Tag Archives: analytics

The Practical Chemist

Building the Foundation of Medical Cannabis Testing – Understanding the Use of Standards and Reference Materials – Part 2

By Joe Konschnik
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In the last article I referred to the analogy of the analytical reference material being a keystone of the laboratory foundation, the stone upon which all data relies. I then described the types of reference materials and their use in analytical testing in general terms. This article will describe the steps required to properly manufacture and deliver a certified reference material (CRM) along with the necessary documentation.

A CRM is an exclusive reference material that meets strict criteria defined by ISO Guide 34 and ISO/IEC 17025.  ISO is the International Organization for Standardization and IEC is the International Electrotechnical Commission. These organizations work together to set globally recognized standards. In order for a reference material to be labeled as a CRM it must 1) be made with raw or starting materials which are characterized using qualified methods and instruments, 2) be produced in an ISO-accredited lab under documented procedures, and 3) fall under the manufacturer’s scopes of accreditation. Verifying a CRM supplier has these credentials is easily done by viewing their certificates which should include their scopes of accreditation. Restek_accredit

There are many steps required to produce a CRM that meets the above three criteria.  The first step requires a review of the customer’s, or end-user’s requirements to carefully define what is to be tested, at what levels and which analytical workflow will be used.  Such information enables the producer to identify the proper compounds and solvents required to properly formulate the requested CRM.

The next step requires sourcing and acquiring the raw, or starting materials, then verifying their compatibility and stability using stability and shipping studies in accordance with ISO requirements. Next the chemical identify and purity of the raw materials must be characterized using one or more analytical techniques such as: GC-FID, HPLC, GC-ECD, GC-MS, LC-MS, refractive index and melting point. In some cases, the percent purity is changed by the producer when their testing verifies it’s different from the supplier label. All steps are of course documented.

restek_CRMThe producer’s analytical balances must be verified using NIST traceable weights and calibrated annually by an accredited third party provider to guarantee accurate measurement. CRMs must be prepared using Class A volumetric glassware, and all ampules and vials used in preparation and final packaging must be chemically treated to prevent compound degradation during storage. Next, CRMs are packaged in an appropriate container, labeled then properly stored to maintain the quality and stability until it’s ready to be shipped. All labels must include critical storage, safety and shelf life information to meet federal requirements. The label information must be properly linked to documentation commonly referred to as a certificate of analysis (COA) which describes all of the above steps and verifies the traceability and uncertainty of all measurements for each compound contained in the CRM. Restek_CRM2

My company, RESTEK, offers a variety of documentation choices to accompany each CRM. Depending on the intended use and data quality objectives specified by the end-user, which were defined way back at the first step, three options are typically offered: They include gravimetric only, qualitative which includes gravimetric, and fully quantitative which includes all three levels of documentation. The graphic to the right summarizes the three options and what they include.

It’s important to understand which level you’re purchasing especially when ordering a custom CRM from a supplier. Most stock CRMs include all three levels of documentation, but it’s important to be sure.

Understanding what must be done to produce and deliver a CRM sets it apart from other reference material types, however it’s important to understand there are some instances where CRMs are either not available, nor required and in those situations other types of reference materials are perfectly acceptable.

If you have any questions or would like more details about reference materials please contact me, Joe Konschnik at (800) 356-1688 ext. 2002 by phone, or email me at joe.konschnik@restek.com.

From The Lab

HPLC Column Selection for Cannabis Chromatographers

By Danielle Mackowsky
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If your laboratory utilizes an HPLC system for cannabinoid and pesticide analysis, it can be a daunting task to select a stationary phase that is both practical and sufficient for the separation at hand. Typically, when developing a new method, an analyst will either evaluate a column they already have in house or seek out a referenced phase/dimension in the literature before exploring other available alternatives.

Tetrahydrocannabinol (THC)
Chemical structure of Tetrahydrocannabinol (THC)

A C18 phase is an excellent first choice for non-polar or slightly polar compounds. If the analyte in question has a minimum ratio of three carbon atoms for every heteroatom, it will be sufficiently retained on this phase. THC and other relative cannabinoids are prime candidates for separation via C18 due to their non-polar nature and structural components.

In addition to a universal C18 phase, alternative selectivity options do exist for laboratories concerned with the analysis of cannabinoid content. Another prevalent column choice features an aromatic or poly-aromatic stationary phase. Compatible with highly aqueous mobile phases, aromatic and poly-aromatic columns primarily rely on hydrophobic and π-π interactions as their main analyte retention mechanisms. Poly-aromatic phases provide enhanced retention and are more hydrophobic when compared to a single phenyl ring structure. While C18 phases are not ideal for resolving structural isomers, poly-aromatic columns are capable of separating these ring-based compounds. Chromatographers with a background in forensic analysis may be very familiar with this type of HPLC column due to its extensive use in drug testing applications.

Chemical structure of chlormequat, a hazardous polar pesticide commonly banned for use in cannabis cultivation
Chemical structure of chlormequat, a hazardous polar pesticide commonly banned for use in cannabis cultivation

Besides cannabinoid content, many cannabis scientists are equally concerned with accurate quantitation of pesticides within a given sample. Many pesticides that have found themselves on regulatory lists in states such as Massachusetts, Washington or Nevada are extremely polar. In order to increase retention of these compounds, and thus improve your overall chromatographic method, it can be extremely advantageous to select a column that allows you to start your gradient at 100% aqueous mobile phase. An aqueous or polar modified C18 column contains an embedded polar group, polar side chain or polar end-capping to allow for separation of polar compounds, while still retaining and resolving non-polar analytes. For laboratories that necessitate the use of only one analytical column, an aqueous C18 phase will allow for separation of monitored pesticides without compromising the quality of cannabinoid data produced.

One must also take into account column length, pore size and particle size when purchasing a column. For the purposes of any cannabis related analysis, a pore size of 100-120Å will suffice. Larger pore columns are typically reserved for large peptides, proteins and polymers. Depending on the sensitivity and resolution needed within your laboratory, particle size can range from 1.8-5um, with the highest sensitivity and resolution coming from the smaller particle size. Core shell technology is also a popular option for laboratories who want to keep the pressure of their HPLC system low, without sacrificing any quality of their resolution. Column lengths of 50 or 100 mm are common for chromatographers who want to achieve sufficient sample separation while keeping their run times relatively short.UCTcolumns

Regardless of the HPLC phase selected, it is very important that a guard cartridge is also used. Guard cartridges are traditionally the same phase and particle size of the HPLC column choice and help to prolong analytical column life. They provide additional sample clean up and are widely recommended by the majority of chromatography experts. Upon reviewing one’s options for HPLC phases and acquiring the necessary guard column, your cannabis laboratory will be ready to get the most out of your HPLC system for your analysis needs.

The Practical Chemist

Calibration – The Foundation of Quality Data

By Amanda Rigdon
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This column is devoted to helping cannabis analytical labs generate valid data right now with a relatively small amount of additional work. The topic for this article is instrument calibration – truly the foundation of all quality data. Calibration is the basis for all measurement, and it is absolutely necessary for quantitative cannabis analyses including potency, residual solvents, terpenes, and pesticides.

Just like a simple alarm clock, all analytical instruments – no matter how high-tech – will not function properly unless they are calibrated. When we set our alarm clock to 6AM, that alarm clock will sound reproducibly every 24 hours when it reads 6AM, but unless we set the correct current time on the clock based on some known reference, we can’t be sure when exactly the alarm will sound. Analytical instruments are the same. Unless we calibrate the instrument’s signal (the response) from the detector to a known amount of reference material, the instrument will not generate an accurate or valid result.

Without calibration, our result may be reproducible – just like in our alarm clock example – but the result will have no meaning unless the result is calibrated against a known reference. Every instrument that makes a quantitative measurement must be calibrated in order for that measurement to be valid. Luckily, the principle for calibration of chromatographic instruments is the same regardless of detector or technique (GC or LC).

Before we get into the details, I would like to introduce one key concept:

Every calibration curve for chromatographic analyses is expressed in terms of response and concentration. For every detector the relationship between analyte (e.g. a compound we’re analyzing) concentration and response is expressible mathematically – often a linear relationship.

Now that we’ve introduced the key concept behind calibration, let’s talk about the two most common and applicable calibration options.

Single Point Calibration

This is the simplest calibration option. Essentially, we run one known reference concentration (the calibrator) and calculate our sample concentrations based on this single point. Using this method, our curve is defined by two points: our single reference point, and zero. That gives us a nice, straight line defining the relationship between our instrument response and our analyte concentration all the way from zero to infinity. If only things were this easy. There are two fatal flaws of single point calibrations:

  1. We assume a linear detector response across all possible concentrations
  2. We assume at any concentration greater than zero, our response will be greater than zero

Assumption #1 is never true, and assumption #2 is rarely true. Generally, single point calibration curves are used to conduct pass/fail tests where there is a maximum limit for analytes (i.e. residual solvents or pesticide screening). Usually, quantitative values are not reported based on single point calibrations. Instead, reports are generated in relation to our calibrator, which is prepared at a known concentration relating to a regulatory limit, or the instrument’s LOD. Using this calibration method, we can accurately report that the sample contains less than or greater than the regulatory limit of an analyte, but we cannot report exactly how much of the analyte is present. So how can we extend the accuracy range of a calibration curve in order to report quantitative values? The answer to this question brings us to the other common type of calibration curve.

Multi-Point Calibration:

A multi-point calibration curve is the most common type used for quantitative analyses (e.g. analyses where we report a number). This type of curve contains several calibrators (at least 3) prepared over a range of concentrations. This gives us a calibration curve (sometimes a line) defined by several known references, which more accurately expresses the response/concentration relationship of our detector for that analyte. When preparing a multi-point calibration curve, we must be sure to bracket the expected concentration range of our analytes of interest, because once our sample response values move outside the calibration range, the results calculated from the curve are not generally considered quantitative.

The figure below illustrates both kinds of calibration curves, as well as their usable accuracy range:

Calibration Figure 1

This article provides an overview of the two most commonly used types of calibration curves, and discusses how they can be appropriately used to report data. There are two other important topics that were not covered in this article concerning calibration curves: 1) how can we tell whether or not our calibration curve is ‘good’ and 2) calibrations aren’t permanent – instruments must be periodically re-calibrated. In my next article, I’ll cover these two topics to round out our general discussion of calibration – the basis for all measurement. If you have any questions about this article or would like further details on the topic presented here, please feel free to contact me at amanda.rigdon@restek.com.

TeganAdams_Eurofinsexperchem
Quality From Canada

Following a Cannabis Sample Through the Lab: 9 Important Steps

By Tegan Adams
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TeganAdams_Eurofinsexperchem

Anytime a cannabis sample enters a laboratory, the sample is received, handled, weighed, identified and traced throughout the testing and disposal process. Laboratories working with cannabis must have quality systems in place to ensure every action taken to test the cannabis sample is documented and in compliance with good manufacturing practices. Eurofins-Experchem’s sample receipt and handling SOPs includes the following key elements.

  1. Purpose: The purpose of the SOP is outlined to make sure it’s outcome is understood
  2. Scope: The Scope of the SOP explains what events the SOP is intended to avoid and which events the SOP is intended to encourage
  3. Responsibilities: All positions that the SOP affects are outlined
  4. Initial Receipt of the Sample: Samples are submitted to Eurofins Experchem Laboratories with a Sample Information Form. In Canada, cannabis is regulated as a controlled substance. Controlled substances come with a special shipping document and must be weighed upon receipt to the lab to make sure the weight is the same as the client has indicated. Cannabis samples received are inspected to ensure no tampering or damage has occurred to the sample before it is tested. Any temperature and/or storage requirements are noted and followed. If any conditions are not understood the client is contacted for clarification immediately. Pending the sample’s conditions are met, the sample is placed into the laboratory.
  5. Procedure: Eurofins Experchem uses its own sample tracking software to track a sample across the lab. A unique project number and date of entry is given to the sample.  Client name, product name, condition of sample, test(s) performed, ID or lot number and size of samples are all recorded. A sticker is attached to the sample to clarify.
  6. Rush Samples: Rush samples are stamped “RUSH” in red and are placed in a priority sequence. The sample is placed in the safe until required for testing. If the product is not cannabis, the sample is placed on a shelf corresponding with the actual day of the month it was received and entered into sample tracking. If the sample requires cold temperatures it is placed in a refrigerated area and monitored in a similar way.
  7. Discrepancies: Any discrepancies in information found on the sample that may differentiate from what the client requests will be communicated to the client upon finding.
  8. Controlled Documents: Stickers, original lab specification sheets, sample submission forms, and SOP training evaluation questionnaires.
  9. Results: As soon as testing is completed, lab results are approved by quality assurance reviewers. A Certificate of Analysis (COA) is electronically and automatically sent through the sample tracking system to the client’s email.
TeganAdams_Eurofinsexperchem
Quality From Canada

Quality Training in a GMP Testing Facility: 8 Steps to Get Employees Compliant

By Tegan Adams
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TeganAdams_Eurofinsexperchem

Eurofins-Experchem Laboratories is a Health Canada and FDA-accredited analytical laboratory with a regulatory support division. The laboratory carries out testing for many different sectors including pharmaceuticals, cosmetics, natural health products and medical devices. Starting in 2014, cannabis testing was incorporated into the mix. One reason our results so accurate is due to rigorous staff orientation and training method. Diligent staff training and monitoring is very important for success as a Good Manufacturing Practices (GMP) facility with a Drug Establishment Licence and Narcotics License. So what does that look like on the inside? Saif Al-Dujaili, our quality assurance manager, Sohil Mana, our vice president of operations, and I will provide some guidelines for developing training programs below.

  1. Introductory Session: When any new employee starts an introductory phase, it begins with general admin, a facility tour, policy manual training, govt. legislation overview and health and safety training and orientation (WHIMS and Bill 168) specific to our lab. We record signatures on any pertinent forms for SOPs that the new employee will be using.
  2. Standard Operating Procedures: Any new employee must read all related SOPs and is evaluated on their understanding of them through questionnaires/quizzes. SOPs are written for all equipment, instrumentation or process that is applied in the lab, to ensure consistency across operations.
  3. Laws and Regulations: New employees must be familiar or familiarized with Good Manufacturing Practices and Good Laboratory Practices. Analysts are required to read all sections of the USP pertinent to their role, as decided by the quality manager and/or dept. head and a checklist is recorded on training.
  4. Methods: Different methods are used to test products including Compendium or other published methods with organizations such as the Association of Analytical Communities (AOAC) and the American Chemical Society (ACS). Client Methods and house-developed methods are also used. If there is a change to any method, a change control form must be filled out and documented.
  5. Documentation: Documentation is very important in a GMP lab. All data is recorded in a hard cover bound book and/or approved worksheets. Quality assurance data reviewers are responsible for ensuring all data is being recorded properly.
  6. Sample Management: Employees are trained on sample management related to sample entry, how samples are distributed to analysts, turn-around time, and where finished projects are placed.
  7. Training Forms: Everything an employee learns must be recorded and filed for records. Analysts must follow a training matrix on qualitative and quantitative testing methods. Recurrent training occurs each 3 years or less depending on the position the analyst holds. Any updates on GMPs, new instruments or equipment is ongoing and recorded. Experchem runs “ghost” samples through its laboratory to ensure compliance by employees at any given time. Employees are evaluated on their abilities to comply.
  8. Ongoing Training: Once employees are up and running they also receive monthly training in the lab and an annual GMP training followed by a comprehensive quiz that must be passed for them to continue work. 

Interested in learning more about cannabis testing in Canada and the US? Contact Tegan Adams, business development manager with Eurofins at teganadams@eurofins.com.


Editor’s Note: Eurofins-Experchem has helped submit over 150 MMPR applications to Health Canada and continues to work with 10 of the 27 licensed MMPR producers in Canada. Their regulatory affairs division has started working with companies applying to produce and distribute cannabis in those states, which are new to its sale and distribution. They offer services include writing SOPs, training staff and performing mock inspection audits.

Nic Easley: How Far Have We Come?

By Cannabis Industry Journal Staff
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Nic Easley, chief executive officer at Comprehensive Cannabis Consulting (3C), delivered the keynote address at the first annual Cannabis Labs Conference, co-located with Pittcon. Easley begins with a discussion of the 2014 milestone where Colorado and Washington legalized recreational cannabis, opening the floodgates for a diverse range of products and business opportunities in quality and safety testing. With members of his team sitting on the Colorado Department of Agriculture’s Pesticide working group, they are working with industry leaders and regulators to comprehensively write the standards. “The industry gets regulated in 2014 in Colorado with a total of $2.7 billion in sales in the first year of the industry’s history,” says Easley. “We have this giant influx of business, but without process validation, good agricultural practices and proper SOPs, each state is left to fend for themselves to write regulations.”

keynotecannabislabs

Nic Easley Delivers Keynote at Cannabis Labs Conference

By Cannabis Industry Journal Staff
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keynotecannabislabs

Nic Easley, chief executive officer at Comprehensive Cannabis Consulting (3C), delivered the keynote address at the first annual Cannabis Labs Conference, co-located with Pittcon. Easley set the tone of the conference early on by identifying safety and quality concerns in the current cannabis marketplace. “We can choose to do business as usual or we can create a new model with outside industry expertise to help guide this industry forward responsibly,” says Easley. Noting the existing comprehensive standards in food and agriculture, Easley emphasized the value of the Cannabis Labs Conference in bringing that expertise to the cannabis space. “We have the guidance and expertise in this room alone to help move the cannabis industry forward out of the closet and into the sunlight,” adds Easley.

 

Ask the Expert: Straight Talk on Safety, Defense and Security, Part II

By Aaron G. Biros, Bruce E. Lesniak, Lezli Engelking
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In this week’s Straight Talk on Safety, Defense and Security, we answer a reader’s question about traceability in quality processes and offer some practical advice for building a safety and security strategy. Travis Lodolinsky from Gleason Technology submitted this week’s question. For a response, we sit down with Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), to help answer your questions. If you have questions about safety, defense and security in cannabis, please ask them in the comments section below and we will address them in the next edition of Straight Talk on Safety, Defense and Security.

T. Lodolinsky: How are safety processes being tracked in the industry to ensure regulations and quality assurance are being uniformly enforced throughout?

Lezli Engelking: In related industries, such as herbal products or pharmaceuticals, the FDA has created guidelines, or current good manufacturing processes (CGMP) that control for the quality, consistency and safety of the products being produced. Businesses must be certified by independent third parties to demonstrate they are following CGMP to protect public health and consumer safety. CGMP is a proactive approach to quality assurance. A basic tenant of CGMP is that quality cannot be tested into a product after it is made; quality must be built into the product during all stages of the manufacturing process. One common misconception is that CGMP only covers the process of manufacturing itself. CGMP actually covers all aspects of the production process including materials, premises, equipment, storage, staff training and hygiene, how complaints are handled and record keeping.

Because cannabis is federally illegal in the US, the FDA has not developed cannabis-specific CGMP guidelines, so lawmakers do not have the benefit of having those guidelines available to base regulations on. So to answer your question, state cannabis regulations do not track processes and procedures used by cannabis businesses to control for safety or quality because they do not have the federal guidelines. Instead, most state cannabis regulations currently take a reactive approach to safety, mandating only for testing of the final product. While testing is an extremely important and valuable part of any quality management program, just analytics is not enough.

This is precisely why FOCUS was created and how they assist business owners and regulators, while fulfilling the mission of protecting public health, consumer safety and safeguarding the environment. The FOCUS standards are a cannabis-specific system of guidelines (cannabis-specific current good manufacturing practices) to ensure products are consistently produced according to quality standards. FOCUS provides detailed guidance and independent, third party auditing services for all key aspects of the cannabis industry including cultivation, extraction, infusion, retail, laboratory, security, packaging, labeling and sustainability.

CannabisIndustryJournal: What advice can you offer to cannabis businesses for product safety, defense and security prior to standardization?

Bruce E. Lesniak: Businesses that make products infused with cannabis (I call these businesses “plus one” companies because they produce products that include one more ingredient than traditional food products), require a carefully written master plan that specifically addresses the unique qualities, sensitivities and critical areas of the business. When building a comprehensive plan I address three questions:

  • Why (identify the why, this is your preventative, overarching strategy)?
  • How (addresses the “why question” with products, services and training)?
  • What (what is your reactive strategy that addresses actions and activities to be performed in the event of a breech)?

First and foremost, consumer-facing businesses must safeguard their products to the public. One product recall or illness related incident could spell disaster. Build your plan correctly the first time. Contact an industry expert to review your facility and help build and implement your plan. This will save you money by quickly exposing vulnerabilities and providing corrective measures specific to your business needs and requirements. Even though product safety and defense are closely related to security and should share a complementary strategy, product safety and defense are unique (due to standards and regulations), and should be treated as such.

Banks not accepting industry money complicates normal business operations and security planning, causing retail operations to handle and store large sums of cash. I asked industry expert and security professional, Tony Gallo of Sapphire Protection LLC, what is the single most important piece of security equipment you are currently providing for the retail and dispensary owner? “Design an air tight policy of handling money,” says Gallo. “Remove money often from cash registers and place it into the best safe for your application!”

Spend time familiarizing yourself with all things product safety and defense (there are volumes written on food safety and food defense, thus the “plus one” reference). This a great starting point and protecting the consumer protects your business. When it comes to designing your security application, consult an expert! Take into account that the cannabis industry is unique due to its “plus one” ingredient. Therefore you need to build your security systems, applications and policies to systematically protect your employees, facility, suppliers, transportation, manufacturing, distribution, warehousing, supply chain and brand.

dana and dani luce

Setting a Benchmark in Cannabis Testing: GOAT Labs

By Aaron G. Biros
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dana and dani luce

GOAT Labs, Inc. is a veteran-owned, i502-certified cannabis testing company with laboratories in Vancouver, Washington and Portland, Oregon. The laboratory launched in 2010 by Dana Luce, the owner, with a personal mission to provide safe and tested cannabis to patients in need.

Dana Luce’s daughter, Dani Luce, CEO of GOAT Labs, has previous experience working in dialysis and watched cancer patients lose their battle to the illness. Many years later, Dani’s oldest son was diagnosed with stage IV Hodgkin lymphoma. Cannabis proved instrumental in alleviating the side effects of chemotherapy. “With a severely compromised immune system, we had to find a place to test all the raw foods given to him, including cannabis,” says Dani Luce.

dana and dani luce
Dana Luce (left), owner of GOAT Labs, and Dani Luce (right), CEO, in the GOAT Labs office.

Dani Luce’s son was in remission nine months after starting chemotherapy in conjunction with cannabis and has now been in remission for five years. “We want to ensure patients are not ingesting something potentially toxic and that proper testing is done, which includes not only potency, but testing for microbials, pathogens, and pesticides.”

GOAT Labs is a member of the Cannabis Coalition for Standards and Ethics (CCSE) along with the American Oil Chemist Society (AOCS), where they participate in the Expert Committee for Cannabis Oil.

With pesticide use on cannabis recently entering the spotlight, there is a growing need for standards in cannabis testing. “We need better regulatory oversight so that all laboratories are standardized, including proficiency testing done by the state,” argues the Luce’s.

billlucesample
Bill Luce, lab technician at GOAT Labs, preparing samples for testing

Roger Brauninger, biosafety program manager of A2LA (American Association for Lab Accreditation), is working on an accreditation process for cannabis laboratories that would be accepted nationally. “We believe that an accreditation process would increase efficacy of lab results, reduce laboratory shopping, and create consistency with results across different laboratories,” says Brauninger.

GOAT Labs, among a number of other laboratories and organizations, is working toward putting cannabis in the lens of mainstream medicine. Not only are they looking to achieve a safe standard for medicine, they are advancing legalization efforts nationwide by setting the benchmark for getting patients access to safe, lab-tested cannabis.

Cannabis Labs: The Need For Standardized Analytics

Laboratory testing is an integral part of the cannabis industry for the same reasons it is important in the food industry. To ensure the consumer is ingesting a safe product, accurate testing should be required for microbials, pathogens, pesticides, heavy metals, and perhaps most importantly dosage. Unfortunately, however, the problem is that testing requirements are not quite there yet in the handful of states that have legalized marijuana for recreational or medical purposes. This creates a degree of uncertainty in the marketplace, which is detrimental to the growth of the industry as a whole.

Cannabis samples are liquified in strong acid in a pressurized microwave prior to evaluation for heavy metal content. Image courtesy of Digipath, Inc.
Cannabis samples are liquified in strong acid in a pressurized microwave prior to evaluation for heavy metal content. Image courtesy of Digipath, Inc.

Lauren Finesilver, Executive Chef at Sweet Grass Kitchen, sits on a counsel for compliance with C4 (Colorado Cannabis Chamber of Commerce). Finesilver believes “We are a food manufacturer first and foremost so we need to ensure we sell a final product that is safe for the public and [one] that consumers know is coming from a responsible manufacturer.” Ahead of marijuana rule changes that are soon to come, Colorado’s Marijuana Enforcement Division (MED) announced five new rulemaking working groups, one of which will address testing, packaging, and labeling.

Some states, including Colorado and Nevada, have made impressive strides in implementing proper testing regulations.

“Nevada has done a really good job from the start in designing a program where they have at least addressed some of the issues with product quality including testing, labeling, and potency requirements,” says Tobias Paquet, Chief Scientific Officer of C3 Labs, LLC (Cannabis Chemistry Consulting).

Paquet, who previously worked at Waters Corporation as a field chemistry specialist, cites potential contamination at almost every step of the cannabis supply chain from seed to sale. “Some of the biggest concerns with contamination during cultivation or extraction are pesticides, heavy metals, and microbial contamination,” he says, adding that he is most concerned about two microbial carcinogens—mycotoxin and aflatoxins.

“We aim to provide reliable and consistent labeling that is accurate and reflects the contents of that product,” says Paquet. “This comes with a validated method on qualified instruments and laboratory accreditation.”

Determining the moisture content in a dried cannabis sample for adjusting potency numbers and checking for appropriate curing. Image courtesy of Digipath, Inc.
Determining the moisture content in a dried cannabis sample for adjusting potency numbers and checking for appropriate curing. Image courtesy of Digipath, Inc.

Much like the food industry, accurate testing across the board is needed for consumers to feel safe ingesting edibles containing marijuana. Laboratories that operate in states where marijuana is already legal need to utilize good laboratory practices and standards to ensure consistency.

“We have been working to create an accreditation process that is accepted on a national level,” says Roger Brauninger, biosafety program manager at the American Association for Laboratory Accreditation (A2LA). “Without firm state laboratory accreditation regulatory requirements in place, the possibility exists that people may shop laboratories to get the results they want. So if applied across the board, ISO 17025 accreditation would help reduce that, thereby helping to create greater consistency of tests results between laboratories, ultimately helping to reduce marketplace confusion.”

The cannabis industry has the momentum to become a safe and regulated marketplace as state reforms continue, with testing and analytics acting as the wind behind its sails.

Matt Karnes, founder and managing partner of GreenWave Advisors, LLC, suggests that by 2020, assuming full legalization occurs in all 50 states and D.C., the lab testing industry could easily reach $850 million (this figure includes testing, data analytics and consulting services). The firm provides an analysis of each state’s potential market size which is predicated on its U.S. retail marijuana forecast of $35 billion (again, assuming full legalization by 2020). Karnes was recently cited in a Forbes article suggesting that cannabis testing is one of a handful of top new technology investment opportunities.

Karnes’ predictions echo that of many when discussing the cannabis analytics space. “More states are becoming focused on standardized laboratory testing requirements,” he says. “There is really no consistency, which is something that needs to be worked out.”

While a handful of states work toward achieving good laboratory standards, players in the cannabis industry, including laboratories, dispensaries, and cultivators, continue to self-regulate when it comes to safety and quality.

CannabisIndustryJournal.com, our newest publication, will be launched in late September. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!