Medicinal Cannabis Testing & Regulation in Australia
Medicinal cannabis in Australia undergoes rigorous cannabis testing, both to test its contents and to ensure its compliance with the standards set forth by the Therapeutic Goods Administration (TGA).The stringent testing involves several stages and different pieces of equipment to ensure all medicinal cannabis is free from contaminants and pesticides.
Medicinal cannabis undergoes testing using sophisticated lab testing equipment. The two main types of testing employed to detect the potency and purity of the medicinal cannabis are gas chromatography (GC) and high performance liquid chromatography (HPLC).
Both forms of chromatography involve analytical chromatography machines, which measure the precise contents of a medicinal cannabis sample. A sample is dissolved into a solvent and pushed through an absorbent surface. The time that a cannabis compound takes to move through the absorbent surface will determine which compound it is. Each compound will also leave a distinct colour trail, which aids with identification.
Of the two cannabis testing types, high performance liquid chromatography is the more advanced. Gas chromatography predominantly determines the cannabinoid content of a medicinal cannabis sample. While it can also be used to ascertain the cannabinoid structure and stability, gas chromatography can be limited due to the heat of the gas chromatography port involved in the testing process.
HPLC is considered to be an extremely effective means of cannabis analytical testing, as it can be used to compare any variance that may exist between the major cannabinoid compounds, as well as to determine any potential antioxidant activity in the cannabis plant. It can also accurately determine the structure and stability of the cannabinoids that it detects.
Another key part of the medicinal cannabis testing process is analysing the sample’s precise moisture content. This is necessary as the sample’s composites and potency will be recorded as a percentage of its dry weight. Further, the amount of water a sample might retain can distort the reading for the presence of major cannabinoid compounds, like THC, rendering the analysis inaccurate. Any medicinal cannabis sample will have the water content eliminated from its mass content before testing begins.
All tests performed on medicinal cannabis need to be carried out using previously validated methods to ensure that the test will produce accurate and repeatable results. Laboratories providing testing services (service providers) are licenced under state/territory laws for the handling of controlled and prohibited drugs.
A certificate of analysis is a certificate produced by an accredited laboratory that verifies it has undergone cannabis testing and confirms the safety and quality of a product, in this instance, medicinal cannabis.
A verified certificate of analysis should provide information about the laboratory the tests were carried out in, as well as the product itself, including information about its ingredients, quality and potency.
One of the most significant pieces of information contained within a CoA is the information related to its cannabinoid profile. After cannabis testing, the laboratory will list the amounts of each minor and major cannabinoid detected within the product (for example CBD, CBG, CBC, THC and so on). Their potency will be measured in mg/ml or mg/g and will also be listed as a percentage of the product’s overall dry weight, in order to display its ratio.
The CoA may also verify the amounts of specific terpenes found within the product, although this is not a requirement of TGO93, so it may not be contained on the COA. Testing for terpene content and potency varies depending lab to lab, with some laboratories not testing for all potential terpenes. Terpenes can influence the flavour and aroma of medicinal cannabis, so it’s important for the CoA to list terpene contained in full.
The results section will also attest that the product is free from any microbes of harmful contaminants, such as heavy metals, pesticides, moulds or bacteria. This purity testing will also check the medicinal cannabis for moisture content or water activity, as well as the presence of foreign materials.
Medicinal cannabis in Australia is regulated by the Therapeutic Goods Association, which is responsible for medicinal cannabis regulations and stipulates that medicinal cannabis must comply with the quality standards: TGO 93 and TGO 100.
TGO 93 is the standard that specifically applies to medicinal cannabis. It applies to the cannabis plant, the ingredients used in manufacture, processes carried out to manufacture the medicinal cannabis and the medicinal cannabis itself. It applies to both imported products and medicinal cannabis that is produced locally.
It also refers to potential contaminants within medicinal cannabis, with part of the standard stipulating that any potential contaminants are below the mandated threshold.
TG100 focuses on limiting the amount of harmful microbes, such as mould or harmful bacteria. It is concerned with reducing the amount of potential contamination within a cannabis product to minimise the risk of potential side-effects.
TG100 applies to all non-sterile pharmaceutical products, while TG093 is concerned only with cannabis. Both standards are vital for ensuring that medicinal cannabis maintains the quality required for potential treatment. The TGA audits medicinal cannabis products to ensure compliance with TGO 93 and TGO 100
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