Printed on: Wed Feb 08 2023, 11:07:12 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-23C5D015-D812-475A-BE71-DF629168A1B5_4_en-US

Printed by: Dang Van Vu Official Date: Official as of 01-Aug-2022 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: 62jrn DOI: https://doi.org/10.31003/USPNF_M16298_04_01
1

Chapter Guide: Non-Complex Active Drug Products

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Universal Tests
Description
• á1ñ Injections and Implanted Drug Products (Parenterals)—Product Quality Tests
• á2ñ Oral Drug Products—Product Quality Tests
• á3ñ Topical and Transdermal Drug Products—Product Quality Tests
• á4ñ Mucosal Drug Products—Product Quality Tests
• á5ñ Inhalation and Nasal Drug Products—General Information and Product Quality Tests
• á7ñ Labeling
• á1121ñ Nomenclature
• á1821ñ Radioactivity—Theory and Practice
• á1823ñ Positron Emission Tomography Drugs—Information
Identification
• á1ñ Injections and Implanted Drug Products (Parenterals)—Product Quality Tests
• á2ñ Oral Drug Products—Product Quality Tests
• á3ñ Topical and Transdermal Drug Products—Product Quality Tests

al
• á4ñ Mucosal Drug Products—Product Quality Tests
• á5ñ Inhalation and Nasal Drug Products—General Information and Product Quality Tests
• á191ñ Identification Tests—General
• á197ñ Spectroscopic Identification Tests
• á201ñ Thin-Layer Chromatographic Identification Test
ci
• á202ñ Identification of Fixed Oils by Thin-Layer Chromatography
• á203ñ High-Performance Thin-Layer Chromatography Procedure for Identification of Articles of Botanical Origin
• á501ñ Salts of Organic Nitrogenous Bases
• á621ñ Chromatography
• á735ñ X-Ray Fluorescence Spectrometry
ffi
• á736ñ Mass Spectrometry
• á761ñ Nuclear Magnetic Resonance Spectroscopy
• á821ñ Radioactivity
• á823ñ Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses
• á852ñ Atomic Absorption Spectroscopy
O

• á853ñ Fluorescence Spectroscopy

• á854ñ Mid-Infrared Spectroscopy
• á856ñ Near-Infrared Spectroscopy
• á857ñ Ultraviolet-Visible Spectroscopy
• á858ñ Raman Spectroscopy
• á1064ñ Identification of Articles of Botanical Origin by High-Performance Thin-Layer Chromatography Procedure
• á1730ñ Plasma Spectrochemistry—Theory and Practice
• á1735ñ X-Ray Fluorescence Spectrometry—Theory and Practice
• á1736ñ Applications of Mass Spectrometry
• á1761ñ Applications of Nuclear Magnetic Resonance Spectroscopy
• á1776ñ Image Analysis of Pharmaceutical Systems
• á1852ñ Atomic Absorption Spectroscopy—Theory and Practice
• á1853ñ Fluorescence Spectroscopy—Theory and Practice
• á1854ñ Mid-Infrared Spectroscopy—Theory and Practice
• á1856ñ Near-Infrared Spectroscopy—Theory and Practice
• á1857ñ Ultraviolet-Visible Spectroscopy—Theory and Practice
• á1858ñ Raman Spectroscopy—Theory and Practice
Assay
• á1ñ Injections and Implanted Drug Products (Parenterals)—Product Quality Tests
• á2ñ Oral Drug Products—Product Quality Tests
• á3ñ Topical and Transdermal Drug Products—Product Quality Tests
• á4ñ Mucosal Drug Products—Product Quality Tests
• á5ñ Inhalation and Nasal Drug Products—General Information and Product Quality Tests
• á81ñ Antibiotics—Microbial Assays
• á341ñ Antimicrobial Agents—Content
• á351ñ Assay for Steroids

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Printed on: Wed Feb 08 2023, 11:07:12 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-23C5D015-D812-475A-BE71-DF629168A1B5_4_en-US
Printed by: Dang Van Vu Official Date: Official as of 01-Aug-2022 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: 62jrn DOI: https://doi.org/10.31003/USPNF_M16298_04_01
2

• á391ñ Epinephrine Assay

• á415ñ Medical Gases Assay
• á451ñ Nitrite Titration
• á501ñ Salts of Organic Nitrogenous Bases
• á541ñ Titrimetry
• á611ñ Alcohol Determination
• á621ñ Chromatography
• á761ñ Nuclear Magnetic Resonance Spectroscopy
• á801ñ Polarography
• á821ñ Radioactivity
• á823ñ Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses
• á852ñ Atomic Absorption Spectroscopy
• á853ñ Fluorescence Spectroscopy
• á854ñ Mid-Infrared Spectroscopy
• á855ñ Nephelometry and Turbidimetry
• á856ñ Near-Infrared Spectroscopy
• á857ñ Ultraviolet-Visible Spectroscopy
• á858ñ Raman Spectroscopy
• á1065ñ Ion Chromatography
• á1223.1ñ Validation of Alternative Methods to Antibiotic Microbial Assays

al
• á1730ñ Plasma Spectrochemistry—Theory and Practice
• á1735ñ X-Ray Fluorescence Spectrometry—Theory and Practice
• á1761ñ Applications of Nuclear Magnetic Resonance Spectroscopy
• á1852ñ Atomic Absorption Spectroscopy—Theory and Practice
ci
• á1853ñ Fluorescence Spectroscopy—Theory and Practice
• á1854ñ Mid-Infrared Spectroscopy—Theory and Practice
• á1856ñ Near-Infrared Spectroscopy—Theory and Practice
• á1857ñ Ultraviolet-Visible Spectroscopy—Theory and Practice
• á1858ñ Raman Spectroscopy—Theory and Practice
ffi
Impurities
Organic
• á1ñ Injections and Implanted Drug Products (Parenterals)—Product Quality Tests
• á2ñ Oral Drug Products—Product Quality Tests
• á3ñ Topical and Transdermal Drug Products—Product Quality Tests
O

• á4ñ Mucosal Drug Products—Product Quality Tests

• á5ñ Inhalation and Nasal Drug Products—General Information and Product Quality Tests
• á227ñ 4-Aminophenol in Acetaminophen-Containing Drug Products
• á413ñ Impurities Testing in Medical Gases
• á461ñ Nitrogen Determination
• á466ñ Ordinary Impurities
• á476ñ Control of Organic Impurities in Drug Substances and Drug Products
• á621ñ Chromatography
• á761ñ Nuclear Magnetic Resonance Spectroscopy
• á781ñ Optical Rotation
• á801ñ Polarography
• á821ñ Radioactivity
• á823ñ Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses
• á852ñ Atomic Absorption Spectroscopy
• á853ñ Fluorescence Spectroscopy
• á854ñ Mid-Infrared Spectroscopy
• á855ñ Nephelometry and Turbidimetry
• á856ñ Near-Infrared Spectroscopy
• á857ñ Ultraviolet-Visible Spectroscopy
• á858ñ Raman Spectroscopy
• á1086ñ Impurities in Drug Substances and Drug Products
• á1469ñ Nitrosamine Impurities
• á1761ñ Applications of Nuclear Magnetic Resonance Spectroscopy
• á1776ñ Image Analysis of Pharmaceutical Systems
• á1852ñ Atomic Absorption Spectroscopy—Theory and Practice
• á1853ñ Fluorescence Spectroscopy—Theory and Practice

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Printed on: Wed Feb 08 2023, 11:07:12 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-23C5D015-D812-475A-BE71-DF629168A1B5_4_en-US
Printed by: Dang Van Vu Official Date: Official as of 01-Aug-2022 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: 62jrn DOI: https://doi.org/10.31003/USPNF_M16298_04_01
3

• á1854ñ Mid-Infrared Spectroscopy—Theory and Practice

• á1856ñ Near-Infrared Spectroscopy—Theory and Practice
• á1857ñ Ultraviolet-Visible Spectroscopy—Theory and Practice
• á1858ñ Raman Spectroscopy—Theory and Practice
Inorganic
• á1ñ Injections and Implanted Drug Products (Parenterals)—Product Quality Tests
• á2ñ Oral Drug Products—Product Quality Tests
• á3ñ Topical and Transdermal Drug Products—Product Quality Tests
• á4ñ Mucosal Drug Products—Product Quality Tests
• á5ñ Inhalation and Nasal Drug Products—General Information and Product Quality Tests
• á232ñ Elemental Impurities—Limits
• á233ñ Elemental Impurities—Procedures
• á281ñ Residue on Ignition
• á730ñ Plasma Spectrochemistry
• á733ñ Loss on Ignition
• á735ñ X-Ray Fluorescence Spectrometry
• á821ñ Radioactivity
• á823ñ Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses
Residual Solvents
• á1ñ Injections and Implanted Drug Products (Parenterals)—Product Quality Tests

al
• á2ñ Oral Drug Products—Product Quality Tests
• á3ñ Topical and Transdermal Drug Products—Product Quality Tests
• á4ñ Mucosal Drug Products—Product Quality Tests
• á5ñ Inhalation and Nasal Drug Products—General Information and Product Quality Tests
ci
• á467ñ Residual Solvents
• á621ñ Chromatography
• á821ñ Radioactivity
• á823ñ Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses
• á1467ñ Residual Solvents—Verification of Compendial Procedures and Validation of Alternative Procedures
ffi
Specific Tests
Equipment
• á31ñ Volumetric Apparatus
• á41ñ Balances
• á1051ñ Cleaning Glass Apparatus
O

• á1228.4ñ Depyrogenation by Rinsing

• á1229.13ñ Sterilization-in-Place
• á1229.15ñ Sterilizing Filtration of Gases
• á1251ñ Weighing on an Analytical Balance
Water Content
• á541ñ Titrimetry
• á731ñ Loss on Drying
• á891ñ Thermal Analysis
• á921ñ Water Determination
• á922ñ Water Activity
Performance Tests
Mucosal
Ophthalmic1
• á755ñ Minimum Fill
• á771ñ Ophthalmic Products—Quality Tests
• á785ñ Osmolality and Osmolarity
• á789ñ Particulate Matter in Ophthalmic Solutions
• á791ñ pH
• á905ñ Uniformity of Dosage Units
• á1085ñ Guidelines on Endotoxins Test
• á1099ñ Limit on Number of Large Deviations when Assessing Content Uniformity in Large Samples
(postponed indefinitely)
• á1771ñ Ophthalmic Products—Performance Tests
Nasal

1 See Microbiology Products.

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Printed on: Wed Feb 08 2023, 11:07:12 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-23C5D015-D812-475A-BE71-DF629168A1B5_4_en-US
Printed by: Dang Van Vu Official Date: Official as of 01-Aug-2022 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: 62jrn DOI: https://doi.org/10.31003/USPNF_M16298_04_01
4

•á60ñ Microbiological Examination of Nonsterile Products: Tests for Burkholderia Cepacia Complex
•á61ñ Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
•á62ñ Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
•á432ñ Determination of Zeta Potential by Electrophoretic Light Scattering
•á601ñ Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests
•á604ñ Leak Rate
•á791ñ pH
•á905ñ Uniformity of Dosage Units
•á1099ñ Limit on Number of Large Deviations when Assessing Content Uniformity in Large Samples
(postponed indefinitely)
• á1603ñ Good Cascade Impactor Practices
Parenteral
• á56ñ Methods for Determination of Resistance of Microorganisms to Sterilization Processes
• á71ñ Sterility Tests
• á85ñ Bacterial Endotoxins Test
• á87ñ Biological Reactivity Tests, In Vitro
• á88ñ Biological Reactivity Tests, In Vivo
• á151ñ Pyrogen Test
• á381ñ Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems
• á382ñ Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems

al
• á432ñ Determination of Zeta Potential by Electrophoretic Light Scattering
• á697ñ Container Content for Injections
• á729ñ Globule Size Distribution in Lipid Injectable Emulsions
• á787ñ Subvisible Particulate Matter in Therapeutic Protein Injections
ci
• á788ñ Particulate Matter in Injections
• á790ñ Visible Particulates in Injections
• á791ñ pH
• á905ñ Uniformity of Dosage Units
• á1085ñ Guidelines on Endotoxins Test
ffi
• á1099ñ Limit on Number of Large Deviations when Assessing Content Uniformity in Large Samples (postponed
indefinitely)
• á1113ñ Microbial Characterization, Identification, and Strain Typing
• á1211ñ Sterility Assurance
• á1228ñ Depyrogenation
O

• á1228.1ñ Dry Heat Depyrogenation

• á1228.3ñ Depyrogenation by Filtration
• á1228.4ñ Depyrogenation by Rinsing
• á1228.5ñ Endotoxin Indicators for Depyrogenation
• á1229ñ Sterilization of Compendial Articles
• á1229.2ñ Moist Heat Sterilization of Aqueous Liquids
• á1229.3ñ Monitoring of Bioburden
• á1229.4ñ Sterilizing Filtration of Liquids
• á1229.14ñ Sterilization Cycle Development
• á1229.15ñ Sterilizing Filtration of Gases
• á1229.18ñ Viral Clearance Methods
• á1788ñ Methods for the Determination of Subvisible Particulate Matter
• á1788.1ñ Light Obscuration Method for the Determination of Subvisible Particulate Matter
• á1788.2ñ Membrane Microscope Method for the Determination of Subvisible Particulate Matter
• á1788.3ñ Flow Imaging Method for the Determination of Subvisible Particulate Matter
• á1787ñ Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections
Oral
• á60ñ Microbiological Examination of Nonsterile Products: Tests for Burkholderia Cepacia Complex
• á61ñ Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
• á62ñ Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
• á301ñ Acid-Neutralizing Capacity
• á432ñ Determination of Zeta Potential by Electrophoretic Light Scattering
• á698ñ Deliverable Volume
• á701ñ Disintegration
• á705ñ Quality Attributes of Tablets Labeled as Having a Functional Score
• á711ñ Dissolution

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Printed on: Wed Feb 08 2023, 11:07:12 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-23C5D015-D812-475A-BE71-DF629168A1B5_4_en-US
Printed by: Dang Van Vu Official Date: Official as of 01-Aug-2022 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: 62jrn DOI: https://doi.org/10.31003/USPNF_M16298_04_01
5

• á724ñ Drug Release

• á755ñ Minimum Fill
• á905ñ Uniformity of Dosage Units
• á1005ñ Acoustic Emission
• á1087ñ Intrinsic Dissolution Testing Procedures for Rotating Disk and Stationary Disk
• á1088ñ In Vitro and In Vivo Evaluation of Oral Dosage Forms
• á1090ñ Assessment of Solid Oral Drug Product Performance and Interchangeability, Bioavailability,
Bioequivalence, and Dissolution
• á1092ñ The Dissolution Procedure: Development and Validation
• á1094ñ Capsules—Dissolution Testing and Related Quality Attributes
• á1099ñ Limit on Number of Large Deviations when Assessing Content Uniformity in Large Samples (postponed
indefinitely)
• á1216ñ Tablet Friability
• á1217ñ Tablet Breaking Force
• á1711ñ Oral Dosage Forms—Performance Tests
Topical
• á60ñ Microbiological Examination of Nonsterile Products: Tests for Burkholderia Cepacia Complex
• á61ñ Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
• á62ñ Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
• á603ñ Topical Aerosols

al
• á604ñ Leak Rate
• á724ñ Drug Release
• á755ñ Minimum Fill
• á791ñ pH ci
• á905ñ Uniformity of Dosage Units
• á1099ñ Limit on Number of Large Deviations when Assessing Content Uniformity in Large Samples (postponed
indefinitely)
• á1724ñ Semisolid Drug Products—Performance Tests
Inhalational
ffi
• á60ñ Microbiological Examination of Nonsterile Products: Tests for Burkholderia Cepacia Complex
• á61ñ Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
• á62ñ Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
• á601ñ Inhalation and Nasal Drug Products: Aerosols, Sprays, and Powders—Performance Quality Tests
• á602ñ Propellants
O

• á604ñ Leak Rate

• á791ñ pH
• á905ñ Uniformity of Dosage Units
• á1601ñ Products for Nebulization—Characterization Tests
• á1602ñ Spacers and Valved Holding Chambers Used With Inhalation Aerosols—Characterization Tests
• á1603ñ Good Cascade Impactor Practices
Mucosal (7 membrane surfaces)
• á755ñ Minimum Fill
• á905ñ Uniformity of Dosage Units
• á1004ñ Mucosal Drug Products—Performance Tests
• á1099ñ Limit on Number of Large Deviations when Assessing Content Uniformity in Large Samples (postponed
indefinitely)

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