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USP 38 Guide to General Chapters / Chapter Charts 15

Chapter Charts

Chart GuideUSP General Chapters1

Official Articles
Noncomplex Active Drug SubstancesUniversal Tests: See Chart 1a
Noncomplex Active Drug SubstancesSpecific Tests: See Chart 1b
Biotechnology-Derived Drug Substances: See Chart 2
ExcipientsUniversal Tests: See Chart 3a
ExcipientsSpecific Tests: See Chart 3b
Noncomplex Active Drug ProductsUniversal Tests: See Chart 4a
Noncomplex Active Drug ProductsSpecific Tests: See Chart 4b
Biotechnology-Derived Drug Products: See Chart 5
Vaccines: See Chart 6
Blood and Blood Products: See Chart 7
Cell, Gene, and Tissue Based Products: See Chart 8
Dietary Supplement Ingredients: See Chart 11
Dietary Supplement Products: See Chart 12
CompoundingSubstance/Preparation/Practice: See Chart 13
Medical Devices

General Chapters
691 Cotton
861 SuturesDiameter
871 SuturesNeedle Attachment
Generally Applicable
Basic Elements
1058 Analytical Instrument Qualification
1097 Bulk Powder Sampling Procedures
1151 Pharmaceutical Dosage Forms
1196 Pharmaceutical Harmonization
1224 Transfer of Analytical Procedures
1225 Validation of Compendial Procedures
1226 Verification of Compendial Procedures
Drug Product Distribution: See Chart 9
MicrobiologyNonsterile Products: See Chart 10a
MicrobiologySterile Products: See Chart 10b

1 This table and the Charts 113 that follow are intended as a guide to the chapters in this publication. They may not be all-inclusive, and they are not intended to
describe expectations for articles or limit the application of tests to any article in the USPNF.

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16 Chapter Charts / Guide to General Chapters USP 38

Chart 1a. Noncomplex Active Drug SubstancesUniversal Tests

Impurities
Residual Sol-
Chapter Description Identification Assay Organic Inorganic vents
11 USP Reference Standards
81 AntibioticsMicrobial Assays
181 Identification Organic Nitrogenous

Bases
191 Identification TestsGeneral
193 Identification TestsTeracyclines
197 Spectrophotometric Identification

Test
201 Thin-Layer Chromatographic Identifi-

cation Tests
206 Aluminum
211 Arsenic
221 Chloride and Sulfate
223 Dimethylanline
231 Heavy Metals
General Chapters

232 Elemental ImpuritiesLimits

233 Elemental ImpuritiesProcedures
241 Iron
251 Lead
261 Mercury
281 Residue on Ignition
291 Selenium
351 Assay for Steroids
361 Barbiturate Assay
391 Epinephrine Assay
401 Fats and Fixed Oils
425 Iodometric AssayAntibiotics
451 Nitrate Titration
461 Nitrogen Determination
466 Ordinary Impurities
467 Residual Solvents
471 Oxygen Flask Combustion
511 Single-Steroid Assay
541 Titrimetry
616 Bulk Density and Tapped Destiny
621 Chromatography
659 Packaging and Storage Require-

ments
730 Plasma Spectrochemistry
731 Loss on Drying
733 Loss on Ignition
735 X-Ray Fluorescence Spectrometry
736 Mass Spectrometry
761 Nuclear Magnetic Resonance Spec-

troscopy
776 Optical Microscopy
781 Optical Rotation
801 Polarography
851 Spectrophotometry and Light-Scat-

tering

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USP 38 Guide to General Chapters / Chapter Charts 17

Chart 1a. Noncomplex Active Drug SubstancesUniversal Tests (Continued)

Impurities
Residual Sol-
Chapter Description Identification Assay Organic Inorganic vents
941 Characterization of Crystalline and
Partially Crystalline Solids by X-Ray Pow-
der Diffraction (XRPD)
1086 Impurities in Drug Substances and

Drug Products
1119 Near-Infrared Spectroscopy
1120 Raman Spectroscopy
1761 Applications of Nuclear Magnetic

Resonance Spectroscopy

Chart 1b. Noncomplex Active Drug SubstancesSpecific Tests

Physicochemical Charac-
Chapter terization Equipment Water Content
21 Thermometers
31 Volumetric Apparatus
41 Balances

General Chapters
268 Porosity by Nitrogen AdsorptionDesorption
301 Acid-Neutralizing Capacity
429 Light Diffraction Measurement of Particle

Size
541 Titrimetry
616 Bulk Density and Tapped Destiny
631 Color and Achromicity
641 Completeness of Solution
651 Congealing Temperature
695 Crystalinity
699 Density of Solids
721 Distilling Range
731 Loss on Drying
735 X-Ray Fluorescence Spectrometry
741 Melting Range or Temperature
761 Nuclear Magnetic Resonance Spectroscopy
776 Optical Microscopy
781 Optical Rotation
785 Osmolality and Osmolarity
786 Particle Size Distribution Estimation by Ana-

lytical Sieving
791 pH
811 Powder Fineness
821 Radioactivity
831 Refractive Index
841 Specific Gravity
846 Specific Surface Area
881 Tensile Strength
891 Thermal Analysis
911 ViscosityCapillary Methods
912 ViscosityRotational Methods
913 ViscosityRolling Ball Method
921 Water Determination
941 Characterization of Crystalline and Partially
Crystalline Solids by X-Ray Powder Diffraction
(XRPD)

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18 Chapter Charts / Guide to General Chapters USP 38

Chart 1b. Noncomplex Active Drug SubstancesSpecific Tests (Continued)

Physicochemical Charac-
Chapter terization Equipment Water Content
1051 Cleaning Glass Apparatus
1119 Near-Infrared Spectroscopy
1120 Raman Spectroscopy
1171 Phase-Solubility Analysis
1251 Weighing on an Analytical Balance
1761 Applications of Nuclear Magnetic Reso-

nance Spectroscopy
1911 Rheometry

Chart 2. Biotechnology-Derived Drug Substances

Impurities
Prod- Charac-
Descrip- Identifica- As- Physico- Equip- Process uct Re- teriza-
Chapter tion tion Safety say chemical ment Related lated tion
11 USP Reference Standards
21 Thermometers
General Chapters

31 Volumetric Apparatus
41 Balances
61 Microbiological Examination of
Nonsterile Products: Microbial Enumer-
ation Tests
62 Microbiological Examination of
Nonsterile Products: Tests for Specified
Microorganisms
63 Mycoplasma Tests
71 Sterility Tests
81 AntibioticsMicrobial Assays
85 Bacterial Endotoxins Test
87 Biological Reactivity Tests, In Vitro
88 Biological Reactivity Tests, In Vivo
111 Design and Analysis of Biological

Assays
121 Insulin Assays
121.1 Physicochemical Analytical Pro-

cedures for Insulins
130 Protein A Quality Attributes
191 Identification TestsGeneral
197 Spectrophotometric Identification

Tests
208 Anti-factor Xa and Anti-factor IIA
Assays for Unfractionated and Low Mo-
lecular Weight Heparins
231 Heavy Metals
232 Elemental ImpuritiesLimits
233 Elemental ImpurititesProcedures
467 Residual Solvents
503 Acetic Acid in Peptides
541 Titrimetry
621 Chromatography
631 Color and Achromicity
695 Crystalinity
726 Electrophoresis
730 Plasma Spectrochemistry
731 Loss on Drying

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USP 38 Guide to General Chapters / Chapter Charts 19

Chart 2. Biotechnology-Derived Drug Substances (Continued)

Impurities
Prod- Charac-
Descrip- Identifica- As- Physico- Equip- Process uct Re- teriza-
Chapter tion tion Safety say chemical ment Related lated tion
736 Mass Spectrometry
761 Nuclear Magnetic Resonance

Spectroscopy
781 Optical Rotation
786 Particle Size Distribution Estima-

tion by Analytical Sieving
831 Refractive Index
851 Spectrophotometry and Light-

Scattering
921 Water Determination
1030 Biological Assay Chapters

Overview and Glossary
1032 Design and Development of Bio-

logical Assays

General Chapters
1033 Biological Assay Validation
1034 Analysis of Biological Assays
1041 Biologics
1044 Cryopreservation of Cells
1045 Biotechnology-Derived Articles
1048 Quality of Biotechnological Prod-
ucts: Analysis of the Expression Con-

struct in Cells Used for Production of
r-DNA Derived Protein Products
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
1065 Ion Chromatography
1084 Glycoprotein and Glycan Analy-

sisGeneral Considerations
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
1113 Microbial Characterization,

Identification, and Strain Typing
1121 Nomenclature
1125 Nucleic Acid-Based Techniques

General
1126 Nucleic Acid-Based Techniques

Extraction, Detection, and Sequencing
1127 Nucleic Acid-Based Techniques

Amplification

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20 Chapter Charts / Guide to General Chapters USP 38

Chart 2. Biotechnology-Derived Drug Substances (Continued)

Impurities
Prod- Charac-
Descrip- Identifica- As- Physico- Equip- Process uct Re- teriza-
Chapter tion tion Safety say chemical ment Related lated tion
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)
1180 Human Plasma
1181 Scanning Electron Microscopy
1211 Sterilization and Sterility Assur-

ance of Compendial Articles
1229 Sterilization of Compendial Arti-

cles
1229.4 Sterilizing Filtration of Liquids
1251 Weighing on an Analytical Bal-
General Chapters

ance
1761 Applications of Nuclear Magnet-

ic Resonance Spectroscopy

Chart 3a. ExcipientsUniversal Tests

Impurities
Residual
Chapter Description Identification Assay Organic Inorganic Solvents
181 IdentificationOrganic Nitro-

genous Bases
191 Identification TestsGeneral
197 Spectrophotometric Identifica-

tion Tests
201 Thin-Layer Chromatographic

Identification Test
206 Aluminum
211 Arsenic
221 Chloride and Sulfate
226 4-Epianhydrotetracycline
228 Ethylene Oxide and Dioxane
231 Heavy Metals
232 Elemental ImpuritiesLimits
233 Elemental ImpuritiesProce-

dures
241 Iron
251 Lead
261 Mercury
281 Residue on Ignition
291 Selenium
311 Alginates Assay
345 Assay for Citric Acid/Citrate

and Phosphate
401 Fats and Fixed Oils
425 Iodometric AssayAntibiotics
431 Methoxy Determination
461 Nitrogen Determination
466 Ordinary Impurities
467 Residual Solvents

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USP 38 Guide to General Chapters / Chapter Charts 21

Chart 3a. ExcipientsUniversal Tests (Continued)

Impurities
Residual
Chapter Description Identification Assay Organic Inorganic Solvents
471 Oxygen Flask Combustion
541 Titrimetry
621 Chromatography
730 Plasma Spectrochemistry
731 Loss on Drying
733 Loss on Ignition
735 X-Ray Fluorescence Spectrom-

etry
736 Mass Spectrometry
781 Optical Rotation
801 Polarography
851 Spectrophotometry and Light-

Scattering
941 Characterization of Crystal-
line and Partially Crystalline Solids

General Chapters

by X-Ray Powder Diffraction
(XRPD)
1086 Impurities in Drug Substan-

ces and Drug Products
1091 Labeling of Inactive Ingredi-

ents
1119 Near-Infrared Spectroscopy

Table 3b. ExcipientsSpecific Tests

Physicochemical Char- Functionality/Safety/
Chapter acterization Equipment Pharmaceutical Water1 GMPs
21 Thermometers
31 Volumetric Apparatus
41 Balances
268 Porosity by Nitrogen

AdsorptionDesorption
301 Acid-Neutralizing Ca-

pacity
429 Light Diffraction Meas-

urement of Particle Size
541 Titrimetry
616 Bulk Density and Tap-

ped Destiny
631 Color and Achromicity
641 Completeness of Solu-

tion
643 Total Organic Carbon
645 Water Conductivity
651 Congealing Tempera-

ture
695 Crystallinity
699 Density of Solids
721 Distilling Range
731 Loss on Drying
735 X-Ray Fluorescence

Spectrometry
741 Melting Range or Tem-

perature
1 See Microbiology (Chart 10).

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22 Chapter Charts / Guide to General Chapters USP 38

Table 3b. ExcipientsSpecific Tests (Continued)

Physicochemical Char- Functionality/Safety/
Chapter acterization Equipment Pharmaceutical Water1 GMPs
761 Nuclear Magnetic Res-

onance Spectroscopy
776 Optical Microscopy
781 Optical Rotation
785 Osmolality and Osmo-

larity
786 Particle Size Distribu-
tion Estimation by Analytical
Sieving
791 pH
801 Polarography
811 Powder Fineness
821 Radioactivity
831 Refractive Index
841 Specific Gravity
846 Specific Surface Area
General Chapters

881 Tensile Strength

891 Thermal Analysis
911 ViscosityCapillary

Methods
912 ViscosityRotational

Methods
913 ViscosityRolling Ball

Method
921 Water Determination
941 Characterization of
Crystalline and Partially

Crystalline Solids by X-Ray
Powder Diffraction (XRPD)
1045 Biotechnology-Derived

Articles
1051 Cleaning Glass Appa-

ratus
1059 Excipient Performance
1074 Excipient Biological

Safety Evaluation Guidelines
1078 GMPs for Bulk Phar-

maceutical Excipients
1080 Bulk Pharmaceutical
ExcipientsCertificate of
Analysis
1081 Gel Strength of Gela-

tin
1097 Bulk Powder Sampling

Procedures
1119 Near-Infrared Spec-

troscopy
1174 Powder Flow
1195 Significant Change
Guide for Bulk Pharmaceuti-
cal Excipients
1197 Good Distribution
Practices for Bulk Pharma-
ceutical Excipients
1230 Water for Hemodialy-

sis Applications
1 See Microbiology (Chart 10).

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USP 38 Guide to General Chapters / Chapter Charts 23

Table 3b. ExcipientsSpecific Tests (Continued)

Physicochemical Char- Functionality/Safety/
Chapter acterization Equipment Pharmaceutical Water1 GMPs
1231 Water for Pharma-

ceutical Purposes
1251 Weighing on an Ana-

lytical Scale
1644 Theory and Practice
of Electrical Conductivity
Measurements of Solutions
1761 Applications of Nucle-
ar Magnetic Resonance
Spectroscopy
1911 Rheometry
1 See Microbiology (Chart 10).

Chart 4a. Noncomplex Active Drug ProductsUniversal Tests

Impurities
Residual Sol-
Chapter Description Identification Assay Organic Inorganic vents

General Chapters
81 AntibioticsGeneral
191 Identification TestsGen-

eral
197 Spectrophotometric Identi-

fication Tests
201 Thin-Layer Chromato-

graphic Identification Test
232 Elemental Impurities

Limits
233 Elemental ImpuritiesPro-

cedures
281 Residue on Ignition
341 Antimicrobial Agents

Content
351 Assay for Steroids
361 Barbiturate Assay
391 Epinephrine Assay
413 Impurities Testing in Medi-

cal Gases
415 Medical Gases Assay
451 Nitrate Titration
461 Nitrogen Determination
466 Ordinary Impurities
467 Residual Solvents
501 Salts of Organic Nitroge-

nous Bases
541 Titrimetry
611 Alcohol Determination
621 Chromatography
730 Plasma Spectrochemistry
733 Loss on Ignition
735 X-Ray Fluorescence Spec-

trometry
736 Mass Spectrometry
781 Optical Rotation
801 Polarography
851 Spectrophotometry and

Light-Scattering
1065 Ion Chromatography

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24 Chapter Charts / Guide to General Chapters USP 38

Chart 4a. Noncomplex Active Drug ProductsUniversal Tests (Continued)

Impurities
Residual Sol-
Chapter Description Identification Assay Organic Inorganic vents
1086 Impurities in Drug Sub-

stances and Drug Products
1121 Nomenclature

Chart 4b. Noncomplex Active Drug ProductsSpecific Tests

Performance Tests
Mucosal
Equip- Water Ophthal- Parenter- Inhala-
Chapter ment Content mic1 Nasal al Oral Topical tional
1 Injections
2 Oral Drug Products

Product Quality Tests
3 Topical and Transdermal
Drug ProductsProduct
Quality Tests
5 Inhalation and Nasal
General Chapters

Drug ProductsGeneral In-

formation and Product
Quality Checks
21 Thermometers
31 Volumetric Apparatus
41 Balances
71 Sterility Tests
85 Bacterial Endotoxins Test
87 Biological Reactivity

Tests, In Vitro
88 Biological Reactivity

Tests, In Vivo
151 Pyrogen Test
301 Acid-Neutralizing Ca-

pacity
381 Elastometric Closures

for Injections
541 Titrimetry
601 Inhalation and Nasal
Drug Products: Aerosols,

Sprays, and PowdersPer-
formance Quality Tests
602 Propellants
603 Topical Aerosols
604 Leak Rate
701 Disintegration
711 Dissolution
724 Drug Release
729 Globule Size Distribu-
tion in Lipid Injectable Emul-
sions
731 Loss on Drying
733 Loss on Ignition
735 X-Ray Fluorescence
Spectrometry
736 Mass Spectrometry
741 Melting Range or Tem-
perature
1 See Microbiology (Chart 10).

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USP 38 Guide to General Chapters / Chapter Charts 25

Chart 4b. Noncomplex Active Drug ProductsSpecific Tests (Continued)

Performance Tests
Mucosal
Equip- Water Ophthal- Parenter- Inhala-
Chapter ment Content mic1 Nasal al Oral Topical tional
751 Metal Particles in Oph-

thalmic Ointments
771 Ophthalmic Ointments
785 Osmolality and Osmo-

larity
787 Subvisible Particulate
Matter in Therapeutic Pro-
tein Injections
788 Particulate Matter in

Injections
789 Particulate Matter in

Ophthalmic Solutions
790 Visible Particulates in

Injections
791 pH

General Chapters
891 Thermal Analysis
905 Uniformity of Dosage

Units
921 Water Determination
1005 Acoustic Emission
1051 Cleaning Glass Appa-

ratus
1087 Apparent Intrinsic
DissolutionDissolution
Testing Procedures for Ro-
tating Disk and Stationary
Disk
1088 In Vitro and In Vivo

Evaluation of Dosage Forms
1090 Assessment of Drug
Product PerformanceBioa-

vailability, Bioequivalence,
and Dissolution
1092 The Dissolution Proce-
dure: Development and Vali-
dation
1094 CapsulesDissolution
Testing and Related Quality
Attributes
1113 Microbial characteri-
zation, Identification, and
Strain Typing
1174 Powder Flow
1195 Significant Change
Guide for Bulk Pharmaceuti-
cal Excipients
1216 Tablet Friability
1217 Tablet Breaking Force
1229 Sterilization of Com-

pendial Articles
1229.2 Steam Sterilization

of Aqueous Liquids
1229.3 Monitoring of Bio-

burden
1 See Microbiology (Chart 10).

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26 Chapter Charts / Guide to General Chapters USP 38

Chart 4b. Noncomplex Active Drug ProductsSpecific Tests (Continued)

Performance Tests
Mucosal
Equip- Water Ophthal- Parenter- Inhala-
Chapter ment Content mic1 Nasal al Oral Topical tional
1229.4 Sterilizing Filtration

of Liquids
1251 Weighing on an Ana-

lytical Balance
1601 Products for Nebuliza-

tionCharacterization Tests
1724 Semisolid Drug Prod-

uctsPerformance Tests
1788 Methods for the De-
termination of Particulate

Matter in Injections and
Ophthalmic Solutions
1 See Microbiology (Chart 10).

Chart 5. Biotechnology-Derived Drug Products

General Chapters

Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
1 Injections
11 USP Reference Stand-

ards
21 Thermometers
31 Volumetric Apparatus
41 Balances
61 Microbiological Ex-
amination of Nonsterile

Products: Microbial Enu-
meration Tests
62 Microbiological Ex-
amination of Nonsterile

Products: Tests for Speci-
fied Microorganisms
63 Mycoplasma Tests
71 Sterility Tests
85 Bacterial Endotoxins

Test
87 Biological Reactivity

Tests, In Vitro
88 Biological Reactivity

Tests, In Vivo
90 Fetal Bovine Serum
Quality Attributes and
Functionality Tests
111 Design and Analysis

of Biological Assays
121 Insulin Assays
121.1 Physicochemical
Analytical Procedures for
Insulins
123 Glucagon Bioidenti-

ty Tests
130 Protein A Quality

Attributes
130 Protein A Quality
Attributes

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USP 38 Guide to General Chapters / Chapter Charts 27

Chart 5. Biotechnology-Derived Drug Products (Continued)

Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
151 Pyrogen Test
191 Identification

TestsGeneral
197 Spectrophotometric

Identification Tests
208 Anti-factor Xa and
Anti-factor IIa Assays for
Unfractionated and Low
Molecular Weight Hepa-
rins
231 Heavy Metals
232 Elemental Impuri-

tiesLimits
233 Elemental Impuri-

tiesProcedures

General Chapters
341 Antimicrobial

AgentsContent
467 Residual Solvents
503 Acetic Acid in Pepti-

des
541 Titrimetry
621 Chromatography
631 Color and Achro-

micity
660 ContainersGlass
661 ContainersPlas-

tics
671 ContainersPer-

formance Testing
695 Crystallinity
726 Electrophoresis
730 Plasma Spectro-

chemistry
731 Loss on Drying
736 Mass Spectrometry
761 Nuclear Magnetic

Resonance Spectroscopy
781 Optical Rotation
785 Osmolality and Os-

molarity
786 Particle Size Distri-
bution Estimation by An-
alytical Sieving
788 Particulate Matter

in Injections
791 pH
831 Refractive Index
851 Spectrophotometry

and Light-Scattering
921 Water Determina-

tion
1024 Bovine Serum

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28 Chapter Charts / Guide to General Chapters USP 38

Chart 5. Biotechnology-Derived Drug Products (Continued)

Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
1030 Biological Assay
ChaptersOverview and
Glossary
1032 Design and Devel-
opment of Biological As-
says
1033 Biological Assay

Validation
1034 Analysis of Biologi-

cal Assays
1041 Biologics
1044 Cryopreservation

of Cells
1045 Biotechnology-De-

rived Articles
General Chapters

1050 Viral Safety Evalu-

ation of Biotechnology
Products Derived from
Cell Lines of Human or
Animal Origin
1052 Biotechnology De-
rived ArticlesAmino
Acid Analysis
1053 Capillary Electro-

phoresis
1054 Biotechnology De-
rived ArticlesIsoelectric
Focusing
1055 Biotechnology De-
rived ArticlesPeptide
Mapping
1056 Biotechnology De-
rived ArticlesPolyacry-

lamide Gel Electrophore-
sis
1057 Biotechnology De-
rived ArticlesTotal Pro-
tein Assay
1065 Ion Chromatogra-

phy
1084 Glyccoprotein and
Glycan AnalysisGener-
al Considerations
1102 Immunological
Test MethodsGeneral
Considerations
1103 Immunological
Test MethodsEnzyme-

Linked Immunosorbent
Assay (ELISA)
1104 Immunological
Test MethodsImmuno-
blot Analysis
1105 Immunological
Test MethodsSurface
Plasmon Resonance

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USP 38 Guide to General Chapters / Chapter Charts 29

Chart 5. Biotechnology-Derived Drug Products (Continued)

Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
1106 Immunological
Test MethodsDesign
and Validation of Immu-
noassays to Detect Anti-
Drug Antibiotics
1111 Microbiological Ex-
amination of Nonsterile
Products: Acceptance Cri-
teria for Pharmaceutical
Preparations and Sub-
stances for Pharmaceuti-
cal Use
1113 Microbial Charac-
terization, Identification,
and Strain Typing
1121 Nomenclature

General Chapters
1125 Nucleic Acid-Based

TechniquesGeneral
1126 Nucleic Acid-Based
TechniquesExtraction,

Detection, and Sequenc-
ing
1127 Nucleic Acid-Based
TechniquesAmplifica-
tion
1128 Nucleic Acid-Based

TechniquesMicroarray
1129 Nucleic Acid-Based

TechniquesGenotyping
1130 Nucleic Acid-Based
TechniquesApproaches
for Detecting Trace Nu-
cleic Acids (Residual DNA
Testing)
1181 Scanning Electron

Microscopy
1211 Sterilization and
Sterility Assurance of
Compendial Articles
1229 Sterilization of

Compendial Articles
1229.4 Sterilizing Filtra-

tion of Liquids
1251 Weighing on an

Analytical Balance
1761 Applications of
Nuclear Magnetic Reso-
nance Spectroscopy

Chart 6. Vaccines
Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
1 Injections
11 USP Reference Stand-

ards

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30 Chapter Charts / Guide to General Chapters USP 38

Chart 6. Vaccines (Continued)

Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
21 Thermometers
31 Volumetric Apparatus
41 Balances
63 Mycoplasma Tests
71 Sterility Tests
81 AntibioticsMicrobi-

al Assays
85 Bacterial Endotoxins

Test
88 Biological Reactivity

Tests, In Vivo
90 Fetal Bovine Serum
Quality Attributes and
Functionality Tests
General Chapters

111 Design and Analysis

of Biological Assays
151 Pyrogen Test
341 Antimicrobial

AgentsContent
621 Chromatography
660 ContainersGlass
661 ContainersPlas-

tics
671 ContainersPer-

formance Testing
695 Crystallinity
726 Electrophoresis
731 Loss on Drying
736 Mass Spectrometry
761 Nuclear Magnetic

Resonance Spectroscopy
786 Particle Size Distri-
bution Estimation by An-
alytical Sieving
787 Subvisible Particu-
late Matter in Therapeu-
tic Protein Injections
788 Particulate Matter

in Injections
790 Visible Particulates

in Injections
791 pH
851 Spectrophotometry

and Light-Scattering
921 Water Determina-

tion
1024 Bovine Serum
1030 Biological Assay
ChaptersOverview and
Glossary
1032 Design and Devel-
opment of Biological As-
says

Official from May 1, 2015

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Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
USP 38 Guide to General Chapters / Chapter Charts 31

Chart 6. Vaccines (Continued)

Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
1033 Biological Assay

Validation
1034 Analysis of Biologi-

cal Assays
1041 Biologics
1044 Cryopreservation

of Cells
1045 Biotechnology-De-

rived Articles
1052 Biotechnology De-
rived ArticlesAmino
Acid Analysis
1053 Capillary Electro-

phoresis

General Chapters
1054 Biotechnology De-
rived ArticlesIsoelectric
Focusing
1055 Biotechnology De-
rived ArticlesPeptide
Mapping
1056 Biotechnology De-
rived ArticlesPolyacry-

lamide Gel Electrophore-
sis
1057 Biotechnology De-
rived ArticlesTotal Pro-
tein Assay
1065 Ion Chromatogra-

phy
1084 Glyccoprotein and
Glycan AnalysisGener-
al Considerations
1102 Immunological
Test MethodsGeneral
Considerations
1103 Immunological
Test MethodsEnzyme-

Linked Immunosorbent
Assay (ELISA)
1104 Immunological
Test MethodsImmuno-
blot Analysis
1105 Immunological
Test MethodsSurface
Plasmon Resonance
1113 Microbial Charac-
terization, Identification,
and Strain Typing
1121 Nomenclature
1126 Nucleic Acid-Based
TechniquesExtraction,

Detection, and Sequenc-
ing
1127 Nucleic Acid-Based
TechniquesAmplifica-
tion
1128 Nucleic Acid-Based

TechniquesMicroarray

Official from May 1, 2015

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 Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
32 Chapter Charts / Guide to General Chapters USP 38

Chart 6. Vaccines (Continued)

Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
1129 Nucleic Acid-Based

TechniquesGenotyping
1130 Nucleic Acid-Based
TechniquesApproaches
for Detecting Trace Nu-
cleic Acids (Residual DNA
Testing)
1211 Sterilization and
Sterility Assurance of
Compendial Articles
1229 Sterilization of

Compendial Articles
1229.4 Sterilizing Filtra-

tion of Liquids
1235 Vaccines for Hu-
General Chapters

man UseGeneral Con-

siderations
1237 Virology Test

Methods
1238 Vaccines for Hu-
man UseBacterial Vac-
cines
1251 Weighing on an

Analytical Balance
1660 Evaluation of the
Inner Surface Durability
of Glass Containers
1761 Applications of
Nuclear Magnetic Reso-
nance Spectroscopy

Chart 7. Blood and Blood Products

Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
1 Injections
11 USP Reference Stand-

ards
21 Thermometers
31 Volumetric Apparatus
41 Balances
51 Antimicrobial Effec-

tiveness Testing
61 Microbiological Ex-
amination of Nonsterile

Products: Microbial Enu-
meration Tests
62 Microbiological Ex-
amination of Nonsterile

Products: Tests for Speci-
fied Microorganisms
71 Sterility Tests
85 Bacterial Endotoxins

Test

Official from May 1, 2015

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Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
USP 38 Guide to General Chapters / Chapter Charts 33

Chart 7. Blood and Blood Products (Continued)

Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
87 Biological Reactivity

Tests, In Vitro
88 Biological Reactivity

Tests, In Vivo
111 Design and Analysis

of Biological Assays
151 Pyrogen Test
191 Identification

TestsGeneral
197 Spectrophotometric

Identification Tests
208 Anti-factor Xa and
Anti-factor IIa Assays for
Unfractionated and Low
Molecular Weight Hepa-

General Chapters
rins
341 Antimicrobial

AgentsContent
621 Chromatography
631 Color and Achro-

micity
660 ContainersGlass
661 ContainersPlas-

tics
671 ContainersPer-

formance Testing
695 Crystallinity
726 Electrophoresis
731 Loss on Drying
736 Mass Spectrometry
761 Nuclear Magnetic

Resonance Spectroscopy
785 Osmolality and Os-

molarity
787 Subvisible Particu-
late Matter in Therapeu-
tic Protein Injections
788 Particulate Matter

in Injections
790 Visible Particulates

in Injections
791 pH
851 Spectrophotometry

and Light-Scattering
921 Water Determina-

tion
1030 Biological Assay
ChaptersOverview and
Glossary
1032 Design and Devel-
opment of Biological As-
says
1033 Biological Assay

Validation

Official from May 1, 2015

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 Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
34 Chapter Charts / Guide to General Chapters USP 38

Chart 7. Blood and Blood Products (Continued)

Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
1034 Analysis of Biologi-

cal Assays
1035 Biological Indica-

tors for Sterilization
1041 Biologics
1044 Cryopreservation

of Cells
1045 Biotechnology-De-

rived Articles
1052 Biotechnology De-
rived ArticlesAmino
Acid Analysis
1053 Capillary Electro-

phoresis
General Chapters

1054 Biotechnology De-

rived ArticlesIsoelectric
Focusing
1055 Biotechnology De-
rived ArticlesPeptide
Mapping
1056 Biotechnology De-
rived ArticlesPolyacry-

lamide Gel Electrophore-
sis
1057 Biotechnology De-
rived ArticlesTotal Pro-
tein Assay
1065 Ion Chromatogra-

phy
1102 Immunological
Test MethodsGeneral
Considerations
1103 Immunological
Test MethodsEnzyme-

Linked Immunosorbent
Assay (ELISA)
1104 Immunological
Test MethodsImmuno-
blot Analysis
1105 Immunological
Test MethodsSurface
Plasmon Resonance
1111 Microbiological Ex-
amination of Nonsterile
Products: Acceptance Cri-
teria for Pharmaceutical
Preparations and Sub-
stances for Pharmaceuti-
cal Use
1113 Microbial Charac-
terization, Identification,
and Strain Typing
1116 Microbiological
Control and Monitoring

of Aseptic Processing En-
vironments
1121 Nomenclature

Official from May 1, 2015

Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.
Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
USP 38 Guide to General Chapters / Chapter Charts 35

Chart 7. Blood and Blood Products (Continued)

Impurities
Proc-
ess Prod-
Identifica- Characteri- Equip- Misc. Descrip- Safe- As- Physico- Rela- uct Re-
Chapter tion zation ment Tests tion ty say chemical ted lated
1125 Nucleic Acid-Based

TechniquesGeneral
1130 Nucleic Acid-Based
TechniquesApproaches
for Detecting Trace Nu-
cleic Acids (Residual DNA
Testing)
1180 Human Plasma
1211 Sterilization and
Sterility Assurance of
Compendial Articles
1229 Sterilization of

Compendial Articles
1229.4 Sterilizing Filtra-

tion of Liquids

General Chapters
1237 Virology Test

Methods
1251 Weighing on an

Analytical Balance
1660 Evaluation of the
Inner Surface Durability
of Glass Containers
1761 Applications of
Nuclear Magnetic Reso-
nance Spectroscopy

Chart 8. Cell, Gene, and Tissue Based Products

Universal Tests Specific Tests1,2
Prod
Microbial/ Produc- uct
Identifica- Biocompati- Sterility Is- tion Is- Is- Equip- Characteri-
Chapter tion Assay bility sues sues sues ment zation
1 Injections
11 USP Reference Stand-

ards
21 Thermometers
31 Volumetric Apparatus
41 Balances
61 Microbiological Ex-
amination of Nonsterile

Products: Microbial Enu-
meration Tests
62 Microbiological Ex-
amination of Nonsterile

Products: Tests for Speci-
fied Microorganisms
63 Mycoplasma Tests
71 Sterility Tests
85 Bacterial Endotoxins

Test
87 Biological Reactivity

Tests, In Vitro
88 Biological Reactivity

Tests, In Vivo
1 For Functionality test, see 881 Tensile Strength
2 For Water test, see 1231 Water for Pharmaceutical Purposes

Official from May 1, 2015

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 Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
36 Chapter Charts / Guide to General Chapters USP 38

Chart 8. Cell, Gene, and Tissue Based Products (Continued)

Universal Tests Specific Tests1,2
Prod
Microbial/ Produc- uct
Identifica- Biocompati- Sterility Is- tion Is- Is- Equip- Characteri-
Chapter tion Assay bility sues sues sues ment zation
90 Fetal Bovine Serum
Quality Attributes and
Functionality Tests
92 Growth Factors and
Cytokines Used in Cell
Therapy Manufacturing
111 Design and Analysis

of Biological Assays
151 Pyrogen Test
161 Transfusion and In-
fusion Assemblies and
Similar Medical Devices
381 Elastomeric Closures

for Injections
621 Chromatography
General Chapters

726 Electrophoresis
785 Osmolality and Os-

molarity
787 Subvisible Particu-
late Matter in Therapeu-
tic Protein Injections
788 Particulate Matter

in Injections
791 pH
797 Pharmaceutical
CompoundingSterile
Preparations
905 Uniformity of Dos-

age Units
911 ViscosityCapillary

Methods
912 ViscosityRotation-

al Methods
913 ViscosityRolling

Ball Method
1024 Bovine Serum
1027 Flow Cytometry
1030 Biological Assay
ChaptersOverview and
Glossary
1031 The Biocompatibil-
ity of Materials Used in

Drug Containers, Medical
Devices, and Implants
1032 Design and Devel-
opment of Biological As-
says
1033 Biological Assay

Validation
1034 Analysis of Biologi-

cal Assays
1041 Biologics
1 For Functionality test, see 881 Tensile Strength
2 For Water test, see 1231 Water for Pharmaceutical Purposes

Official from May 1, 2015

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Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
USP 38 Guide to General Chapters / Chapter Charts 37

Chart 8. Cell, Gene, and Tissue Based Products (Continued)

Universal Tests Specific Tests1,2
Prod
Microbial/ Produc- uct
Identifica- Biocompati- Sterility Is- tion Is- Is- Equip- Characteri-
Chapter tion Assay bility sues sues sues ment zation
1043 Ancillary Materials
for Cell, Gene, and Tis-
sue-Engineered Products
1044 Cryopreservation

of Cells
1045 Biotechnology-De-

rived Articles
1046 Cellular and Tis-

sue-Based Products
1047 Gene Therapy

Products
1048 Quality of Biotech-
nology Products: Analysis
of the Expression Con-

struct in Cells Used for

General Chapters
Production of r-DNA De-
rived Protein Products
1049 Quality of Biotech-
nological Products: Sta-
bility Testing of Biotech-
nological/Biological Prod-
ucts
1050 Viral Safety Evalu-
ation of Biotechnology
Products Derived from
Cell Lines of Human or
Animal Origin
1051 Cleaning Glass Ap-

paratus
1052 Biotechnology De-
rived ArticlesAmino
Acid Analysis
1053 Capillary Electro-

phoresis
1054 Biotechnology De-
rived ArticlesIsoelectric
Focusing
1055 Biotechnology De-
rived ArticlesPeptide
Mapping
1056 Biotechnology De-
rived ArticlesPolyacry-

lamide Gel Electrophore-
sis
1057 Biotechnology De-
rived ArticlesTotal Pro-
tein Assay
1074 Excipient Biological
Safety Evaluation Guide-
lines
1084 Glycoprotein and
Glycan AnalysisGener-
al Considerations
1086 Impurities in Drug
Substances and Drug
Products
1 For Functionality test, see 881 Tensile Strength
2 For Water test, see 1231 Water for Pharmaceutical Purposes

Official from May 1, 2015

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 Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
38 Chapter Charts / Guide to General Chapters USP 38

Chart 8. Cell, Gene, and Tissue Based Products (Continued)

Universal Tests Specific Tests1,2
Prod
Microbial/ Produc- uct
Identifica- Biocompati- Sterility Is- tion Is- Is- Equip- Characteri-
Chapter tion Assay bility sues sues sues ment zation
1102 Immunological
Test MethodsGeneral
Considerations
1103 Immunological
Test MethodsEnzyme-

Linked Immunosorbent
Assay (ELISA)
1104 Immunological
Test MethodsImmuno-
blot Analysis
1113 Microbial Charac-
terization, Identification,
and Strain Typing
1116 Microbiological
Control and Monitoring

General Chapters

of Aseptic Processing En-

vironments
1121 Nomenclature
1126 Nucleic Acid-Based
TechniquesExtraction,

Detection, and Sequenc-
ing
1127 Nucleic Acid-Based
TechniquesAmplifica-
tion
1128 Nucleic Acid-Based

TechniquesMicroarray
1129 Nucleic Acid-Based

TechniquesGenotyping
1130 Nucleic Acid-Based
TechniquesApproaches
for Detecting Trace Nu-
cleic Acids (Residual DNA
Testing)
1151 Pharmaceutical

Dosage Forms
1184 Sensitization Test-

ing
1208 Sterility Testing
Validation of Isolator Sys-
tems
1211 Sterilization and
Sterility Assurance of
Compendial Articles
1227 Validation of Mi-
crobial Recovery from
Pharmacopeial Articles
1229 Sterilization of

Compendial Articles
1229.3 Monitoring of Bi-

oburden
1229.4 Sterilizing Filtra-

tion of Liquids
1237 Virology Test

Methods
1 For Functionality test, see 881 Tensile Strength
2 For Water test, see 1231 Water for Pharmaceutical Purposes

Official from May 1, 2015

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Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
USP 38 Guide to General Chapters / Chapter Charts 39

Chart 8. Cell, Gene, and Tissue Based Products (Continued)

Universal Tests Specific Tests1,2
Prod
Microbial/ Produc- uct
Identifica- Biocompati- Sterility Is- tion Is- Is- Equip- Characteri-
Chapter tion Assay bility sues sues sues ment zation
1251 Weighing on an

Analytical Balance
1285 Preparation of Bio-
logical Specimens for His-

tologic and Immunohis-
tochemical Analysis
1285.1 Hematoxylin
and Eosin Staining of

Sectioned Tissue for Mi-
croscopic Examination
1 For Functionality test, see 881 Tensile Strength
2 For Water test, see 1231 Water for Pharmaceutical Purposes

Chart 9. Drug Product Distribution

Manufac- Whole- Sample Distri- Repackag- Phar- Practi-
Chapter turer Shipper saler bution er macy tioner

General Chapters
17 Prescription Container La-

beling
87 Biological Reactivity Tests,

In Vitro
88 Biological Reactivity Tests,

In Vivo
381 Elastomeric Closures for In-

jections
659 Packaging and Storage Re-

quirements
660 ContainersGlass
661 ContainersPlastics
670 Auxiliary Packaging Com-

ponents
671 ContainersPerformance

Testing
698 Deliverable Volume
735 X-Ray Fluorescence Spec-

trometry
755 Minimum Fill
1066 Physical Environments
That Promote Safe Medication
Use
1079 Good Storage and Distri-
bution Practices for Drug Prod-
ucts
1118 Monitoring Devices
Time, Temperature, and Humid-
ity
1136 Packaging and Repack-

agingSingle-Unit Containers
1151 Pharmaceutical Dosage

Forms
1177 Good Packaging Practices
1178 Good Repackaging Prac-

tices
1191 Stability Considerations

in Dispensing Practice
1265 Written Prescripion Drug

InformationGuidelines

Official from May 1, 2015

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 Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
40 Chapter Charts / Guide to General Chapters USP 38

Chart 9. Drug Product Distribution (Continued)

Manufac- Whole- Sample Distri- Repackag- Phar- Practi-
Chapter turer Shipper saler bution er macy tioner
1660 Evaluation of the Inner
Surface Durability of Glass Con-
tainers

Chart 10a. MicrobiologyNonsterile Products

Absence of Objectionable Mi-
Chapter Microbial Enumeration croorganisms
61 Microbiological Examination of Nonsterile Products: Microbial Enumera-

tion Tests
62 Microbiological Examination of Nonsterile Products: Tests for Specified

Microorganisms
63 Mycoplasma Tests
610 Alternative Microbiological Sampling Methods for Nonsterile Inhaled

and Nasal Products
1111 Microbiological Examination of Nonsterile Products: Acceptance Crite-

ria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
1113 Microbial Characterization, Identification, and Strain Typing
General Chapters

2021 Microbial Enumeration TestsNutritional and Dietary Supplements

2022 Microbiological Procedures for Absence of Specified Microorganisms

Nutritional and Dietary Supplements
2023 Microbiological Attributes for Nonsterile Nutritional and Dietary Sup-

plements

Chart 10b. MicrobiologySterile Products1

Assembly2 Terminal Sterilization
Steri- Aseptic Termi-
lity Myco- Pro- Filtra- Assem- Oth- nal Ster- Moist Dry Radia-
Chapter Tests plasma cessing tion bly er ilization Heat Heat tion EtO
55 Biological IndicatorsRe-

sistance Performance Tests
61 Microbiological Examina-
tion of Nonsterile Products:
Microbial Enumeration Tests
62 Microbiological Examina-
tion of Nonsterile Products:
Tests for Specified Microorgan-
isms
63 Mycoplasma Tests
71 Sterility Tests
151 Pyrogen Tests
610 Alternative Microbiologi-
cal Sampling Methods for
Nonsterile Inhaled and Nasal
Products
1035 Biological Indicators for

Sterilization
1072 Disinfectants and Anti-

septics
1111 Microbiological Exami-
nation of Nonsterile Products:
Acceptance Criteria for Phar-
maceutical Preparations and
Substances for Pharmaceutical
Use
1112 Application of Water Ac-
tivity Determination to Non-

sterile Pharmaceutical Prod-
ucts
1 For endotoxins limits, see 85 Bacterial Endotoxins Test
2 For BFS, FFS, and SFS, see 1116 Microbiological Control and Monitoring of Aseptic Processing Envrionments

Official from May 1, 2015

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Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
USP 38 Guide to General Chapters / Chapter Charts 41

Chart 10b. MicrobiologySterile Products1 (Continued)

Assembly2 Terminal Sterilization
Steri- Aseptic Termi-
lity Myco- Pro- Filtra- Assem- Oth- nal Ster- Moist Dry Radia-
Chapter Tests plasma cessing tion bly er ilization Heat Heat tion EtO
1113 Microbial Characteriza-
tion, Identification, and Strain
Typing
1116 Microbiological Control
and Monitoring of Aseptic Pro-
cessing Environments
1117 Microbiological Best

Laboratory Practices
1207 Sterile TestingIntegri-

ty Evaluation
1208 Sterility TestingVali-

dation of Isolator Systems
1209 SterilizationChemical
and Physicochemical Indica-
tors and Integrators
1211 Sterilization and Sterility

General Chapters
Assurance of Compendial Arti-
cles
1222 Terminally Sterilized
Pharmaceutical Products
Parametric Release
1223 Validation of Alternative

Microbiological Methods
1229 Sterilization of Compen-

dial Articles
1229.1 Steam Sterilization by

Direct Contact
1229.2 Steam Sterilization by

Aqueous Liquids
1229.3 Monitoring of Biobur-

den
1229.4 Sterilizing Filtration of

Liquids
1229.7 Gaseous Sterilization
1229.8 Dry Heat Sterilization
1229.10 Radiation Steriliza-

tion
1 For endotoxins limits, see 85 Bacterial Endotoxins Test
2 For BFS, FFS, and SFS, see 1116 Microbiological Control and Monitoring of Aseptic Processing Envrionments

Chart 11. Dietary Supplement Ingredients

Nonbotani-
Botanicals cals1,2
Safe-
Con- ty/ Physicohemical Oth- Vitamin As-
Chapter Description Identification tent Purity Characterization er says3
91 Calcium Pantohenate Assay
171 Vitamin B12 Activity Assay
197 Spectrophotometric Identification

Tests
201 Thin-Layer Chromatographic Iden-

tification Test
211 Arsenic
231 Heavy Metals
1 For complex see Biotechnology-Derived Drug Substances (Chart 2)
2 For noncomplex Minerals, Amino Acids, and Metabolites, see Noncomplex Active Drug Substances (Chart 1)
3 See also Noncomplex Active Drug Substances (Chart 1).

Official from May 1, 2015

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 Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
42 Chapter Charts / Guide to General Chapters USP 38

Chart 11. Dietary Supplement Ingredients (Continued)

Nonbotani-
Botanicals cals1,2
Safe-
Con- ty/ Physicohemical Oth- Vitamin As-
Chapter Description Identification tent Purity Characterization er says3
251 Lead
261 Mercury
281 Residue on Ignition
401 Fats and Fixed Oils
411 Folic Acid Assay
441 Niacin or Niacinamide Assay
451 Nitrate Titration
531 Thiamine Assay
541 Titrimetry
551 Vitamin E Assay
561 Articles of Botanical Origin
563 Identification of Articles of Botani-

cal Origin
General Chapters

565 Botanical Extracts

571 Vitamin A Assay
581 Vitamin D Assay
591 Zinc Determination
611 Alcohol Determination
621 Chromatography
730 Plasma Spectrochemistry
735 X-Ray Fluorescence Spectrometry
736 Mass Spectrometry
761 Nuclear Magnetic Resonance

Spectroscopy
776 Optical Microscopy
851 Spectrophotometry and Light-

Scattering
1065 Ion Chromatography
1113 Microbial Characterization, Iden-

tification, and Strain Typing
1181 Scanning Electron Microscopy
1761 Applications of Nuclear Magnetic

Resonance Spectroscopy
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 Sup-
plements
2030 Supplemental Information for Ar-

ticles of Botanical Origin
2232 Elemental Contaminants in Diet-

ary Supplements
1 For complex see Biotechnology-Derived Drug Substances (Chart 2)
2 For noncomplex Minerals, Amino Acids, and Metabolites, see Noncomplex Active Drug Substances (Chart 1)
3 See also Noncomplex Active Drug Substances (Chart 1).

Official from May 1, 2015

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Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
USP 38 Guide to General Chapters / Chapter Charts 43

Chart 12. Dietary Supplement Products

Universal Tests Specific Tests
Impurities Safe-
Descrip- Identifica- Assay/ Or- Inor- Residual Equip- Perform- ty/
Chapter tion tion Content ganic ganic Solvents ment ance Tests Purity
21 Thermometers
31 Volumetric Apparatus
41 Balances
91 Calcium Pantothenate

Assay
171 Vitamin B12 Assay
191 Identification Tests

General
197 Spectrophotometric

Identification Tests
201 Thin-Layer Chromato-

graphic Identification Test
211 Arsenic
231 Heavy Metals

General Chapters
251 Lead
261 Mercury
281 Residue on Ignition
411 Folic Acid Assay
441 Niacin or Niacinamide

Assay
451 Nitrate Titration
466 Ordinary Impurities
467 Residual Solvents
531 Thiamine Assay
541 Titrimetry
551 Vitamin E Assay
561 Articles of Botanical

Origin
563 Identification of Articles

of Botanical Origin
565 Botanical Extracts
571 Vitamin A Assay
581 Vitamin D Assay
621 Chromatography
730 Plasma Spectrochemis-

try
733 Loss on Ignition
735 X-Ray Fluorescence

Spectrometry
736 Mass Spectrometry
776 Optical Microscopy
781 Optical Rotation
801 Polarography
851 Spectrophotometry and

Light-Scattering
1051 Cleaning Glass Appa-

ratus
1065 Ion Chromatography
1086 Impurities in Drug
Substances and Drug Prod-
ucts

Official from May 1, 2015

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 Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
44 Chapter Charts / Guide to General Chapters USP 38

Chart 12. Dietary Supplement Products (Continued)

Universal Tests Specific Tests
Impurities Safe-
Descrip- Identifica- Assay/ Or- Inor- Residual Equip- Perform- ty/
Chapter tion tion Content ganic ganic Solvents ment ance Tests Purity
1094 CapsulesDissolution
Testing and Related Quality
Attributes
1113 Microbial Characteri-
zation, Identification, and
Strain Typing
1151 Pharmaceutical Dos-

age Forms
1216 Tablet Friability
1251 Weighing on an Ana-

lytical Balance
2021 Microbiological Enu-
meration TestsNutritional
and Dietary Supplements
2022 Microbiological Proce-
General Chapters

dures for Absence of Speci-

fied MicroorganismsNutri-
tional and Dietary Supple-
ments
2023 Microbiological Attrib-
utes of Nonsterile Nutrition-
al and Dietary Supplements
2030 Supplemental Infor-
mation for Articles of Botani-
cal Origin
2040 Disintegration and
Dissolution of Dietary Sup-
plements
2091 Weight Variation of

Dietary Supplements
2232 Elemental Contami-
nants in Dietary Supple-
ments
2750 Manufacturing Practi-

ces for Dietary Supplements

Chart 13. CompoundingSubstance/Preparation/Practice

Impurities
Physico- Proc- Prod-
chemical ess uct
Glob- Descrip- Identifica- As- Packag- Characteri- Safe- Equip- Rela- Rela-
Chapter al tion tion say ing zation ty ment ted ted
11 USP Reference Stand-

ards
21 Thermometers
31 Volumetric Apparatus
41 Balances
61 Microbiological Exami-
nation of Nonsterile Prod-

ucts: Microbial Enumera-
tion Tests
62 Microbiological Exami-
nation of Nonsterile Prod-

ucts: Tests for Specified Mi-
croorganisms
71 Sterility Tests
81 AntibioticsMicrobial

Assays

Official from May 1, 2015

Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.
Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
USP 38 Guide to General Chapters / Chapter Charts 45

Chart 13. CompoundingSubstance/Preparation/Practice (Continued)

Impurities
Physico- Proc- Prod-
chemical ess uct
Glob- Descrip- Identifica- As- Packag- Characteri- Safe- Equip- Rela- Rela-
Chapter al tion tion say ing zation ty ment ted ted
85 Bacterial Endotoxins

Test
87 Biological Reactivity

Tests, In Vitro
88 Biological Reactivity

Tests, In Vivo
111 Design and Analysis

of Biological Assays
191 Identification Tests

General
197 Spectrophotometric

Identification Tests
201 Thin-Layer Chromato-

graphic Identification Test

General Chapters
231 Heavy Metals
541 Titrimetry
621 Chromatography
659 Packaging and Stor-

age Requirements
660 ContainersGlass
661 ContainersPlastics
671 ContainersPerform-

ance Testing
726 Electrophoresis
730 Plasma Spectrochem-

istry
731 Loss on Drying
736 Mass Spectrometry
761 Nuclear Magnetic

Resonance Spectroscopy
781 Optical Rotation
786 Particle Size Distribu-
tion Estimation by Analyti-
cal Sieving
795 Pharmaceutical Com-
poundingNonsterile
Preparations
797 Pharmaceutical Com-
poundingSterile Prepara-
tions
823 Positron Emission To-
mography Drugs for Com-

pounding, Investigational,
and Research Uses
831 Refractive Index
851 Spectrophotometry

and Light-Scattering
921 Water Determination
1015 Automated Radio-
chemical Synthesis Appa-
ratus
1031 The Biocompatibility
of Materials Used in Drug

Containers, Medical Devi-
ces, and Implants

Official from May 1, 2015

Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.
 Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
46 Chapter Charts / Guide to General Chapters USP 38

Chart 13. CompoundingSubstance/Preparation/Practice (Continued)

Impurities
Physico- Proc- Prod-
chemical ess uct
Glob- Descrip- Identifica- As- Packag- Characteri- Safe- Equip- Rela- Rela-
Chapter al tion tion say ing zation ty ment ted ted
1045 Biotechnology-De-

rived Articles
1052 Biotechnology-De-
rived ArticlesAmino Acid
Analysis
1053 Capillary Electropho-

resis
1054 Biotechnology-De-
rived ArticlesIsoelectric
Focusing
1055 Biotechnology-De-
rived ArticlesPeptide
Mapping
1056 Biotechnology-De-
rived ArticlesPolyacryla-
General Chapters

mide Gel Electrophoresis

1057 Biotechnology-De-
rived ArticlesTotal Pro-
tein Assay
1065 Ion Chromatogra-

phy
1066 Physical Environ-
ments That Promote Safe
Medication Use
1113 Microbial Character-
ization, Identification, and
Strain Typing
1121 Nomenclature
1136 Packaging and Re-
packagingSingle-Unit
Containers
1151 Pharmaceutical Dos-

age Forms
1160 Pharmaceutical Cal-
culations in Prescription
Compounding
1163 Quality Assurance in
Pharmaceutical Com-
pounding
1176 Prescription Balan-
ces and Volumetric Appa-
ratus
1191 Stability Considera-
tions in Dispensing Prac-
tice
1229 Sterilization of Com-

pendial Articles
1229.2 Steam Steriliza-

tion of Aqueous Liquids
1229.3 Monitoring of Bio-

burden
1229.4 Sterilizing Filtra-

tion of Liquids
1229.7 Gaseous Steriliza-

tion
1229.8 Dry Heat Steriliza-

tion

Official from May 1, 2015

Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.
Accessed from 10.6.1.10 by merck1 on Wed Jan 28 06:27:49 EST 2015
USP 38 Guide to General Chapters / Chapter Charts 47

Chart 13. CompoundingSubstance/Preparation/Practice (Continued)

Impurities
Physico- Proc- Prod-
chemical ess uct
Glob- Descrip- Identifica- As- Packag- Characteri- Safe- Equip- Rela- Rela-
Chapter al tion tion say ing zation ty ment ted ted
1229.10 Radiation Sterili-

zation
1231 Water for Pharma-

ceutical Purposes
1251 Weighing on an An-

alytical Balance
1265 Written Prescription
Drug InformationGuide-
lines
1660 Evaluation of the In-
ner Surface Durability of
Glass Containers
1761 Applications of Nu-
clear Magnetic Resonance
Spectroscopy

General Chapters

Official from May 1, 2015

Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.