New USP Proposal for CBD Monograph

Because there is no existing USP monograph for Cannabidiol (CBD), a new monograph is being proposed. The previously published proposal for the USP CBD monograph has now been canceled and is being replaced with a new proposal. The proposed monograph aims to provide specifications for highly purified CBD from Cannabis sativa. CBD obtained from synthetic routes of production could result in different impurity profiles. Thus, the proposal does not include specifications for synthetically derived CBD. Synthetic impurities to differentiate the naturally derived CBD from synthetically derived CBD (e.g., Olivetol, 4-Monobromo-CBD) are not included anymore in the test for organic impurities. The USP draft CBD monograph has been published in Pharmacopeial Forum (PF) 50(3) and is open for comments until 31 July 2024. A Ph. Eur. CBD monograph is meanwhile available.

Changes compared to the previous proposal

On the basis of comments received, the following changes have been made:

• Replace the test procedures for Organic Impurities with a newly proposed method.
• Replace the liquid chromatographic procedure in the Assay with one based on analyses performed with a Phenyl-X column. 
• Remove the test for Specific Rotation because it is not a part of the essential tests for plant-derived cannabidiol nor a specific quality parameter.
• The limit for the Water test according to USP <921> has been changed from previously proposed max. 1.0% to max. 0.3%.

The proposed USP monograph for Cannabidiol (CBD) is available after registration to the Pharmacopeial Forum.