USP Dietary Supplements Compendium · PDF fileAdmission Criteria and Safety Classification for Dietary Supplements Guideline1 is performed for the sole ... process flow charts,

DSC Contents iii

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

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

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

USP–NF General Chapters . . . . . . . . . . . . . . . . . . . . 25

USP–NF Dietary Supplement Monographs . . . . . . 847

USP–NF 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 Dietary Supplements Admission Evaluations 1

Dietary Supplements Admission Evaluations

This section includes summaries for some of the admission evaluations completed by the USP Dietary Supplements Information Expert Committee [2005–2010] and by the USP Monographs—Dietary Supplements and Herbal Medicines Expert Committee [2010–2015] for commonly used dietary ingredients. USP’s admission evaluation of a dietary ingredient under the Admission Criteria and Safety Classification for Dietary Supplements Guideline1 is performed for the sole purpose of helping to inform the Dietary Supplement and Herbal Medicine Expert Committee’s determination whether to proceed with consideration for admission into the compendia and should not be relied upon as any finding about the intrinsic safety or effectiveness of the dietary supplement ingredient under review. Summaries of Admission Evaluations are available for articles that were cleared for monograph development. The following articles did not clear the admission review stage and are not undergoing monograph development: Natto Extract, Phyllanthus amarus Extract, and Calcium Magnesium Phytate. Additional information on these articles may be available upon request under USP’s document disclosure process.2

Introduction to Dietary Supplements Summary Admission Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Admission Criteria and Safety Classification for Dietary Supplements Guideline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8N-Acetyl-D-Glucosamine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Andrographis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Ashwagandha Root . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Astaxanthin Esters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Astragalus Root . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Aztec Marigold Zeaxanthin Extract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Bacopa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34Banaba Leaf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Beta Glucan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Black Cohosh. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Borage Seed Oil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Boswellia serrata . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Calcium l-5-Methyltetrahydrofolate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Centella asiatica. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Chinese Salvia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66Diosmin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72Evening Primrose Oil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Fenugreek . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82Flaxseed Lignans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Forskohlii . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91Ganoderma Lucidum Fruiting Body . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95Garcinia cambogia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101Garcinia indica. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Glutathione . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107Green Tea Extract, Powdered Decaffeinated. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 Guggul . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117Gymnema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120Holy Basil Leaf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1255-Hydroxy-L-tryptophan (5-HTP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

1 Available at http://www.usp.org/sites/default/files/usp_pdf/EN/dietarySupp/admissiondsguideline_vers_1.1.pdf2 Available at http://www.usp.org/sites/default/files/usp_pdf/EN/aboutUSP/document_disclosure.pdf

2 Dietary Supplements Admission Evaluations DSC

Krill Oil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135Maca . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139Malabar Nut Tree, Leaf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144Mangosteen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147Melatonin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149Menaquinone-7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154Methylcobalamin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160Noni . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164Northern Schisandra Fruit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169Phyllanthus amarus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174Rhodiola rosea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179Rosemary Leaf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184Spirulina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190Tienchi Ginseng Root and Rhizome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195meso-Zeaxanthin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

DSC USP Dietary Supplement Verification Program 205

USP Dietary Supplement Verification Program

USP conducts voluntary verification programs for manufacturers of dietary ingredients and dietary supplements. Through these programs, USP verifies the identity, strength, purity, and quality of ingredients and finished products. In this section, we include overviews, process flow charts, and checklists for these USP Dietary Supplement and Ingredient Verification Programs. This information is excerpted from the participant manuals for the verification programs. The complete and current version of the participant manual is available free of charge on the USP website at www.usp.org.

Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208Criteria for Participation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209Required Process and Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210Process Overview Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211USP-DSVP Product Category-Family Matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212Product Acceptance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214Evaluation of Initial Audit Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215Sampling and Submission of Product Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218Evaluation of Quality Control Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221Evaluation of Manufacturing Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225Testing of Product Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226Specifications for Dietary Supplement Raw Material and/or Finished Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228USP-DSVP Notification of Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231Issuance and Use of the USP Verified Program Mark Need for Re-Evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233Need for Re-Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235Participant’s Internal Audit and Annual Product Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237Market Surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239Appeals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242Product Recalls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245Forms and Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249

Checklist for Quality Control Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250Checklist for Manufacturing Documentation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253Checklist for On-Site Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255

Legal Notices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

DSC Dietary Supplements Regulatory Framework 283

Dietary Supplements Regulatory Framework

This section of the compendium contains excerpted information on U.S. federal legal and regulatory requirements that are pertinent to dietary ingredients and dietary supplements.

The publication of FDA guidances and other regulatory information in the USP Dietary Supplements Compendium is for informational purposes only and is not intended as legal advice or to impart any legal effect. Note that the information in this section may be revised from time to time, and it is the responsibility of the user to ascertain the most current version of these documents.

Federal Food, Drug, and Cosmetic Act Requirements Relating to Dietary Supplements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285

Good Manufacturing Practices for Dietary Supplements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321

Good Manufacturing Practices for Foods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 346

FDA Guidance for Industry: A Dietary Supplement Labeling Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 355

FDA Guidance for Industry: A Food Labeling Guide 12. Appendix D: Qualified Health Claims . . . . . . . . . . . . . . . . . . . 391

FDA Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 406

FDA Compliance Program Guidance Manual: Dietary Supplements—Import and Domestic . . . . . . . . . . . . . . . . . . . 439

FDA Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act . . . . . . . . . . . . . . 469

FDA Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements . . . . . . . . . . . . 480

Federal Trade Commission Act Requirements Relating to Dietary Supplements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 484

Dietary Supplements: An Advertising Guide for Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 492

California Safe Drinking Water and Toxic Enforcement Act of 1986 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .503

FDA Guidance for Industry Gluten-Free Labeling of Foods; Small Entity Compliance Guide . . . . . . . . . . . . . . . . . . . . . . . 505

FDA Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages . . . . . . . . . . . . . . . . . . . . . . . . . . . 510

DSC Tables of Dietary Intake Levels 517

Tables of Dietary Intake LevelsThis section contains an international comparison of Dietary Reference Intakes (DRIs), Recommended Daily Intakes (RDIs),

and Tolerable Upper Intake Levels (UL) of vitamins, minerals, and electrolytes for adults compiled by regulatory authorities and organizations.

Comparison Chart of Dietary Reference Intakes (DRIs [USA & Canada]) and Recommended Daily Intakes (RDAs/PRIs) of Vitamins, Minerals, and Electrolytes for Adults; Vitamins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 519

Comparison Chart of Dietary Reference Intakes (DRIs [USA & Canada]) and Recommended Daily Intakes (RDAs/PRIs) of Vitamins, Minerals, and Electrolytes for Adults; Minerals and Electrolytes. . . . . . . . . . . . . . . . . . . . . . . . . . 521

References for the Comparison Chart of Dietary Reference Intakes (DRIs [USA & Canada]) and Recommended Daily Intakes (RDAs/PRIs) of Vitamins, Minerals, and Electrolytes for Adults; Vitamins, Minerals, and Electrolytes. . . . . . . . . . . . 524

Tolerable Upper Intake Levels (UL) of Vitamins, Minerals, and Electrolytes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 526

DSC Guidance Documents 533

Guidance DocumentsThese ancillary documents have been provided by stakeholder organizations. USP acknowledges the American

Herbal Products Association, Natural Products Association, Consumer Health Products Association, and the Council for Responsible Nutrition for their contributions to this section.

Guidance for Manufacture and Sale of Bulk Botanical Extracts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 535Use of Marker Compounds in Manufacturing and Labeling Botanically Derived Dietary Supplements. . . . . . . . . . . . . . . 544Guidance for the Retail Labeling of Dietary Supplements Containing Soft or Powdered Botanical Extracts . . . . . . . . . . 550Standardization of Botanical Products: White Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 551AHPA-AHP Good Agricultural and Collection Practice for Herbal Raw Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 568Standardized Information on Dietary Ingredients (SIDI™) Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .585Shelf Life Dating of Botanical Supplement Ingredients and Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 607

DSC Illustrations 623

IllustrationsThis section contains additional information for selected articles generally organized in two sections: botanical characteris-

tics and chemical characteristics. The information provided in this section is not intended to impose any monograph require-ments and is not official text.

Botanical characteristics include macro/microscopic photographs and diagrams that are provided to aid in the interpreta-tions of pharmacopeial descriptions of plant materials. These photographs and diagrams are intended to help users in the identification of plant specimens and determination of contamination with closely related plant species.

Chemical characteristics include chemical structures of relevant constituents and marker compounds and chromatograms. The chromatograms are TLC color pictures and HPLC or GC of representative articles, provided to assist in the performance of compendial tests.

N-Acetylglucosamine . . . . . . . . . . . . . . . . . . . . . . . . . . 629CHEMICAL CHARACTERISTICS

a. Chemical Structures . . . . . . . . . . . . . . . . . . . . . . 629b. High Performance Liquid Chromatography . . . . 629

Ademetionine Disulfate Tosylatesee S-Adenosyl-L-methionine Disulfate Tosylate . . . . 1046

American Ginseng see Ginseng, American, Asian, and Tienchi . . . . . . . 888

Andrographis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 631BOTANICAL CHARACTERISTICS

a. Macroscopic Description . . . . . . . . . . . . . . . . . . 631b. Microscopic Description . . . . . . . . . . . . . . . . . . 632

CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . . 635b. Thin Layer Chromatography . . . . . . . . . . . . . . . 636c. High Performance Liquid Chromatography . . . . 638

Asian Ginseng see Ginseng, American, Asian, and Tienchi . . . . . . . 888

Ashwagandha Root . . . . . . . . . . . . . . . . . . . . . . . . . . . . 639BOTANICAL CHARACTERISTICS



Astaxanthin Esters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 645CHEMICAL CHARACTERISTICS


Astragalus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 647BOTANICAL CHARACTERISTICS



Aztec Marigold Zeaxanthin Extract . . . . . . . . . . . . . . . . 658CHEMICAL CHARACTERISTICS


Bacopa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 661BOTANICAL CHARACTERISTICS


CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . . 665b. Thin Layer Chromatography . . . . . . . . . . . . . . . 665

Banaba Leaf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 669BOTANICAL CHARACTERISTICS



Beta Carotene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 678CHEMICAL CHARACTERISTICS


Bilberry Extract, Powdered . . . . . . . . . . . . . . . . . . . . . . 680CHEMICAL CHARACTERISTICS

a. Chemical Structures . . . . . . . . . . . . . . . . . . . . . . 680b. Thin Layer Chromatography . . . . . . . . . . . . . . . 681c. High Performance Liquid Chromatography . . . . 683

Black Cohosh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 684BOTANICAL CHARACTERISTICS



Black Pepper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 693BOTANICAL CHARACTERISTICS



Borage Seed Oil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 700CHEMICAL CHARACTERISTICS

a. High Performance Thin Layer Chromatography . 700

624 Illustrations DSC

b. Gas Chromatography . . . . . . . . . . . . . . . . . . . . 701

Boswellia serrata . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 702BOTANICAL CHARACTERISTICS

a. Macroscopic Description . . . . . . . . . . . . . . . . . . 702CHEMICAL CHARACTERISTICS


Calcium L-5-Methyltetrahydrofolate . . . . . . . . . . . . . . . 710CHEMICAL CHARACTERISTICS


Capsicum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 713BOTANICAL CHARACTERISTICS


CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . . 716b. High Performance Liquid Chromatography . . . . 716

Cascara Sagrada . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 718BOTANICAL CHARACTERISTICS


CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . . 722

Cat’s Claw . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 723BOTANICAL CHARACTERISTICS



Centella asiatica . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 731BOTANICAL CHARACTERISTICS



Chamomile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 739BOTANICAL CHARACTERISTICS


CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . . 742b. Thin Layer Chromatography . . . . . . . . . . . . . . . 743c. High Performance Liquid Chromatography . . . . 745d. Gas Chromatography . . . . . . . . . . . . . . . . . . . . 746

Chaste Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 747BOTANICAL CHARACTERISTICS



Chinese Salvia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 754BOTANICAL CHARACTERISTICS



Chondroitin Sulfate Sodium . . . . . . . . . . . . . . . . . . . . . 763CHEMICAL CHARACTERISTICS


Cinnamomum cassia Bark . . . . . . . . . . . . . . . . . . . . . . . 765BOTANICAL CHARACTERISTICS



Cinnamomum verum Bark . . . . . . . . . . . . . . . . . . . . . . . 770BOTANICAL CHARACTERISTICS



Cod Liver Oil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 775CHEMICAL CHARACTERISTICS

a. Gas Chromatography . . . . . . . . . . . . . . . . . . . . . 775

Coenzyme Q see Ubidecarone . . . . . . . . . . . . . . . . . . . . . . . . . . 1091

Cranberry Liquid Preparation . . . . . . . . . . . . . . . . . . . . 776CHEMICAL CHARACTERISTICS


Cyanocobalamin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 778CHEMICAL CHARACTERISTICS


Diosmin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 780CHEMICAL CHARACTERISTICS


Echinacea angustifolia Root, Echinacea pallida Root, Echinacea purpurea Root and Echinacea purpureaAerial Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 782

BOTANICAL CHARACTERISTICSa. Macroscopic Description . . . . . . . . . . . . . . . . . . 782b. Microscopic Description . . . . . . . . . . . . . . . . . . 784


CHEMICAL CHARACTERISTICS a. Chemical Structures . . . . . . . . . . . . . . . . . . . . . . 795b. Thin Layer Chromatography . . . . . . . . . . . . . . . 796c. High Performance Liquid Chromatography . . . . 803

Eleuthero . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 808BOTANICAL CHARACTERISTICS



Elm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 814BOTANICAL CHARACTERISTICS


Evening Primrose Oil . . . . . . . . . . . . . . . . . . . . . . . . . . . 817CHEMICAL CHARACTERISTICS

a. Thin Layer Chromatography . . . . . . . . . . . . . . . 817b. Gas Chromatography . . . . . . . . . . . . . . . . . . . . 818

Fenugreek Seed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 819BOTANICAL CHARACTERISTICS



Feverfew . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 827BOTANICAL CHARACTERISTICS



Fish Oil Containing Omega-3 Acids . . . . . . . . . . . . . . . 834CHEMICAL CHARACTERISTICS

a. Gas Chromatography . . . . . . . . . . . . . . . . . . . . . 834

Flax Seed Oil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 836CHEMICAL CHARACTERISTICS

a. Thin Layer Chromatography . . . . . . . . . . . . . . . 836b. Gas Chromatography . . . . . . . . . . . . . . . . . . . . 837

Forskohlii . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 838BOTANICAL CHARACTERISTICS



Ganoderma Lucidum Fruiting Body . . . . . . . . . . . . . . . 844BOTANICAL CHARACTERISTICS



Garcinia cambogia and Garcinia indica . . . . . . . . . . . . . . . 852BOTANICAL CHARACTERISTICS



Garlic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 860BOTANICAL CHARACTERISTICS



Ginger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 869BOTANICAL CHARACTERISTICS



Ginkgo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 876BOTANICAL CHARACTERISTICS



Ginseng, American, Asian, and Tienchi . . . . . . . . . . . . . 888BOTANICAL CHARACTERISTICS



Goldenseal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 904BOTANICAL CHARACTERISTICS



Grape Seeds Oligomeric Proanthocyanidins . . . . . . . . . 909CHEMICAL CHARACTERISTICS

a. Chemical Structures . . . . . . . . . . . . . . . . . . . . . . 909


b. Thin Layer Chromatography . . . . . . . . . . . . . . . 910c. High Performance Liquid Chromatography . . . . 911

Green Tea Extract, Powdered Decaffeinated . . . . . . . . . 914CHEMICAL CHARACTERISTICS


Guggul . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 919BOTANICAL CHARACTERISTICS

a. Macroscopic Description . . . . . . . . . . . . . . . . . . 919CHEMICAL CHARACTERISTICS


Gymnema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 923BOTANICAL CHARACTERISTICS



Hawthorn Leaf with Flower . . . . . . . . . . . . . . . . . . . . . . 930BOTANICAL CHARACTERISTICS



Holy Basil Leaf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 940BOTANICAL CHARACTERISTICS



Horse Chestnut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 948BOTANICAL CHARACTERISTICS



Hydroxocobalamin . . . . . . . . . . . . . . . . . . . . . . . . . . . . 954CHEMICAL CHARACTERISTICS


Krill Oil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 956CHEMICAL CHARACTERISTICS

a. Chemical Structures . . . . . . . . . . . . . . . . . . . . . . 956b. Gas Chromatography . . . . . . . . . . . . . . . . . . . . 957

Licorice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 958BOTANICAL CHARACTERISTICS



Lutein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 966CHEMICAL CHARACTERISTICS


Lycopene and Tomato Extract Containing Lycopene . . . 968CHEMICAL CHARACTERISTICS


Malabar Nut Tree, Leaf . . . . . . . . . . . . . . . . . . . . . . . . . 972BOTANICAL CHARACTERISTICS



Maritime Pine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 979BOTANICAL CHARACTERISTICS


CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . . 981b. High Performance Liquid Chromatography . . . . 982

Melatonin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 983CHEMICAL CHARACTERISTICS


Menaquinone-7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 985CHEMICAL CHARACTERISTICS


Methylcobalamin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 988CHEMICAL CHARACTERISTICS


Milk Thistle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 991BOTANICAL CHARACTERISTICS



Myrrh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 997BOTANICAL CHARACTERISTICS

a. Macroscopic Description . . . . . . . . . . . . . . . . . . 997



Nettle see Stinging Nettle . . . . . . . . . . . . . . . . . . . . . . . . 1077

Northern Schisandra . . . . . . . . . . . . . . . . . . . . . . . . . . 1002BOTANICAL CHARACTERISTICS

a. Macroscopic Description . . . . . . . . . . . . . . . . . 1002b. Microscopic Description . . . . . . . . . . . . . . . . . 1003

CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . 1005b. Thin Layer Chromatography . . . . . . . . . . . . . . 1006c. High Performance Liquid Chromatography . . . 1007

Phyllanthus amarus . . . . . . . . . . . . . . . . . . . . . . . . . . . 1008BOTANICAL CHARACTERISTICS



Plantago Seed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1013BOTANICAL CHARACTERISTICS


Pygeum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1016BOTANICAL CHARACTERISTICS


CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . 1019b. Gas Chromatography . . . . . . . . . . . . . . . . . . . 1019c. High Performance Liquid Chromatography . . . 1020

Quercetin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1021CHEMICAL CHARACTERISTICS

a. Chemical Structures . . . . . . . . . . . . . . . . . . . . . 1021b. High Performance Liquid Chromatography . . . 1021

Red Clover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1023BOTANICAL CHARACTERISTICS


CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . 1025b. High Performance Thin Layer Chromatography 1026c. High Performance Liquid Chromatography . . . 1028

Rhodiola rosea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1029BOTANICAL CHARACTERISTICS



Rosemary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1035BOTANICAL CHARACTERISTICS



Rutin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1044CHEMICAL CHARACTERISTICS


S-Adenosyl-L-methionine Disulfate Tosylate . . . . . . . . 1046CHEMICAL CHARACTERISTICS


St. John’s Wort . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1048BOTANICAL CHARACTERISTICS



SAMe see S-Adenosyl-L-methionine Disulfate Tosylate . . . 1046

Saw Palmetto . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..1057BOTANICAL CHARACTERISTICS


CHEMICAL CHARACTERISTICSa. Gas Chromatography . . . . . . . . . . . . . . . . . . . . 1061

Senna Leaf and Pods . . . . . . . . . . . . . . . . . . . . . . . . . . 1063BOTANICAL CHARACTERISTICS


CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . 1069

Siberian Ginsengsee Eleuthero . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 808

Slippery Elmsee Elm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 814

Soy Isoflavones . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1070CHEMICAL CHARACTERISTICS


Spirulina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1072BOTANICAL CHARACTERISTICS



CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . 1074b. Gas Chromatography . . . . . . . . . . . . . . . . . . . 1075

Stinging Nettle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1077BOTANICAL CHARACTERISTICS


CHEMICAL CHARACTERISTICSa. Chemical Structures . . . . . . . . . . . . . . . . . . . . . 1080b. Thin Layer Chromatography . . . . . . . . . . . . . . 1080c. Gas Chromatography . . . . . . . . . . . . . . . . . . . . 1082d. High Performance Liquid Chromatography . . . 1083

Turmeric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1084BOTANICAL CHARACTERISTICS



Ubidecarenone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1091CHEMICAL CHARACTERISTICS


Valerian. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1093BOTANICAL CHARACTERISTICS



Vinpocetine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1101CHEMICAL CHARACTERISTICS


Wheat Bran . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1103BOTANICAL CHARACTERISTICS


meso-Zeaxanthin . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1106CHEMICAL CHARACTERISTICS
