Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an Emerging Cannabis-Based Pharmaceutical Industry

Abstract

The plant genus Cannabis is a prolific producer of unique pharmaceutically relevant metabolites, commonly referred to as cannabinoids. Robust and standardised methods for the quantification of cannabinoids within botanical and drug forms is a critical step forward for an emerging Cannabis-based pharmaceutical industry, which is poised for rapid expansion. Despite a growing body of analytical methods for the quantification of cannabinoids, few have been validated using internationally accredited guidelines. Moreover, standardised methods have yet to be developed for application at various stages of manufacture as well as for different levels of processing and refinement. Validation parameters for establishing robust standardised methods for cannabinoid quantification within Cannabis-based drug forms are critically discussed. Determining an appropriate level of specificity (discrimination) among heterogeneous botanical matrices as well as evaluating accuracy (recovery) and inter-laboratory precision (reproducibility) within strict and volatile regulatory environments are potential obstacles to the establishment of robust analytical procedures. We argue that while some of these challenges remain unique to Cannabis, others are common to botanical-based drug development and manufacture. In order to address potential barriers to analytical method standardisation, a collaborative research initiative inclusive of academic and commercial stakeholders is proposed.

A Colorimetric Method for the Rapid Estimation of the Total Cannabinoid Content in Cannabis Samples

“…This interest has generated a great expansion of the market for cannabis-related products. As a result, there is an increasing demand for chemical information about cannabis plants in the forensic, toxicological, and medical fields, as well as in nutraceutical, food, and cosmetics industries, among others [ 1 , 2 ]. In this respect, LC is currently the technique of choice, and several chromatographic assays can be found in the literature that allow the accurate determination of cannabinoids in a variety of samples [ 6 ].…”

“…In recent years, a great interest in Cannabis sativa L. plants and derived products has been observed, not only due their widespread use for recreational purposes, but also because of their employment in the pharmaceutical, nutraceutical, food, and cosmetic industries [ 1 , 2 ]. Cannabinoids are the most abundant constituents of cannabis plants, with Δ 9 -tetrahydrocannabidiol (THC) being the main psychoactive compound.…”

Analytical strategies for herbal Cannabis samples in forensic applications: A comprehensive review

“…Overall, the significance of Cannabis is rapidly growing in the scientific world. For therapeutic purposes, for instance, there is a renewed interest in discovering the medicinal and pharmaceutical benefits of Cannabis and its derivatives, for which quality control during sample testing is needed (Sarris et al, 2020; Welling et al, 2019). Also, in forensic laboratories, because of the high number of seizures of the controlled drug, there is a demand for robust methods and technologies to analyze Cannabis.…”

Simultaneous Quantification of 17 Cannabinoids in Cannabis Inflorescence by Liquid Chromatography-Mass Spectrometry

“…This might be in part due to the regulatory constraints, which necessitate specific licences to handle this scheduled drug and limit the availability of standard compounds and test samples. Due to this, the cannabis testing industry remains poorly established, with only a relatively limited number of laboratories offering analytical services and a lack of standardized protocols for extraction and analysis [5].…”