| dc.description.abstract | In the last few years, there has been an increase in the use of cannabis-based products for
medicinal purposes. The preparation procedure, however, has not been standardised but is
decided by the individual groups of scientists globally. As cannabis-based products are more
frequently used for medicinal and recreational uses, standardised quality control methods must
be developed, validated and harmonised. This study relates to the three major quality control
parameters of interest in cannabis-based products in South Africa. These three quality control
tests include cannabis potency, residual solvent residues and heavy metal residues.
For cannabis potency a total of 840 samples were analysed in duplicate (1680 datapoints in total)
and reported in an anonymous format. Samples were categorised into 7 different types: Edible,
Extract, Infusion, Liquid, Other, Plant material, and Solid. Each category was divided into the
following weight by percentage concentration levels: <0.1 wt.-%, 0.1 wt.-% to 1 wt.-% and finally
>1 wt.-%. The results indicated that high amounts of tetrahydrocannabinol (THC) are present
in most of the cannabis-based products in South Africa. This is of concern due to the health
implications of these products, and the current South African legislation related to cannabidiol
(CBD) and THC.
For heavy metal residues a total of 310 samples were analysed. The submitted samples were
divided into different category classifications and grouped according to relevance for oral or
inhalation specification. The results showed an alarming 15% sample failure rate compared to
the oral specification limit and a 44% failure rate compared to the inhalation specification limit. It
is of the utmost importance for manufacturers to have the appropriate quality control regimes in
place, especially for heavy metal residues, in South Africa. Furthermore, it is imperative to ensure
regulation is enforced and the South African public is educated about the risks associated with
using these products.
Solvent residue analysis employed a total of 279 samples in duplicate and the results are reported
in an anonymised format. The results showed an alarming 37% sample solvent residue failure
rate with respect to adherence to USP 467 specification.
As seen from the facets discussed above, manufacturers, as well as cultivators should adhere to
the current GMP guidelines set forth, to ensure the safety of the consumer as well as the quality
of the product produced. With the current findings the safety of consumers is brought into
question. With this data South African regulators as well as the public might be informed about
the current state of cannabis-based products. | en_US |
