Fast-forward almost a year and EVIO Labs Florida is continuing their expansion in the state, now with locations in Broward County and Gainesville. “We are always looking at opportunities to better serve our clients and the patients of Florida,” says Martinez. “Opening Gainesville within a year of Davie was a goal we set for our team. We knew there was a need and opening Gainesville helped support the continued growth of FL medical marijuana program.” He says that between the two locations, they can now process upwards of 1,400 samples a day.
According to Martinez, much of that expanded throughput is thanks to their partnership with Shimadzu. “Our relationship with Shimadzu is very unique,” says Martinez. “Shimadzu instrumentation allows us to test in parts per billion for accuracy and sensitivity levels that empower us to see deep into the chemical makeup of these medicines. Operating in this space where speed and turnaround times are key, these instruments provide us with a platform to meet 24/48-hour deadlines.” They can now screen for contaminants such as pesticides, heavy metals, residual solvents, mycotoxins, aflatoxins and pathogens using instruments such as HPLC, GC-MS/MS, LC-MS/MS and ICP-MS, all provided by Shimadzu.
While Florida doesn’t currently have a final rule on testing thresholds, there are proposed regulations that would require independent lab testing for medical cannabis products. “Our clients are self-regulating at this time and in favor of the current proposed regulation,” says Martinez. “The proposed regulations will give Florida the most comprehensive and stringent testing regulation in the U.S. and arguably the world.”
For Martinez and the rest of the EVIO Labs Florida team, this is about protecting public health. “Our lab’s main focus is always first and foremost patient safety,” says Martinez. “As the market continues to grow, we continue to innovate through business intelligence software and other technologies to streamline the testing process for our customer’s.”
The quality of your edible cannabis product can only be as reliable as the components that comprise it. The three types of components include active ingredients (such as CBD oil), packaging components (such as the bottles that hold finished product) and inactive ingredients (such as coconut oil). When evaluating a potential supplier for these three areas, a risk-based method follows a vendor selection process that highlights critical ingredients and also adequately assesses excipients. With this approach, the vetting process for a supplier is based on the impact the potential ingredient or component will have on the quality and purity of the finished product.
Choose only those suppliers who can provide certification that the packaging components are food-grade or food-safeThere are three basic categories to guide vendor assessment. Is the supplier providing 1) a packaging component with product contact, 2) an excipient, or inactive ingredient, or 3) the active ingredient? Regardless of the category, due to the factious nature of cannabis, it is important to first verify with a vendor that it will sell its products to a company in the cannabis industry. Once that is determined, the evaluation process may begin.
Packaging components, such as bottles and caps, are considered primary packaging because they have direct contact with the finished product. Suppliers of the primary packaging must be able to provide assurance that their goods do not contain additives that are harmful to consumers. Therefore, choose only those suppliers who can provide certification that the packaging components are food-grade or food-safe. Reputable vendors will also be able to provide a certificate of compliance, also known as a certificate of conformance, which states that the component meets specifications required for that part. Many cannabis regulations require finished products to be sold in child-resistant packaging, so the supplier will need to provide child-resistant certification for the packaging components, if applicable.
Excipients are ingredients that are added to a product for the purposes of streamlining the manufacturing process and enhancing physical characteristics such as taste and color. Some examples could include coconut oil, starch and alcohol. Though they do not have the same critical nature as active ingredients, their potential risk to a finished product is generally greater than that of a packaging component. As such, there are additional factors to consider for an excipient vendor. Verify with the supplier that it can provide the following documentation. While governing regulations may not require some information, the data included in these documents are important to ensure the quality of your finished product.
Certificate of Analysis (or, certificate of conformance), for each lot of material. The information on a certificate, including the tests performed, specifications and test results must be sufficient to determine if the material is acceptable for use in the product.
Allergen Statement. This statement is important to accurately include or disclaim allergens on the finished product label.
Residual Solvent Statement. Solvents are commonly used to bolster the manufacturing process for a material. In order to maintain acceptable levels of residual solvents in a final product, it is necessary to also consider the toxicity and level of each solvent in the raw material.
Heavy Metals Certification. Since metals pose a risk to consumer safety, it is important to know what amounts, if any, are being contributed to your product by raw materials.
Because changes in an excipient can impact your finished product, make every attempt to obtain a commitment from a supplier to notify you if changes are made to the excipient’s specifications.
Cannabis oil is the ingredient that, when the edible cannabis product is consumed, is biologically “active.” Thus, it is considered to be the active ingredient in cannabis products. Since cannabis oil has a direct impact on the quality of a product, it is critical that the oil supplier be appropriately evaluated. One of the main considerations for a cannabis oil supplier is whether the supplier is willing to host initial and periodic audits of its manufacturing facility. Such audits are crucial in assessing the capability of the vendor to comply with regulatory requirements and established procedures – can the supplier consistently provide quality material? The answer to this question is too important to risk for you and your customers.As anyone working in the industry has experienced, anything related to cannabis is placed under an unprecedented critical lens.
Additionally, verify the oil supplier will provide key documentation, such as that listed above for excipients, to support the quality and purity of the oil. And last but not least, ensure the information reported by the supplier is adequate to meet the requirements of your finished product.
Evaluation guidelines and criteria such as these should be added to standard operating procedures to ensure consistency and quality across all products. As anyone working in the industry has experienced, anything related to cannabis is placed under an unprecedented critical lens. The importance of consumer safety and bolstering industry integrity is paramount. Sourcing validation is a critical initial step in the production process that can directly impact a company’s success and longevity in the cannabis industry.
Cannabis extraction has been used as a broad term for what can best be described as cannabis processing. A well-thought-out cannabis process goes far beyond just extraction, largely overlapping with cultivation on the front-end and product development on the back-end1. With this in mind, four pillars emerge as crucial capabilities for developing a cannabis process: Cultivation, Extraction, Analytics and Biochemistry.
The purpose and value of each pillar on their own is clear, but it is only when combined that each pillar can be optimized to provide their full capacities in a well-designed process. As such, it is best to define the goals of each pillar alone, and then explain how they synergize with each other.
At the intersection of each pillar, specific technology platforms exist that can effectively drive an innovation and discovery cycle towards the development of ideal products.Cultivation is the foundation of any horticultural process, including cannabis production. Whether the goal be to convert pigments, flavors or bioactive compounds into a usable form, a natural process should only utilize what is provided by the raw material, in this case cannabis flower. That means cultivation offers a molecular feedstock for our process, and depending on our end goals there are many requirements we may consider. These requirements start as simply as mass yield. Various metrics that can be used here include mass yield per square foot or per light. Taken further, this yield may be expressed based not only on mass, but the cannabinoid content of the plants grown. This could give rise to a metric like CBD or THC yield per square foot and may be more representative of a successful grow. Furthermore, as scientists work to learn more about how individual cannabinoids and their combinations interact with the human body, cultivators will prioritize identifying cultivars that provide unique ratios of cannabinoids and other bioactive compounds consistently. Research into the synergistic effect of terpenes with cannabinoids suggests that terpene content should be another goal of cultivation2. Finally, and most importantly, it is crucial that cultivation provide clean and safe materials downstream. This means cannabis flower free of pesticides, microbial growth, heavy metals and other contaminants.
Extraction is best described as the conversion of target molecules in cannabis raw material to a usable form. Which molecules those are depends on the goals of your product. This ranges from an extract containing only a pure, isolated cannabinoid like CBD, to an extract containing more than 100 cannabinoids and terpenes in a predictable ratio. There are countless approaches to take in terms of equipment and process optimization in this space so it is paramount to identify which is the best fit for the end-product1. While each extraction process has unique pros and cons, the tunability of supercritical carbon dioxide provides a flexibility in extraction capabilities unlike any other method. This allows the operator to use a single extractor to create extracts that meet the needs of various product applications.
Analytics provide a feedback loop at every stage of cannabis production. Analytics may include gas chromatography methods for terpene content3 or liquid chromatography methods for cannabinoids 3, 4, 5. Analytical methods should be specific, precise and accurate. In an ideal world, they can identify the compounds and their concentrations in a cannabis product. Analytics are a pillar of their own due simply to the efforts required to ensure the quality and reliability of results provided as well as ongoing optimization of methods to provide more sensitive and useful results. That said, analytics are only truly harnessed when paired with the other three pillars.
Biochemistry can be split into two primary focuses. Plant biochemistry focuses back towards cultivation and enables a cannabis scientist to understand the complicated pathways that give rise to unique ratios of bioactive molecules in the plant. Human biochemistry centers on how those bioactive molecules interact with the human endocannabinoid system, as well as how different routes of administration may affect the pharmacokinetic delivery of those active molecules.
Each of the pillars require technical expertise and resources to build, but once established they can be a source of constant innovation. Fig. 1 above shows how each of these pillars are connected. At the intersection of each pillar, specific technology platforms exist that can effectively drive an innovation and discovery cycle towards the development of ideal products.
For example, at the intersection of analytics and cultivation I can develop raw material specifications. This sorely needed quality measure could ensure consistencies in things like cannabinoid content and terpene profiles, more critically they can ensure that the raw material to be processed is free of contamination. Additionally, analytics can provide feedback as I adjust variables in my extraction process resulting in optimized methods. Without analytics I am forced to use very rudimentary methods, such as mass yield, to monitor my process. Mass alone tells me how much crude oil is extracted, but says nothing about the purity or efficiency of my extraction process. By applying plant biochemistry to my cultivation through the use of analytics I could start hunting for specific phenotypes within cultivars that provide elevated levels of specific cannabinoids like CBC or THCV. Taken further, technologies like tissue culturing could rapidly iterate this hunting process6. Certainly, one of the most compelling aspects of cannabinoid therapeutics is the ability to harness the unique polypharmacology of various cannabis cultivars where multiple bioactive compounds are acting on multiple targets7. To eschew the more traditional “silver bullet” pharmaceutical approach a firm understanding of both human and plant biochemistry tied directly to well characterized and consistently processed extracts is required. When all of these pillars are joined effectively we can fully characterize our unique cannabis raw material with targeted cannabinoid and terpene ratios, optimize an extraction process to ensure no loss of desirable bioactive compounds, compare our extracted product back to its source and ensure we are delivering a safe, consistent, “nature identical” extract to use in products with predictable efficacies.
Using these tools, we can confidently set about the task of processing safe, reliable and well characterized cannabis extracts for the development of world class products.
 Sweeney, C. “Goal-Oriented Extraction Processes.” Cannabis Science and Technology, vol 1, 2018, pp 54-57.
 Russo, E. B. “Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects.” British Journal of Pharmacology, vol. 163, no. 7, 2011, pp. 1344–1364.
 Giese, Matthew W., et al. “Method for the Analysis of Cannabinoids and Terpenes in Cannabis.” Journal of AOAC International, vol. 98, no. 6, 2015, pp. 1503–1522.
 Gul W., et al. “Determination of 11 Cannabinoids in Biomass and Extracts of Different Varieties of Cannabis Using high-Performance Liquid Chromatography.” Journal of AOAC International, vol. 98, 2015, pp. 1523-1528.
 Mudge, E. M., et al. “Leaner and Greener Analysis of Cannabinoids.” Analytical and Bioanalytical Chemistry, vol. 409, 2017, pp. 3153-3163.
 Biros, A. G., Jones, H. “Applications for Tissue Culture in Cannabis Growing: Part 1.” Cannabis Industry Journal, 13 Apr. 2017, www.cannabisindustryjournal.com/feature_article/applications-for-tissue-culture-in-cannabis-growing-part-1/.
 Brodie, James S., et al. “Polypharmacology Shakes Hands with Complex Aetiopathology.” Trends in Pharmacological Sciences, vol. 36, no. 12, 2015, pp. 802–821.
Recorded 4/24/18, this webinar, dives into the regulatory environments surrounding cannabis testing, as well as terpene, residual solvent and heavy metals testing. Are you finding it difficult to keep up with changing regulations for the cannabis industry? Are you looking to reduce hands-on analysis time? Speed up sample processing? Have less waste? Possibly reduce the number of individual tests running in your laboratory? Hosted by PerkinElmer and CIJ.
EVIO Labs recently became the first cannabis laboratory in Florida to obtain ISO 17025 accreditation. Perry Johnson Laboratory Accreditation, Inc. (PJLA), an organization that provides third-party assessments to ISO/IEC 17025, accredited EVIO Labs. The assessment process that lead to ISO 17025 accreditation for EVIO Labs included a thorough review of their quality management system, their capability to perform potency and contaminant testing for cannabis products.
Tracy Szerszen, president and operations manager at PJLA, encourages this international standard for laboratories to provide confidence to end-users that the test results they receive are reliable. She says laboratories that achieve this accreditation are showing they have the proper tools, equipment and staff to provide accurate testing. “It is a very critical component of the industry, and becoming accredited provides the assurance that laboratories are performing to the highest standard,” says Szerszen. “EVIO Labs has taken the right step in their commitment towards meeting this standard and providing clean and safe cannabis for the patients of Florida.”
EVIO Labs provides cannabis testing for cannabinoid and terpene profiles, microbiological and pesticides contamination, residual solvent, heavy metals, mycotoxins, water activity and moisture content. Chris Martinez, co-founder and president of EVIO Labs Florida explains that the Florida Department of Health mandates that an independent third-party laboratory tests medical cannabis to ensure that these products are safe for human consumption. Martinez says their first priority is the safety of their patients, and ensuring that EVIO Labs provides clean and safe cannabis for Florida.
Martinez launched their laboratory with some help from Shimadzu last year. “Our Broward lab is powered by Shimadzu with over $1.2M in the latest testing equipment utilizing LCMS technology with the world’s fastest polarity switching time of 5 m/sec and scan speeds of 30,000 u/sec with UF Qarray sensitivity 90 times that of previously available technologies,” says Martinez. According to Martinez, their licensing agreement with EVIO Labs (OTC:SGBYD) marked a first for the publicly traded company with exclusivity in the Florida market. The agreement includes proprietary testing methodologies, operating procedures, training and support.
Every certificate of analysis is reviewed by a lab director with over 20 years of experience operating in FDA regulated labs. Martinez says that EVIO has some of the most advanced technology in the industry, which provides them the opportunity to quickly provide results, frequently as fast as a 24-hour period. Martinez and his team are currently building a 3,300 square-foot laboratory in Gainesville, which is expected to be running by March of this year.
For about a month now, California’s adult use market has been open for business and the market is booming. About thirty days into the world’s largest adult use market launch, we are beginning to see side effects of the growing pains that come with adjusting the massive industry.
Consumers are also feeling sticker shock as the new taxes add up to a 40% increase in price.While the regulatory and licensing roll out has been relatively smooth, some municipalities are slower than others in welcoming the adult use cannabis industry. It took Los Angeles weeks longer than other counties to begin licensing dispensaries. Meanwhile, retailers in San Diego say the first month brought a huge influx of customers, challenging their abilities to meet higher-than-expected demand.
Businesses are struggling to deal with large amounts of cash, but California State Treasurer John Chiang may have a solution in store. Yesterday, his department announced they are planning to create a taxpayer-backed bank for cannabis businesses.
In the regulatory realm, some are concerned that a loophole in the rules allows bigger cultivation operations to squeeze out the competition from smaller businesses. The California Growers Association filed a lawsuit against the California Department of Food and Agriculture to try and close this loophole, hoping to give smaller cultivators a leg up before bigger companies can dominate the market.
The Bureau of Cannabis Control (known as just “The Bureau”) began holding meetings and workshops to help cannabis businesses get acquainted with the new rules. Public licensing workshops in Irvine and San Diego held last week were designed to focus on information required for licensing and resources for planning. The Bureau also held their first cannabis advisory committee meeting, as well as announcing new subcommittees and an input survey to help the Bureau better meet business needs.
On the lab-testing front, the state has phased in cannabinoids, moisture content, residual solvent, pesticide, microbial impurities and homogeneity testing. On July 1, the state will phase in additional residual solvent and pesticide testing in addition to foreign material testing. At the end of 2018, they plan on requiring terpenoids, mycotoxins, heavy metals and water activity testing as well.
Currently, there are no lab testing regulations for Florida’s medical cannabis market. Chris Martinez, co-founder and chief operating officer of EVIO Labs Florida, a veteran-owned business, is looking to change that.
When Martinez co-founded EVIO Labs Florida, he saw the need for a dedicated cannabis lab to ensure safety and quality of medicine for patients in the state. Partnering with EVIO Labs to accomplish this goal, Martinez secured a 5,500 sq. ft. facility in Broward County to test for potency, pesticides, microbial contaminants, terpenes, residual solvents and heavy metals. Their lab, a first of its kind in the industry, qualifies as a true pharmaceutical-grade clean room. This week, Martinez also secured their 2nd laboratory location in the City of Gainsville, where they will test for potency, microbials, terpenes and residual solvents. And he isn’t doing it on the cheap. “Our Broward lab is powered by Shimadzu with over $1.2M in the latest testing equipment utilizing LCMS technology with the world’s fastest polarity switching time of 5 m/sec and scan speeds of 30,000 u/sec with UF Qarray sensitivity 90 times that of previously available technologies,” says Martinez.
Martinez, an entrepreneur at heart, started the lab with a team of experts to become the first completely cannabis-focused laboratory in Florida. Jorge Segredo, their head chemist and quality assurance director, has over 18 years of experience in the development of nutraceutical and pharmaceutical products under ISO and FDA accreditation. Segredo has helped launch three independent FDA-accredited laboratories and has extensive knowledge of HPLC, GCMS, LCMS, ICPMS technologies and development/validation of testing methods and procedures. Cynthia Brewer, their director of operations, was an active participant in the 2017 state legislative session and has been an advocate for medical cannabis, working with legislators on a suitable framework to increase patient access to cannabis.
EVIO is one of the nation’s leaders in cannabis testing, research science and advisory services. It is an evolving network of laboratories with nine EVIO cannabis laboratories operating in five different states: Oregon, Colorado, Massachusetts, Florida and California. “After speaking with industry chemists around the country for months, the EVIO name was constantly brought up in conversation,” says Martinez. “When we spoke with the EVIO Team it was an easy decision for us to partner.” He says Lori Glauser, chief operating officer of EVIO, and William Waldrop, chief executive officer of EVIO, are truly visionaries in the cannabis industry.
According to Martinez, their licensing agreement with EVIO Labs (OTC:SGBYD) marked a first for the publicly traded company with exclusivity in the Florida market. The agreement includes proprietary testing methodologies, operating procedures, training and support.
In addition to testing cannabis for safety and quality, they are launching a technology platform called MJ Buddy, essentially a software tool that takes efficacy feedback from patients and uses testing and genetic data they gather from EVIO Labs across the country. “This will provide real data to the cannabis industry as to the medical benefits for thousands of patients in relation to the genotype and cannabinoid profiles of their medicine,” says Martinez.
Of the states that have legalized some form of cannabis, a large number of them have some lab testing regulations on the book, with some more comprehensive than others. Martinez says he hopes the Florida Department of Health, Office of Medical Marijuana Use follows some of the more thorough state programs, such as Oregon. His team has compiled a set of documents for regulators with recommendations for regulating the lab testing industry.
Without any regulations on paper, it is up to businesses to produce safe and quality medicine, without any oversight. EVIO Labs Florida follows FDA Good Laboratory Practices, has an ISO 17025:2005 accreditation pending, and is working on TNI 2016 accreditation.
When discussing what he wants to see happen with Florida’s regulatory framework, Martinez says the rules need to be specific to Florida. For example, due to the climate being so humid, microbial contaminant testing for things like yeast and mold will be particularly imperative. Because processing methods like butane and alcohol extraction are legal, he emphasizes the need for comprehensive residual solvents testing. “The most important regulation would be to have the laboratories select the samples at the MMTC facility and have the state randomly verify laboratory results to ensure accurate unbiased testing,” says Martinez.
In addition to that, he hopes their pesticide thresholds will be realistic and based on actual science. “We believe the public should receive carcinogenic data for products that are inhaled,” says Martinez. “Chemicals may be introduced into the processing of cannabis to vape liquid that may cause harm. This is important information for public health and communication of the risk related to exposure to such materials.” Martinez says EVIO Labs Florida was founded on the belief that through technology and science we can increase safety and patient outcomes.
Heavy metals are common environmental contaminants often resulting from mining operations, industrial waste, automotive emissions, coal fired power plants, amount other sources. Several remediation strategies exist that are common for the reduction/elimination of metals in the environment. Phytoremediation is one method for removing metals from soil, utilizing plants to uptake metals which then bioaccumulate in the plant matter. In one study, cesium concentrations were found to be 8,000 times greater in the plant roots compared to the surrounding water in the soil. In 1998, cannabis was specifically tested at the Chernobyl nuclear disaster site for its ability to remediate the contaminated soil. These examples demonstrate that cannabis must be carefully cultivated to avoid the uptake of toxic metals. Possible sources would not only include the growing environment, but also materials such as fertilizers. Many states publish metal content in fertilizer products allowing growers to select the cleanest product for their plants. For cannabis plant material and concentrates several states have specific limits for cadmium (Cd), Lead (Pb), Arsenic (As) and Mercury (Hg), based on absolute limits in product or daily dosage by body weight.
Analytical Approaches to Metals Determination
Flame Atomic Absorption Spectroscopy (Flame AA) and Graphite Furnace Atomic Absorption Spectroscopy (GFAA) are both techniques that determine both the identity and quantity of specific elements. For both of these techniques, the absorption in intensity of a specific light source is measured following the atomization of the sample digestate using either a flame or an electrically heated graphite tube. Reference standards are analyzed prior to the samples in order to develop a calibration that relates the concentration of each element relative to its absorbance. For these two techniques, each element is often determined individually, and the light source, most commonly a hollow cathode lamp (HLC) or electrodeless discharge lamp (EDL) are specific for each element. The two most common types of Atomic Emission Spectroscopy (AES) are; Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES) and ICP-Mass Spectrometry (ICP-MS). Both of these techniques use an argon plasma for atomization of the sample digestates. This argon plasma is maintained using a radio frequency generator that is capable of atomization and excitation of the majority of the elements on the periodic table. Due to the considerably higher energy of the plasma-based instruments, they are more capable than the flame or furnace based systems for measurement of a wide range of elements. Additionally, they are based on optical emission, or mass spectrometric detection, and are capable of analysis of all elements at essentially the same time.
Flame AA is easy to use, inexpensive and can provide reasonable throughput for a limited number of elements. However, changes to light sources and optical method parameters are necessary when determining different metals. GFAA is also limited by similar needs to change the light sources, though it is capable of greater sensitivity for most elements as compared to flame AA. Runtimes are on the order of three minutes per element for each sample, which can result in lower laboratory throughput and greater sample digestate consumption. While the sensitivity of the absorption techniques is reasonable, the dynamic range can be more limited requiring re-analyses and dilutions to get the sample within the calibration range. ICP-OES allows the simultaneous analysis of over 70 elements in approximately a minute per sample with a much greater linear dynamic range. ICP-OES instruments cost about 2-5 times more than AA instruments. ICP-MS generally has the greatest sensitivity (sub-parts-per-trillion, for some elements) with the ability to determine over 70 elements per minute. Operator complexity, instrument expense and MS stability, as well as cost are some of the disadvantages. The US FDA has a single laboratory validated method for ICP-MS for elements in food using microwave assisted digestion, and New York State recently released a method for the analysis of metals in medical cannabis products by ICP-MS (NYS DOH LINC-250).
The use of fertilizers, and other materials, with low metal content is one step necessary to providing a safe product and maintaining customer confidence. The state-by-state cannabis regulations will continue to evolve which will require instrumentation that is flexible enough to quickly accommodate added metals to the regulatory lists, lower detection limits while adding a high level of confidence in the data.
Formerly named the Bureau of Medical Cannabis Regulation under the state’s Department of Consumer Affairs, the Bureau of Marijuana Control is tasked with overseeing the development, implementation and enforcement of the regulations for the state’s cannabis industry. In their statement of reasons for the lab testing regulations, the bureau says they are designed with public health and safety at top of mind. At first glance, much of these laboratory rules seem loosely modeled off of Colorado and Oregon’s already implemented testing regulations.
The regulations lay out requirements for testing cannabis products prior to bringing them to market. That includes testing for residual solvents and processing chemicals, microbiological contaminants, mycotoxins, foreign materials, heavy metals, pesticides, homogeneity as well as potency in quantifying cannabinoids.
The microbiological impurities section lays out some testing requirements designed to prevent food-borne illness. Labs are required to test for E. coli, Salmonella and multiple species of the pathogenic Aspergillus. If a lab detects any of those contaminants, that batch of cannabis or cannabis products would then fail the test and could not be sold to consumers. A lab must report all of that information on a certificate of analysis, according to the text of the regulations.
The proposed regulations stipulate requirements for sampling, including requiring labs to develop sampling plans with standard operating procedures (SOPs) and requiring a lab-approved sampler to follow chain-of-custody protocols. The rules also propose requiring SOPs for analytical methodology. That includes some method development parameters like the list of analytes and applicable matrices. It also says all testing methods need to be validated and labs need to incorporate guidelines from the FDA’s Bacterial Analytical Manual, the U.S. Pharmacopeia and AOAC’s Official Methods of Analysis for Contaminant Testing, or other scientifically valid testing methodology.
Labs will be required to be ISO 17025-accredited in order to perform routine cannabis testing. Laboratories also need to participate in proficiency testing (PT) program “provided by an ISO 17043 accredited proficiency-test provider.” If a laboratory fails to participate in the PT program or fails to pass to receive a passing grade, that lab may be subject to disciplinary action against the lab’s license. Labs need to have corrective action plans in place if they fail to get a passing grade for any portion of the PT program.
Election Day 2016 resulted in historic gains for state level cannabis prohibition reform. Voters in California, Maine, Massachusetts and Nevada chose to legalize adult use of Cannabis sp. and its extracts while even traditionally conservative states like Arkansas, Florida, Montana and North Dakota enacted policy allowing for medical use. More than half of the United States now allows for some form of legal cannabis use, highlighting the rapidly growing need for high quality analytical testing.
For the uninitiated, analytical instrumentation can be a confusing mix of abbreviations and hyphenation that provides little obvious information about an instrument’s capability, advantages and disadvantages. In this series of articles, my colleagues and I at Restek will break down and explain in practical terms what instruments are appropriate for a particular analysis and what to consider when choosing an instrumental technique.
Potency analysis refers to the quantitation of the major cannabinoids present in Cannabis sp. These compounds are known to provide the physiological effects of cannabis and their levels can vary dramatically based on cultivation practices, product storage conditions and extraction practices.
The primary technique is high performance liquid chromatography (HPLC) coupled to ultraviolet absorbance (UV) detection. Gas chromatography (GC) coupled to a flame ionization detector (FID) or mass spectrometry (MS) can provide potency information but suffers from issues that preclude its use for comprehensive analysis.
Pesticide Residue Analysis
Pesticide residue analysis is, by a wide margin, the most technically challenging testing that we will discuss here. Trace levels of pesticides incurred during cultivation can be transferred to the consumer both on dried plant material and in extracts prepared from the contaminated material. These compounds can be acutely toxic and are generally regulated at part per billion parts-per-billion levels (PPB).
Depending on the desired target pesticides and detection limits, HPLC and/or GC coupled with tandem mass spectrometry (MS/MS) or high resolution accurate mass spectrometry (HRAM) is strongly recommended. Tandem and HRAM mass spectrometry instrumentation is expensive, but in this case it is crucial and will save untold frustration during method development.
Residual Solvents Analysis
When extracts are produced from plant material using organic solvents such as butane, alcohols or supercritical carbon dioxide there is a potential for the solvent and any other contaminants present in it to become trapped in the extract. The goal of residual solvent analysis is to detect and quantify solvents that may remain in the finished extract.
Residual solvent analysis is best accomplished using GC coupled to a headspace sample introduction system (HS-GC) along with FID or MS detection. Solid phase microextraction (SPME) of the sample headspace with direct introduction to the GC is another option.
Terpene Profile Analysis
While terpene profiles are not a safety issue, they provide much of the smell and taste experience of cannabis and are postulated to synergize with the physiologically active components. Breeders of Cannabis sp. are often interested in producing strains with specific terpene profiles through selective breeding techniques.
Both GC and HPLC can be employed successfully for terpenes analysis. Mass spectrometry is suitable for detection as well as GC-FID and HPLC-UV.
Heavy Metals Analysis
Metals such as arsenic, lead, cadmium, chromium and mercury can be present in cannabis plant material due to uptake from the soil, fertilizers or hydroponic media by a growing plant. Rapidly growing plants like Cannabis sp. are particularly efficient at extracting and accumulating metals from their environment.
Several different types of instrumentation can be used for metals analysis, but the dominant technology is inductively coupled plasma mass spectrometry (ICP-MS). Other approaches can also be used including ICP coupled with optical emission spectroscopy (ICP-OES).
Rebecca is an Applications Scientist at Restek Corporation and is eager to field any questions or comments on cannabis analysis, she can be reached by e-mail, email@example.com or by phone at 814-353-1300 (ext. 2154)
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