Kenneth Aldous (Presenter)
Wadsworth Center , NY State Department of Health
Bio: Dr. Aldous received his Bachelor of Science in Chemistry and Ph.D. in Analytical Chemistry from Imperial College of Science and Technology, University of London, UK. He joined the New York State Department of Health Laboratory in 1970 and his present position there is Director Emeritus, Division of Environmental Health Sciences at the NYSDOH Wadsworth Center. He has worked on CDC funded programs for human biomonitoring and chemical threat preparedness and is presently a principal investigator at Wadsworth’s NIEHS funded Children’s Health Exposure Analysis Resource (CHEAR) laboratory center.
Authorship: Kenneth Aldous, Lingyun Li, Lei Li, M. Dittmar, L. Durocher, E. Delaney, R. Acosta and D. Spink.
Wadsworth Center, New York State Department of Health
| Short Abstract Medicinal cannabis (MC) is available in 28 States of the US. The lack of standardized state regulations and testing has resulted in inconsistent quality and potency of products. NY State’s Public Health Laboratory has been required to develop validated methods for testing and confirm the quality and potency of distributed products to meet MC program regulations and identify illegal synthetic cannabinoids. We present the laboratory assays developed, applying mass spectrometry methods, for the analysis of final MC products that are approved under the current NY state program regulations. Methods developed for determining 9 major phytocannabinoids and contaminants such as pesticides, growth regulators and trace elements are presented. |
Long Abstract
Introduction
On July 5, 2014, Gov. Andrew Cuomo signed a limited medical marijuana bill into law, New York became the 23rd state with an effective medical marijuana law. Initially five Registered Organizations (RO) received approval to grow and produce medical marijuana products for distribution at a total of 20 dispensaries statewide beginning January 2016. Approved medical marijuana products must be produced from extracts of plant material using supercritical CO2 and are limited to the following forms and routes of administration: a) liquid or oil preparations for metered oromucosal or sublingual administration b) metered liquid or oil preparations for vaporization c) capsules for oral administration and d) any additional form and route of administration approved by the commissioner. Smoking is not an approved route of administration.
Medical marijuana products produced by a registered organization must be examined in a laboratory located in New York State that is licensed by the federal Drug Enforcement Administration (DEA) and approved for the analysis of medical marijuana by the NYS Health Department in accordance with article 5 of the public health law and subpart 55-2 (1).
The following are required tests to be completed by an approved laboratory to verify the cannabinoid content stated on the label, dosage and freedom from contaminants. The following are required test to be completed on selected samples of final packaged products before the product lot may be distributed.
Potency tests:
Each medical marijuana product brand, in its final form, shall be defined as having a specific concentration of total Tetrahydrocannabinol (THC) and total Cannabidiol (CBD) and shall have a consistent cannabinoid profile. The concentration of the following cannabinoids, at a minimum, must be reported: THC, THCA, THCV, CBD, CBDA, CBDV, CBN, CBG and CBC or any cannabinoid at levels higher than 0.1%.
Contaminants tests:
Mycotoxin contaminants: Aflatoxin, Ochratoxin
Trace metal and metalloid contaminants: Sb, As, Cd, Cr, Cu, Pb, Ni, Zn, Hg
Any pesticide/herbicide/fungicide used during production of medical marihuana product
Any growth regulator used
Bacterial contaminants tests:
E. Coli, Klebsiella, Pseudomonas, Salmonella, Streptococcus, Bile tolerant gram negative bacteria, Aspergillus, Mucor species, Penicillium species, Thermophilic Actinomycetes species
Methods
Manufactured product lots intended for distribution are sampled and individual forms of the cannabis extract are prepared for chemical testing following aseptic removal of subsamples for bacterial testing. Depending on the specific form of the cannabis product (liquid, capsule, vaporization oil, etc) a measured portion of the remaining sample is prepared for instrumental analysis. For targeted chemical testing the following mass spectrometry platforms are employed. ICP-MS for trace elements, LC-MS/MS for mycotoxins, pesticides, herbicides/fungicides, and growth regulators. Potency methods have been developed and validated using LC- MS/MS (Qtrap) and the method transferred and validated for LC-PDA detection. Details of these methods have been made available specifically to other NY state laboratories on the NYDOH website to assist in generating additional approved capacity for testing cannabis in NY (2). The performance of these analytical methods for testing the various medical cannabis products will be presented along with the experience gained during the setting up of this laboratory facility.
One concern remained, pesticides screening and analysis are still a very challenging tasks since hundreds of pesticides could be present and a small amount of residue left in the complex sample matrix and may not be detected. Another public health problem often directed to the PH laboratory is related to the availability and adverse health effects of synthetic cannabinoids or K2/spice.
To attempt a solution these problems, we have adopted a screening and quantitation platforms using liquid chromatography (LC) in combination with a quadrupole time-of-flight (QTOF) instrument with sequential window acquisition of all theoretical fragments-ion spectra (SWATH) acquisition method. With this LC QTOF SWATH platform, we were able to perform pesticides and SCs screening based on an accurate mass database. For the identified compounds, we can use the MS/MS fragments to perform quantitative analysis. This universal method platform can be easily applied to biological sample analysis for non-targeted metabolites/biomarker screening and quantitation, for any chemical or biological compounds which can be analyzed in mass spectrometry.
Results
The medical cannabis program has been operating in NY for almost two years and all products so far have been analyzed by Wadsworth’s Public Health Laboratory. During 2016 we analyzed approximately 3,700 medical cannabis samples for potency, pesticides and mycotoxins resulting in over 40,000 analytical results reported. A similar amount of data from 2017 are being compiled and will be compared to determine trends in product quality and cannabinoid profiles. We will discuss the results of this investigation as well as the analyses and identification of synthetic cannabinoids that have been obtained recently by law enforcement and from poison control centers in NY.
Conclusions & Discussion
Setting up the medical cannabis testing laboratory for New York State has allowed testing data to be assembled from several production facilities to determine the variability and potency of cannabinoid profile being provided to those patients in the program. The mass spirometry laboratory has been able to develop validated test methods to cover the chemical testing required by state regulations and ensure the potency and purity of product being distributed. The LC-Q-TOF instrument has permitted a screening method to be developed that allow for rapid identification of synthetic cannabinoids in K2/spice products for law enforcement purposes and poison control/emergency rooms. We intend to continue to apply untargeted analysis using the high resolution Q-TOF MS capability to analyze environmental samples as well as biomonitoring specimens to expand the scope of exposure assessment.
We continue to work with a network of other public health laboratories through the Association of Public Health Laboratories (APHL) to harmonize methods and provide reference materials to ensure consistent national reporting of potency and purity.
References & Acknowledgements:
(1) https://regs.health.ny.gov/content/section-55-215-requirements-laboratories-performing-testing-medical-marihuana
(2) Approved methods for testing Medical Marijuana (MM) for the NY State MM program. https://www.wadsworth.org/regulatory/elap/medical-marijuana.
We acknowledge staff of Wadsworth Center, NYS DOH H. Valente, Ph.D. and B. Duffy, Ph.D. for technical support and A. Walsh, Ph.D., M.D. for support and oversight of this program.
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