Abstract
Medical cannabis is increasingly being used in the treatment and support of several diseases and syndromes. The quantitative determination of active ingredients (delta-9 tetrahydrocannabinol, THC, and cannabidiol, CBD) in galenic oily preparations is prescribed by law for each produced batch. The aim of this work is to describe the organization of the titration activity centralized at three regional reference laboratories in Northern Italy. Pre-analytical, analytical, and post-analytical phases have been defined in order to guarantee high quality standards. A cross-validation between laboratories allowed for the definition of the procedures that guarantee the interchangeability between reference laboratories. The risk management protocol adopted can be useful for others who need to undertake this activity.
Highlights
In Italy, Cannabis sativa for medical use has been subjected to specific regulation since 2015
The methods of packaging, transport, and acceptance have been defined in detail by a standard operating procedure in compliance with ISO 9001/2015 Quality Management
We have shown for the first time the process management of the titration activity centralized in three reference laboratories in Northern Italy
Summary
In Italy, Cannabis sativa for medical use has been subjected to specific regulation since 2015. The two main cannabinoids at the basis of the therapeutic activity and present in the inflorescences of Cannabis sativa L are delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD) which derive from their acid precursors, tetrahydrocannabinolic acid (THC-A) and cannabidiolic acid (CBD-A), respectively, following oxidation due to exposure to light, air, and direct heating [2]. Other cannabinoids present in the phytocomplex are cannabinol (CBN), which originates from the oxidation of THC, cannabichromene (CBC)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
