Analytical Testing and Quality Assurance for Cannabis

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1 Analytical Testing and Quality Assurance for Cannabis Anthony Smith, Ph.D Kenevir Research, 2016

2 Analytical Testing and Quality Assurance for Cannabis 1. Cannabis is a complex matrix 2. What is the role of testing labs? 3. Contaminants in Cannabis 4. Cannabis assays and endpoints 5. Laboratory QA, accreditation, proficiency testing 6. Value in lab testing Kenevir Research, 2016

3 Cannabis Inflorescence is a Complex Matrix. Sesquiterpenes Terpenes Flavonoids Sugars Fats Lignin Starches Cannabinoids Pigments Chlorophyll Waxes Pectins Cellulose Kenevir Research, 2016

4 Cannabis Inflorescence is a Complex Matrix. Sesquiterpenes Terpenes Flavonoids Sugars Fats Lignin Starches Cannabinoids Pigments Chlorophyll Waxes Pectins Cellulose Kenevir Research, 2016

5 Cannabis Inflorescence is a Complex Matrix. Cannabis Plant Material Terpenes, Terpenoids, Flavonoids, Pigments, Sugars, Chlorophyll, Fats, Waxes, Lignin, Pectins, Starches, Cellulose Essential Oils ( Hash oil & resin concentrates) Terpenes, Terpenoids, Flavonoids, Pigments, Fats, Waxes Semi- Purified Cannabinoids THC-A, THC, CBD-A, CBD, CBN and trace cannabinoids Kenevir Research, 2016

6 Cannabis Inflorescence is a Complex Matrix. Cannabis Plant Material Terpenes, Terpenoids, Flavonoids, Pigments, Sugars, Chlorophyll, Fats, Waxes, Lignin, Pectins, Starches, Cellulose Hundreds of mixed individual compounds complex, by nature Myriad potential for contaminants Ag & Industrial processes Welcome to natural products research the matrix is unique, but the need for standardization is not! Kenevir Research, 2016

The Push for Standardization in Cannabis Testing

Mycotoxins Residual Solvents Kenevir Research,

7 The Push for Standardization in Cannabis Testing Moisture Content THC Potency Cannabinoid Profile Terpene Profile Pesticide/Herbicide Screening Heavy Metals Microbiological Screening Mycotoxins Residual Solvents Kenevir Research, 2016 Courtesy of: Creative Commons 2016, creativecommons.org

8 Why Standardize? Commercialization of both recreational and medicinal cannabis products requires standardization Standardization ensures consumer confidence, product efficacy and consistency Standardization brings credibility to new products and markets Facilitates development of new products and technologies Quality Assurance safety, cost and process control Kenevir Research, 2016

9 What would we standardize? Batch size specification Sampling and testing frequency Sample preparation Certified reference standards Standard operating procedures (SOPs) Instrumentation Proficiency testing & accreditation Action levels for contaminants (pesticides, metals, mycotoxins, microbial load, by-products) Kenevir Research, 2016 Courtesy of: Creative Commons 2016, creativecommons.org

10 Issues: Marijuana remains a DEA Schedule 1 drug and is not recognized as a useable commodity, food or drug by Federal regulators States must devise their own regulations for cannabis production, Quality Assurance and standardization Sample preparation Commercial adulterants (pesticides, PGRs, synthetic cannabinoids) Kenevir Research, 2016 Courtesy of: Creative Commons 2016, creativecommons.org

Fungi, Bacteria, Mycotoxins, Endotoxins Agrochemical

11 Contaminants in Cannabis Sources of Pollution/Contamination: Biological Contaminants Fungi, Bacteria, Mycotoxins, Endotoxins Agrochemical Agents Pesticides, Herbicides, Fumigants, PGRs Organic Solvents Heavy Metals

12 Biological Contaminants Fungi Mycotoxins Powdery Mildew Bacteria Bacterial Endotoxins Salmonella

13 Fungal Contaminants Molds Mold, potentially Aspergillus Yeasts

Agrochemical Agents - Pesticides Insecticide

synthetic compounds that mimic pyrethrins

14 Agrochemical Agents - Pesticides Insecticide Major Classes: -Carbamates: Nonpersistent central nervous system (CNS) disrupter -Organochlorines (Chlorinated Hydrocarbons): persistent compounds that disrupt CNS -Organophosphates: mostly nonpersistent compounds that disrupt CNS -Pyrethroids: synthetic compounds that mimic pyrethrins from chrysanthemum flowers

15 Agrochemical Agents - Pesticides The presence of pesticides might arise from sprays during growth, soil treatments before cultivation, or fumigation before or during drying and storage. Organochlorines and some organophosphates persist in the environment for long periods of time and can cause recurring contaminations of plants grown in contaminated soil or water. DDT, a persistent organochlorine pesticide

Spinosad Azadirachtin Α-Limonene Myclobutanil Fungicides:

16 Agrochemical Agents Unclassed pesticides, fungicides, PGRs Pesticides: Imidocloprid Bifenazate Abemectin Natural Pesticides Spinosad Azadirachtin Α-Limonene Myclobutanil Fungicides: Myclobutanil Azoxystrobin Trifloxistrobin PGRs: Paclobutrazol Chlormequat Daminozide

17 Concentrate quality & safety: Propoxur Bifenazate Imidacloprid THC Malathion Kenevir Research, 2016 Carbaryl Bifenthrin

18 Concentrate quality & safety: Propoxur Bifenazate Imidacloprid Malathion Kenevir Research, 2016 Carbaryl Bifenthrin

19 Concentrate quality & safety: Kenevir Research, 2016 Source:

20 Concentrate quality & safety: Kenevir Research, 2016 Source:

21 Seriously!?

22 Putting Things into Perspective Individuals with healthy immune systems can encounter many different toxins without experiencing ill health effects. Chronic exposure to a toxin is often the cause of negative health effects. Immuno-compromised individuals treating health problems with medicinal herbs should verify that the product has been produced according to a quality assurance system and has been tested for contaminants by a third-party laboratory.

23 Harm Reduction Prevention is Primary Contamination should be avoided and controlled through quality assurance measures such as good agricultural and collection practice (GACP) for medicinal plants, and good manufacturing practices (GMP) for herbal medicines. World Health Organization

24 Industry evolution: Courtesy of Cindy Orser, Digipath Labs; Emerald Conference, 2016

25 Basic QA tests for Cannabis: Moisture Content THC Potency Cannabinoid Profile Terpene Profile Pesticide/Herbicide Screening Heavy Metals Microbiological Screening Mycotoxins Residual Solvents Kenevir Research, 2016 Courtesy of: Creative Commons 2016, creativecommons.org

26 Basic QA tests for Cannabis: Moisture Content THC Potency Cannabinoid Profile Terpene Profile Pesticide/Herbicide Screening Heavy Metals Microbiological Screening Mycotoxins Residual Solvents LOD, Karl-Fisher titration, Water activity Chromatography (LC, GC) Chromatography (LC) Chromatography (GC, HS-GC) Chromatography (LC-MS/MS, GC-MS/MS) Mass Spectrometry (ICP-MS) Culture, PCR Lateral Flow Assay, Chromatography Chromatography (HS-GC) Kenevir Research, 2016 Courtesy of: Creative Commons 2016, creativecommons.org

27 Chromatography chro ma tog ra phy /krōməˈtäɡrəfē/ in CHEMISTRY the separation of a mixture by passing it in solution or suspension or as a vapor (as in gas chromatography) through a medium in which the components move at different rates. Kenevir Research, 2016 Courtesy of: Creative Commons 2016, creativecommons.org

28 Chromatography: molecular Plinko

29 Chromatography is separation science! ΔT Large molecule Small molecule

30 GC vs LC: Gas Chromatograph

31 GC vs LC: Liquid Chromatograph

32 Chromatographic separation of cannabinoids

33 Laboratory Quality Assurance Natural product (and Cannabis!) Laboratory Responsibilities Seek and maintain accreditation (ISO 17025, TNI) Management commitment to independent third party status Educate clients and industry at large with valid data and science Provide accurate, timely results Affordable prices Service Level Agreements Quality partner with clients Collaboration with competitors

34 Lab Quality Assurance: Method Uncertainty Analytical target profile development & target measurement of uncertainty Error probability Risk management THC/CBD Pesticides Terpenes Microbiology Design Qualification Continuous verification Reportable result Is target measurement uncertainty attainable? Critical uncertainty variables defined Has batch/process/met hod uncertainty changed?

35 Laboratory accreditation ISO & TNI Management commitment to Quality Document, record and data control Method validation, controls, SOPs Technician DOCs Criteria, triggers and specifications Corrective/Preventive actions Proficiency testing Annual auditing

36 Cannabis quality & safety for the consumer: Become a quality connoisseur Observe clarity, color, odor Learn/ask about extraction and cleanup process Ask to see the certificate of analysis Call the laboratory! Be moderate Kenevir Research, 2016

37 Thank you!

Role of LIMS in Implementing Regulatory Compliance in Cannabis Testing

Role of LIMS in Implementing Regulatory Compliance in Cannabis Testing Stephen Goldman Head of R&D, EVIO Inc. Laboratory Director, PhytaTech (Denver, CO) Advisory Board Member, CloudLIMS OTCQB: EVIO ABOUT