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2015 Dietary Supplements Compendium DSC Volume 1 General Notices and Requirements USP–NF General Chapters USP–NF Dietary Supplement Monographs USP–NF Excipient Monographs FCC General Provisions FCC Monographs FCC Identity Standards FCC Appendices Reagents, Indicators, and Solutions Reference Tables DSC217M_DSCVol1_Title_2015-01_V3.indd 1 2/2/15 12:18 PM 2 Notice and Warning Concerning U.S. Patent or Trademark Rights The inclusion in the USP Dietary Supplements Compendium of a monograph on any dietary supplement in respect to which patent or trademark rights may exist shall not be deemed, and is not intended as, a grant of, or authority to exercise, any right or privilege protected by such patent or trademark. All such rights and privileges are vested in the patent or trademark owner, and no other person may exercise the same without express permission, authority, or license secured from such patent or trademark owner. Concerning Use of the USP Dietary Supplements Compendium Attention is called to the fact that USP Dietary Supplements Compendium text is fully copyrighted. Authors and others wishing to use portions of the text should request permission to do so from the Legal Department of the United States Pharmacopeial Convention. Copyright © 2015 The United States Pharmacopeial Convention ISBN: 978-1-936424-41-2 12601 Twinbrook Parkway, Rockville, MD 20852 All rights reserved. DSC Contents iii Contents USP Dietary Supplements Compendium Volume 1 Volume 2 Members . v. Preface . v Mission and Preface . 1 Dietary Supplements Admission Evaluations . 1. General Notices and Requirements . 9 USP Dietary Supplement Verification Program . .205 USP–NF General Chapters . 25 Dietary Supplements Regulatory USP–NF Dietary Supplement Monographs . 847 Framework . .283 USP–NF Excipient Monographs . 1723 Tables of Dietary Intake Levels . .517 FCC General Provisions . 1937 Guidance Documents . .533 FCC Monographs . 1947 Illustrations . .623 FCC Identity Standards . 2227 Index . .I-1 FCC Appendices . 2235 Reagents, Indicators, and Solutions . 2413 Reference Tables . 2513 Index . I-1 USP Reference Standards Index . I-35 DSC General Notices 11 General Notices and Requirements Applying to Standards, Tests, Assays, and Other Specifications of the United States Pharmacopeia 1. Title and Revision ...................... 13 6.50. Preparation of Solutions .................. 17 6.60. Units Necessary to Complete a Test ......... 18 6.70. Reagents ............................. 18 2. Official Status and Legal 6.80. Equipment ........................... 18 Recognition ............................. 13 2.10. Official Text ........................... 13 2.20. Official Articles ........................ 13 7. Test Results ............................ 18 2.30. Legal Recognition ...................... 13 7.10. Interpretation of Requirements ............. 18 7.20. Rounding Rules ........................ 19 3. Conformance to Standards ............ 13 3.10. Applicability of Standards ................. 13 8. Terms and Definitions ................. 19 3.20. Indicating Conformance .................. 14 8.10. Abbreviations ......................... 19 8.20. About .............................. 19 8.30. Alcohol Content ....................... 19 4. Monographs and General Chapters ... 14 8.40. Atomic Weights ....................... 19 4.10. Monographs .......................... 14 8.50. Blank Determinations ................... 19 4.20. General Chapters ....................... 15 8.60. Concomitantly ........................ 19 8.70. Desiccator ........................... 19 8.80. Logarithms ........................... 19 5. Monograph Components .............. 15 8.90. Microbial Strain ....................... 19 5.10. Molecular Formula ...................... 15 8.100. Negligible ........................... 20 5.20. Added Substances ...................... 15 8.110. NLT/NMT ........................... 20 5.30. Description and Solubility ................. 16 8.120. Odor .............................. 20 5.40. Identity .............................. 16 8.130. Percent ............................. 20 5.50. Assay ............................... 16 8.140. Percentage Concentrations ............... 20 5.60. Impurities and Foreign Substances .......... 16 8.150. Pressure ............................ 20 5.70. Performance Tests ...................... 17 8.160. Reaction Time ........................ 20 5.80. USP Reference Standards ................. 17 8.170. Specific Gravity ....................... 20 8.180. Temperatures ........................ 20 6. Testing Practices and Procedures ..... 17 8.190. Time ............................... 20 6.10. Safe Laboratory Practices ................. 17 8.200. Transfer ............................. 20 6.20. Automated Procedures ................... 17 8.210. Vacuum ............................ 20 6.30. Alternative and Harmonized Methods and 8.220. Vacuum Desiccator .................... 20 Procedures ........................... 17 8.230. Water .............................. 20 6.40. Dried, Anhydrous, Ignited, or Solvent- 8.240. Weights and Measures .................. 20 Free Basis ............................ 17 Official text. Reprinted from First Supplement to USP38-NF33. 12 General Notices DSC 9. Prescribing and Dispensing ............ 21 10. Preservation, Packaging, Storage, 9.10 Use of Metric Units ...................... 21 and Labeling ......................... 22 9.20 Changes in Volume ...................... 21 10.10. Packaging and Storage .................. 22 10.40. Labeling ............................ 23 Official text. Reprinted from First Supplement to USP38-NF33. DSC USP±NF General Chapters 25 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. Chapters specifically dedicated to dietary supplements are numbered above 2000. General Requirements for Tests and Assays 〈2〉 Oral Drug ProductsÐProduct Quality Tests ..................................................... 29 〈11〉 USP Reference Standards ................................................................. 34 Apparatus for Tests and Assays 〈21〉 Thermometers ........................................................................ 36 〈31〉 Volumetric Apparatus .................................................................... 37 〈41〉 Balances ............................................................................. 38 Microbiological 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 .................... 48 Biological Tests and Assays 〈91〉 Calcium Pantothenate Assay ............................................................... 55 〈111〉 Design and Analysis of Biological Assays ..................................................... 57 〈115〉 Dexpanthenol Assay ................................................................... 72 〈171〉 Vitamin B12 Activity Assay ................................................................ 74 Chemical Tests and Assays: Identification Tests 〈181〉 IdentificationÐOrganic Nitrogenous Bases ................................................... 77 〈191〉 Identification TestsÐGeneral .............................................................. 77 〈197〉 Spectrophotometric Identification Tests ...................................................... 80 〈201〉 Thin-Layer Chromatographic Identification Test ................................................ 81 〈202〉 Identification of Fixed Oils by Thin-Layer Chromatography ........................................ 82 〈203〉 High-Performance Thin-Layer Chromatography Procedure for Identification Of Articles Of Botanical Origin ..... 84 Limit Tests 〈206〉 Aluminum ........................................................................... 86 〈211〉 Arsenic ............................................................................. 86 〈221〉 Chloride and Sulfate ................................................................... 88 〈228〉 Ethylene Oxide and Dioxane ............................................................. 89 〈231〉 Heavy Metals ........................................................................ 91 〈233〉 Elemental Impurities - Procedures .......................................................... 93 〈241〉 Iron ............................................................................... 97 〈251〉 Lead ............................................................................... 98 〈261〉 Mercury ............................................................................ 99 〈271〉 Readily Carbonizable Substances Test ...................................................... 101 〈281〉 Residue on Ignition ................................................................... 101 〈291〉 Selenium .......................................................................... 102 Other Tests and Assays 〈301〉 Acid-Neutralizing Capacity .............................................................. 103 〈311〉 Alginates Assay ...................................................................... 104 〈341〉 Antimicrobial AgentsÐContent ........................................................... 105 〈345〉 Assay for Citric Acid/Citrate and Phosphate .................................................
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