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Broughton Adds New Extractables and Leachables Service For Cannabis Products

Original story from Broughton Group

Published: Jul 13, 2023   
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Image credit: Broughton

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To help support the development of the cannabis sector and ensure better product understanding and safety, scientific consultancy, and contract research organization (CRO), Broughton has launched a new extractables and leachables (E&L) testing service for the cannabis industry. As regulatory bodies increase their focus on E&L, producers must identify and assess the toxicological risks. Broughton’s new service will offer tailored E&L studies for cannabis flower, medicinal cannabis products as licensed medicines, and consumer CBD products regulated under UK and EU Novel Food regulations pathways. Its fully integrated approach combines technical and analytical services, in-house toxicology consultancy, and regulatory compliance support.  

Aimed at supporting the wider cannabis sector across cultivation, medicinal product development, and consumer CBD products, the service is available across all stages of the product development lifecycle, from early-stage innovation and product development to commercialization and post-market surveillance. The new testing service includes study design, extractables studies, extractables toxicology assessments, leachables method development and validation, leachables shelf-life studies, and leachable toxicology evaluation. Customers will benefit from Broughton’s fully integrated service with access to analytical method development and validation, study design, on-site stability storage, analytical testing, and toxicology support.

The service covers material characterization screens for raw materials, including cannabis flower, and a range of matrices, including medicinal delivery systems such as capsules, oils, and tincture and inhalation products for potential leachables from container closure systems, packaging and manufacturing and processing equipment.

“Extractable and leachable studies are essential to the MAA regulatory pathway for medicinal products, but also a key part of responsible product stewardship in less regulated areas to ensure product understanding, safety and effectively manage risk,” said Chris Allen, CEO of Broughton.

“Organic compounds and elemental impurities such as heavy metals can leach into a product from the manufacturing process, the container closure system (CCS) or packaging materials, and even the delivery mechanism. For example, terpenes may degrade some forms of plastic packaging and rubber components, influencing both the production process and packaging choices. A robust E&L approach ensures product quality, prevents potential health issues, and reduces environmental pollution."

This article has been republished from materials provided by Broughton. Note: material may have been edited for length and content. For further information, please contact the cited source.


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