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  • Analysis of Cannabinoids Concentration in Cannabis Oil Galenic Preparations: Harmonization between Three Laboratories in Northern Italy.

Analysis of Cannabinoids Concentration in Cannabis Oil Galenic Preparations: Harmonization between Three Laboratories in Northern Italy.

Pharmaceuticals (Basel, Switzerland) (2021-06-03)
Alice Palermiti, Alessia Cafaro, Sebastiano Barco, Paolo Bucchioni, Paolo Franceschini, Jessica Cusato, Amedeo De Nicolò, Alessandra Manca, Elisa Delia De Vivo, Eleonora Russo, Francesco Cecchi, Federica Pigliasco, Flavia Lillo, Gino Tripodi, Antonio D'Avolio, Giuliana Cangemi
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.

MATERIALS
Product Number
Brand
Product Description

Supelco
(−)-Δ9-THC-D3 solution, 100 μg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®
Supelco
(−)-trans-Δ9-THC solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®
Supelco
Cannabidiolic acid solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material, Cerilliant®