number that is displayed in brackets next to the chapter name (for example, chromatography).
General chapters may include the following:

Tests and processes for applications through individual monographs,
Practices and conditions for pharmaceutical compounding: Specifications and Descriptions,
information generally used to interpret commendation criteria,

General information for manufacturers of official substances or official goods, including a description of available pharmaceutical storage, dispensing, and packaging practices.
The acceptance criteria can be supplied after the large intestine when the general chapter is mentioned in the monograph.

A summary of the Introduction to Exam or analytical methods can be found in several chapters. Other general chapters with approaches, information on how to do something, and occasionally acceptance criteria can be referred to by them.

〈1〉 Injections and Implanted Drug Products (Parenterals)—Product Quality Tests		〈481〉 Riboflavin Assay
〈2〉 Oral Drug Products—Product Quality Tests		〈501〉 Salts of Organic Nitrogenous Bases
〈3〉 Topical and Transdermal Drug Products—Product Quality Tests		〈503.1〉 Trifluoroacetic Acid (TFA) in Peptides
〈4〉 Mucosal Drug Products—Product Quality Tests		〈503〉 Acetic Acid in Peptides
〈5〉 Inhalation and Nasal Drug Products—General Information and Product Quality Tests		〈507〉 Protein Determination Procedures
〈7〉 Labeling		〈509〉 Residual DNA Testing
〈11〉 USP Reference Standards		〈511〉 Single-Steroid Assay
〈17〉 Prescription Container Labeling		〈525〉 Sulfur Dioxide
〈31〉 Volumetric Apparatus		〈531〉 Thiamine Assay
〈41〉 Balances		〈541〉 Titrimetry
〈51〉 Antimicrobial Effectiveness Testing		〈551〉 Vitamin E Assay
〈55〉Biological Indicators—Resistance Performance Tests		〈561〉 Articles of Botanical Origin
〈56〉 Methods for Determination of Resistance of Microorganisms to Sterilization Processes		〈563〉 Identification of Articles of Botanical Origin
〈60〉 Microbiological Examination of Nonsterile Products Tests for Burkholderia Cepacia Complex		〈565〉 Botanical Extracts
〈61〉 Microbiological Examination of Nonsterile Products Microbial Enumeration Tests		〈571〉 Vitamin A Assay
〈62〉 Microbiological Examination of Nonsterile Products Tests for Specified Microorganisms		〈580〉 Vitamin C Assay
〈63〉 Mycoplasma Tests		〈581〉 Vitamin D Assay
〈64〉 Probiotic Tests		〈591〉 Zinc Determination
〈71〉 Sterility Tests		〈601〉 Inhalation and Nasal Drug Products Aerosols, Sprays, and Powders—Performance Quality Tests
〈81〉 Antibiotics—Microbial Assays		〈602〉 Propellants
〈85〉 Bacterial Endotoxins Test		〈603〉 Topical Aerosols
〈87〉 Biological Reactivity Tests, In Vitro		〈604〉 Leak Rate
〈88〉 Biological Reactivity Tests, In Vivo		〈607〉 Pharmaceutical Foams—Product Quality Tests
〈89.1〉 Collagenase I		〈610〉 Alternative Microbiological Sampling Methods for Nonsterile Inhaled and Nasal Products
〈89.2〉 Collagenase II		〈611〉 Alcohol Determination
〈89〉 Enzymes Used as Ancillary Materials in Pharmaceutical Manufacturing		〈616〉 Bulk Density and Tapped Density of Powders
〈90〉 Fetal Bovine Serum—Quality Attributes and Functionality Tests		〈621〉 Chromatography
〈91〉 Calcium Pantothenate Assay		〈630〉 Visual Comparison
〈92〉 Growth Factors and Cytokines Used in Cell Therapy Manufacturing		〈631〉 Color and Achromicity
〈111〉 Design and Analysis of Biological Assays		〈641〉 Completeness of Solution
〈115〉 Dexpanthenol Assay		〈643〉 Total Organic Carbon
〈121.1〉 Physicochemical Analytical Procedures for Insulins		〈644〉 Conductivity of Solutions
〈121〉 Insulin Assays		〈645〉 Water Conductivity
〈123〉 Glucagon Bioidentity Tests		〈651〉 Congealing Temperature
〈124〉 Erythropoietin Bioassays		〈659〉 Packaging and Storage Requirements
〈126〉 Somatropin Bioidentity Test		〈660〉 Containers—Glass
〈126〉 Somatropin Bioidentity Tests		〈661.1〉 Plastic Materials of Construction
〈127〉 Flow Cytometric Enumeration of CD34+ Cells		〈661.2〉 Plastic Packaging Systems For Pharmaceutical Use
〈129〉 Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies		〈661〉 Plastic Packaging Systems and Their Materials Of Construction
〈151〉 Pyrogen Test		〈665〉 Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceuticals Drug Substances and Products
〈161〉 Medical Devices—Bacterial Endotoxin and Pyrogen Tests		〈670〉 Auxiliary Packaging Components
〈162〉 Diphtheria Antitoxin Potency Testing for Human Immune Globulins		〈671〉 Containers—Performance Testing
〈165〉 Prekallikrein Activator		〈695〉 Crystallinity
〈171〉 Vitamin B12 Activity Assay		〈696〉 Characterization of Crystalline Solids by Microcalorimetry and Solution Calorimetry
〈181〉 Identification—Organic Nitrogenous Bases		〈697〉 Container Content for Injections
〈191〉 Identification Tests—General		〈698〉 Deliverable Volume
〈193〉 Identification—Tetracyclines		〈699〉 Density of Solids
〈197〉 Spectroscopic Identification Tests		〈701〉 Disintegration
〈198〉 Nuclear Magnetic Resonance Spectroscopy Identity Testing of Bacterial Polysaccharides Used in Vaccine Manufacture		〈705〉 Quality Attributes of Tablets Labeled as Having A Functional Score
〈201〉 Thin-Layer Chromatographic Identification Test		〈711〉 Dissolution
〈202〉 Identification of Fixed Oils By Thin-Layer Chromatography		〈721〉 Distilling Range
〈203〉 High-Performance Thin-Layer Chromatography Procedure for Identification of Articles of Botanical Origin		〈724〉 Drug Release
〈206〉 Aluminum		〈729〉 Globule Size Distribution in Lipid Injectable Emulsions
〈207〉 Test for 1,6-Anhydro Derivative for Enoxaparin Sodium		〈730〉 Plasma Spectrochemistry
〈208〉 Anti-Factor Xa and Anti-Factor IIa Assays for Unfractionated and Low Molecular Weight Heparins		〈731〉 Loss on Drying
〈209〉 Low Molecular Weight Heparin Molecular Weight Determinations		〈733〉 Loss on Ignition
〈210〉 Monosaccharide Analysis		〈735〉 X-Ray Fluorescence Spectrometry
〈211〉 Arsenic		〈736〉 Mass Spectrometry
〈212〉 Oligosaccharide Analysis		〈741〉 Melting Range or Temperature
〈221〉 Chloride and Sulfate		〈755〉 Minimum Fill
〈223〉 Dimethylaniline		〈761〉 Nuclear Magnetic Resonance Spectroscopy
〈226〉 4-Epianhydrotetracycline		〈771〉 Ophthalmic Products—Quality Tests
〈227〉 4-Aminophenol in Acetaminophen-Containing Drug Products		〈776〉 Optical Microscopy
〈228〉 Ethylene Oxide and Dioxane		〈781〉 Optical Rotation
〈232〉 Elemental Impurities—Limits		〈782〉 Vibrational Circular Dichroism Spectroscopy
〈233〉 Elemental Impurities—Procedures		〈785〉 Osmolality and Osmolarity
〈241〉 Iron		〈786〉 Particle Size Distribution Estimation by Analytical Sieving
〈251〉 Lead		〈787〉 Subvisible Particulate Matter in Therapeutic Protein Injections
〈261〉 Mercury		〈788〉 Particulate Matter in Injections
〈267〉 Porosimetry by Mercury Intrusion		〈789〉 Particulate Matter in Ophthalmic Solutions
〈268〉 Porosity by Nitrogen Adsorption–Desorption		〈790〉 Visible Particulates in Injections
〈271〉 Readily Carbonizable Substances Test		〈791〉 pH
〈281〉 Residue on Ignition		〈795〉 Pharmaceutical Compounding—Nonsterile Preparations
〈291〉 Selenium		〈797〉 Pharmaceutical Compounding—Sterile Preparations
〈301〉 Acid-Neutralizing Capacity		〈800〉 Hazardous Drugs—Handling in Healthcare Settings
〈311〉 Alginates Assay		〈801〉 Polarography
〈313〉 Molecular Weight and Polymer Chain Length Determination for Polypropylene Glycol Fatty Ethers		〈811〉 Powder Fineness
〈341〉 Antimicrobial Agents—Content		〈821〉 Radioactivity
〈345〉 Assay for Citric Acid Citrate and Phosphate		〈823〉 Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses
〈351〉 Assay for Steroids		〈825〉 Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging
〈381〉 Elastomeric Components in Injectable Pharmaceutical Product Packaging Delivery Systems		〈831〉 Refractive Index
〈382〉 Elastomeric Component Functional Suitability in Parenteral Product Packaging Delivery Systems		〈841〉 Specific Gravity
〈391〉 Epinephrine Assay		〈846〉 Specific Surface Area
〈401〉 Fats and Fixed Oils		〈852〉 Atomic Absorption Spectroscopy
〈411〉 Folic Acid Assay		〈853〉 Fluorescence Spectroscopy
〈413〉 Impurities Testing in Medical Gases		〈854〉 Mid-Infrared Spectroscopy
〈415〉 Medical Gases Assay		〈855〉 Nephelometry and Turbidimetry
〈425〉 Iodometric Assay—Antibiotics		〈856〉 Near-Infrared Spectroscopy
〈426〉 Histamine Test Method		〈857〉 Ultraviolet-Visible Spectroscopy
〈429〉 Light Diffraction Measurement of Particle Size		〈858〉 Raman Spectroscopy
〈431〉 Methoxy Determination		〈861〉 Sutures—Diameter
〈432〉 Determination of Zeta Potential by Electrophoretic Light Scattering		〈871〉 Sutures—Needle Attachment
〈441〉 Niacin Or Niacinamide Assay		〈881〉 Tensile Strength
〈451〉 Nitrite Titration		〈891〉 Thermal Analysis
〈461〉 Nitrogen Determination		〈905〉 Uniformity of Dosage Units
〈466〉 Ordinary Impurities		〈911〉 Viscosity—Capillary Methods
〈467〉 Residual Solvents		〈912〉 Viscosity—Rotational Methods
〈469〉 Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances		〈913〉 Viscosity—Rolling Ball Method
〈471〉 Oxygen Flask Combustion		〈914〉 Viscosity—Pressure Driven Methods
〈476〉 Control of Organic Impurities in Drug Substances and Drug Products		〈915〉 Measurement of Structural Strength of Semisolids by Penetrometry
〈921〉 Water Determination		〈1207.1〉 Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation
〈922〉 Water Activity		〈1207.2〉 Package Integrity Leak Test Technologies
〈941〉 Characterization of Crystalline and Partially Crystalline Solids By X-Ray Powder Diffraction (XRPD)		〈1207.3〉 Package Seal Quality Test Technologies
〈1001〉 In Vitro Release Test Methods for Parenteral Drug Preparations		〈1207〉 Package Integrity Evaluation—Sterile Products
〈1004〉 Mucosal Drug Products—Performance Tests		〈1208〉 Sterility Testing—Validation of Isolator Systems
〈1005〉 Acoustic Emission		〈1210〉 Statistical Tools for Procedure Validation
〈1010〉 Analytical Data—Interpretation and Treatment		〈1211〉 Sterility Assurance
〈1024〉 Bovine Serum		〈1212〉 Probe Tack Test
〈1025〉 Pancreatin		〈1216〉 Tablet Friability (1)
〈1027〉 Flow Cytometry		〈1216〉 Tablet Friability
〈1029〉 Good Documentation Guidelines		〈1217〉 Tablet Breaking Force
〈1030〉 Biological Assay Chapters—Overview and Glossary		〈1220〉 Analytical Procedure Life Cycle
〈1031〉 The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants		〈1222〉 Terminally Sterilized Pharmaceutical Products—Parametric Release
〈1032〉 Design and Development of Biological Assays		〈1223.1〉 Validation of Alternative Methods to Antibiotic Microbial Assays
〈1033〉 Biological Assay Validation		〈1223〉 Validation of Alternative Microbiological Methods
〈1034〉 Analysis of Biological Assays		〈1224〉 Transfer of Analytical Procedures
〈1039〉 Chemometrics		〈1225〉 Validation of Compendial Procedures
〈1041〉 Biologics		〈1226〉 Verification of Compendial Procedures
〈1042〉 Cell Banking Practices for Recombinant Biologics		〈1227〉 Validation of Microbial Recovery from Pharmacopeial Articles
〈1043〉 Ancillary Materials for Cell, Gene, and Tissue-Engineered Products		〈1228.1〉 Dry Heat Depyrogenation
〈1044〉 Cryopreservation of Cells		〈1228.3〉 Depyrogenation by Filtration
〈1046〉 Cell-Based Advanced Therapies and Tissue-Based Products		〈1228.4〉 Depyrogenation by Rinsing
〈1047〉 Gene Therapy Products		〈1228.5〉 Endotoxin Indicators for Depyrogenation
〈1048〉 Quality of Biotechnological Products Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products		〈1228〉 Depyrogenation
〈1049〉 Quality of Biotechnological Products Stability Testing of Biotechnological Biological Products		〈1229.1〉 Steam Sterilization by Direct Contact
〈1050.1〉 Design, Evaluation, and Characterization of Viral Clearance Procedures		〈1229.2〉 Moist Heat Sterilization of Aqueous Liquids
〈1050〉 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin		〈1229.3〉 Monitoring of Bioburden
〈1051〉 Cleaning Glass Apparatus		〈1229.4〉 Sterilizing Filtration of Liquids
〈1052〉 Biotechnology-Derived Articles—Amino Acid Analysis		〈1229.5〉 Biological Indicators for Sterilization
〈1053〉 Capillary Electrophoresis		〈1229.6〉 Liquid-Phase Sterilization
〈1054〉 Biotechnology-Derived Articles—Isoelectric Focusing		〈1229.7〉 Gaseous Sterilization
〈1055〉 Biotechnology-Derived Articles—Peptide Mapping		〈1229.8〉 Dry Heat Sterilization
〈1056〉 Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis		〈1229.9〉 Physicochemical Integrators and Indicators for Sterilization
〈1057〉 Biotechnology-Derived Articles—Total Protein Assay		〈1229.10〉 Radiation Sterilization
〈1058〉 Analytical Instrument Qualification		〈1229.11〉 Vapor Phase Sterilization
〈1059〉 Excipient Performance		〈1229.12〉 New Sterilization Methods
〈1061〉 Color—Instrumental Measurement		〈1229.13〉 Sterilization-In-Place
〈1062〉 Tablet Compression Characterization		〈1229.14〉 Sterilization Cycle Development
〈1063〉 Shear Cell Methodology for Powder Flow Testing		〈1229.15〉 Sterilizing Filtration of Gases
〈1064〉 Identification of Articles of Botanical Origin by High-Performance Thin-Layer Chromatography Procedure		〈1229.16〉 Prion Inactivation
〈1065〉 Ion Chromatography		〈1229.17〉 Mycoplasma Sterilization
〈1066〉 Physical Environments That Promote Safe Medication Use		〈1229.18〉 Viral Clearance Methods
〈1071〉 Rapid Sterility Testing of Short Life Products A Risk Based Approach		〈1229〉 Sterilization of Compendial Articles
〈1072〉 Disinfectants and Antiseptics		〈1230〉 Water for Hemodialysis Applications
〈1074〉 Excipient Biological Safety Evaluation Guidelines		〈1231〉 Water for Pharmaceutical Purposes
〈1078〉 Good Manufacturing Practices for Bulk Pharmaceutical Excipients		〈1234〉 Vaccines for Human Use—Polysaccharide and Glycoconjugate Vaccines
〈1079.1〉 Storage and Transportation of Investigational Drug Products		〈1235〉 Vaccines for Human Use—General Considerations
〈1079.2〉 Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products		〈1236〉 Solubility Measurements
〈1079〉 Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products		〈1237〉 Virology Test Methods
〈1080〉 Bulk Pharmaceutical Excipients—Certificate of Analysis		〈1238〉 Vaccines for Human Use—Bacterial Vaccines
〈1083〉 Supplier Qualification		〈1239〉 Vaccines for Human Use—Viral Vaccines
〈1084〉 Glycoprotein and Glycan Analysis—General Considerations		〈1240〉 Virus Testing of Human Plasma for Further Manufacture
〈1085〉 Guidelines On Endotoxins Test		〈1241〉 Water–Solid Interactions in Pharmaceutical Systems
〈1086〉 Impurities in Drug Substances and Drug Products		〈1251〉 Weighing on an Analytical Balance
〈1087〉 Intrinsic Dissolution—Dissolution Testing Procedures for Rotating Disk and Stationary Disk		〈1265〉 Written Prescription Drug Information—Guidelines
〈1088〉 in Vitro and in Vivo Evaluation of Oral Dosage Forms		〈1285.1〉 Hematoxylin and Eosin Staining of Sectioned Tissue for Microscopic Examination
〈1090〉 Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution		〈1285〉 Preparation of Biological Specimens for Histologic and Immunohistochemical Analysis
〈1091〉 Labeling of Inactive Ingredients		〈1381〉 Assessment of Elastomeric Component Used in Injectable Pharmaceutical Product Packaging Delivery Systems
〈1092〉 The Dissolution Procedure Development And Validation		〈1382〉 Assessment of Elastomeric Component Functional Suitability in Parenteral Product Packaging Delivery Systems
〈1094〉 Capsules—Dissolution Testing and Related Quality Attributes		〈1430.1〉 Analytical Methodologies Based on Scattering Phenomena — Static Light Scattering
〈1097〉 Bulk Powder Sampling Procedures		〈1430.2〉 Analytical Methodologies Based on Scattering Phenomena — Light Diffraction Measurements of Particle Size
〈1099〉 Limit on Number of Large Deviations When Assessing Content Uniformity in Large Samples		〈1430.3〉 Analytical Methodologies Based on Scattering Phenomena—Dynamic Light Scattering
〈1102〉 Immunological Test Methods—General Considerations		〈1430.4〉 Analytical Methodologies Based on Scattering Phenomena — Electrophoretic Light Scattering (Determination of Zeta Potential)
〈1103〉 Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)		〈1430.5〉 Analytical Methodologies Based on Scattering Phenomena—Small Angle X-Ray Scattering and Small Angle Neutron Scattering
〈1104〉 Immunological Test Methods—Immunoblot Analysis		〈1430.6〉 Analytical Methodologies Based on Scattering Phenomena—Particle Counting Via Light Scattering
〈1105〉 Immunological Test Methods—Surface Plasmon Resonance		〈1430.7〉 Analytical Methodologies Based on Scattering Phenomena—Nephelometry and Turbidimetry
〈1106.1〉 Immunogenicity Assays—Design and Validation of Assays to Detect Anti-Drug Neutralizing Antibody		〈1430〉 Analytical Methodologies Based on Scattering Phenomena—General
〈1106〉 Immunogenicity Assays—Design and Validation of Immunoassays to Detect Anti-Drug Antibodies		〈1467〉 Residual Solvents—Verification Of Compendial Procedures And Validation Of Alternative Procedures
〈1108〉 Assays to Evaluate Fragment Crystallizable (FC)—Mediated Effector Function		〈1469〉 Nitrosamine Impurities
〈1111〉 Microbiological Examination of Nonsterile Products Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use		〈1503〉 Quality Attributes of Synthetic Peptide Drug Substances
〈1112〉 Application of Water Activity Determination to Nonsterile Pharmaceutical Products		〈2022〉 Microbiological Procedures for Absence of Specified Microorganisms—Nutritional and Dietary Supplements
〈1113〉 Microbial Characterization, Identification, and Strain Typing		〈2023〉 Microbiological Attributes of Nonsterile Nutritional and Dietary Supplements
〈1115〉 Bioburden Control of Nonsterile Drug Substances and Products		〈2030〉 Supplemental Information for Articles of Botanical Origin
〈1116〉 Microbiological Control and Monitoring of Aseptic Processing Environments		〈2040〉 Disintegration and Dissolution of Dietary Supplements
〈1117〉 Microbiological Best Laboratory Practices		〈2091〉 Weight Variation of Dietary Supplements
〈1118〉 Monitoring Devices—Time, Temperature, and Humidity		〈2232〉 Elemental Contaminants in Dietary Supplements (1)
〈1121〉 Nomenclature		〈2232〉 Elemental Contaminants in Dietary Supplements
〈1125〉 Nucleic Acid-Based Techniques—General		〈2250〉 Detection of Irradiated Dietary Supplements
〈1126〉 Nucleic Acid-Based Techniques—Extraction, Detection, and Sequencing		〈2251〉 Screening for Undeclared Drugs and Drug Analogues
〈1127〉 Nucleic Acid-Based Techniques—Amplification		〈2740〉 Manufacturing Practices For Dietary Ingredients
〈1128〉 Nucleic Acid-Based Techniques—Microarray		〈2750〉 Manufacturing Practices for Dietary Supplements
〈1129〉 Nucleic Acid-Based Techniques—Genotyping		Alcoholometric Table
〈1130〉 Nucleic Acid-Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual Dna Testing)		Articles of Incorporation
〈1132〉 Residual Host Cell Protein Measurement in Biopharmaceuticals		Atomic Weights
〈1149〉 Guidelines for Assessing and Controlling the Physical Stability of Chemical and Biological Pharmaceutical Raw Materials, Intermediates, and Dosage Forms		Biotechnology-Derived Drug Products
〈1151〉 Pharmaceutical Dosage Forms		Biotechnology-Derived Drug Substances (1)
〈1152〉 Animal Drugs for Use in Animal Feeds		Biotechnology-Derived Drug Substances
〈1153〉 Drug Products Containing Nanomaterials		Blood and Blood Products
〈1160〉 Pharmaceutical Calculations in Pharmacy Practice		Chapter Charts
〈1163〉 Quality Assurance in Pharmaceutical Compounding		Compounding—Substance Preparation Practice
〈1168〉 Compounding for Phase I Investigational Studies		Containers for Dispensing Capsules and Tablets
〈1174〉 Powder Flow		Description and Relative Solubility (1)
〈1176〉 Prescription Balances and Volumetric Apparatus Used in Compounding		Description and Relative Solubility (2)
〈1178〉 Good Repackaging Practices		Description and Relative Solubility
〈1180〉 Human Plasma		Dietary Supplement Ingredients
〈1181〉 Scanning Electron Microscopy		Dietary Supplement Products
〈1184〉 Sensitization Testing		Drug Product Distribution
〈1191〉 Stability Considerations in Dispensing Practice		Excipients
〈1195〉 Significant Change for Bulk Pharmaceutical Excipients		Gene and Cell Therapy Products
〈1197〉 Good Distribution Practices for Bulk Pharmaceutical Excipients		General Information
General Notices and Requirements		Non-Complex Drug Substances
Half-Lives of Selected Radionuclides		Notice and Warning
Intrinsic Viscosity Table		Six-Month Implementation Guideline
Medical Devices		Solubilities
Microbiology Products		USP Admissions List (1)
Mission and Preface		USP Admissions List (2)
NF Admissions List (1)		USP Admissions List
NF Admissions List		USP Annotated List (1)
NF Annotated List (1)		USP Annotated List (2)
NF Annotated List (2)		USP Annotated List
NF Annotated List		Vaccines
Non-Complex Active Drug Products

Monograph

In pharmacopeia, monographs are used to refer to names, descriptions, definitions, and other details on labeling, storage, and packaging. The specifications' methods, tests, and approval of the standards serve to guarantee the items' identification, strength, quality, and purity.

For general information on various monograph components, see section 5, "Monograph components." Because monographs might not provide standards for all important features, some official substances might be compliant with USP or NF standards but differ due to their non-standard nature, which is significant to their usage in a specific preparation.

To ensure interchangeability in such situations, users may want to verify the equality of the FUND function or define these features before usage.

You can find a pdf of each drug monograph listed below in this format.

5-Hydroxy-l-tryptophan		Acetohydroxamic Acid Tablets
Abacavir and Lamivudine Tablets		Acetohydroxamic Acid
Abacavir Oral Solution		Acetone
Abacavir Sulfate		Acetylcholine Chloride for Ophthalmic Solution
Abacavir Tablets		Acetylcholine Chloride
Abacavir, Lamivudine and Zidovudine Tablets		Acetylcysteine Compounded Solution
Abiraterone Acetate Tablets		Acetylcysteine Solution
Abiraterone Acetate		Acetylcysteine
Absorbable Gelatin Film		Acetyltributyl Citrate
Absorbable Gelatin Sponge		Acetyltriethyl Citrate
Absorbable Surgical Suture		Acitretin Capsules
Absorbent Gauze		Acitretin
Acacia Syrup		Activated Attapulgite
Acacia		Activated Charcoal
Acamprosate Calcium		Acyclovir Capsules
Acarbose Tablets		Acyclovir for Injection
Acarbose		Acyclovir Injection
Acebutolol Hydrochloride Capsules		Acyclovir Ointment
Acebutolol Hydrochloride		Acyclovir Oral Suspension
Acepromazine Maleate Injection		Acyclovir Tablets
Acepromazine Maleate Tablets		Acyclovir
Acepromazine Maleate		Adapalene Gel
Acesulfame Potassium		Adapalene
Acetaminophen and Aspirin Tablets		Adenine
Acetaminophen and Caffeine Tablets		Adenosine Injection
Acetaminophen and Codeine Phosphate Capsules		Adenosine
Acetaminophen and Codeine Phosphate Oral Solution		Adhesive Bandage
Acetaminophen and Codeine Phosphate Oral Suspension		Adhesive Tape
Acetaminophen and Codeine Phosphate Tablets		Adipic Acid
Acetaminophen and Diphenhydramine Citrate Tablets		Agar
Acetaminophen and Pseudoephedrine Hydrochloride Tablets		Alanine
Acetaminophen Capsules		Albendazole Oral Suspension
Acetaminophen Extended-Release Tablets		Albendazole Tablets
Acetaminophen for Effervescent Oral Solution		Albendazole
Acetaminophen Oral Solution		Albumin Human
Acetaminophen Oral Suspension		Albuterol Extended-Release Tablets
Acetaminophen Suppositories		Albuterol Inhalation Solution
Acetaminophen Tablets		Albuterol Sulfate
Acetaminophen, Aspirin, and Caffeine Tablets		Albuterol Tablets
Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide Tablets		Albuterol
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, and Pseudoephedrine Hydrochloride Oral Solution		Alclometasone Dipropionate Cream
Acetaminophen, Diphenhydramine Hydrochloride, and Pseudoephedrine Hydrochloride Tablets		Alclometasone Dipropionate Ointment
Acetaminophen		Alclometasone Dipropionate
Acetazolamide Compounded Oral Suspension		Alcohol
Acetazolamide for Injection		Alendronate Sodium Tablets
Acetazolamide Tablets		Alendronate Sodium
Acetazolamide		Alfadex
Acetic Acid Irrigation		Alfentanil Hydrochloride
Acetic Acid Otic Solution		Alfentanil Injection
Acetic Acid		Alfuzosin Hydrochloride Extended-Release Tablets
Alfuzosin Hydrochloride		Aluminum Dichlorohydrex Propylene Glycol
Alginic Acid		Aluminum Hydroxide Gel
Alkyl (C12–15) Benzoate		Aluminum Monostearate
Allantoin		Aluminum Oxide
Allopurinol Compounded Oral Suspension		Aluminum Phosphate Gel
Allopurinol Tablets		Aluminum Sesquichlorohydrate Solution
Allopurinol		Aluminum Sesquichlorohydrate
Allyl Isothiocyanate		Aluminum Sesquichlorohydrex Polyethylene Glycol
Almond Oil		Aluminum Sesquichlorohydrex Propylene Glycol
Almotriptan Malate		Aluminum Subacetate Topical Solution
Almotriptan Tablets		Aluminum Sulfate and Calcium Acetate for Topical Solution
Aloe		Aluminum Sulfate and Calcium Acetate Tablets for Topical Solution
Alosetron Hydrochloride		Aluminum Sulfate
Alosetron Tablets		Aluminum Zirconium Octachlorohydrate Solution
Alpha Lipoic Acid Capsules		Aluminum Zirconium Octachlorohydrate
Alpha Lipoic Acid Tablets		Aluminum Zirconium Octachlorohydrex Gly Solution
Alpha Lipoic Acid		Aluminum Zirconium Octachlorohydrex Gly
Alpha-Lactalbumin		Aluminum Zirconium Pentachlorohydrate Solution
Alprazolam Compounded Oral Suspension		Aluminum Zirconium Pentachlorohydrate
Alprazolam Extended-Release Tablets		Aluminum Zirconium Pentachlorohydrex Gly Solution
Alprazolam Orally Disintegrating Tablets		Aluminum Zirconium Pentachlorohydrex Gly
Alprazolam Tablets		Aluminum Zirconium Tetrachlorohydrate Solution
Alprazolam		Aluminum Zirconium Tetrachlorohydrate
Alprostadil Injection		Aluminum Zirconium Tetrachlorohydrex Gly Solution
Alprostadil		Aluminum Zirconium Tetrachlorohydrex Gly
Alteplase for Injection		Aluminum Zirconium Trichlorohydrate Solution
Alteplase		Amantadine Hydrochloride Capsules
Altretamine Capsules		Amantadine Hydrochloride Oral Solution
Altretamine		Amantadine Hydrochloride Tablets
Alumina and Magnesia Oral Suspension		Amantadine Hydrochloride
Alumina and Magnesia Tablets		Amcinonide Cream
Alumina and Magnesium Carbonate Oral Suspension		Amcinonide Ointment
Alumina and Magnesium Carbonate Tablets		Amcinonide
Alumina and Magnesium Trisilicate Oral Suspension		American Ginseng Capsules
Alumina and Magnesium Trisilicate Tablets		American Ginseng Root and Rhizome Dry Extract
Alumina, Magnesia, and Calcium Carbonate Chewable Tablets		American Ginseng Root and Rhizome Powder
Alumina, Magnesia, and Calcium Carbonate Oral Suspension		American Ginseng Root and Rhizome
Alumina, Magnesia, and Simethicone Chewable Tablets		American Ginseng Tablets
Alumina, Magnesia, and Simethicone Oral Suspension		Amifostine for Injection
Alumina, Magnesia, Calcium Carbonate, and Simethicone Chewable Tablets		Amifostine
Alumina, Magnesium Carbonate, and Magnesium Oxide Tablets		Amikacin Sulfate Injection
Aluminum Acetate Topical Solution		Amikacin Sulfate
Aluminum Chloride		Amikacin
Aluminum Chlorohydrate Solution		Amiloride Hydrochloride and Hydrochlorothiazide Tablets
Aluminum Chlorohydrate		Amiloride Hydrochloride Tablets
Aluminum Chlorohydrex Polyethylene Glycol		Amiloride Hydrochloride
Aluminum Chlorohydrex Propylene Glycol		Amiloxate
Aluminum Dichlorohydrate Solution		Amino Methacrylate Copolymer
Aluminum Dichlorohydrate		Aminobenzoate Potassium Capsules
Aluminum Dichlorohydrex Polyethylene Glycol		Aminobenzoate Potassium
Aminobenzoate Sodium		Ammonium Sulfate
Aminobenzoic Acid Gel		Amobarbital Sodium for Injection
Aminobenzoic Acid		Amobarbital Sodium
Aminocaproic Acid Injection		Amodiaquine Hydrochloride Tablets
Aminocaproic Acid Oral Solution		Amodiaquine Hydrochloride
Aminocaproic Acid Tablets		Amodiaquine
Aminocaproic Acid		Amoxapine Tablets
Aminohippurate Sodium Injection		Amoxapine
Aminohippuric Acid		Amoxicillin and Clavulanate Potassium for Oral Suspension
Aminolevulinic Acid Hydrochloride		Amoxicillin and Clavulanate Potassium Tablets
Aminopentamide Sulfate Injection		Amoxicillin and Clavulanic Acid Extended-Release Tablets
Aminopentamide Sulfate Tablets		Amoxicillin Boluses
Aminopentamide Sulfate		Amoxicillin Capsules
Aminophylline Delayed-Release Tablets		Amoxicillin for Injectable Suspension
Aminophylline Injection

US Pharmacopoeia 2023 (USP 46 –NF 41)