DSC217M DSCVol1 Title 2015-01 V3 - USP
2015Dietary Supplements CompendiumDSCVolume 1General Notices and RequirementsUSP–NF General ChaptersUSP–NF Dietary Supplement MonographsUSP–NF Excipient MonographsFCC General ProvisionsFCC MonographsFCC Identity StandardsFCC AppendicesReagents, Indicators, and SolutionsReference TablesDSC217M DSCVol1 Title 2015-01 V3.indd 12/2/15 12:18 PM
2Notice and WarningConcerning U.S. Patent or Trademark RightsThe inclusion in the USP Dietary Supplements Compendium of a monograph on any dietary supplement in respect to whichpatent or trademark rights may exist shall not be deemed, and is not intended as, a grant of, or authority to exercise, anyright or privilege protected by such patent or trademark. All such rights and privileges are vested in the patent or trademarkowner, and no other person may exercise the same without express permission, authority, or license secured from suchpatent or trademark owner.Concerning Use of the USP Dietary Supplements CompendiumAttention is called to the fact that USP Dietary Supplements Compendium text is fully copyrighted. Authors and otherswishing to use portions of the text should request permission to do so from the Legal Department of the United StatesPharmacopeial Convention.Copyright 2015 The United States Pharmacopeial ConventionISBN: 978-1-936424-41-212601 Twinbrook Parkway, Rockville, MD 20852All rights reserved.
DSCContents iiiContentsUSP Dietary Supplements CompendiumVolume 1Volume 2Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vPreface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vMission and Preface . . . . . . . . . . . . . . . . . . . . . . . . . . 1Dietary Supplements Admission Evaluations . . . . . . . 1General Notices and Requirements . . . . . . . . . . . . . . 9USP Dietary Supplement VerificationProgram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205USP–NF General Chapters . . . . . . . . . . . . . . . . . . . . 25USP–NF Dietary Supplement Monographs . . . . . . 847USP–NF Excipient Monographs . . . . . . . . . . . . . . 1723FCC General Provisions . . . . . . . . . . . . . . . . . . . . 1937FCC Monographs . . . . . . . . . . . . . . . . . . . . . . . . . 1947FCC Identity Standards . . . . . . . . . . . . . . . . . . . . 2227FCC Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . 2235Reagents, Indicators, and Solutions . . . . . . . . . . 2413Reference Tables . . . . . . . . . . . . . . . . . . . . . . . . . 2513Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1USP Reference Standards Index . . . . . . . . . . . . . . I-35Dietary Supplements RegulatoryFramework . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283Tables of Dietary Intake Levels . . . . . . . . . . . . . . . .517Guidance Documents . . . . . . . . . . . . . . . . . . . . . . . 533Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .623Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .I-1
DSCGeneral Notices 11General Notices and RequirementsApplying to Standards, Tests,Assays, and Other Specificationsof the United States Pharmacopeia1. Title and Revision . . . . . . . . . . . . . . . . . . . . . . 132. Official Status and LegalRecognition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132.10. Official Text . . . . . . . . . . . . . . . . . . . . . . . . . . . 132.20. Official Articles . . . . . . . . . . . . . . . . . . . . . . . . 132.30. Legal Recognition . . . . . . . . . . . . . . . . . . . . . . 133. Conformance to Standards . . . . . . . . . . . . 133.10. Applicability of Standards . . . . . . . . . . . . . . . . . 133.20. Indicating Conformance . . . . . . . . . . . . . . . . . . 144. Monographs and General Chapters . . . 144.10. Monographs . . . . . . . . . . . . . . . . . . . . . . . . . . 144.20. General Chapters . . . . . . . . . . . . . . . . . . . . . . . 155. Monograph Components . . . . . . . . . . . . . . r Formula . . . . . . . . . . . .Added Substances . . . . . . . . . . . .Description and Solubility . . . . . . .Identity . . . . . . . . . . . . . . . . . . . .Assay . . . . . . . . . . . . . . . . . . . . .Impurities and Foreign SubstancesPerformance Tests . . . . . . . . . . . .USP Reference Standards . . . . . . . 15. 15. 16. 16. 16. 16. 17. 176. Testing Practices and Procedures . . . . . 176.10. Safe Laboratory Practices . . . . . . . . . . . .6.20. Automated Procedures . . . . . . . . . . . . . .6.30. Alternative and Harmonized Methods andProcedures . . . . . . . . . . . . . . . . . . . . . .6.40. Dried, Anhydrous, Ignited, or SolventFree Basis . . . . . . . . . . . . . . . . . . . . . . . . . . . 17. . . . . 17. . . . . 17. . . . . 176.50.6.60.6.70.6.80.Preparation of Solutions . . . . .Units Necessary to Complete aReagents . . . . . . . . . . . . . . . .Equipment . . . . . . . . . . . . . .Test. 17. 18. 18. 187. Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187.10. Interpretation of Requirements . . . . . . . . . . . . . 187.20. Rounding Rules . . . . . . . . . . . . . . . . . . . . . . . . 198. Terms and Definitions . . . . . . . . . . . . . . . . . 198.10. Abbreviations . . . . . . . . . .8.20. About . . . . . . . . . . . . . . .8.30. Alcohol Content . . . . . . . .8.40. Atomic Weights . . . . . . . .8.50. Blank Determinations . . . .8.60. Concomitantly . . . . . . . . .8.70. Desiccator . . . . . . . . . . . .8.80. Logarithms . . . . . . . . . . . .8.90. Microbial Strain . . . . . . . .8.100. Negligible . . . . . . . . . . . .8.110. NLT/NMT . . . . . . . . . . . .8.120. Odor . . . . . . . . . . . . . . .8.130. Percent . . . . . . . . . . . . . .8.140. Percentage Concentrations8.150. Pressure . . . . . . . . . . . . .8.160. Reaction Time . . . . . . . . .8.170. Specific Gravity . . . . . . . .8.180. Temperatures . . . . . . . . .8.190. Time . . . . . . . . . . . . . . . .8.200. Transfer . . . . . . . . . . . . . .8.210. Vacuum . . . . . . . . . . . . .8.220. Vacuum Desiccator . . . . .8.230. Water . . . . . . . . . . . . . . .8.240. Weights and Measures . . .Official text. Reprinted from First Supplement to USP38-NF33. 19. 19. 19. 19. 19. 19. 19. 19. 19. 20. 20. 20. 20. 20. 20. 20. 20. 20. 20. 20. 20. 20. 20. 20
12 General NoticesDSC9. Prescribing and Dispensing . . . . . . . . . . . . 219.10 Use of Metric Units . . . . . . . . . . . . . . . . . . . . . . 219.20 Changes in Volume . . . . . . . . . . . . . . . . . . . . . . 2110. Preservation, Packaging, Storage,and Labeling . . . . . . . . . . . . . . . . . . . . . . . . . 2210.10. Packaging and Storage . . . . . . . . . . . . . . . . . . 2210.40. Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Official text. Reprinted from First Supplement to USP38-NF33.
DSCUSP–NF General Chapters 25USP–NF General ChaptersThis section contains selected official general chapters that are reprinted from the USP. Only those USP chapters consideredrelevant for the analysis and/or manufacturing of dietary supplements are included in this section. Chapters specifically dedicatedto dietary supplements are numbered above 2000.General Requirements for Tests and Assays〈2〉 Oral Drug Products—Product Quality Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29〈11〉 USP Reference Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Apparatus for Tests and Assays〈21〉 Thermometers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36〈31〉 Volumetric Apparatus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37〈41〉 Balances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Microbiological Tests〈51〉 Antimicrobial Effectiveness Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38〈61〉 Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests . . . . . . . . . . . . . . . . . . . . . . . . . 41〈62〉 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms . . . . . . . . . . . . . . . . . . . . 48Biological Tests and Assays〈91〉 Calcium Pantothenate Assay . . . . . . . . . .〈111〉 Design and Analysis of Biological Assays〈115〉 Dexpanthenol Assay . . . . . . . . . . . . . .〈171〉 Vitamin B12 Activity Assay . . . . . . . . . . .55577274Chemical Tests and Assays: Identification Tests〈181〉 Identification—Organic Nitrogenous Bases . . . . . . . . . . . . .〈191〉 Identification Tests—General . . . . . . . . . . . . . . . . . . . . . . . .〈197〉 Spectrophotometric Identification Tests . . . . . . . . . . . . . . . .〈201〉 Thin-Layer Chromatographic Identification Test . . . . . . . . . .〈202〉 Identification of Fixed Oils by Thin-Layer Chromatography . .〈203〉 High-Performance Thin-Layer Chromatography Procedure for.Identification Of Articles Of Botanical Origin.777780818284Limit Tests〈206〉 Aluminum . . . . . . . . . . . . . . . . . . . .〈211〉 Arsenic . . . . . . . . . . . . . . . . . . . . . .〈221〉 Chloride and Sulfate . . . . . . . . . . . .〈228〉 Ethylene Oxide and Dioxane . . . . . .〈231〉 Heavy Metals . . . . . . . . . . . . . . . . .〈233〉 Elemental Impurities - Procedures . . .〈241〉 Iron . . . . . . . . . . . . . . . . . . . . . . . .〈251〉 Lead . . . . . . . . . . . . . . . . . . . . . . . .〈261〉 Mercury . . . . . . . . . . . . . . . . . . . . .〈271〉 Readily Carbonizable Substances Test〈281〉 Residue on Ignition . . . . . . . . . . . . .〈291〉 Selenium . . . . . . . . . . . . . . . . . . . . 86. 86. 88. 89. 91. 93. 97. 98. 99101101102Other Tests and Assays〈301〉 Acid-Neutralizing Capacity . . . . . . . . . . . .〈311〉 Alginates Assay . . . . . . . . . . . . . . . . . . . .〈341〉 Antimicrobial Agents—Content . . . . . . . . .〈345〉 Assay for Citric Acid/Citrate and Phosphate〈401〉 Fats and Fixed Oils . . . . . . . . . . . . . . . . .103104105108109
26 USP–NF General ��Folic Acid Assay . . . . . . . . . . . . . . . . . . . . . .Light Diffraction Measurement of Particle SizeNiacin or Niacinamide Assay . . . . . . . . . . . .Nitrogen Determination . . . . . . . . . . . . . . . .Ordinary Impurities . . . . . . . . . . . . . . . . . . .Residual Solvents . . . . . . . . . . . . . . . . . . . . .Oxygen Flask Combustion . . . . . . . . . . . . . .Riboflavin Assay . . . . . . . . . . . . . . . . . . . . . .Salts of Organic Nitrogenous Bases . . . . . . . .Thiamine Assay . . . . . . . . . . . . . . . . . . . . . .Titrimetry . . . . . . . . . . . . . . . . . . . . . . . . . .Vitamin E Assay . . . . . . . . . . . . . . . . . . . . . .Articles of Botanical Origin . . . . . . . . . . . . . .Identification of Articles of Botanical Origin . .Botanical Extracts . . . . . . . . . . . . . . . . . . . .Vitamin A Assay . . . . . . . . . . . . . . . . . . . . . .Vitamin D Assay . . . . . . . . . . . . . . . . . . . . .Zinc Determination . . . . . . . . . . . . . . . . . . .DSC.Tests and DeterminationsAlcohol Determination . . . . . . . . . . . . . . . . . . .Bulk Density and Tapped Density of Powders . . .Chromatography . . . . . . . . . . . . . . . . . . . . . . .Color and Achromicity . . . . . . . . . . . . . . . . . . .Completeness of Solution . . . . . . . . . . . . . . . . .Total Organic Carbon . . . . . . . . . . . . . . . . . . .Water Conductivity . . . . . . . . . . . . . . . . . . . . .Congealing Temperature . . . . . . . . . . . . . . . . .Packaging and Storage Requirements . . . . . . . .Containers—Glass . . . . . . . . . . . . . . . . . . . . . .Containers—Plastics . . . . . . . . . . . . . . . . . . . . .Auxiliary Packaging Components . . . . . . . . . . .Containers—Performance Testing . . . . . . . . . . .Crystallinity . . . . . . . . . . . . . . . . . . . . . . . . . . .Deliverable Volume . . . . . . . . . . . . . . . . . . . . .Density of Solids . . . . . . . . . . . . . . . . . . . . . . .Disintegration . . . . . . . . . . . . . . . . . . . . . . . . .Quality Attributes of Tablets Labeled as Having aDissolution . . . . . . . . . . . . . . . . . . . . . . . . . . .Distilling Range . . . . . . . . . . . . . . . . . . . . . . . .Plasma Spectrochemistry . . . . . . . . . . . . . . . . .Loss on Drying . . . . . . . . . . . . . . . . . . . . . . . .Loss on Ignition . . . . . . . . . . . . . . . . . . . . . . .X-Ray Fluorescence Spectrometry . . . . . . . . . . .Mass Spectrometry . . . . . . . . . . . . . . . . . . . . .Melting Range or Temperature . . . . . . . . . . . . .Minimum Fill . . . . . . . . . . . . . . . . . . . . . . . . .Nuclear Magnetic Resonance Spectroscopy . . . .Optical Microscopy . . . . . . . . . . . . . . . . . . . . .Optical Rotation . . . . . . . . . . . . . . . . . . . . . . .Particle Size Distribution Estimation by AnalyticalpH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Polarography . . . . . . . . . . . . . . . . . . . . . . . . .Powder Fineness . . . . . . . . . . . . . . . . . . . . . . .Refractive Index . . . . . . . . . . . . . . . . . . . . . . . .Specific Gravity . . . . . . . . . . . . . . . . . . . . . . . 96206.Functional Score.Sieving . . . . . . 320321321
��USP–NF General Chapters 27Specific Surface Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Spectrophotometry and Light-Scattering . . . . . . . . . . . . . . . . . . . . .Atomic Absorption Spectroscopy . . . . . . . . . . . . . . . . . . . . . . . . . .Fluorescence Spectroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Mid-Infrared Spectroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Ultraviolet-Visible Spectroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . .Thermal Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Uniformity of Dosage Units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Viscosity—Capillary Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Water Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Characterization of Crystalline and Partially Crystalline Solids by X-ray.Powder.Diffraction.(XRPD)General Information Chapters〈1005〉 Acoustic Emission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .〈1010〉 Analytical Data—Interpretation and Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .〈1032〉 Design a
DSC USP–NF General Chapters25 USP–NF General Chapters This section contains selected official general chapters that are reprinted from the USP.Only those USP chapters considered relevant for the analysis and/or manufacturing of dietary supplements are included in this section.
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