Tag Archives: analytical

EVIO Labs Expands To Florida

By Aaron G. Biros
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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.

Chris Martinez, co-founder and chief operating officer of EVIO Labs Florida

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.

The EVIO team is using instruments from Shimadzu

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.

Ask the Expert: Q&A with Steve Stadlmann on Cannabis lab Accreditation

By Aaron G. Biros
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Steve Stadlmann has an extensive background as an analytical chemist working in laboratories since the early 90’s. He is now a sales specialist at PerkinElmer, an analytical instrument manufacturer that provides instruments for cannabis testing labs, in addition to a host of other industries. With over two decades of experience working in environmental testing labs, food and beverage labs and agricultural testing labs, Stadlmann is extremely familiar with the instruments used in cannabis labs.

Steve Stadlmann, sales specialist at Perkin Elmer

In 2014, he started working in the cannabis space with TriQ, Inc., a technology solutions provider for cannabis growers, where he worked in product development on a line of nutrients. In April of 2016, he started working at Juniper Analytics, a cannabis-testing laboratory in Bend, Oregon. As laboratory director there, he created their quality manual, quality assurance plan, SOP’s and all the technical documentation for ORELAP accreditation. He developed new methodologies for cannabis testing industry for residual solvents, terpene profiles and potency analysis. He worked with PerkinElmer on pesticide methodology for the QSight™ Triple Quadrupole LC/MS/MS system and implemented operational procedures and methods for LC-UV, GCMS and LC-MS/MS, including sample prep for cannabis products.

He left Juniper Analytics about two months ago to work with PerkinElmer as a sales specialist. With extensive experience in helping get Juniper’s lab accredited, he is a wealth of knowledge on all things cannabis laboratory accreditation. PerkinElmer will be hosting a free webinar on September 12th that takes a deep dive into all things cannabis lab accreditation. Ahead of the upcoming webinar, Getting Accreditation in the Cannabis Industry, we sit down with Stadlmann to hear his observations on what instruments he recommends for accreditation, and processes and procedures to support that. Take a look at our conversation below to get a glimpse into what this webinar will discuss.

CannabisIndustryJournal: How can cannabis labs prepare for accreditation with selecting instrumentation?

Steve: Finding the appropriate instrumentation for the regulations is crucial. Ensuring the instrumentation not only has the capabilities of analyzing all the required compounds, but also able to achieve appropriate detection limit requirements. In addition, having an instrument manufacturer as a partner, that is willing and able to assist in method development, implementation and continued changes to the testing requirements at the state level (and potentially national level) is key.

Another consideration is robustness of the equipment. The instrumentation must be capable of high throughput for fast turnaround times of results. Unlike the environmental industry, the cannabis industry has consumer products with expiration dates. Clients demand quick turnaround of results to get product to market as quickly as possible and avoid sitting on inventory for any length of time.

To add to the robustness need, sample matrices in the cannabis industry can be quite challenging in relation to analytical instrumentation. Equipment that is able to handle these matrices with minimal downtime for routine service is becoming a requirement to maintain throughput needs of the industry.

CIJ: What are the most crucial procedures and practices for achieving ISO 17025 accreditation?

Steve: Development and documentation of processes and procedures following Good Laboratory Practices and procedures is essential to a successful accreditation process. Great attention must be paid to the quality objectives of the laboratory as well as associated documentation, including tracking of any errors, deviations, updates, complaints, etc.

Data integrity is a key component to any accrediting body and includes implementation and/or development of appropriate methods with support data proving acceptable results. In addition, documentation of all procedures and processes along with tracking of all steps in the process during routine laboratory work should be a priority. The ability to show a complete, documented trail of all procedures done to any sample is important in ensuring the results can be reproduced and ensuring no deviations occurred, in turn potentially causing questionable results.

Last but not least: training. Laboratory staff should be well versed in any procedures they are involved in to ensure high data quality and integrity. If any laboratory staff does not receive appropriate training in any operating procedures, the data quality becomes suspect.

CIJ: What are some of the biggest obstacles or pitfalls cannabis labs face when trying to get accredited?

Steve: Not fully preparing to meet any agency and testing regulations and requirements will cause delays in the accreditation process and potentially more work for the laboratory. From documentation to daily operations, if any aspect becomes a major finding for an auditor, additional data is usually required to prove the error has been fixed satisfactorily.

Taking the time early on to ensure all documentation, processes and procedures are adhering to any regulatory agency requirements is important for a smooth accreditation process. It is easy to overlook small details when building out the operating procedures that might be essential in the process. Again, going back to data quality, the laboratory must ensure all steps are outlined and documented to ensure high quality (reproducible) data and integrity.

A new employee should be able to come in and read a quality manual and standard operating procedure and produce equivalent data to any laboratory analyst doing the same job. With difficult or challenging operating procedures it becomes even more important that training and documentation are adhered to.


PerkinElmer’s free webinar will dive into these points and others in more detail. To learn more and sign up, click here.

The Practical Chemist

Potency Analysis of Cannabis and Derivative Products: Part 2

By Rebecca Stevens
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As mentioned in Part 1, the physiological effects of cannabis are mediated by a group of structurally related organic compounds known as cannabinoids. The cannabinoids are biosynthetically produced by a growing cannabis plant and Figure 1 details the biosynthetic pathways leading to some of the most important cannabinoids in plant material.

Potency figure 1
Figure 1: The biosynthetic pathway of phytocannabinoid production in cannabis has been deeply studied through isotopic labeling experiments

The analytical measurement of cannabinoids is important to ensure the safety and quality of cannabis as well as its extracts and edible formulations. Total cannabinoid levels can vary significantly between different cultivars and batches, from about 5% up to 20% or more by dry weight. Information on cannabinoid profiles can be used to tailor cultivars for specific effects and allows end users to select an appropriate dose.

Routine Analysis vs. Cannabinomics 

Several structurally analogous groups of cannabinoids exist. In total, structures have been assigned for more than 70 unique phytocannabinoids as of 2005 and the burgeoning field of cannabinomics seeks to comprehensively measure these compounds.¹

Considering practical potency analysis, the vast majority of cannabinoid content is accounted for by 10-12 compounds. These include Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD), cannabigerol (CBG), Δ9-tetrahydrocannabivarian (THCV), cannabidivarin (CBDV) and their respective carboxylic acid forms. The cannabinoids occur primarily as carboxylic acids in plant material. Decarboxylation occurs when heat is applied through smoking, vaporization or cooking thereby producing neutral cannabinoids which are more physiologically active.

Potency Analysis by HPLC and GC

Currently, HPLC and GC are the two most commonly used techniques for potency analysis. In the case of GC, the heat used to vaporize the injected sample causes decarboxylation of the native cannabinoid acids. Derivatization of the acids may help reduce decarboxylation but overall this adds another layer of complexity to the analysis² ³. HPLC is the method of choice for direct analysis of cannabinoid profiles and this technique will be discussed further.

A sample preparation method consisting of grinding/homogenization and alcohol extraction is commonly used for cannabis flower and extracts. It has been shown to provide good recovery and precision² ³. An aliquot of the resulting extract can then be diluted with an HPLC compatible solvent such as 25% water / 75% acetonitrile with 0.1% formic acid. The cannabinoids are not particularly water soluble and can precipitate if the aqueous percentage is too high.

To avoid peak distortion and shifting retention times the diluent and initial mobile phase composition should be reasonably well matched. Another approach is to make a smaller injection (1-2 µL) of a more dissimilar solvent. The addition of formic acid or ammonium formate buffer acidifies the mobile phase and keeps the cannabinoid acids protonated.

The protonated acids are neutral and thus well retained on a C18 type column, even at higher (~50% or greater) concentrations of organic solvent² ³.

Detection is most often done using UV absorbance. Two main types of UV detectors are available for HPLC, single wavelength and diode array. A diode array detector (DAD) measures absorbance across a range of wavelengths producing a spectrum at each point in a chromatogram while single wavelength detectors only monitor absorbance at a single user selected wavelength. The DAD is more expensive, but very useful for detecting coelutions and interferences.

References

  1. Chemical Constituents of Marijuana: The Complex Mixture of Natural Cannabinoids. Life Sciences, 78, (2005), pp. 539
  2. Development and Validation of a Reliable and Robust Method for the Analysis of Cannabinoids and Terpenes in Cannabis. Journal of AOAC International, 98, (2015), pp. 1503
  3. Innovative Development and Validation of an HPLC/DAD Method for the Qualitative and Quantitative Determination of Major Cannabinoids in Cannabis Plant Material. Journal of Chromatography B, 877, (2009), pp. 4115

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, rebecca.stevens@restek.com or by phone at 814-353-1300 (ext. 2154)