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Non-Complex Active Drug Products
Non-Complex Active Drug Products
Printed by: Dang Van Vu Official Date: 01-Aug-2023 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: qq1pw DOI: https://doi.org/10.31003/USPNF_M16298_05_01
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• á7ñ Labeling
• á1121ñ Nomenclature
• á1821ñ Radioactivity—Theory and Practice
• á1823ñ Positron Emission Tomography Drugs—Information
Identification
ci
• 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
ffi
• 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
• á202ñ Identification of Fixed Oils by Thin-Layer Chromatography
O
• 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
• á736ñ Mass Spectrometry
• á761ñ Nuclear Magnetic Resonance Spectroscopy
e
• á821ñ Radioactivity
• á823ñ Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses
• á852ñ Atomic Absorption Spectroscopy
B
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Printed on: Wed Feb 08 2023, 11:07:44 PM(EST) Status: Not Yet Official on 09-Feb-2023 DocId: GUID-23C5D015-D812-475A-BE71-DF629168A1B5_5_en-US
Printed by: Dang Van Vu Official Date: 01-Aug-2023 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: qq1pw DOI: https://doi.org/10.31003/USPNF_M16298_05_01
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• á852ñ Atomic Absorption Spectroscopy
• á853ñ Fluorescence Spectroscopy
• á854ñ Mid-Infrared Spectroscopy
• á855ñ Nephelometry and Turbidimetry
• á856ñ Near-Infrared Spectroscopy
ci
• á857ñ Ultraviolet-Visible Spectroscopy
• á858ñ Raman Spectroscopy
• á1065ñ Ion Chromatography
• á1223.1ñ Validation of Alternative Methods to Antibiotic Microbial Assays
ffi
• 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
• á1853ñ Fluorescence Spectroscopy—Theory and Practice
O
• 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
Impurities
Organic
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• 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
B
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Printed on: Wed Feb 08 2023, 11:07:44 PM(EST) Status: Not Yet Official on 09-Feb-2023 DocId: GUID-23C5D015-D812-475A-BE71-DF629168A1B5_5_en-US
Printed by: Dang Van Vu Official Date: 01-Aug-2023 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: qq1pw DOI: https://doi.org/10.31003/USPNF_M16298_05_01
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• á233ñ Elemental Impurities—Procedures
• á281ñ Residue on Ignition
• á730ñ Plasma Spectrochemistry
• á733ñ Loss on Ignition
• á735ñ X-Ray Fluorescence Spectrometry
ci
• 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
ffi
• 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
• á467ñ Residual Solvents
• á621ñ Chromatography
O
• 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
Specific Tests
Equipment
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• á31ñ Volumetric Apparatus
• á41ñ Balances
• á1051ñ Cleaning Glass Apparatus
B
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Printed on: Wed Feb 08 2023, 11:07:44 PM(EST) Status: Not Yet Official on 09-Feb-2023 DocId: GUID-23C5D015-D812-475A-BE71-DF629168A1B5_5_en-US
Printed by: Dang Van Vu Official Date: 01-Aug-2023 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: qq1pw DOI: https://doi.org/10.31003/USPNF_M16298_05_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
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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
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• 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
ffi
• 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
• á788ñ Particulate Matter in Injections
• á790ñ Visible Particulates in Injections
O
• 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)
• á1113ñ Microbial Characterization, Identification, and Strain Typing
e
• á1211ñ Sterility Assurance
• á1228ñ Depyrogenation
• á1228.1ñ Dry Heat Depyrogenation
B
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Printed on: Wed Feb 08 2023, 11:07:44 PM(EST) Status: Not Yet Official on 09-Feb-2023 DocId: GUID-23C5D015-D812-475A-BE71-DF629168A1B5_5_en-US
Printed by: Dang Van Vu Official Date: 01-Aug-2023 Document Type: GENERAL CHAPTER @2023 USPC
Do Not Distribute DOI Ref: qq1pw DOI: https://doi.org/10.31003/USPNF_M16298_05_01
5
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indefinitely)
• á1216ñ Tablet Friability
• á1217ñ Tablet Breaking Force
• á1711ñ Oral Dosage Forms—Performance Tests
Topical
ci
• 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
• á604ñ Leak Rate
ffi
• á724ñ Drug Release
• á755ñ Minimum Fill
• á791ñ pH
• á905ñ Uniformity of Dosage Units
• á1099ñ Limit on Number of Large Deviations when Assessing Content Uniformity in Large Samples (postponed
O
indefinitely)
• á1212ñ Probe Tack Test
• á1724ñ Semisolid Drug Products—Performance Tests
Inhalational
• á60ñ Microbiological Examination of Nonsterile Products: Tests for Burkholderia Cepacia Complex
• á61ñ Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
e
• 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
B
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