Analytical Testing Laboratoryfor Commercial Cannabis Products

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OUR GOAL IS SIMPLE: To deliver state-of-the-art science and superior solutions to develop transparency, trust, and safety for the commercial cannabis industry.

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Cannabis consumers need accurate information from producers to discern which products are safe, effective, and trustworthy. With no federal guidance and inconsistent state-by-state regulation, cannabis product producers have difficulty evaluating the preclinical development of cannabis extracts and the precise formulation of cannabis products.

Kanabolytix, a Toxikon company, is the United States’ first licensed and accredited analytical laboratory for testing the safety and dosage of cannabis products. With over 40 years of proven expertise in pharmaceutical testing, Toxikon has the scientific knowledge, state-of-the-art facilities, and regulatory expertise necessary to offer the market’s most reliable analysis of pharmacological efficacy and potency The Kanabolytix team is on the forefront of cannabis science through collaboration with experts in the field, to adapt to the evolution of federal, state, and industry standards.

Consumers, growers, and product developers have questions about the purity and safety of cannabis products.

Our answer is simple: choose the lab you can trust.

The Kanabolytix suite of cannabis testing includes:

› CANNABINOID PROFILING

› PESTICIDES

› HEAVY METALS

› MYCOTOXINS

› RESIDUAL SOLVENTS

› TERPENES

› MOLD AND BACTERIA

› PRECLINICAL IN VIVO &

IN VITRO SERVICES

A Laboratory You Can Trust

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Potency Profiling& Cannabinoid Characterization

Cannabinoids are chemical compounds found in cannabis; they affect the user by interacting with specific receptors in the central nervous system, particularly in the limbic system and mesolimbic pathway.

The cannabis plant contains more than 500 chemical constituents, including 113 cannabinoids – each with unique and significant biological effects. Genetics, cultivation techniques, harvesting, and processing all affect the composition of cannabinoids in the plant and determine its suitability for various commercial applications.

Precise analysis of each strain and lot is critical; understanding the accurate profile of canna-binoid ratios, such as THC to CBD, in your materials will allow you to confidently designate each lot for a particular product application based on the effects of the profiled cannabinoids.

Δ9-Tetrahydrocannbinol (Δ 9-THC)Δ9-Tetrahydrocannbinolic acid-A (THCAA)Cannabidiol (CBD) Δ8-Tetrahydrocannibol (Δ8-THC) Cannabinol (CBN)Cannabigerol (CBG) Cannabichromene (CBC)

Cannabidiolic acid (CBDA) Cannabigerolic acid (CBGA) Cannabidivarinic acid (CBDVA) Tetrahydrocannabivarian (THCV) Cannabicyclol (CBL) Cannabidivarin (CBDV)

The Kanabolytix profiling method quantifies 13 important cannabinoids so you can understand the relative potency of your product. Employing a fully-validated high-performance liquid chromatography (HPLC) column with a diode array detector (DAD) ensures the accurate quantitation of cannabinoids in various matrices – resulting in a cannabinoid profile that allows you to choose the best product to fit each unique need.

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Pesticide Testing

The responsible use of pesticides can promote cannabis plant health and increase crop yield; unfortunately, the same active ingredients in pesticides that inhibit pest viability also have negative effects in humans.

Pesticides have been linked to a wide range of human health hazards, ranging from short-term impacts including head-aches and nausea, to chronic impacts including cancer, reproductive harm, and endocrine disruption.

Assessing the presence of residual pesti-cides in cannabis products helps ensure that any remaining material is within the acceptable tolerable limits, promoting end-user safety and product efficacy.

The Kanabolytix pesticide testing service uses high-performance liquid chromatography (HPLC) with mass selective detection (MSD) to test for a wide variety of typical pesticide classes in cannabis materials.

› Carbamates

› Neonicotinoids

› Organophosphates

› Pyrazoles

› Pyrethroids

› Strobins

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Heavy Metals Analysis

Heavy metals are loosely defined as metallic elements with a high molecular weight or a high density. Although some concentration of heavy metals in soil occurs naturally, human activities can raise concentrations to unsafe levels: pesticides, preservatives, metal scrap, paint, batteries, and other trash are all potential contaminants. The increasing level of global pollution poses a serious threat to the environment, including the commercial growth and harvest of cannabis crops.

Heavy metals may be safe and even beneficial to humans in permissible doses, but present a serious health risk at elevated levels, as they accumulate in the body and interfere with metabolic processes. Cannabis plants are effective accumulators of heavy metals via uptake, particularly in leaves. Consumers who repeatedly use cannabis products contaminated by heavy metal uptake are at a greater risk for illness and toxicity.

Kanabolytix uses inductively coupled plasma (ICP) with mass selective detection (MSD) to test for four heavy metals. We employ microwave digestion techniques for complete sample degradation, yielding the most accurate representation of heavy metals in your products.

100 μg/kg

› Mercury

200 μg/kg

› Arsenic

› Cadmium

500 μg/kg

› Lead

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Mycotoxin Testing

The proper environmental conditions – temperature, air movement, and humidity – can all promote healthy cannabis growth. Poor environmental conditions, particularly following harvest, encourage the growth of mold; aspergillus, penicillium, rhizopus, mucor, and botrytis can all affect cannabis plants. These molds produce toxic metabolites, called mycotoxins.

Mycotoxins can cause serious disease or even death in consumers. Mycotoxin exposure can induce rashes, nausea, headaches, respiratory distress, and more.

Kanabolytix uses high-performance liquid chromatography (HPLC) with a fluorescent intensity detector (FID) to monitor five critical mycotoxins, ensuring mycotoxin levels are kept below FDA action levels and reducing the risk of toxic, immunogenic, and carcinogenic effects.

› Aflatoxin B1

› Aflatoxin B2

› Aflatoxin G1

› Aflatoxin G1

› Ochratoxin A

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Residual Solvent Analysis

Carbon-based organic solvents dissolve or disperse another substance. They are a type of volatile organic compound (VOC). Cannabis concentrates are extracted from the cannabis plant using organic solvents.

Several different organic solvents may be used to concentrate cannabis materials; many of these solvents may be toxic or carcinogenic. Depending on the methodology used to extract cannabis products from the plant, some residual solvents may remain in the final product.

Over time, the consumer may ingest an appreciable quantity of these harmful materials. Cannabis products should be tested for residual solvent contamination to ensure consumer safety.

Kanabolytix uses gas chromatography (GC) with mass selective detection (MSD) and headspace analysis to detect levels of residual volatile organic compounds in your product. With this method, the residual solvents are heated to further volatility, allowing for quantification of VOCs within the sample. Confirming the lack of residual VOCs in your product offers you and your customers confidence the product is safe for consumption.

ICHA Classification of Solvents:

Category 3:Low-Toxicity Compounds

› Acetic acid

› Acetone

› Heptane

Category 2:Toxic Compounds

›Acetonitrile

›Methanol

›Toulene

Category 1:Carcinogenic Compounds

›Benzene

›Carbon tetrachloride

›Trichloroethane

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Terpene Profiling

Terpenes are volatile organic compounds in plants that serve as defense mechanism against predators and attract pollinators; in cannabis, they’re what gives each strain its signature smell and flavor. Terpenes are thought to have a synergistic effect with cannabinoids, binding themselves to receptors in the brain to enhance medicinal and pharmacological effects.

Individual strains contain different combinations of the over 140 individual terpenes identified in the cannabis plant. Specific combinations of terpenes yield different tastes and aromas, which may help consumers choose products suited to their needs and preferences.

There is a great opportunity for the continued research of the biological utility of terpenes, as they are relatively scientifically unstudied.

In the cannabis plant, many factors influence the development of terpenes: climate, environmental conditions, age and maturation, fertilizers, soil composition, and even time of harvest.

Kanabolytix quantifies the terpenes of interest in your products using high-performance liquid chromatography (HPLC) with mass selective detection (MSD), giving you a detailed profile of these potentially important chemical constituents.

› Caryophyllene

› Humulene

› Limonene

› Linalool

› Myrcene

› Ocimene

› Pipene

› Terpinolene

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Mold & Bacteria Testing

Mold can cause biodegradation of natural materials, including plant structures. Large green plants provide a hospitable ecosystem for a number of biological organisms, including several types of molds. Certain species of molds seem to have a preference for cannabis plants – and the moisture and heat present in growth environments can cause a mild infestation to become a crop-wide epidemic.

The consumption of cannabis products contaminated by mold can pose a high risk of danger to consumers, especially for medicinal patients who may have compromised immune systems. Injecting or inhaling a mold-contaminated cannabis product can cause respiratory illness, eye irritation, skin reactions, anaphylatic reactions, and serious infections.

Kanabolytix offers a wide range of microbiology testing services, including characterization of microbial bioburden, total aerobic bacteria, total yeast and mold, total coliform, and bile-tolerant gram-negative bacteria. We also offer genetic identification of individual colonies to ensure the absence of pathogenic E. Coli and Salmonella.

Cannabis Material

Microbial Limits (CFU/gram)

Total Aerobic Bacteria

Total Yeast and Mold

Total ColiformBile-Tolerant

BacteriaPathogenic

E. ColiSalmonella spp.

Unprocessed 105 104 103 103 0 0

Processed 105 104 103 103 0 0

CO2 and Solvent-Based

Extracts105 104 103 103 0 0

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Toxikon: A Lab You Can Trust

Kanabolytix is the cannabis testing division of the Toxikon Corporation. Launched in 2017, Kanabolytix draws on Toxikon’s longstanding history and depth of experience in analytical sciences to offer consumers and producers confidence in the safety and efficacy of commercial cannabis products.

Toxikon, founded in 1982, is a preclinical contract research organization (CRO) that provides in vitro, in vivo, and analytical testing services for the pharmaceutical, biotechnology, and medical device sectors. Toxikon is accredited to ISO/IEC 17025, and is registered with the United States Food and Drug Administration and the Japan Ministry of Health, Labor, and Welfare for drug and medical testing.

Toxikon employs hundreds of scientific researchers, associates, laboratory support staff, and others to provide a center of excellence to support product development and testing requirements.

Toxikon currently works globally across the life science sector with over 1,000 active medical device, pharmaceutical, and biologic companies and their suppliers, in over 60 countries.

Testing services Include:

› Acute, subchronic, and chronic toxicity

› Reproductive toxicity

› Genetic toxicity

› Carcinogenicity

› Pharmacokinetics

› Toxicokinetics

› Bioavailability

› Absorption, distribution, metabolism, and excretion (ADME)

› Chemical characterization

› Impurity analysis and synthesis

› Bioanalysis

› Microbiology

15 Wiggins Ave.Bedford, MA 01730(781) 275-3330

www.kanabolytix.com©2017 Toxikon Corporation.

All rights reserved.606-01-Rev1