The stability programme designed in accordance with the ICH Q1 Guidelines on Stability is required to establish the shelf life of a product and for receiving a marketing authorization.
According to EU-GMP (Chapter 6), the manufacturer must have an ongoing stability programme to support the shelf life of the product. The programme shall meet ICH Q1 requirements. Bracketing and matrixing is possible according to ICH Q1 Guidelines (“Stability studies should be performed on each individual strength and container size of the drug product unless bracketing or matrixing is applied”). For multidose containers, in-use stability studies are required in principle according to EMA´s NOTE FOR GUIDANCE ON IN-USE STABILITY TESTING OF HUMAN MEDICINAL PRODUCTS. However, for example, stability testing is usually not required under GPP (e.g. Canada / NZ).
The specific requirements for stability testing of herbal drugs like Cannabis, which is a narcotic substance, are sometimes challenging. E.g. storage needs to be done in climate chambers in specifically designed and secured facilities. In addition, specific rules have to be followed concerning import/export (e.g. need for special licenses), transport (e.g. GDP + additional security measures), sample & waste handling and documentation.
How do CBD and THC degrade?
In an acidic milieu Cannabidiol (CBD) converts to Δ8- und Δ9-THC, whereas in an (highly) alkaline milieu, oxidation to a chinone due to reaction with oxygen occurs. During storage in presence of air, THC can be dehydrated to Cannabinol (CBN). CBN is also an oxidation product of Tetrahydrocannabinol (THC). Therefore, most of the national Pharmacopoeias set a limit of max. 1% for CBN (D, DK, CH) in flowers (D: in extracts max. 2.5%) and max. 1.5 % (Israela) as stability indicator. The USP Cannabis Expert Panelb proposes for THC-dominant and THC/CBD intermediate types that CBN is max. 2% of the content of total THC.
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