Recently, the Australian Therapeutics Good Administration (TGA) reported several medicinal cannabis products on the Australian market testing out of specification.
CLR received yesterday from Australia based Novachem the following statement with regard to
Bedrocan 22% THC flos for vaporisation.
We write with regards to your article discussing the TGA testing which included our sponsored product, Bedrocan 22% THC flos for vaporisation.
After in depth discussion with the TGA as to the source of this issue, the TGA has amended its findings on that Bedrocan batch 19I30EY19K05. The TGA accept the label claim is based on an anhydrous basis (dried according to Dutch Monograph and European Pharmacopoeia Loss on drying method C (2.2.32)), which actually tested at 79.9% of the label claim.
For your information, please see the release certificate for this product at https://www.novachem.com.au/page/certificates-of-analysis.
Please also see the amended information at https://www.tga.gov.au/testing-medicinal-cannabis-products-being-supplied-sas-australia
Having worked through the testing results with TGA, Novachem are happy with the outcome.
The TGA will now adopt a more robust and clear methodology for testing Bedrocan products in the future. From our end, to ensure future clarity for prescribers, pharmacists and patients, product labelling will now include the claim “OAB” which is “On Anhydrous Basis”.
Background on Novachem
From their website
Novachem Superior Standards
Novachem Pty Ltd is a specialist supplier of consumables and reagents for research and analysis in the chemical, physical and biological sciences. Novachem specialises in stable isotopes from Cambridge Isotope Laboratories for NMR and Mass Spectrometry applications (deuterated solvents and isotope labelled compounds) as well as standards for forensic and environmental analysis as internal standards and reference standards. Our ranges cover organic and inorganic reference standards and CRMs, and a variety of specialist chemicals for research and development.
Novachem also provides access to one of the World’s largest range of Proficiency Testing (PT) schemes with over 30 available, the majority of which are accredited to the international standard ISO/IEC 17043. The PT schemes are managed and run by LGC Standards, one of Europe’s largest suppliers and manufacturers of reference standards (both inorganic standards and organic standards) and proficiency testing.
Novachem supplies to a wide range of industries including academia and health, pharmaceutical and environmental testing, mining and food quality as well as clinical diagnostic and forensic laboratories. Note that Novachem’s products are, unless specified otherwise, for research / analytical use only and not to be ingested or taken.
For almost 40 years, Novachem has continuously provided this diverse range of specialty products and we are continuing to develop new market opportunities wherever analytical chemistry is utilised. We ensure that whatever the requirement, it is sourced quickly, efficiently and delivered securely to your door.
Novachem distributes products in Australia and a limited number of products to New Zealand only at this time. Please find a local vendor if you require shipping outside Australia.