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  • 2015Dietary Supplements Compendium

    DSC

    Volume 1

    General Notices and Requirements

    USPNF General Chapters

    USPNF Dietary Supplement Monographs

    USPNF 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 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 Compendium

    Attention 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 Convention ISBN: 978-1-936424-41-212601 Twinbrook Parkway, Rockville, MD 20852All rights reserved.

  • DSC Contents iii

    Volume 1Members . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .v

    Mission and Preface . . . . . . . . . . . . . . . . . . . . . . . . . . 1

    General Notices and Requirements . . . . . . . . . . . . . . 9

    USPNF General Chapters . . . . . . . . . . . . . . . . . . . . 25

    USPNF Dietary Supplement Monographs . . . . . . 847

    USPNF Excipient Monographs . . . . . . . . . . . . . . 1723

    FCC General Provisions . . . . . . . . . . . . . . . . . . . . 1937

    FCC Monographs . . . . . . . . . . . . . . . . . . . . . . . . . 1947

    FCC Identity Standards . . . . . . . . . . . . . . . . . . . . 2227

    FCC Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . 2235

    Reagents, Indicators, and Solutions . . . . . . . . . . 2413

    Reference Tables . . . . . . . . . . . . . . . . . . . . . . . . . 2513

    Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1

    USP Reference Standards Index . . . . . . . . . . . . . . I-35

    Volume 2Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

    Dietary Supplements Admission Evaluations . . . . . . .1

    USP Dietary Supplement VerificationProgram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .205

    Dietary Supplements Regulatory Framework . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .283

    Tables of Dietary Intake Levels . . . . . . . . . . . . . . . .517

    Guidance Documents . . . . . . . . . . . . . . . . . . . . . . . .533

    Illustrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .623

    Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .I-1

    Contents

    USP Dietary Supplements Compendium

  • DSC General Notices 11

    General Notices and Requirements

    Applying to Standards, Tests,Assays, and Other Specifications

    of the United States Pharmacopeia

    6.50. Preparation of Solutions . . . . . . . . . . . . . . . . . . 171. Title and Revision . . . . . . . . . . . . . . . . . . . . . . 136.60. Units Necessary to Complete a Test . . . . . . . . . 186.70. Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

    2. Official Status and Legal 6.80. Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Recognition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132.10. Official Text . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 7. Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182.20. Official Articles . . . . . . . . . . . . . . . . . . . . . . . . 13 7.10. Interpretation of Requirements . . . . . . . . . . . . . 182.30. Legal Recognition . . . . . . . . . . . . . . . . . . . . . . 13 7.20. Rounding Rules . . . . . . . . . . . . . . . . . . . . . . . . 19

    3. Conformance to Standards . . . . . . . . . . . . 13 8. Terms and Definitions . . . . . . . . . . . . . . . . . 193.10. Applicability of Standards . . . . . . . . . . . . . . . . . 13 8.10. Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 193.20. Indicating Conformance . . . . . . . . . . . . . . . . . . 14 8.20. About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198.30. Alcohol Content . . . . . . . . . . . . . . . . . . . . . . . 19

    4. Monographs and General Chapters . . . 14 8.40. Atomic Weights . . . . . . . . . . . . . . . . . . . . . . . 194.10. Monographs . . . . . . . . . . . . . . . . . . . . . . . . . . 14 8.50. Blank Determinations . . . . . . . . . . . . . . . . . . . 194.20. General Chapters . . . . . . . . . . . . . . . . . . . . . . . 15 8.60. Concomitantly . . . . . . . . . . . . . . . . . . . . . . . . 19

    8.70. Desiccator . . . . . . . . . . . . . . . . . . . . . . . . . . . 198.80. Logarithms . . . . . . . . . . . . . . . . . . . . . . . . . . . 195. Monograph Components . . . . . . . . . . . . . . 15 8.90. Microbial Strain . . . . . . . . . . . . . . . . . . . . . . . 195.10. Molecular Formula . . . . . . . . . . . . . . . . . . . . . . 15 8.100. Negligible . . . . . . . . . . . . . . . . . . . . . . . . . . . 205.20. Added Substances . . . . . . . . . . . . . . . . . . . . . . 15 8.110. NLT/NMT . . . . . . . . . . . . . . . . . . . . . . . . . . . 205.30. Description and Solubility . . . . . . . . . . . . . . . . . 16 8.120. Odor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205.40. Identity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 8.130. Percent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205.50. Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 8.140. Percentage Concentrations . . . . . . . . . . . . . . . 205.60. Impurities and Foreign Substances . . . . . . . . . . 16 8.150. Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205.70. Performance Tests . . . . . . . . . . . . . . . . . . . . . . 17 8.160. Reaction Time . . . . . . . . . . . . . . . . . . . . . . . . 205.80. USP Reference Standards . . . . . . . . . . . . . . . . . 17 8.170. Specific Gravity . . . . . . . . . . . . . . . . . . . . . . . 208.180. Temperatures . . . . . . . . . . . . . . . . . . . . . . . . 208.190. Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206. Testing Practices and Procedures . . . . . 178.200. Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206.10. Safe Laboratory Practices . . . . . . . . . . . . . . . . . 178.210. Vacuum . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206.20. Automated Procedures . . . . . . . . . . . . . . . . . . . 178.220. Vacuum Desiccator . . . . . . . . . . . . . . . . . . . . 206.30. Alternative and Harmonized Methods and8.230. Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 178.240. Weights and Measures . . . . . . . . . . . . . . . . . . 206.40. Dried, Anhydrous, Ignited, or Solvent-

    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 . . . . . . . . . . . . . . . . . . . . . . . . . 229.20 Changes in Volume . . . . . . . . . . . . . . . . . . . . . . 21 10.10. Packaging and Storage . . . . . . . . . . . . . . . . . . 22

    10.40. Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

    Official text. Reprinted from First Supplement to USP38-NF33.

  • DSC USPNF General Chapters 25

    USPNF General ChaptersThis 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 dedicatedto dietary supplements are numbered above 2000.

    General Requirements for Tests and Assays2 Oral Drug ProductsProduct Quality Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2911 USP Reference Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

    Apparatus for Tests and Assays21 Thermometers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3631 Volumetric Apparatus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3741 Balances . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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