USP Draft Monograph for CBD
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5/6 June 2024
All relevant GMP/GDP/GACP aspects for Medical Cannabis
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The USP already contains the two official monographs Dronabinol and Dronabinol Capsules. However, there is currently no existing USP monograph for Cannabidiol (CBD). Thus, a new USP monograph for CBD is being developed. The proposed monograph has been published in the current issue of Pharmacopeial Forum (PF) 48(1), January 2022. The deadline for comments is March 31, 2022.
According to the USP, the proposed monograph aims to provide specifications for highly purified CBD from Cannabis sativa. In order to differentiate the naturally derived CBD from synthetically derived CBD potential synthetic substances (e.g., Olivetol, 4-Monobromo-CBD) are included in the tests for organic impurities besides the natural impurities (like CBN, for example). Interested stakeholders are invited to comment whether these specifications need any changes to appropriately define the quality of CBD (e.g., whether additional impurities should be considered).
Definition
CBD is obtained from Cannabis sativa. It contains 98.0% - 102.0 % of CBD calculated on the anhydrous basis.
Impurities
- For organic Impurities multiple methods (Procedures 1-4) are provided. The following acceptance criteria are proposed for CBD (list is not exhaustive). In addition, the current official limits for Dronabinol USP are provided for information.
| Impurities | Proposed CBD Monograph | USP Dronabinol Monograph |
| Cannabinol (CBN) | max. 0.15 % | max. 1.5 % |
| Δ-9-Tetrahydrocannabinol (Δ⁹-THC) | max. 0.10 % | — ** |
| Δ-8-Tetrahydrocannabinol (Δ⁸-THC) | Not detected * | max. 2.0 % |
| Any individual unspecified impurity | max. 0.10 % | max. 1.0 % |
| Total impurities | max. 2.0 % | max. 5.0 % |
* see also: USP Cannabis Expert Panel statement on Δ⁸-THC published on USP´s "Cannabis for medical use" website
** Dronabinol is Δ⁹-THC [in particular (–)-Δ⁹-trans-THC]
- Residual solvents are controlled according to USP general chapter Residual Solvents <467>. All USP articles are subject to relevant control of residual solvents, even when no test is specified in the individual monograph.
- Elemental impurities in official drug products are controlled according to USP general chapter Elemental Impurities—Limits <232>.
Additional Requirements
- Packaging and Storage: Preserve in tight, light-resistant containers. Store at controlled room temperature.
- Labeling: If a test for Organic Impurities other than Procedure 1 is used, the labeling states with which procedure the article complies. The labeling indicates that CBD is obtained from the Cannabis sativa plant.
The proposed USP monograph for Cannabidiol (CBD) is available after registration to the Pharmacopeial Forum.
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