American Herbal Pharmacopoeia ® Cannabis Inflorescence Editors and Technical Advisors Cannabis spp. Roy Upton RH DAyu American Herbal Pharmacopoeia® Scotts Valley, CA Lyle Craker PhD PAGES University of Massachusetts Standards of Identity,MONOGRAPH Analysis, and Amherst, MA Quality Control 64 Mahmoud ElSohly PhD University of Mississippi University, MS Aviva Romm MD CPM American Herbal Pharmacopoeia® Lennox, MA Ethan Russo MD COMPLETE GW Pharmaceuticals Salisbury, UK OF MONOGRAPH Michelle Sexton ND BS Americans for Safe Access Washington, DC The Center for the Study of Cannabis and Social Policy Seattle, WA Research PREVIEWAssociates Jahan Marcu PhD Green Standard DiagnosticsCOMPLETE Henderson, NV Diana Swisher MA American Herbal Pharmacopoeia® Scotts Valley, CA Table of Contents Nomenclature 2 Constituents 32 Botanical Nomenclature Botanical Family Pharmaceutical Nomenclature Analytical 40 Pharmacopoeial Definition Thin-Layer Chromatography (TLC) Common Names High Performance Liquid Chromatography (HPLC) Gas Chromatography with Flame Ionization Detection (GC-FID) Limit Tests Identification 2 Foreign Organic Matter Botanical Identification Total Ash Macroscopic Identification Acid-insoluble Ash Organoleptic Characterization Loss on Drying Microscopic Identification Pesticide Limits Microbial and Fungal Limits Metal Limits Commercial Sources and Handling 18 Solvent Residues Sourcing Cultivation Harvest Drying International Status 51 Packaging Storage Natural Contaminants and Adulterants References 55 Qualitative Differentiation Sustainability and Environmental Impact Documentation of Supply Growing and Harvesting Guidelines PAGES Security MONOGRAPH Suppliers and Dispensaries 64 COMPLETE Legal Notification The following Standards of Identity,OF Analysis, and Quality Control of Cannabis are intended to provide scientifi- cally valid methods for the analysis of cannabisMONOGRAPH and its preparations that can be used to comply with state and federal regulations and policies. The analytical methods were obtained from peer reviewed literature, have been used as part of international or federal monitoring programs for cannabis, and have been verified for their scientific validity. Methods other than those presented in this monograph may be scientifically valid and provide reliable results. However, all methods must be verified as being scientifically valid prior to use for regulatory compliance. In the United States, cannabis is a Schedule I controlled substance under federal law; therefore, any use or pos- session of cannabis and its preparations is illegal except pursuant to the compassionate use Investigational New Drug exemption.PREVIEW These standards are not intended to support, encourage or promote the illegal cultivation, use, trade, or commerce of cannabis. Individuals, entities and institutions intending to possess or utilize cannabis and its preparationsCOMPLETE should consult with legal counsel prior to engaging in any such activity. The citing of any commercial names or products does not and should not be construed as constituting an endorse- ment by the American Herbal Pharmacopoeia. Additionally, the reliability, and therefore ability to comply with state or federal regulations, of any conclusions drawn from the analysis of a sample is dependent upon the test sample accurately representing the entire batch. Therefore, when performing all analytical tests, a formal sampling program must be employed. American Herbal Pharmacopoeia® • Cannabis Inflorescence and Leaf • 2013 1 Authors Analytical Washington State Department of Elizabeth Williamson PhD Thin-Layer Chromatography (TLC) Agriculture University of Reading Botanical Identification Gas Chromatography (GC) Olympia, WA Reading, UK Mahmoud ElSohly PhD Mahmoud ElSohly PhD James Kababick Hugh Watson Suman Chandra PhD Desmond Slade PhD Mohammed M Radwan PhD Flora Research Laboratories Marijuana Agricultural Chemical Hemant Lata PhD Grants Pass, OR Specialist University of Mississippi University of Mississippi University, MS Washington State Liquor Control University, MS ao Prof Dr Liselotte Kren Board Macroscopic Identification University of Vienna Olympia, WA High Performance Liquid Vienna, Austria Suman Chandra PhD Chromatography (HPLC) Hemant Lata PhD Kong M Li PhD Prof Dr Reinhard Länger Final Reviewers Mahmoud ElSohly PhD University of Sydney AGES Pharm Med Giovanni Appendino Laurea University of Mississippi Sydney, NSW Vienna, Austria Department of Pharmaceutical University, MS Sciences Microscopic Identification Reviewers Etienne de Meijer University of the Eastern Piedmont GW Pharmaceuticals Novara, Italy Suman Chandra PhD Wendy Appplequist PhD Salisbury, UK Hemant Lata PhD Missouri Botanical Gardens Vincenzo Di Marzo PhD Mahmoud ElSohly PhD St. Louis, MO David Potter PhD Endocannabinoid Research Group University of Mississippi GW Pharmaceuticals (ERG) University, MS Paula Brown PhD Salisbury, UK Institute of Biomolecular Chemistry British Columbia Institute of (ICB) Elizabeth Williamson PhD Technology (BCIT) Eike Reich PhD Consiglio Nazionale delle Ricerche University of Reading British Columbia, Canada CAMAG (CNR) Reading, UK Muttenz, Switzerland Pozzuoli (NA), Italy Rudolf Brenneisen Commercial Sources and University of Bern Handling Jeanette Roberts PhD MPH Raphael Mechoulam PhD Bern, Switzerland University of Wisconsin Hebrew University of Jerusalem Suman Chandra PhD Madison, WI Jerusalem, Israel Hemant Lata PhD Mike Corral PAGES University of Mississippi Wo/Men’s Alliance for Medical Steph Sherer Jonathan Page PhD University, MS Marijuana Americans for SafeMONOGRAPH Access (ASA) National Research Council Santa Cruz, CA Washington, DC Saskatoon, Canada Roy Upton RH DAyu 64 American Herbal Pharmacopoeia Staci Eisner Bill Schoenbart LAc OMD Ethan Russo MD Scotts Valley, CA Cannabis Committee Five Branches University GW Pharmaceuticals American Herbal Products Santa Cruz, CA Salisbury, United Kingdom Constituents Association Mahmoud ElSohly PhD Silver Spring, MD Amala Soumyanath PhD Maged Sharaf PhD Desmond Slade PhD Oregon Health and Science American Herbal Products University of Mississippi Daniel Harder PhD University Association School of Pharmacy Museum of Natural History Portland, OR Silver Spring, MD University, MS Santa Cruz, CA Elan Sudberg Michael Steenhout Erik W Johansen Costa Mesa, CA Washington State Liquor Control Special Pesticide RegistrationCOMPLETE Board Program Coordinator Olympia, WA ISBN: 1-929425-33-3 ISSN: 1538-0297 OFMedical Disclaimer Design & Layout © 2013 American Herbal Pharmacopoeia® The informationMONOGRAPH contained in this monograph Michael Parisi PO Box 66809, Scotts Valley, CA 95067 USA represents a synthesis of the authoritative scien- Aptos, CA tific and traditional data. All efforts have been Cover Photograph All rights reserved. No part of this monograph made to ensure the accuracy of the information may be reproduced, stored in a retrieval system, and findings presented. Those seeking to utilize Cannabis cultivated under the Compassionate or transmitted in any form or by any means with- botanicals as part of a health care program should Investigational New Drug program at the University out written permission of the American Herbal do so under the guidance of a qualified health care of Mississippi administered by the National ® Pharmacopoeia . professional. Institute on Drug Abuse (NIDA). Photograph ® courtesy of: University of Mississippi. The American Herbal Pharmacopoeia is a Statement of Nonendorsement nonprofit corporation 501(c)(3). To purchase monographs or botanical and chemical refer- Reporting on the use of proprietary products ence standards, PREVIEWcontact the American Herbal reflects studies conducted with them and is not Pharmacopoeia® • PO Box 66809 • Scotts Valley, meant to be a product endorsement. CA 95067 • USA • (831) 461-6318 or visit the AHP website at www.herbal-ahp.org.COMPLETE American Herbal Pharmacopoeia® PO Box 66809 Scott’s Valley, CA 95067 831-461-6318 www.herbal-ahp.org [email protected] American Herbal Pharmacopoeia® • Cannabis Inflorescence and Leaf • 2013 2f. PAGES MONOGRAPH2g. 64 COMPLETE 2e. 2h. Figure 2 (continued) Botanical characteristicsOF of cannabisMONOGRAPH inflorescences 2e. Maturing female inflorescence showing young yellow styles and stigmas (often referred to as “pistils”). 2f. Close-up of maturing female inflorescence showing young yellow styles and stigmas senescing brown and shriveling and an abundance of glandular trichomes. 2g. Female inflorescence with senesced reddish-brown styles and stigmas, an indicator of inflorescence maturity. 2h. Close-up of female inflorescence with senesced reddish-brown styles and stigmas. hemp, narrow-leaf drug, etc. to account for the plasticity (male and female flowers occur on separate plants) and representedPREVIEW in the genus. rarely monoecious (male and female flowers occur on the Cannabis is a member of the Cannabaceae family, same plant). Monoecious plants are often referred to as together with anotherCOMPLETE well-known member of the family, “hermaphrodites.” True hermaphrodites bear bisexual flow- hops (Humulus). The family has recently been expanded ers and are less common, whereas monoecious plants bear to contain 9 other genera (Stevens 2001). The following unisexual male and female flowers at different locations on describes the published range of morphological diversity the plant. Staminate (male) plants tend to be taller but less within plants recognized as Cannabis spp. robust than pistillate (female) plants. Height