Brigitte Simons is a business development executive in support of leading-edge laboratory services and data management tools for the development of safe cannabis. Bridging expertise within analytical science, pharma drug development and environmental testing – Brigitte have a professional track record for laboratory testing instrumentation, software and sample contract design for the Canadian federal agencies, such as Canadian Food Inspection, Health Canada, Agriculture Canada and Environment Canada. She spent over 6 years working in the Drug Toxicology and Analysis Division at Health Canada in a mass spectrometry facility testing. She completed two post-doctoral fellowships at the Clinical Sciences Hospital of the National Heart, Blood & Lung Institute within the famous NIH campus in Maryland, USA. Continuing on in lab specialties, Brigitte then joined SCIEX, a global instrumentation vendor for hardware and software for mass spectrometry. With over 15 years experience with operating mass spectrometers, Brigitte managed Canadian federal and provincial government sales for full laboratory services, covering clinical, forensics to product health and environmental safety. Prior to working abroad, Brigitte received her Ph.D. in Chemical Biology at the University of Ottawa in a joint chemistry program with drug pharmacology at Health Canada.

Within the framework of Bill C-45, Canada is positioned to become the global leader in the legal cannabis economy and global exporter. The enactment of this Canadian Cannabis Act provides legal access to marijuana and to control and regulate its production, distribution and sale. The primary objective of Health Canada’s regulatory policy bears stringencies with respect to public health and safety and strict requirements for quality assurance, record keeping and mandatory testing by 3rd party laboratories for product contamination. This opens an opportunity for advancing analytical development for cannabis metabolite profiling of active natural products and bleeds through to the accurate quantitative reporting of pesticides, mycotoxins and heavy metalloids that serve regulatory audit to clear products for sale. A complete LC-MS/MS workflow is described to quantitate 14 cannabinoids and screen for over 40 terpenoids to fingerprint various top cannabis dried flower brands from the large enterprise-producers in a method that is delivered in under 15 mins of analytical run time using a dual ESI and APCI ionization strategy. A wide linear dynamic range of 0.03 to 90% measurement (104 orders LDR) of cannabinoid per LC-MS injection can be reported to provide a more accurate view for product labeling and dosing recommendations. Terpene expression and metabolite measurement in plant cultivars are becoming less challenging with newly identified terpene synthases and availability of new mono-terpenes and sesquiterpene standards. It is of high interest for results of these metabolite profiling experiments to be correlated with plant cultivation parameters to achieve quality control and strengthen the consumer's experience with a brand of cannabis and differentiate products for retail. Furthermore, pesticide residue analysis in cannabis flower and oil formulations has been developed to meet the reporting requirements of Health Canada’s banned pest control ingredients list. With UHPLC linked tandem mass analysis covering all of the 96 banned pesticides except for 11 compounds best suited by GC separation, it is possible to achieve a validated cannabis product certificate of analysis for issuance to cannabis licensed producers in rapid turn-around. Analytical method details include LC separation using the Raptor Restek Column, Raptor Biphenyl and newly available mixtures of pesticide standards to meet the Canadian Pest Management Agency’s list of required pesticide maximum residual levels (down to 10 ppb in most cases). The addition of mycotoxins and other organo-contaminants can also be inserted into our methods with the use of optimized Scheduled MRM mass spec scanning techniques. The assembly of all the potency and ingredients data collection possible can provide information to consumers and track benefits to the cannabis producers stride to bring powerful brands to the global cannabis market.

Manuela Neuman is the CEO of In Vitro Drug Safety and Biotechnology, Toronto, ON., Canada. She is also teaching Pharmacology and Toxicology at the Faculty of Medicine, University of Toronto, Toronto, Canada. She is the Chair of Clinical Toxicology and Drug of Abuse Committee of the International Association ofa Therapeutic Drug Monitoring and Clinical Toxicology. She published 300 peer review articles. Her specialized laboratory provides personalized medicine and precision medicine results for Canada, USA and Europe.

The interplay of alcohol with drugs includes multiple facets. These include the effects of alcohol on the effects of other hepatotoxicants and on the pharmacological effects of various drugs. Also relevant is the possible role of alcohol on the effects of carcinogenic agents. Less striking, but significant, are the effects of other drugs on the effects of ethanol. More difficult to identify but presumably significant, are the effects of alcohol-drug interplay on the development of an alcoholic liver disease. A common denominator of them is the role of ethanol-induced P-4502E1 (CYP2El) in affecting the toxicity ofsome hepatotoxicants and the effects of some drugs. Less prominent but also relevant is the effect of interplay with alcohol dehydrogenase and aldehyde dehydrogenase in the toxicity of some drugs. Alcohol has been shown to be responsible for cirrhosis in the 18th century and was labeled a hepatotoxin in the 19th century. During the second half of the 20th century alcohol has been recognize to enhance the toxic effect of other hepatotoxic agents such as acetaminophen, aflatoxin B1, allyl alcohol,bromobenzene, cocaine, enflurane, galactosamine, halothane, isoniazid, nitrosamines, thioacetamide, vinyl chloride and vitamin A. The toxicity of several hepatotoxicants is unaffected and of at least one, amanitine, is decreased by ethanol. The effect of ethanol on the toxicity of carbon tetrachloride and acetaminophen have been studied most extensively. The enhancement of toxicity by ethanol does not depend on an ethanol-induced hepatic injury but rather on the activity of the cytochrome P450 2E1 that converts the respective toxicants to their active metabolites. Nevertheless, inhibition by ethanol of regenerative response to injury may contribute to an enhancement of toxicity by ethanol. The toxicity produced by ethanol may have a bearing on the liver disease of alcoholism as well as on the toxicity and carcinogenicity of individual toxicants.

Abuzar Kabir is a Research Assistant Professor in the Department of Chemistry and Biochemistry, Florida International University (FIU), Miami, Florida, USA. His research interest primarily focusses on synthesis and applications of novel sol-gel derived advanced material systems (chromatographic stationary phases, surface coatings of high-efficiency microextraction sorbents, nanoparticles, microporous and mesoporous functionalized sorbents) for analyzing polar, medium polar, nonpolar, ionic analytes, heavy metals and organometallic pollutants from biological/pharmaceutical/clinical/environmental sample matrices. He is an ardent advocate of Green Analytical Chemistry (GAC). His recent inventions, fabric phase sorptive extraction (FPSE), dynamic fabric phase sorptive extraction (DFPSE), Capsule Phase Microextraction (CPME), substrate-free liquid chromatographic stationary phases and extraction sorbents, organic polymeric liquid chromatographic stationary phases and extraction sorbents and universal molecular imprinting technology have drawn tremendous interests among the researchers. He has published more than 50 peer-reviewed journal articles, 9 book chapters and 90 conference proceedings. Dr. Kabir has invented numerous chromatographic stationary phases and sample preparation technologies, resulting in 15 US patents.

Statement of the Problem: The invention of fabric phase sorptive extraction (FPSE) has begun a new era in analytical sample preparation by ingeniously combining two competing for sample preparation techniques, solid phase extraction (SPE) and solid phase microextraction (SPME) into a single sample preparation technology platform. The integrated system, FPSE utilizes a flexible, yet active fabric (cellulose, polyester and fiberglass) substrate to host a thin layer of sol-gel derived extracting sorbent. The engineered selectivity of the sol-gel sorbents and the hydrophobicity/hydrophilicity of the fabric substrate synergistically complement to the net polarity of the fabric phase sorptive extraction medium and consequently, determine its extraction efficiency. The sponge-like porous architecture of sol-gel extraction sorbent and the inherent permeability of the fabric create anextraction medium that mimics a solid phase extraction disk and allows permeating aqueous sample matrix through its body, leading to rapid sorbent-analyte interaction and subsequent successful retention of the analyte(s) onto the extraction medium. The flexibility of the FPSE medium permits direct insertion into the sample container for analyte extraction and thus minimizes the number of transfer containers used in the sample preparation process. The sol-gel coating technology allows utilization of typical functional ligands commonly used in solid phase extraction such as C8/C18 as well as polymers used in solid phase microextraction such as polydimethylsiloxane (PDMS). Unlike SPE and SPME, FPSE can be performed either in equilibrium extraction mode (as in SPME) or inexhaustive extraction mode (as in SPE). In addition, sol-gel coated sorbents demonstrate superior thermal, solvent and pH stability (1-13) compared to conventional sorbents. Due to these unmatched advantages, FPSE has gained considerable popularity in a short period and has demonstrated numerous applications in a wide variety of samples including food, biofluids, wastewater and air. In the current talk, analytical data pertaining to some fascinating applications of FPSE will be presented.

Peng Chen received a Ph.D. in Analytical Chemistry from Indiana University in 1998 and a M.S. in Organic Chemistry from the University of Louisville in 1994. Hisgraduate research includes the introduction of osazones as MALDI matrices for carbohydrate analysis and the structural elucidation of fluorescent aging markers. He has been working in various chemical industry sectors in the fields of chromatography and mass spectrometry. His work in recent years at Chemic Labs Inc. involves structural elucidation of small molecules in pharmaceuticals and medical devices by high-resolution QTOF mass spectrometry.

The structural elucidation of small molecules by high-resolution mass spectrometry plays important roles in developmentand quality control of pharmaceuticals and medical devices. Trace amounts of small molecules can be present in forms of impurities, by-products or degradation products, etc. It is often difficult to separate and fractionate enough quantities of these analytes for conventional structural analysis by NMR and FTIR. Recent advances in instrumentation and software of UPLC-MS QTOF with MS/MS fragmentation capability can give structural insight into molecules of interest and in many cases offer structure candidates at high confidence. This presentation will use several practical examples in the analysis of synthetic compounds and identification of impurities associated with pharmaceuticals and medical devices to illustrate the convenience and power of UPLC-QTOF high-resolution mass spectrometry.