To streamline and speed up the UK supply chain of medicinal cannabis, Broughton has launched a set of methods for cannabis batch release testing. Customers will be able to benefit from this service from July 2024, the month the European Pharmacopoeia Monograph (Ph. Eur. 3028) becomes effective. Broughton’s experienced team will conduct analytical testing from its GMP-accredited and Schedule 1 licensed laboratory to ensure the safety, regulatory compliance, purity, and consistency of UK- and Channel Island-grown medicinal cannabis. This avoids the need to send cannabis products to continental Europe for testing, saving time and helping products get to patients faster.
As per the European Pharmacopoeia Monograph, Broughton’s batch release testing methods include three identification tests, macroscopic appearance and odour testing of the flower, microscopic examination of the plant-based properties of the flower, and flower type identification with HPTLC. The company can also determine the amount of foreign matter present and measure moisture content. Using HPLC, Broughton’s analytical scientists can test for the total cannabinol (CBN) present, as well as quantify the amount of THC and CBD to ensure these comply with the client’s label claim.
Later this year, Broughton will also offer testing for the presence of heavy metals using ICP-MS. In line with the General Monograph for Herbal Drugs (Ph. Eur. 1433), Broughton will facilitate testing for pesticides, terpenes, aflatoxins, and ochratoxin A, as well as enable microbiological testing via a trusted third party.
“What we’ve seen up to now is medicinal cannabis products being transported to Portugal or Spain for batch release testing,” said Chris Allen, CEO of Broughton. “This isn’t easy with a Schedule 1 Controlled Substance and adds a long lead time. With an ever-increasing demand for medicinal cannabis products, the industry needs a better way of quality checking these life-enhancing products.
“As a natural product with variability, it is hugely important that the safety and consistency of cannabis flower is tested to ensure it adheres to the same rigorous standards as other medicines,” continued Allen. “We bring decades of experience in rigorous and accurate pharmaceutical testing for raw materials, APIs, solid dose medicines and liquid formulations, alongside a strong skill set in inhaled product development via our work as a trusted partner in next-generation nicotine product development. This means we are well placed to support growers and manufacturers of cannabis products with quality control, product development, regulatory compliance, and in-house stability studies.
All data collected will be hosted in Broughton’s laboratory information management system (LIMS) LabHQ. The company will report results to clients within 15 working days from receipt of the samples, with data accessible on LabHQ. Clients can submit their samples before shipping and, once the data is approved, perform data analysis, export data, access their certificates, perform product trend analysis, and more.
Broughton has offered QC batch release testing for pharmaceutical products since 2006, working to client-specific specifications and pharmacopoeia. The company can provide expertise and support to cannabis flower, oil, and product producers including dosage optimisation, product stability testing, and compatibility assessments with different delivery systems.
For more information, visit https://www.broughton-group.com/cannabinoids/testing.
