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. 2021 May 14;14(5):462.
doi: 10.3390/ph14050462.

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

Alice Palermiti  1 , Alessia Cafaro  2 , Sebastiano Barco  2 , Paolo Bucchioni  3 , Paolo Franceschini  3 , Jessica Cusato  1 , Amedeo De Nicolò  1 , Alessandra Manca  1 , Elisa Delia De Vivo  1 , Eleonora Russo  4 , Francesco Cecchi  4 , Federica Pigliasco  2 , Flavia Lillo  5   6 , Gino Tripodi  2 , Antonio D'Avolio  1 , Giuliana Cangemi  2
Affiliations

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

Alice Palermiti et al. Pharmaceuticals (Basel). .

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.

Keywords: UHPLC/MS-MS; cannabinoids stability; cannabis oil; medical cannabis.

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Conflict of interest statement

A.D. and A.M. declare to be shareholder of CoQua Lab. The other authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Chromatographic peaks and retention times of CBD, CBD-A, THC and THC-A and deuterated internal standards.
Figure 2
Figure 2
Concentration (mg/mL) of THC (A), CBD (B), THC-A (C) and CBD-A (D) measured on 23 galenic preparations in the three laboratories during cross-validation.
Figure 3
Figure 3
Passing Bablok correlation plots for THC, CBD, A–THC and A–CBD. The plots show excellent correlations between the three laboratories for both cannabinoids.
Figure 4
Figure 4
Stability of cannabinoids in FM2 at different temperatures and up to 27 days. The results are expressed as % initial concentration mean of three replicates. Bars indicate CV%.
See this image and copyright information in PMC

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