The Most Comprehensive Cannabinoid Portfolio on the Market
With a singular focus on the development, manufacture, and deployment of advanced cannabinoid ingredients, Purisys maintains the broadest cannabinoid portfolio on the market – with experience producing commercial quantities of high-quality ingredients that goes back over 10 years. Purisys began working with a Drug Master File for Dronabinol (Δ9-THC) (DMF 20682) in 2007.
Today, Purisys produces all major and minor cannabinoids – more than 50 – as well as degradants, metabolites, and analytical standards.
High-Purity Cannabidiol (CBD)
Purisys has been manufacturing cannabidiol since 2016 (DMF33223). Today, we have the ability to produce on the largest commercial scale. Our ultra-high purity CBD is attractive for drug development projects and falls significantly below the 0.3% THC limits set in the 2018 Farm Bill for use in consumer products. Purisys’ patent-protected manufacturing process produces a consistently odorless, tasteless white powder highest-purity form of CBD that exhibits:
• No heavy metals (e.g. lead) from soil
• No pesticide residues
• No environmental influences on quality such as rain, sunlight & soil nutrients
• No plant impurities to remove
• No microbial or mold proliferation
No structural (or stereo chemical) differences exist between an active cannabinoid ingredient manufactured by Purisys and those that are chemically extracted and isolated from plants. They are – in effect – nature-identical.
Purisys manufactures CBD according to cGMP (ICH Q7 and applicable sections of 21 C.F.R. Parts 210 and 211). We use validated analytical test methods and rigorous quality systems for this ingredient.
LIST OF HEALTH AND RELATED CLAIMS UNDER INVESTIGATION
So-called ‘rare cannabinoids’ are only rare in nature. Today, kilogram quantities of all rare cannabinoids can be manufactured in a 99% pure, physically stable form under cGMP conditions. Use of this technology platform can unlock these compounds for human clinical use. Clinical stage supply is available for CBN, D8-THC, CBG, CBC, and THCV.
Purisys maintains a comprehensive reference standard program for research and product development, quality control testing, and health authority regulatory filings. Reference standards materials include:
• Cannabinoid API and Related Impurity Reference Standards
• Nabilone API and Related Impurity Reference Standards
• THC and Related Reference Standards
• A broad assortment of high purity phytocannabinoids that are found in nature.
For more information on Purisys cannabinoid reference standards, go here.