USP publishes proposed Cannabis Monograph

Recommendation

5/6 June 2024

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All relevant GMP/GDP/GACP aspects for Medical Cannabis

Following the previously published USP article in the Journal of Natural Products a proposed monograph for Cannabis Species Inflorescence has been published in the USP Herbal Medicines Compendium (HMC). It is open for public comments for 90 days (until December 20, 2022). 

Definition

Dried pistillate (female) inflorescence of Cannabis sativa L. (Fam. Cannabaceae) and its subspecies, varieties, and chemotypes or all species of Cannabis, depending on how its taxonomy is interpreted.

Content of Cannabinoids and Terpenes

The proposed monograph provides specific Cannabinoid Acceptance Criteria (e.g. different ratios of total THC / CBD content) for the following chemotypes:

• THC-dominant 
• CBD-dominant 
• THC / CBD intermediate 

Cannabinol (CBN)
THC-dominant and THC / CBD intermediate: max. 2% of the total content of THC.

Content Limits 
80% - 120% of the labeled total amount of Tetrahydrocannabinol (THC), total Cannabidiol (CBD) ("total" means with the corresponding acids), and of the labeled amount of all cannabinoids measured (i. e. any cannabinoid present in an amount of 10 mg/g or more must be labeled). The label also indicates the dominant and codominant terpenes.

Microbiological Quality

The microbiological requirements provided are depending on the route of administration (e. g. oral / inhalation use). The label indicates whether the article has been treated to reduce the microbial load and the method used. In cases where the product conforms to the limits for inhalation use found in USP chapter <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use, and in order to aid at-risk populations in choosing lower-risk products, the label should identify the product as having a reduced microbial load.

Other Tests

• Pesticides
• Elemental Impurities
• Aflatoxins
• Foreign Matter
• Total Ash 
• Acid-insoluble Ash
• Water activity

Packaging and Storage

Cannabis Species Inflorescence should be stored in a cool (8°C - 15°C) and dry place (max. 40% average relative humidity at 20°C) in well-closed containers and protected from light and moisture.

More information is available in USP´s Herbal Medicines Compendium monograph Cannabis Species Inflorescence, Proposed For Comment Version 0.1.