Recently, the Australian Therapeutics Good Administration (TGA) reported a number of medicinal hashish merchandise on the Australian market testing out of specification.
CLR acquired yesterday from Australia based mostly Novachem the next assertion with regard to the product
Bedrocan 22% THC flos for vaporisation.
We write on the subject of your article discussing the TGA testing which included our sponsored product, Bedrocan 22% THC flos for vaporisation.
After in depth dialogue with the TGA as to the supply of this difficulty, the TGA has amended its findings on that Bedrocan batch 19I30EY19Okay05. The TGA settle for the label declare relies on an anhydrous foundation (dried in keeping with Dutch Monograph and European Pharmacopoeia Loss on drying methodology C (2.2.32)), which truly examined at 79.9% of the label declare.
For your data, please see the discharge certificates for this product at https://www.novachem.com.au/page/certificates-of-analysis.
Please additionally see the amended data at
Having labored by means of the testing outcomes with TGA, Novachem are pleased with the end result.
The TGA will now undertake a extra sturdy and clear methodology for testing Bedrocan merchandise sooner or later. From our finish, to make sure future readability for prescribers, pharmacists and sufferers, product labelling will now embody the declare “OAB” which is “On Anhydrous Basis”.
Background on Novachem
From their website
Novachem Superior Standards
Novachem Pty Ltd is a specialist provider of consumables and reagents for analysis and evaluation within the chemical, bodily and organic sciences. Novachem specialises in secure isotopes from Cambridge Isotope Laboratories for NMR and Mass Spectrometry purposes (deuterated solvents and isotope labelled compounds) in addition to requirements for forensic and environmental evaluation as inside requirements and reference requirements. Our ranges cowl natural and inorganic reference requirements and CRMs, and a wide range of specialist chemical substances for analysis and growth.
Novachem additionally offers entry to one of many World’s largest vary of Proficiency Testing (PT) schemes with over 30 obtainable, nearly all of that are accredited to the worldwide commonplace ISO/IEC 17043. The PT schemes are managed and run by LGC Standards, one in all Europe’s largest suppliers and producers of reference requirements (each inorganic requirements and natural requirements) and proficiency testing.
Novachem provides to a variety of industries together with academia and well being, pharmaceutical and environmental testing, mining and meals high quality in addition to medical diagnostic and forensic laboratories. Note that Novachem’s merchandise are, until specified in any other case, for analysis / analytical use solely and to not be ingested or taken.
For virtually 40 years, Novachem has repeatedly supplied this numerous vary of specialty merchandise and we’re persevering with to develop new market alternatives wherever analytical chemistry is utilised. We make sure that regardless of the requirement, it’s sourced shortly, effectively and delivered securely to your door.
Novachem distributes merchandise in Australia and a restricted variety of merchandise to New Zealand solely presently. Please discover a native vendor when you require delivery exterior Australia.